and Human Services (HHS)
EXPIRED
INTEGRATING AGING AND CANCER RESEARCH RELEASE DATE: September 24, 2002 PA NUMBER: PA-02-169 EXPIRATION DATE: September 25, 2005, unless reissued National Institute on Aging (NIA) (http://www.nia.nih.gov/) National Cancer Institute (NCI) (http://www.nci.nih.gov/) THIS PA CONTAINS THE FOLLOWING INFORMATION o Purpose of the PA o Research Objectives o Mechanism 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 Required Federal Citations PURPOSE The National Institute on Aging (NIA) and the National Cancer Institute (NCI) invite research grant applications (R01s) for studies directed at cancer in older persons. The majority of cancers affect older persons disproportionately because aging is a high risk factor for malignant tumors. The focus for this research solicitation is on the older adult age group in the U.S. population in which cancer primarily occurs, that is, persons aged 65 years and older. Close to 60% of all newly diagnosed malignant tumors and 71% of all cancer deaths occur in persons in this age group according to the NCI Surveillance, Epidemiology, and End Results (SEER) program data for 1995- 1999. The age-adjusted cancer incidence rate for persons 65 years and older (2208.1 per 100,000 population) is ten times greater than the rate for persons under 65 years (229.2 per 100,000 population). The age-adjusted cancer mortality rate (1140.1 per 100,000 population) for persons 65 years and older is over 16 times greater than the rate for persons under 65 (70.8 per 100,000 population). The cancer statistics showing the disproportionately high burden of cancer for older Americans foretell a greater consequence when cast against the changing demographics of the aging population in the United States. The number of older persons diagnosed with cancer is expected to increase because of the overall aging of the U.S. population and an unprecedented expansion of the 65 years and older age group. In just three decades, 20% of the U.S. population will be age 65 years and older. Age shifts within the 65 years and older segment of the population will increase the proportion of persons 85 years and older from our current 4.3 million to 8.9 million individuals over the next decades. Three factors mainly contribute to our nation"s changing age structure of the population--changing mortality patterns, decreased fertility, and the aging of the "Baby Boom" cohort born between 1946 and 1964 (75 million persons). These factors, in particular the aging of the "Baby Boom" generation, will have far-reaching effects on the future overall health status and cancer burden of Americans. This phenomenon must be factored into our cancer research efforts. The impetus for this announcement is based on the magnitude of the cancer problem of older persons as indicated by the NCI SEER data and the expanding U.S. aging population. Research is needed across the scientific spectrum of cancer control for early detection, diagnosis, prevention, treatment, prognosis and survivorship. Clinical studies and the biology interface of aging and cancer research are included in this initiative. Little is known about how age-associated problems affect cancer patient evaluation, prevention and treatment strategies, and care. Studies are needed on the assessment of the effectiveness of different prevention and treatment relative to the type of malignancy, the stage of disease, and significant features and characteristics of old age and the aging process. Scientific advances in the associations between aging and the development of cancer facilitate the convergence of research perspectives to identify the molecular alterations in carcinogenesis that are related to the aging process. The biology of aging and cancer relationship is well recognized. There is an overlap between cancer and aging that should be addressed in tumor initiation, progression, and maintenance. Research achievements and refined technologies in the biology of both aging and cancer in many areas hold promise for enhancing the knowledge base on the relationship between aging and the natural history of tumors. RESEARCH OBJECTIVES This research initiative is directed at human aging and cancer. The objective is to expand the knowledge base on aging- and age-related aspects of cancer in older persons. The NIA/NCI co-sponsored workshop, Exploring the Role of Cancer Centers for Integrating Aging and Cancer Research, provides an excellent background useful for this Program Announcement (PA). Insights and research recommendations from the NIA/NCI workshop, convened on the NIH Campus, Bethesda, MD, June 13-15, 2001, are indicated in the PA research scope. Applicants are advised to obtain the NIA/NCI Workshop Report from one of the following websites -- http://www.nia.nih.gov/ResearchInformation/ConferencesAndMeetings/WorkshopReport/ or http://www3.cancer.gov/cancercenters to assist in developing a research application. This PA is directed to researchers in the extramural scientific community at large. The NIA and NCI intention, in issuing this particular PA, is to appeal