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EXFOLIATED CELLS, BIOACTIVE FOOD COMPONENTS, AND CANCER RELEASE DATE: June 18, 2004 PA NUMBER: PA-04-114 (see addendum NOT-CA-04-025) EXPIRATION DATE: November 2, 2007, unless reissued. Department of Health and Human Services (DHHS) PARTICIPATING ORGANIZATION: National Institutes of Health (NIH) (http://www.nih.gov/) COMPONENT OF PARTICIPATING ORGANIZATION: National Cancer Institute (NCI) (http://www.nci.nih.gov) CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER(S): 93.393, 93.399 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 Supplementary Instructions o Where to Send Inquiries o Submitting an Application o Supplementary Instructions o Peer Review Process o Review Criteria o Award Criteria o Required Federal Citations PURPOSE OF THIS PA The National Cancer Institute (NCI) invites applications for new R01, R21, and R03 grants which focus on research to critically evaluate the use of exfoliated cells to monitor the physiological effects of dietary bioactive food components thought to be involved with cancer prevention. The objective is to encourage interdisciplinary collaborations between scientists engaged in research using exfoliated cells and those conducting nutrition research related to cancer prevention. This research will help determine the utility of exfoliated cells as a model system to monitor both the absorption and retention of bioactive food components and the concomitant alterations in genomic and epigenetic events that occur in intact cells. RESEARCH OBJECTIVES Background A wealth of evidence points to the diet as one of the most important modifiable determinants of the risk of developing cancer. A large number of bioactive components that are protective at different stages of cancer formation have been identified in food. Although serum and blood cells have frequently been used to evaluate exposure and physiological response to bioactive food components, their evaluation may not always be predictive of the target tissue. Surrogate samples, such as exfoliated cells, may offer a noninvasive opportunity to evaluate not only exposures but also physiological responses in the target tissue. Evidence already exists that exfoliated colonocytes may provide clinical information for evaluating the physiological effects of some food components that may be protective against cancer. However, additional research is needed to validate their utility across the various classes of bioactive food components. Exfoliated colonocytes occurring in stool samples offer a unique opportunity to non-invasively evaluate the effects of bioactive food components in a target tissue (the colon). Exfoliated colonocytes have been used successfully for measurements of DNA mutations, changes in gene expression, protein expression, and associated activities that are biomarkers of colon cancer. Evidence exists that some dietary components can modify molecular markers, such as DNA damage and gene expression, in exfoliated colonocytes. However, these studies did not evaluate changes in gene expression in the exfoliated colonocytes in relation to the tumor or the normal colonic tissue. Thus, the utilization of the exfoliated cells as a surrogate for diet-induced changes in colonic cells remains unresolved. Exfoliated cells from other sites may also be effective tools for monitoring human exposure to bioactive food components. There are many other sources of exfoliated epithelial cells that can be obtained relatively noninvasively as potential surrogates for target tissues of interest. Examples include bladder urothelial cells present in urine samples, and airway epithelial cells present in sputum or from bronchoalveolar lavage specimens. Similar to the colon, the level of DNA damage in exfoliated lung epithelial cells has been shown to be influenced by dietary components. Specifically, consumption of a lycopene-rich vegetable juice has been shown to be associated with significantly decreased levels of DNA damage in lung epithelial cell obtained from healthy volunteers and as measured by the COMET assay. In contrast, no changes were observed in DNA damage in leukocytes, indicating that they do not reflect the target tissue. Although there are technological challenges, mammary epithelial cells have been obtained by ductal lavage, from nipple aspirate fluid and from fine needle aspiration of the breast parenchyma. Prolonged consumption of soy protein isolate has been shown to increase the appearance of hyperplastic epithelial cells obtained by nipple aspiration. Human breast milk has also been shown to be an excellent source of luminal epithelial cells from a cohort of lactating women. Epithelial cells present in milk have been analyzed for carcinogen-DNA adducts in order to assess exposure to dietary and environmental carcinogens. Therefore, exfoliated mammary epithelial cells may also be useful samples for monitoring exposure to bioactive food components. Buccal mucosal cells can be obtained very easily by scraping the cheeks with a tooth brush or wooden spatula and also may be useful samples in nutrition studies. Specifically, green tea was protective against micronuclei formation in exfoliated oral cells of individuals with oral leukoplakia. It has been suggested that global DNA methylation status in buccal mucosal cells may reflect global methylation status in lung tissues because there is a significant association between global DNA methylation in buccal mucosal cells and malignant tissues of the lung, but not between methylation in peripheral leukocytes and lung tissues. Therefore, buccal cells hold promise because of their easy accessibility; however, their response to bioactive food components needs to be compared with the responses of cells in target tissues. Objectives and Scope This initiative is designed to promote innovative preclinical and clinical research to critically evaluate the utility of using exfoliated cells to monitor variation in dietary intakes of bioactive food components thought to be involved with cancer prevention. Collaborations with the mouse models consortium may allow opportunities to simultaneously examine altered genomics on the response to bioactive food components. The emphasis should be on a comparison of the activity of bioactive food components in exfoliated cells, normal cells (such as the target tissue and blood cells), and, when available, tumor cells. Potential