PA-04-103: TESTING TOBACCO PRODUCTS PROMOTED TO REDUCE HARM

Department of Health
and Human Services (HHS)

NIH... Turning Discovery Into Health^®

Note: For help accessing PDF, RTF, MS Word, Excel, PowerPoint, Audio or Video files, see Help Downloading Files.

TESTING TOBACCO PRODUCTS PROMOTED TO REDUCE HARM RELEASE DATE: May 5, 2004 PA NUMBER: PA-04-103 The R01 portion of this funding opportunity has been replaced by PA-07-174, which now uses the electronic SF424 (R&R) application for February 5, 2007 submission dates and beyond. March 2, 2006 (NOT-OD-06-046) Effective with the June 1, 2006 submission date, all R03, R21, R33 and R34 applications must be submitted through Grants.gov using the electronic SF424 (R&R) application. This announcement will stay active for only the May 1, 2006 AIDS and AIDS-related application submission date for these mechanisms. The non-AIDS portion of this funding opportunity for these mechanisms expires on the date indicated below. Other mechanisms relating to this announcement will continue to be accepted using paper PHS 398 applications until the stated expiration date below, or transition to electronic application submission. A replacement R21 (PA-06-361) funding opportunity announcement has been issued for the submission date of June 1, 2006 and submission dates for AIDS and non-AIDS applications thereafter. EXPIRATION DATE for R21 Non-AIDS Applications: March 2, 2006 EXPIRATION DATE for R21 AIDS and AIDS-Related Applications: May 2, 2006 EXPIRATION DATE for All R01 Applications: November 2, 2006 Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov) COMPONENTS OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov/) National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov/) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393, 93.399, 93.279 THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanisms of Support o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Award Criteria o Receipt and Review Schedule o Required Federal Citations PURPOSE OF THIS PA The purpose of this Program Announcement (PA) is to stimulate multidisciplinary research on potential reduced-exposure tobacco products, both smoked and smokeless, through the interplay of basic, biological, and behavioral research, surveillance, and epidemiology. The tobacco industry is currently promoting some new products with claims that they are less harmful or less addictive because these products purportedly deliver lower amounts of toxic, carcinogenic, and/or addictive agents to the user compared with conventional products. However, to date, the scientific evidence is insufficient to evaluate whether these new products actually reduce the users exposure or risk for tobacco-related diseases. The key research question of this PA is, Do potential reduced-exposure tobacco products provide a truly, less-harmful alternative to conventional tobacco products, both on the individual and population level? RESEARCH OBJECTIVES The objective of this Program Announcement (PA) is to stimulate multidisciplinary research on the chemical composition, behavior of use, exposure to toxic agents, addictive properties, differential toxicity, and individual and public health impact of potential reduced-exposure tobacco products. Forty years after the Surgeon General’s first report on smoking and health, tobacco use continues to pose an enormous public health threat in the United States and worldwide. In 2000, 46 million people in the United States (23.3 percent of the adult population 18 years of age or older) were smokers and 44.3 million adults (22.2 percent) were former smokers (CDC, 2002). During the period 1995-1999, more than 440,000 people died annually from smoking- attributable diseases. Current smoking prevalence among U.S. adults is nearly double the nation’s year 2010 health goal of 12 percent (Objective 27-1a, Healthy People 2010). Current low annual quit rates (4.7 percent of current smokers quit and maintained abstinence for 3-12 months in 2000; CDC, 2002) and high relapse rates among those who have tried to quit (60-90 percent after one year off; CDC MMWR, July 2003) present strong challenges to meeting the 2010 goal. Currently, there is increased interest among public health scientists in evaluating potential strategies to reduce the harm among people who continue tobacco use (Stratton et. al., 2001). However, previous tobacco harm reduction efforts pursued by the public health community were limited by incomplete knowledge and methods for evaluating the health impact of modified tobacco products. In the late 1960s, the Federal Trade Commission (FTC) established a laboratory to measure and report on the levels of tar and nicotine in mainstream smoke of cigarettes by brand (National Cancer Institute, 1996). Based on the FTC protocol, the average sales-weighted tar and nicotine smoke yields have decreased by about 70 percent since the 1950s (Hoffmann and Hoffmann, 2001). Yet a recent NCI review of the risks associated with smoking cigarettes with low, machine-measured yields of tar and nicotine demonstrated that there is no convincing evidence that