to a broad-based community of investigators in cancer, aging, and other disciplines and professions throughout the nation, thereby underscoring the value of the creative ideas stemming from the cancer centers workshop and the urgent need to advance the knowledge base on cancer in older persons. The PA increases the potential to produce innovative and much needed research at the aging/cancer interface. A single or combination of research issues from the spectrum identified for this solicitation may be selected. Grant applications are not limited to these areas. The list is neither all-inclusive nor exclusive, nor is it in an order of priority. AGE-RELATED AND AGING PROCESS IMPACT ON EARLY DETECTION, PREVENTION, DIAGNOSIS, PRE-TREATMENT EVALUATION, PROGNOSIS, AND TREATMENT OF TUMORS IN OLDER CANCER PATIENTS o Effects of multiple health problems such as other chronic diseases or concurrent diseases not related or antecedent to the cancer diagnosis on early detection, diagnosis, prognosis, and treatment of cancer patients (e.g., comorbidity may contribute to masking of signs and symptoms of disease, underdiagnosis, and undertreatment). o Studies demonstrating and/or verifying effective management of older cancer patients with pre-existing chronic conditions and concurrent diseases (i.e., comorbidity). o Effects of aging processes and old age on disposition, efficacy, effectiveness, and tolerance of anti-cancer agents in older patients [activities of drug and biologic anti-cancer agents in older patients, the time course of absorption, distribution, metabolism, and excretion of drugs from the aged host (i.e., pharmacokinetics), the response of the aged host to anti-cancer drugs (pharmacodynamics)]. o Studies on the effects of age-related physiologic or pathophysiologic changes of older cancer patients with other serious comorbid health problems concurrent with their malignancy. o Studies of the clinical decision-making made by physicians for older persons with selected tumor type, histology, and stage in the context of patient age, comorbidities, and patient and family preferences. o Prospective and/or retrospective studies of treatment outcomes in older patients with varying age-related functional limitations (e.g., dose-limiting parameters that could predict and affect risk and severity of short-term and long-term side effects of therapy in older cancer patients and survivors) --interdisciplinary studies from the perspectives of pharmacology of aging and the pharmacology of cancer. --response of the older human host to the anti-cancer drug (organ system decline and their decrease in functional capacity). --studies concerning problems that may arise in older cancer patients"use of medications for other health conditions. o Age,race/ethnicity disparities in early diagnosis, treatment, quality of life, and survival of older patients. o Research strategies to ascertain what factors influence older persons" response to signs and symptoms of cancer and the individual variations in actions that may result in delay of early detection of cancer. o Characterization of the treatment of older patients who are inadmissible to cancer treatment protocols and how their outcomes compare with older patients admitted to and treated on protocol. AGING/CANCER HUMAN BIOLOGY RESEARCH INTERFACE. o Characterization of the biological aging/cancer relationship for individuals diagnosed with different tumors for which peak incidence and mortality rates are highest (e.g., colon, rectum, prostate, pancreas, lung, bladder, stomach, and breast) in older persons. o Studies in human biology of cancer and aging that are clinically relevant and reveal which aspects of tumor biology and tumor growth vary by age (e.g., peculiarities of the aged host, various types of tumors presenting differently according to age). These investigations have the potential to provide information that could lead to tailored therapeutic approaches. o Variations in tumor cellular and molecular properties in biopsy or surgical specimens related to age, race, and ethnicity and their relationship to tumor progression and metastases. o Epigenetic studies that explore the differences in cancers affecting younger and older persons (e.g., altered DNA methylation patterns that increase with aging, silencing of tumor suppressor genes associated with promoter hypermethylation). o Translational research to facilitate the transfer of new technologies (to the clinical setting) for early detection risk assessment and prevention of cancer in older persons. o Development and/or evaluation of strategies to prevent, reverse or retard the progression of precancerous lesions in older persons. o Development of analytical techniques to identify older persons at increased risk as indicated by genetic and/or metabolic phenotypes. o Intervention strategies to prevent cancer or pre-cancer progression in older persons. o Innovative research projects on risk of multiple primary tumors (i.e., one or more malignant lesions in the same person that are not recurrences, extensions, or metastases of a previous