areas of investigation include studying the effect of individual dietary components on molecular or biochemical processes (e.g., gene expression, DNA methylation, protein expression, and accumulation of bioactive food components) and predicting the anticancer response in surrogate samples, blood and its constituents and target tissues. Examples of the types of research topics and approaches that would be relevant areas of investigation for the development of R01, R21 and R03 grant applications under this PA include (but are not limited to): o Comparison of global and gene-specific DNA methylation in lung epithelial cells obtained from sputum samples, leukocytes, normal lung cells, and lung tumor cells of humans following consumption of dietary folate. o Examination of relative gene changes in exfoliated colonic epithelial cells, normal colonic mucosal cells, colonic tumor cells, and leukocytes of rats following consumption of omega-3 fatty acids; o Comparison of micronuclei formation in buccal cells, cells in sputum, leukocytes, and cells in the lung as influenced by green tea consumption; o Modulation of carcinogen-DNA adduct formation in rat exfoliated colonic epithelial cells and normal colonic mucosal cells by dietary sulforaphane; and o Comparison of genistein concentrations in cells of the blood, mammary epithelial cells, and mammary biopsy samples after soy supplementation. MECHANISM OF SUPPORT This PA will use the NIH Investigator-initiated Research Project Grant (R01), the NIH Exploratory/Developmental grant (R21), and the NIH Small Grants Program (R03) as award mechanisms. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. An R21 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 any single year. For R03 applications, the total budget may not exceed $100,000 in direct costs for the entire project and the direct costs in any one-year for R03 grant applications must not exceed $50,000. The total project period for R03 applications submitted in response to this announcement may not exceed 2 years. The R21 and R03 grants are not renewable. Investigators are encouraged to seek continued support after completing an Exploratory/Developmental Grant project or a Small Grant project through a Research Project Grant (R01). (Please note that facilities and administrative (F&A;) costs requested by any consortium participants are excluded from the direct cost limit per NIH Guide Notice NOT-OD-04-040.) This PA uses just-in-time concepts. It also uses the modular budgeting format (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 budgeting format. 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. 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: Cindy D. Davis, Ph.D. Nutritional Science Research Group Division of Cancer Prevention National Cancer Institute 6130 Executive Blvd., EPN Room 3159, MSC 7328 Bethesda, MD 20892-7328 Rockville, MD 20852 (for express/courier service) Telephone: (301) 594-9692 FAX: (301) 480-3925 Email: davisci@mail.nih.gov Virginia W. Hartmuller, Ph.D., R.D. Epidemiology and Genetics Research Program Division of Cancer Control and Population Sciences National Cancer Institute 6130 Executive Blvd., EPN Room 5102, MSC 7324 Bethesda, MD 20892-7324 Rockville, MD 20852 (for express/courier service) Telephone: (301) 594-3402 FAX: (301) 402-4279 E-mail: hartmulv@mail.nih.gov o Direct your questions about financial or grants management matters to: Crystal Wolfrey Grants Administration Branch National Cancer Institute 6120 Executive Blvd., EPS Room 234, MSC 7150 Bethesda, MD 20892-7150 Telephone: (301) 496-8634 FAX: (301) 496-8601 Email: wolfreyc@mail.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) 435-0714; 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. SUPPLEMENTARY INSTRUCTIONS: All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions for R21 applications: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 15 pages. No preliminary data is required but may be included if it is available. Please note that a Progress Report is not needed; competing continuation applications for an exploratory/developmental grant will not be accepted. o Appendix. Use the instructions for the appendix detailed in the PHS 398 except that no more than 5 manuscripts, previously accepted for publication, may be included. All instructions for the PHS 398 (rev. 5/2001) must be followed, with these exceptions for R03 applications: o Research Plan Items a - d of the Research Plan (Specific Aims, Background and Significance, Preliminary Studies, and Research Design and Methods) may not exceed a total of 10 pages. Please note that a Progress Report is not needed; competing continuation applications for a small grant will not be accepted. o Appendix. The appendix may include original, glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the page limits of the research plan. No publications or other printed material, with the exception of pre-printed questionnaires or surveys, may be included in the appendix. 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 the NIH institutes or centers who have 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. Include a cover letter sent with the application that identifies 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 an 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 applications 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 the following 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 below on Federal Citations.) 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 below on Federal Citations.) 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. Details are available at 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 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. 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 (http://grants.nih.gov/grants/policy/data_sharing) or state why this is not possible. 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/. HUMAN EMBRYONIC STEM CELLS (hESC): Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov). It is the responsibility of the applicant to provide, in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s) to be used in the proposed research. Applications that do not provide this information will be returned without review. 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 plan 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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