changes in cigarette design between the1950s and the 1980s have resulted in an important decrease in the disease burden caused by cigarette use either for smokers as a group or for the whole population (Burns et al., 2001). The theoretical benefits of low-yield products were offset by the fact that these products were designed to allow compensatory smoking behaviors so that smokers could overcome draw resistance and obtain the desired dose of nicotine (Burns et al., 2001) More intense puffing on ventilated, low-yield products may have resulted in an increase in delivered dosages of cancer- causing agents as well as nicotine to the smoker (Djordjevic et al., 2000). In addition to failing to reduce cancer risk, low-yield cigarettes may have played a significant role in promoting initiation and impeding cessation, the most important determinants of smoking-related diseases (Burns and Benowitz, 2001). In recent years, there has been a proliferation of new potential reduced- exposure tobacco products that are marketed and advertised by the tobacco industry, with claims that they are less harmful or less addictive compared with conventional tobacco products. These products have specifically targeted: (a) current tobacco users who are as yet unable or unwilling to quit; (b) health-conscious individuals who perceive switching to a potentially less hazardous product as beneficial and more appealing than trying to quit; and (c) smokers who want an alternative to cigarettes when they are in smoke-free environments (e.g., workplace, home, during travel). Many of these products have not yet been widely used in larger populations. Their toxicity is generally unknown, and their potential impact on both individual and public health is also unknown. The limited scientific evidence currently available, based on a handful of small studies, is inconsistent and insufficient for developing meaningful conclusions about whether there is any reduction in harm to tobacco users who switch to these products. Some small, short-term clinical studies have suggested that smokers who switch to potential reduced-exposure products have lower levels of biomarkers for known carcinogens, including the lung-specific carcinogen 4-(methylnitrosamino)-1- (3-pyridyl)-1-butanone (NNK) and polynuclear aromatic hydrocarbons (PAHs) (Breland et al., 2003, Melikian et al., 2003). However, other clinical studies have suggested that such products are unlikely to significantly reduce smokers exposure to harmful tobacco smoke constituents (Breland et al., 2002, Lemmonds et al., 2003). Moreover, the design of some products may use ingredients or materials that pose additional health risks (Pauly et al., 1998), and smokers who switch to such products may smoke more often or more intensely to compensate for reduced nicotine delivery (Buchhalter and Eisenberg, 2000). Even if potential reduced-exposure products are shown to be less toxic to the individual, their impact must also be evaluated at the population level. The introduction and marketing of these new products might results in a reduction in quitting rates, an increase in initiation and progression of tobacco use by youth and young adults, and/or a secondary initiation by former smokers.. For example, a recent study found that young males who were not smokers in 1989 but regularly used smokeless tobacco were more than three times as likely as never users to be current smokers 4 years later (Tomar, 2003). Moreover, it is possible that smokers of conventional cigarettes will not completely switch to new products, but will continue using multiple products to obtain desired doses of nicotine. There are also questions regarding harm to nonsmokers who are exposed to secondhand smoke. Although there is a clear reduction in environmental tobacco smoke from using smokeless tobacco or cigarettes that heat rather than burn tobacco, there may be an increase in secondhand smoke exposure if smoking duration or prevalence increases or if new products result in an increase in toxicants present in either sidestream smoke or exhaled mainstream smoke. Applications to study potential reduced-exposure tobacco products and their potential public health impact are encouraged in, though not limited to, the following areas: o studying behavioral changes that accompany use of new smoked and smokeless tobacco products that are being marketed with health claims and how these behaviors, including possible dual use with other products, impact delivered dosages of addictive agents and toxins, including carcinogens; o validating currently available tobacco exposure and candidate disease- specific surrogate biomarkers; o developing new biomarkers that accurately reflect mechanisms of disease to serve as intermediate indicators of disease and disease risk; o exploring differential toxicity of various tobacco and nicotine products using in vitro and in vivo models; o examining the relationship between a reduction in tobacco toxins and health and biomarker endpoints; o developing comprehensive surveillance systems to monitor marketing, patterns of use, and health consequences of new