malignancy) --Studies to advance the methodology on assessment and reporting of multiple primary tumors. --Studies on age differences in host susceptibility to multiple primary tumors. --Assessment of risk potential for treatment-induced multiple primary tumors. o Studies to identify genetic or epigenetic changes associated with older persons/populations at low risk for cancer (i.e., age-resistant phenotype). o Methods to distinguish age-related conditions in patients with and without clinically significant cancer (e.g., indolence versus aggressive tumor behavior in the context of the aged host) and physiologic changes. PATIENT, FAMILY, PROVIDER, AND QUALITY OF LIFE INTERACTION ISSUES. o Studies on methods to apply techniques to enhance quality of cancer survival of older persons through prevention of short-term and long-term adverse physical and medical effects of cancer treatment. o Cancer caregiver(s) quality of life and functioning and their influence on the older cancer patient"s care and treatment. Multidisciplinary collaboration among geriatricians, oncologists, psychologists, and oncology nurses is encouraged for instrument development for this research. o Psychological and social effects of cancer and its treatment on the older patient and family. o Pain and other symptoms associated with cancer and its treatment may occur and persist throughout any or all phases of the cancer trajectory (e.g., diagnosis, treatment, recovery, and/or survivorship of older cancer patients). Studies that apply recent development of better methods of recognition and assessment that can be applied for optimal management to older patients with cancer are encouraged. --Develop and test the efficacy of current methods (pharmacological and nonpharmacological) for effective pain management strategies in older cancer patients. --Test and facilitate the use of evidence-based guidelines for pain relief, physical and affective symptoms, and system clusters. --Develop generic guidelines for problems specific to the elderly such as limited functional reserve and/or comorbid conditions. --Develop standard protocols for documenting and reducing pain and symptom severity. o Evaluate pain management (medications and/or other therapeutic approaches) consequent to cancer therapy--postsurgery, postradiation, and during and after chemotherapy--for older cancer patients regarding adjustment to needs and appropriate administration in the context of age-associated issues (e.g., pharmacokinetics and pharmacodynamics of aging, drug-drug interactions, drug- age interaction, other health problems, and type of neoplasm). o Conduct epidemiological studies to characterize symptom burden, pain perception, response to pain and symptom therapy of older patients and investigations for ways to ameliorate these problems. APPLICATION OF EXISTING DATA TO THE AGING/CANCER RESEARCH INTERFACE. o Innovative studies utilizing aging and age-relevant cancer statistics, cancer treatment, cancer pathology, and cancer genetics databases that could be examined for insights to generate hypotheses at the aging/cancer research interface -- tissue bank data, treatment pattern data, tumor registry data, cancer etiology data, epidemiology data, tumor biology data, etc. DEFINITION OF "OLD AGE" OR "OLDER PERSONS" FOR THIS ANNOUNCEMENT While this PA focuses in particular on individuals 65 years and older because the highest cancer incidence and mortality rates are found in this age segment of the population and the research initiative seeks to increase the knowledge base on this segment of the U.S. population, applicants are expected to identify what is meant by "aged", "old", or "elderly" in the context of their research. It is recognized that for certain tumors or for selected race and/or ethnic population subgroups, age 65 years might not be entirely appropriate. The age demarcation of 65 years is arbitrary and historically associated with entitlements and eligibility for various programs, it does include the age subgroups in which most major tumors primarily occur (i.e., person in their 60"s, 70"s, and 80"s). Comparative studies with younger age groups are welcome and may be included in investigations proposed. Within the age group of 65 years and older, distinctive age comparisons are also appropriate. MECHANISM OF SUPPORT This PA will use the NIH R01 award mechanism. The applicant is solely responsible for planning, directing, and executing the proposed project. 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 format. Otherwise follow the instructions for non- modular research grant applications. 