3 * DRAFT Copy of,Revised Guidel.i.nes Februar,, 19, 1968 i DIVISIOY, OF REGIO-I@AL MEDICAL PROGP@@IS TABLE'OF CONTENTS sk INTRODUCTION CHAPTER PAGE I. HISTORY AND PURPOSES OF REGIONAL MEDICAL PROGRAMS 3 II. THE NATURE AND POTENTIAL OF REGIONAL MEDICAL PROGRAMS 8 GOAL IMPROVED PATIENT CARE 8 MEANS THE PROCESS OF REGIO'i\'ALIZATION 8 Involvement 10 Identification of Needs and Opportunities 11 Assessment of Resources 11 Definition of Objectives 12 Setting of Priorities 12 Implenientation 12 Evaluation 13 Criteria - Evaluation of R ical Pro@lrams 14 III. GRANT POLICIES 15 ELIGIBLE APPLICANT 15 TYPES OF GRANTS i5 Planning 15 Operational 15 THE REGIONAL ADVISORY GROUP 16 ASSURANCES 17 General Responsibiliti6s 17 General Assurances 17 ELIGIBLE ACTIVITIES 19 Categorical EmDhasis 19 Core Support 19 Research . 19 Demonstrations of Patient Care 20 Training and Con@l u@i cation 20 Svstem Anal,,si-9 20 Communicati-on and Public Information 20 CHAPTER PAGE III. GRANT POLICIES (continued) SPECIFIC REQUIRE@lEiNTS 21 Discrimination Prohibited 21 Institutional Assurance Involving Human Subjects 21 Protection of Individual Privacy in Research and Investigation 21 Surveys and Questionnaires 22 Publications 22 Patents and Inventions 22 Animal Care 23 Changes in Approved Program 24 Change in Pro@ram Period 24 Change of Program Coordinator Change of Grantee Organization 24 Early Termination of Grant 24 Single Grantee 25 Reports 25 FINANCIAL @@IAGDIENT 2 General Requirements 26 A?reement of Affiliation 26 Allowable Direct Costs 27 Direct Costs Not Allowed 31 Indirect Costs 31 Rebudgeting of Funds 33 Refunds 34 Unexpended Balance 34 Obligations or Expenditures 34 Accounting, Records, and Audit 35 Equipment (Title and Accountability) 36 Reports 36 Miscellaneous 37 IV. PREPARATION AND REVIEW OF APPLICATIONS TYPES OF APPLICATIO@NTS 38 Neiq Applications 38 Supplemental Applications 38 Continuation Applications 38 Renewal A Fictions 38 Applications for Revision 38 CHAPTER PAGE GENERAL FORMAT FOR ALL APPLICATIONS 38 Form 38 Budget 39 Narrative 39 Supporting Documents 39 SPECIFIC FORMAT 39 Planning Applicatr-iion 3 Planning Supplemental Application 40 New Operational Grant 40 Supplemental Operational Applications 41 Continuation Application 41. Application for Renewai Grant 42 Applications for Revisions 42 APPLICATION PROCEDURE 43 Schedule 43 Number of Copies 43 Style 43 REVIEW PROCESS 43 Receipt of Application 43 Review by Regional Medical ram Revie@q Committee 43 Site Visits 44 Review by National Advisory Council 44 Approval and Award 44 V. GLOSSARY 45 VI. APPENDICES 51 INTRODUCTION In the.19 months since 'Guidelines was first issued, Regional Medical Programs have made substantial progress. Fifty-four Regional Medical Programs now encompass the Nation. Fifty-three of these have received planning grants, five have received operational grants and many more proposals for operating funds are in various stages of development. Rec6gnizina that momentum of Regional Programs has now shifted toward development of these operational proposals, this edition of Guidelines has been thoroughly revised to meet the questions, issues, and problems which can be expected to emerge at this stage of program development. The revised Guidelines is organized into three sections Chapters I and II provide an overview of the Programs. The chapter on@History and Purposes traces the major elements leading to passage of the legislation authorizing establishment of Regional Medical Programs. This is followed by a statement of the Nature and Potential of the Program, including a broad description of the process of regionalization, which is based upon the cumulative and collective experience of the 54 Regional Programs. Chapters III and IV comprise the grants manual, detailing Grant Policies and the Preparation and Review of Applications for planning and operational proposals. Chapter V is a glossary compiled to define as precisely as possible those words and terms commonly used in connection with Regional Medical Programs. The provisions of Guidelines are intended to carry out the purposes and objectives of the authorizing legislation, consistent with overall policies of the Department of Health, Education, and Welfare and sound fiscal procedures. These provisions must be interpreted in light of the basic objectives of the program, and the clear intent of the Congress to stimulate initiative and innovation at the regional level in planning and implementing Regional Programs that are fitted to the needs and resources O'F the region. If the applicant believes there is a conflict between the provisions of Guidelines and the effective implementation of the proposed program in DRAFT 2 his region, he is encouraged to consult with the staff of the Division of Regional Medical Programs. This is a new program in an exploratory phase. It is expected that policies and procedures will evolve with time as both the Applicant and the Division learn from actual planning and operational experience. As with all statements of policy and pro- cedure, Guidelines attempts to strike a balance among desirable and necessary procedures. The Division encourages diversity and innovation in the development of the Regional Medical Program. But