This Program Announcement expires on June 30, 2004, unless reissued. CACHEXIA: RESEARCH INTO BIOBEHAVIORAL MANAGEMENT AND QUALITY OF LIFE Release Date: June 11, 2001 PA NUMBER: PA-01-109 National Institute of Nursing Research (NINR) National Cancer Institute (NCI) National Institute of Child Health and Human Development (NICHD) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) National Institute of Neurological Disorders and Stroke (NINDS) THIS PA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA/PA. PURPOSE This Program Announcement (PA) solicits applications for investigator- initiated research related to the prevention and management of cachexia to improve the quality of life for these patients. Cachexia is a condition of severe malnutrition characterized by anorexia, weight loss and muscle wasting that occurs as a consequence of chronic conditions such as cystic fibrosis, cerebral palsy, cancer, AIDS, congestive heart failure, failure to thrive in older populations, end-stage organ failure, neurological degenerative diseases, chronic obstructive lung disease, chronic liver disease, and chronic renal disease. Cachexia has repeatedly been associated with adverse clinical outcomes, and increased morbidity and mortality. Research findings are reported in the literature which address individual symptoms and speculated causes of cachexia but data are not available to provide a scientific base for a multidisciplinary approach to prevent cachexia and manage the associated symptoms to improve the quality of life for patients suffering from cachexia. The goal of this PA is threefold: 1) to stimulate basic and clinical research in cachexia, 2) to examine cachexia in relation to several related symptoms to improve quality of life, and 3) to examine cachexia symptoms in two or more chronic conditions. 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 Program Announcement (PA), Cachexia: Research into Biobehavioral Management and Quality of Life, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non- profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This PA will use the National Institutes of Health (NIH) Research Project Grant (R01) award mechanism. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this PA may not exceed 5 years. Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at http://grants.nih.gov/grants/funding/modular/modular.htm RESEARCH OBJECTIVES Background Cachexia is a condition of severe malnutrition and negative nitrogen balance characterized by anorexia, weight loss and muscle wasting. The physiological, metabolic, and behavioral changes in cachexia are associated with patient complaints of weakness, fatigue, gastrointestinal distress, sleep/wake disturbances, pain, listlessness, shortness of breath, lethargy, depression, malaise and the fear of being a burden on family and friends. Although cachexia has been classically associated with chronic infections and malignant conditions, it has also been identified in patients after extensive traumatic injury and sepsis, and in aging persons with failure to thrive syndrome. Muscle cachexia, mainly reflecting degradation of myofibrillar proteins, is an important clinical feature in cachectic patients. A redistribution of the body’s protein content occurs, with preferential depletion of skeletal muscle and an increase in the synthesis of proteins involved in the response to tissue injury. Muscle cachexia is associated with increased gene expression and activity of the calcium/calpain and ubiquitin/proteasome-proteolytic pathways. Calcium/calpain-regulated release of myofilaments from the sarcomere is an early, and perhaps rate-limiting, component of the catabolic response in muscle. Understanding the mechanisms regulating muscle protein breakdown is important for the development of therapeutic strategies aimed at preventing and managing muscle cachexia. The catabolic response in skeletal muscle may result in muscle wasting and weakness that has important clinical implications such as difficulty with ambulation, impaired rehabilitation and increased risk for pulmonary complications. The cachexia-anorexia syndrome involves metabolic pathology and is associated with hypertriacylglycerolemia, lipolysis, and acceleration of protein turnover. These changes result in the loss of fat mass and body protein. Increased resting energy expenditure in weight-losing cachectic patients can occur despite the reduced dietary intake, indicating systemic dysregulation of host metabolism. Cachexia, regardless of the underlying diagnosis, can rarely be explained by the actual energy and substrate demands or by the diagnosis itself. Cachexia involves immune changes, and cytokines have been identified in the development and/or progression of the cachexia-anorexia syndrome. For example, interleukin-1, interleukin-6 (and its subfamily such as ciliary neurotrophic factor and leukemia inhibitory factor), interferon-gamma, tumor necrosis factor-alpha, and brain derived neurotrophic factor have been associated in various cachectic conditions. Cytokines are proposed to participate in the development and progression of cachexia. Data show that cytokines may be involved in cachexia processes by being produced and by acting locally in specific brain regions. Brain synthesis of cytokines has been demonstrated in peripheral models of cancer, in peripheral inflammation, and during peripheral cytokine administration. Since the data reveal a multifactorial syndrome in cachexia, understanding the interactions between peripheral and brain mechanisms may be pivotal to characterizing the underlying integrative pathophysiology in this disorder and in designing effective prevention and management strategies. Immunological pathology has been linked to cachexia in different diseases such as cancer and chronic heart failure. Data show that the development of chronic heart failure includes phenotypic changes in numerous