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 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: Rosemary Yancik, Ph.D. Geriatrics and Clinical Gerontology Program National Institute on Aging Gateway Building, Room 3E327 Bethesda, MD 20892-9205 Telephone: (301) 496-5278 FAX: (301) 402 1784 Email: [email protected] Patricia McCormick, Ph.D. Cancer Centers Branch National Cancer Institute 6116 Executive Boulevard Suite 700, MSC 8345 Bethesda, MD 20892-8345 Telephone: (301) 496-8531 FAX: (301) 402-0181 Email: [email protected] o Direct your questions about financial or grants management matters to: Cynthia Riddick Grants and Contracts Management Office National Institute on Aging Gateway Building, Room 2N212 Bethesda, MD 20892-9205 Telephone: (301) 496-1472 FAX: (301) 402-3672 Email: [email protected] Ms. Eileen Natoli Section Chief Grants Administration Branch National Cancer Institute 6120 Executive Blvd, EPS-243 Bethesda, MD 20892 Telephone: (301) 496-8791 FAX: (301) 496-8601 Email: [email protected] SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 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: [email protected]. 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. Applicants requesting more than $500,000 must carry out the following steps: 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 received by or 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 application already reviewed, but such application must include an Introduction addressing the previous critique. PEER REVIEW PROCESS Applications submitted for this PA will be assigned on the basis of established PHS referral guidelines. An appropriate scientific review group 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 Receive a written critique 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 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 discuss the following aspects of your application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment The scientific review group will address and consider each of these criteria in assigning your application"s overall score, weighting them as appropriate for each application. Your 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, you 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 your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? 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? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your 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, your application will also be reviewed with respect to the following: PROTECTIONS: 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. INCLUSION: The adequacy of plans to include subjects from genders, all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria included in the section on Federal Citations, below) BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. OTHER REVIEW CRITERIA: Projects must have a clear relevance to human aging to be considered under this Program Announcement. The research must be focused on human cancer. 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 Responsiveness to the NIA/NCI Workshop Report: High quality grant applications that are responsive to recommendations described in the NIA/NCI workshop report (http://www.nia.nih.gov/ResearchInformation/ConferencesAndMeetings/WorkshopReport/) will be considered for "exception" funding by the NCI. "Exception funding" is used by the NCI to support applications whose priority scores are beyond, but close to the payline and not funded through the accelerated executive review process. These applications will therefore, compete for a limited pool of dollars with those in other high-priority categories: these include applications submitted by new investigators or those addressing cancer health disparities, or areas of extraordinary research opportunity designated by the NCI. Decisions on exceptions are made three times a year. Contact the NCI program director for details. In order to mark an application for consideration, investigators should cite the relevant section (s) of the Report and include the following language in the Background section of their grant applications: "The research described in this application is responsive to recommendations in the NIA/NCI workshop report, Exploring the Role of Cancer Centers for Integrating Aging and Cancer Research." REQUIRED FEDERAL CITATIONS MONITORING PLAN AND DATA SAFETY AND MONITORING BOARD: Research components involving Phase I and II clinical trials must include provisions for assessment of patient eligibility and status, rigorous data management, quality assurance, and auditing procedures. In addition, it is NIH policy that all clinical trials require data and safety monitoring, with the method and degree of monitoring being commensurate with the risks (NIH Policy for Data Safety and Monitoring, NIH Guide for Grants and Contracts, June 12, 1998: http://grants.nih.gov/grants/guide/notice-files/not98-084.html). 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 AMENDMENT "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. 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. 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. 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 No. 93.866 and No. 93.397, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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 described at http://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and to 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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