potential reduced-exposure tobacco products; and/or o examining the impact of marketing on consumers' and healthcare providers' attitudes, knowledge, and perceptions about new products, and exploring ways to communicate accurate information about these products. Additional research questions and priorities related to purported reduced- exposure tobacco products have been identified elsewhere (Stratton et. al. 2001, Hatsukami et al. 2002). MECHANISMS OF SUPPORT This PA will use the NIH investigator-initiated research project grant (R01) and the exploratory/developmental grant (R21) award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. For R01 applications submitted in response to this PA, the total proposed project period may not exceed 5 years. For R21 submissions, the applicant may request a project period of up to 2 years with a combined budget for direct costs of up $275,000 for the 2-year period. For example, the applicant may request $100,000 in the first year and $175,000 in the second year. The request should be tailored to the needs of the project. Normally, no more than $200,000 may be requested in a single year. This PA uses just-in-time concepts. It also uses the modular as well as the non-modular budgeting 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. Otherwise, follow the instructions for non-modular budget research grant applications. This program does not require cost sharing as defined in the current NIH Grants Policy Statement at http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part2.htm. ELIGIBLE INSTITUTIONS You may submit (an) application(s) if your institution has any of the following characteristics: o For-profit or non-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Eligible agencies of the Federal government o Domestic or foreign institutions/organizations o Faith-based or community-based organizations INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS 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. SPECIAL REQUIREMENTS Investigators will be convened twice annually throughout the award period to discuss research findings and methods with other grantees. Support for travel by the Principal Investigator and one co-investigator should be included in the proposed budget. For purposes of estimating budgets, plan on two 2-day meetings each year, with one meeting on the East Coast of the United States and one on the West Coast. WHERE TO SEND INQUIRIES We encourage your inquiries concerning this PA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into two areas: scientific/research and financial or grants management issues: o Direct your questions about scientific/research issues to: Mirjana V. Djordjevic, Ph.D. Division for Cancer Control and Population Sciences National Cancer Institute 6120 Executive Boulevard, EPN Room 4044, MSC 7337 Bethesda, MD 20892 Rockville, MD 20852 (for courier/express service) Telephone: (301) 496-8584 FAX: (301) 496-8675 Email: djordjev@mail.nih.gov Allison L. Chausmer, Ph.D. Division of Neuroscience and Behavioral Research National Institute on Drug Abuse 6001 Executive Boulevard, Room 4282, MSC 9555 Bethesda, MD 20892 Rockville MD 20852 (for courier/express service) Telephone: (301) 402-5088 FAX: (301) 594-6043 Email: achausme@nida.nih.gov o Direct your questions about financial or grants management matters to: Ms. Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, EPS Room 243, MSC 7150 Bethesda, MD 20892-7150 Rockville, MD 20852 (express/courier service) Telephone: 301-496-8634 Fax: 301-496-8601 Email: wolfreyc@mail.nih.gov Gary Fleming, J.D. National Institute on Drug Abuse 6101 Executive Boulevard, Room 250, MSC 8403 Bethesda, MD 20892-9605 Rockville, MD 20852 (for express/courier service) Telephone: (301) 443-6710 FAX: (301) 594-6849 Email: gfleming@nida.nih.gov SUBMITTING AN APPLICATION 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 DUNS number can be obtained by calling (866) 705-5711 or through the web site at http://www.dunandbradstreet.com/. The DUNS number should be entered on line 11 of the face page of the PHS 398 form. 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. The title and number of this program announcement must be typed on line 2 of the face page of the application form and the YES box must be checked. APPLICATION RECEIPT DATES: Applications submitted in response to this program announcement will be accepted at the standard application deadlines, which are available at http://grants.nih.gov/grants/dates.htm. Application deadlines are also indicated in the PHS 398 application kit. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS: Applications requesting up to $250,000 per year in direct costs must be submitted in a modular grant format. The modular grant 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 grants. Additional information on modular grants is available at http://grants.nih.gov/grants/funding/modular/modular.htm. SPECIFIC INSTRUCTIONS FOR APPLICATIONS REQUESTING $500,000 OR MORE PER YEAR: Applications requesting $500,000 or more in direct costs for any year must include a cover letter identifying the NIH staff member within one of NIH institutes or centers who has agreed to accept assignment of the application. Applicants requesting more than $500,000 must carry out the following steps: 1) Contact the IC program staff at least 6 weeks before submitting the application, i.e., as you are developing plans for the study; 2) Obtain agreement from the IC staff that the IC will accept your application for consideration for award; and, 3) Identify, in a cover letter sent with the application, the staff member and IC who agreed to accept assignment of the application. This policy applies to all investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended or revised version of these grant application types. Additional information on this policy is available in the NIH Guide for Grants and Contracts, October 19, 2001 at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-004.html. SENDING AN APPLICATION TO THE NIH: Submit a signed, typewritten original of the application, including the checklist, and five signed photocopies in one package to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be mailed on or before the receipt dates described at http://grants.nih.gov/grants/funding/submissionschedule.htm. The CSR will not accept any application in response to this PA 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 a substantial revision of an unfunded version of an application already reviewed, but such application must include an Introduction addressing the previous critique. Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within 8 weeks. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. Appropriate scientific review groups convened in accordance with the standard NIH peer review procedures (http://www.csr.nih.gov/refrev.htm) will evaluate applications for scientific and technical merit. As part of the initial merit review, all applications will: o Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score o Receive a written critique o Receive a second level review by the appropriate national advisory council or board. REVIEW CRITERIA The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to evaluate 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. o Significance o Approach o Innovation o Investigator o Environment 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? 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 criteria included in the section on Federal Citations, below.) 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 Inclusion Criteria in the sections on Federal Citations, below.) 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. ADDITIONAL REVIEW CONSIDERATIONS Sharing Research Data Applicants requesting more than $500,000 in direct costs in any year of the proposed research are expected to include a data sharing plan in their application. The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or priority score. (http://grants.nih.gov/grants/policy/data_sharing ) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. AWARD CRITERIA Applications submitted in response to a PA will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: o Scientific merit of the proposed project as determined by peer review o Availability of funds o Relevance to program priorities REQUIRED FEDERAL CITATIONS ANIMAL WELFARE PROTECTION: Recipients of PHS support for activities involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf), as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm), as applicable. 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. See 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); and efficacy, effectiveness, and comparative trials (phase III). The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risk to the participants. (See NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, June 12, 1998, at http://grants.nih.gov/grants/guide/notice-files/not98-084.html.) Clinical trials supported or performed by NCI require special considerations. The method and degree of monitoring should be commensurate with the degree of risk involved in participation and the size and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager or NCI program staff or a Data and Safety Monitoring Board (DSMB). These monitoring activities are distinct from the requirement for study review and approval by an Institutional review Board (IRB). For details about the Policy for the NCI for Data and Safety Monitoring of Clinical trials, see http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm. For Phase I and II clinical trials, investigators must submit a general description of the data and safety monitoring plan as part of the research application. For additional information, see NIH Guide Notice on Further Guidance on a Data and Safety Monitoring for Phase I and II Trials at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-038.html. Information concerning essential elements of data safety monitoring plans for clinical trials funded by the NCI is available at http://www.cancer.gov/clinical_trials/. 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. 