homeostasis systems so that in late chronic heart failure, extra-cardiac manifestations occur, in particular immunological abnormalities. Increased levels of the proinflammatory cytokine tumor necrosis factor (TNF) are found in the circulation and in the myocardium of patients with chronic heart failure in higher numbers than in controls. Numerous therapies for chronic heart failure directed against TNF are reported in the literature and represent an approach to heart failure management. Basic and clinical research studies are needed to measure the effectiveness of these therapies in ameriorating the multiple symptoms affecting patients with cachexia. Cachexia can be a hallmark condition of Acquired Immune Deficiency Syndrome (AIDS). Limited success has been reported with the use of several anabolic agents to retard or prevent progressive muscle wasting in persons with AIDS. One recent published finding reported that insulin administration improved metabolic profiles (lowering triglycerides, liver enzymes, and glycohemoglobin concentrations and normalizing the 24 hour urine) to the point of patients being in a positive energy balance. No adverse effects, including hypoglycemic episodes, were reported and a marked rise in CD4 counts and an improvement in the thyroid hormone profile were noted. The possibility that insulin administration may improve cachexia in AIDS and in other chronic conditions may warrant further evaluation. Trials of conventional nutritional supplements in patients with cancer cachexia have failed to show appreciable benefit in terms of weight gain or quality of life. The difficulties in introducing sound and effective nutritional support or metabolic manipulation to reverse cachexia are outlined in the literature. A variety of pharmacological and dietary agents have been studied in an attempt to normalize lipid and protein metabolic changes with only limited success. For example, preliminary clinical studies have shown that eicosapentanoic acid stabilizes body weight and protein and fat reserves in cachectic patients with pancreatic carcinoma. Recent studies have demonstrated the ability of anabolic and anticatabolic agents to mitigate the loss of skeletal muscle and to improve clinical outcomes of cachectic patients in selected circumstances. Preclinical initiatives target the cytokine regulation of protein metabolism. Further, a recent study reported that an energy-enriched formula was more effective in improving the nutritional status of cachectic children with cancer during the intensive phases of treatment than the standard formula. Combinations of nutritional, pharmacological, and alternative/complementary medicine therapies to normalize the metabolic milieu may have the potential to reverse cachexia and improve the associated symptoms that affect quality of life. However, metabolic manipulations in cachexia could have positive or negative clinical effects, which need to be distinguished through basic and clinical research and appropriate clinical trials. In order to improve quality of life during cachexia, numerous educational interventions are available for patients and families to treat and manage physical and emotional symptoms associated with cachexia. However, they have not been scientifically validated. There are published research results to document interventions to ameliorate the inflammation and deterioration of oral mucous membranes as a side effect of cancer therapy and interventions to assist patients in modulating shortness of breath. However, data-based research publications are lacking to describe how patients should manage cachexia-anorexia syndrome to improve their quality of life. Clinical research studies are needed to combine behavioral strategies with nutritional interventions in order to impact the anorexia-cachexia syndrome. Clinical research studies are warranted to test effective approaches to manage unintentional weight loss as a side effect of cancer treatment and AIDS progression. Research studies are needed to validate ways for cachectic patients and their families to increase their ability to intervene appropriately for pain, psychosocial needs, bereavement, depression, and issues for end of life. Research is needed to document how interventions can improve these diverse symptoms. Also, reversing cachexia may not always be possible, for example in patients at the end stages of life. In these conditions, research is needed to test ways to manage multiple associated sequalae of cachexia. Scope This PA solicits applications that investigate ways to prevent and manage cachexia in order to improve the quality of life of patients with this condition. The purpose of the PA is: 1) to stimulate basic and clinical research in cachexia, 2) to examine cachexia in relation to several related symptoms or other sequalae to improve quality of life (e.g., decrease in pain and weakness, fatigue and dyspnea, investigate ways to prevent muscle wasting and evaluate the validity of its effectiveness on patients sleep/wake cycles and complaints of shortness of breath), and 3) to examine cachexia symptoms in two or more chronic conditions (e.g., test effective strategies to manage anorexia in patients diagnosed with AIDS and cancer). Multidisciplinary research teams composed of basic and clinical researchers are encouraged to address the goals of this PA. For example, basic researchers could emphasize the interactions among multiple underlying pathophysiological mechanisms of cachexia while clinical researchers define the specific impact of loss of independence or how patients can improve upon skeletal muscle function recovery. In addition, both basic and clinical research could test multiple combination therapy interventions that include nutritional, immunological, pharmacological, and alternative/complementary medicine components. These combination therapies could be evaluated for their effects on clusters of symptoms occurring with cachexia such as subjective complaints by patients that affect quality of life that include sleep/wake disturbances, malaise, pain, listlessness, shortness of breath, fatigue and depression. Attention could also be directed to differences in therapeutic interventions based on age, gender, and underlying disease. Listed below are examples of areas of basic and clinical research that would be responsive to this program announcement. They are not listed in any priority order and are not intended to be inclusive or restrictive. These examples are only illustrative examples, and applicants are encouraged to propose other topics consistent with the goals of this program. o Determine which symptoms of cachexia are amenable to metabolic or biochemical interventions and which symptoms require behavioral interventions in order to improve quality of life, o Identify and test nutritional, pharmacological, and psychoneuroimmunological interventions to prevent or treat the anticipated onset of anorexia with cachexia, o Test biobehavioral interventions to promote quality of life in cachectic patients who have different underlying conditions/diseases, o Compare and contrast traditional treatments alone or in tandem with alternative/complementary therapies to arrest cachexia in two or more different underlying conditions/diseases, o Identify biological, immunological, chemical, genetic or behavioral markers to be used as an index of successful outcome measures in cachexia or the treatment and management of cachexia, o Explore regimens (e.g., physical activity and nutrient supplementation) to improve dyspnea, impaired mobility, pain, anorexia and fatigue associated with cachexia, o Explore the role of the neuroendocrine system in the development of cachexia, and o Examine the contribution of cachexia to the progression of neurodegenerative disease. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the UPDATED "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000 (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html), a complete copy of the updated Guidelines are available at http://grants.nih.gov/grants/funding/women_min/guidelines_update.htm: The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. URLS IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. APPLICATION PROCEDURES Applications are to be submitted on the grant application form PHS 398 (rev. 4/98) and will be accepted at the standard application deadlines as indicated in the application kit. Application kits are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: GrantsInfo@nih.gov. Applicants planning to submit an investigator-initiated new (type 1), competing continuation (type 2), competing supplement, or any amended/revised version of the preceding grant application types requesting $500,000 or more in direct costs for any year are advised that he or she must contact the Institute or Center (IC) program staff before submitting the application, i.e., as plans for the study are being developed. Furthermore, the application must obtain agreement from the IC staff that the IC will accept the application for consideration for award. Finally, the applicant must identify, in a cover letter sent with the application, the staff member and Institute or Center who agreed to accept assignment of the application. This policy requires an applicant to obtain agreement for acceptance of both any such application and any such subsequent amendment. Refer to the NIH Guide for Grants and Contracts, March 20, 1998 at http://grants.nih.gov/grants/guide/notice-files/not98-030.html The modular grant concept establishes specific modules in which direct costs may be requested as well as a maximum level for requested budgets. Only limited budgetary information is required under this approach. The just-in-time concept allows applicants to submit certain information only when there is a possibility for an award. It is anticipated that these changes will reduce the administrative burden for the applicants, reviewers and Institute staff. The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants, with the modifications noted below. SPECIFIC INSTRUCTIONS FOR MODULAR GRANT APPLICATIONS BUDGET INSTRUCTIONS Modular Grant applications will request direct costs in $25,000 modules, up to a total direct cost request of $250,000 per year. (Applications that request more than $250,000 direct costs in any year must follow the traditional PHS 398 application instructions.) The total direct costs must be requested in accordance with the program guidelines and the modifications made to the standard PHS 398 application instructions described below: PHS 398 o FACE PAGE: Items 7a and 7b should be completed, indicating Direct Costs (in $25,000 increments up to a maximum of $250,000) and Total Costs [Modular Total Direct plus Facilities and Administrative (F&A) costs] for the initial budget period Items 8a and 8b should be completed indicating the Direct and Total Costs for the entire proposed period of support. o DETAILED BUDGET FOR THE INITIAL BUDGET PERIOD - Do not complete Form Page 4 of the PHS 398. It is not required and will not be accepted with the application. o BUDGET FOR THE ENTIRE PROPOSED PERIOD OF SUPPORT - Do not complete the categorical budget table on Form Page 5 of the PHS 398. It is not required and will not be accepted with the application. o NARRATIVE BUDGET JUSTIFICATION - Prepare a Modular Grant Budget Narrative page. (See http://grants.nih.gov/grants/funding/modular/modular.htm for sample pages.) At the top of the page, enter the total direct costs requested for each year. This is not a Form page. o Under Personnel, list all project personnel, including their names, percent of effort, and roles on the project. No individual salary information should be provided. However, the applicant should use the NIH appropriation language salary cap and the NIH policy for graduate student compensation in