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 - Amended, October, 2001," published in the NIH Guide for Grants and Contracts on October 9, 2001 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines are 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 RESEARCH INVOLVING HUMAN SUBJECTS: The NIH maintains a policy 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. 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 proposals for research involving human subjects. You will find this policy announcement in the NIH Guide for Grants and Contracts Announcement, dated June 5, 2000, at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. A continuing education program in the protection of human participants in research is available online at http://cme.nci.nih.gov/. 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. References Breland, A.B., Buchhalter, A.R., Evans, S.E., and Eissenberg, T. (2002) Evaluating acute effects of potential, reduced-exposure products for smokers: Clinical laboratory methodology. Nicotine & Tobacco Research 4 (Supplement 2): S131-S140. Breland, A.B., Acosta, M.C., and Eissenberg, T. (2003) Tobacco-specific nitrosamines and potential reduced exposure products for smokers: A preliminary evaluation of Advance TM. Tobacco Control 12: 317-321. Buchhalter, A.R. and Eissenberg, T. (2000) Preliminary evaluation of a novel smoking system: Effects on subjective and physiological measures and on smoking behavior. Nicotine & Tobacco Research 2: 39-43. Burns, D.M. and Benowitz, N.L. (2001) Public health implications of changes in cigarette design and marketing. In Smoking and Tobacco Control Monograph No. 13: Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and Nicotine. U.S. Department of Health and Human Services. Public Health Service. National Institutes of Health, National Cancer Institute, pp. 1-12. Burns, D.M., Major, J.M., Shanks, T.G., Thun, M.J., and Samet, J. (2001) Smoking lower-yield cigarettes and disease risk. In Smoking and Tobacco Control Monograph No. 13: Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and Nicotine. U.S. Department of Health and Human Services. Public Health Service. National Institutes of Health, National Cancer Institute, pp. 65-158. Centers for Disease Control and Prevention (CDC). (2002) Cigarette smoking among adults United States, 2000. Morbidity and Mortality Weekly Reports (MMWR) 51: 642-645. Centers for Disease Control and Prevention (CDC).(2003) Smoking cessation during previous year among adults United States, 1990 and 1991. Morbidity and Mortality Weekly Reports (MMWR) 42: 504-507. Djordjevic, M. V., Stellman, S. D., Zang, E. (2000). Doses of Nicotine and Lung Carcinogens Delivered to Cigarette Smokers. J Natl Cancer Inst 92: 106- 111. Hatsukami, D. K., Slade, J., Benowitz, N. L., Giovino, G. A., Gritz, E. R., Leischow, S. and Warner, K. E. (2002) Reducing tobacco harm: research challenges and issues. Nicotine & Tobacco Research 4(Supplement 2): S89-S101. Hoffmann, D. and Hoffmann, I. (2001) The changing cigarette: Chemical studies and bioassays. In Smoking and Tobacco Control Monograph No. 13: Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and Nicotine. U.S. Department of Health and Human Services. Public Health Service. National Institutes of Health, National Cancer Institute, pp. 159- 191. Lemmonds, C., Murphy, S., Hecht, S., and Hatsukami, D. (2003) 9th Annual Meeting of the Society for Research on Nicotine and Tobacco (SYM 7D), New Orleans, Louisiana, Feb. 19-22. Melikian, A.A., J. Hosey, J. Zhang, S. Colosimo, E. Zang, D. Hoffmann, M. Varga, J.H. Jaffe, W. H. Barr (2003) Reduction of Urinary Metabolites of Tobacco Carcinogens in Smokers who Switched from Conventional Light Cigarettes to a New Cigarette with Low Levels of Tobacco-Specific Nitrosamines and a Modified Filter Tip. Abstract # 6414. Proceedings of the American Association for Cancer Research. 44 (2nd ed): 1283. National Cancer Institute. (1996) The FTC Cigarette Test Method for Determining Tar, Nicotine, and Carbon Monoxide Yields of U.S. Cigarettes. Smoking and Tobacco Control Monograph 7. Bethesda, MD; National Cancer Institute. Pauly, J.L., Allart, H.A., Rodrigez, M.I., and Streck, R.J. (1995) Fibers released from cigarette filters: An additional health risk to the smoker? Cancer Research 55: 253-258. Stratton, K.S., Wallace, R., Bondurant, S. (eds.) (2001) Clearing the Smoke: Assessing the Science Base for Tobacco Harm Reduction. Washington, DC: National Academy Press. Tomar, S. (2003) Is use of smokeless tobacco a risk factor for cigarette smoking? The U.S. experience. Nicotine & Tobacco Research 5/4: 661-569. U.S. Department of Health and Human Services. Healthy People 2010. 2nd ed. With Understanding and Improving Health and Objectives for Improving Health. 2 vols. Washington, DC: U.S. Government Printing Office, November 2000. World Health Organization, SACTob (Scientific Advisory Committee on Tobacco regulation) (2003). Statement of principles guiding the evaluation of new or modified tobacco products. IBN 92 4 159051 3 (LC/NLM classification: HD 9130.6. Geneva, Switzerland.

Weekly TOC for this Announcement
NIH Funding Opportunities and Notices