developing the budget request. For Consortium/Contractual costs, provide an estimate of total costs (direct plus facilities and administrative) for each year, each rounded to the nearest $1,000. List the individuals/organizations with whom consortium or contractual arrangements have been made, the percent effort of all personnel, and the role on the project. Indicate whether the collaborating institution is foreign or domestic. The total cost for a consortium/contractual arrangement is included in the overall requested modular direct cost amount. Include the Letter of Intent to establish a consortium. Provide an additional narrative budget justification for any variation in the number of modules requested. o BIOGRAPHICAL SKETCH - The Biographical Sketch provides information used by reviewers in the assessment of each individual"s qualifications for a specific role in the proposed project, as well as to evaluate the overall qualifications of the research team. A biographical sketch is required for all key personnel, following the instructions below. No more than three pages may be used for each person. A sample biographical sketch may be viewed at: http://grants.nih.gov/grants/funding/modular/modular.htm - Complete the educational block at the top of the form page, - List position(s) and any honors, - Provide information, including overall goals and responsibilities, on research projects ongoing or completed during the last three years. - List selected peer-reviewed publications, with full citations, o CHECKLIST - This page should be completed and submitted with the application. If the F&A rate agreement has been established, indicate the type of agreement and the date. All appropriate exclusions must be applied in the calculation of the F&A costs for the initial budget period and all future budget years. o The applicant should provide the name and phone number of the individual to contact concerning fiscal and administrative issues if additional information is necessary following the initial review. The title and number of the program announcement must be typed on line 2 of the face page of the application form and the YES box must be marked. 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) REVIEW CONSIDERATIONS Applications will be assigned on the basis of established PHS referral guidelines. Applications will be evaluated for scientific and technical merit by an appropriate scientific review group convened in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed, assigned a priority score, and 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 the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Additional scientific/technical merit criteria specific to the objectives of the PA and the mechanism used must be included if they are to be used in the review. AWARD CRITERIA Applications will compete for available funds with all other recommended applications. The following will be considered in making funding decisions: Quality of the proposed project as determined by peer review, availability of funds, and program priority. INQUIRIES Inquiries are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Dr. Hilary Sigmon Office of Extramural Programs National Institute of Nursing Research Building 45, Room Number 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5970 FAX: (301) 480-8260 Email: Hilary_Sigmon@nih.gov Dr. Claudette Varricchio Program Director Division of Cancer Prevention National Cancer Institute 6130 Executive Blvd. EPN 300 Bethesda, MD, 20892 Telephone: (301) 496-8541 FAX: (301) 496-8667 Email: varriccc@mail.nih.gov Dr. Louis A. Quatrano National Center for Medical Rehabilitation Research National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 2A03, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 402-4221 FAX: (301) 402-0832 E-mail: lq2n@nih.gov Dr. Frank A. Hamilton Chief, Digestive Disease Program Branch Division of Digestive Diseases and Nutrition National Institute of Diabetes and Digestive and Kidney Diseases 6707 Democracy Blvd. Room 669 Bethesda, Maryland 20892-5450 Telephone: (301) 594-8877 FAX: (301) 480-8300 Email: fh14e@nih.gov Dr. Jill E. Heemskerk Program Director National Institute of Neurological Disorders and Stroke National Institutes of Health Neuroscience Center, Room 2204 6001 Executive Boulevard Bethesda, MD 20892-9525 (for courier service, use: Rockville, MD 20852) Telephone: (301) 496-5680 FAX: (301) 480-1080 E-mail: jill_heemskerk@nih.gov Direct inquiries regarding fiscal matters to: Ms. Tara Mowrey Office of Grants and Contract Management National Institute of Nursing Research Building 45, Room Number 3AN12, MSC 6300 Bethesda, MD 20892-6300 Telephone: (301) 594-5979 FAX: (301) 480-8260 Email: Tara_Mowrey@nih.gov Ms. Eileen Natoli Grants Administration Branch National Cancer Institute 6120 Executive Boulevard, Room 243, MSC 7150 Rockville, MD 20892-7150 Telephone: (301) 496-8791 FAX: (301) 402-0275 Email: natolie@gab.nci.nih.gov Ms. Carolyn Kofa Grants Management Branch National Institute of Diabetes and Digestive and Kidney Diseases Bethesda, MD 20892 Telephone: (301) 594-7687 FAX: (301) 480-3504 Email: KofaC@extra.niddk.nih.gov Mr. Christopher Myers Grants Management Branch National Institute of Child Health and Human Development 6100 Executive Boulevard, Room 8A17H, MSC 7510 Bethesda, MD 20892-7510 Telephone: (301) 435-6996 FAX: (301) 402-0915 E-mail: cm143g@nih.gov Ms. Kimberly Pendleton Grants Management Branch National Institute of Neurological Disorders and Stroke 6001 Executive Blvd., NSC Room 3260 Bethesda, Maryland 20892 (USPS) Rockville, MD 20852 (Courier and FedEx) Tel: 301-496-7480 Fax: 301-402-0219 Email: kp33e@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.361 (NINR), 93.393 (NCI),93.929, 93.848 (NIDDK), and 93.853 (NINDS). Awards are made under authorization of sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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