this flexibility of approach must take place within the boundaries of the legislative authority, applicable general policies, and the necessary accountability for public funds. DRAFT 3 CHAPTER I HISTORY AND PURPOSES OF REGIONAL MEDICAL PROGRAMS On October 6, 1965, the President signed Public Law 89-239. It authorizes the establishment and maintenance of Regional Medical Programs to assist the Nation's health resources in making available the best possible patient care for heart disease, cancer, stroke and related diseases. This legislation, which will be referred to in these Guidelines as The Act, was shaped by the interaction of four antecedents: the historical thrust toward regionalization of health resources; the development of a national biomedical research community of unprecedented size and productivity; the changing needs of society; and finally, the particular legislative process leading to The Act itself. The concept of regionalization as a means to meet health needs effectively and economically is not new. During the 1930's, Assis- tant Surgeon General Joseph W. Mountin was one of the earliest pioneers urging this approach for the delivery of health services. The national Committee on the Costs of Medical Care also focused attention in 1932 on the potential benefits of reuionalization. In that same year, the Bingham Associates Fund initiated the first comprehensive regional effort to improve patient care in the United States. This program linked the hospitals and programs for continuing education of physicians in the State of Maine with the university centers of Boston. Advocates of regionalization next gained national attention more than a decade later in the report of the Commission on Hospital Care and in the Hospital Survey and Construction (Hill.-Burton) Act of 1946. Other proposals and attempts to introduce rea.ionalization of health resources can be chronicled, but a strong national movement toward regionalization had to await the convergence of other factors which occurred in 1964 and 1965. One of these factors was the creation of a national biomedical research effort unprecedented in history and unequalled anywhere else in the world. The effect of this activity is intensified by the swiftness of its creation: at the beginnning of World War II the national expenditure for medical research totaled $45 million; by 1947 it was $87 million; and in 1967 the total was $2.257 billion--a 5,000 percent increase in 27 years. The most significant characteristic of this research effort is the tremendous rate it is producing new knowledge in the medical sciences, an outpouring which only recently began and which shows no signs of decline. As a result, chanaes in DRAFT DRAFT 4 health care have been dramatic. Today, there are cures where none existed before, a number of diseases have all but disappeared with the application of new vaccines, and patient care generally is far more effective than even a decade ago. It has become apparent in the last few years, however, (despite substantial achievements), that new and better means must also be found to convey the ever- increasing volume of research results to the practicing physician and to meet growing complexities in medical and hospital care, including specialization, increasingly intricate and expensive types of diagnosis and treatment, and the distribution of scarce manpower, facilities, and other resources. The degree of urgency attached to the need to cope with these issues is heightened by an increasing public demand that the latest and best health care be made available to everyone. This public demand, in turn, is largely an expression of expectations aroused by awareness of the results and promise of biomedical research. In a sense, the national commitment to biomedical investigation is one manifestation of the third factor which contributed to the creation of Regional Medical Programs: the changing needs of society-- in this case, health needs. The decisions by various private and public institutions to support biomedical research were responses to this societal need perceived and interpreted by these institutions. In addition to the support of research, the same interpretive process led the Federal Government to develOD a broad range of other programs to improve the quality and availability of health care in the Nation. The Hill-Burton Program which began with the passage of the previously- mentioned Hospital Survey and Construction Act of 1946, together with the National Mental Health Act of 1946, was the first in a series of post-world War II legislative actions having major impact on health affairs. When the 89th Con5zress adjourned in 1966, 25 health-related bills had been enacted into law. Among these were Medicare and Medicaid to pay for hospital and physician services for the Nation's aged and poor; the Comprehensive Health Planning Act to provide funds to each state for non-categorical health planning and to support services rendered through state and other health activities; and Public Law 89-239 authorizing Regional Medical Programs. The report of the President's Commission on Heart Disease, Cancer, and Stroke, issued in December 1964, focused attention on societal needs and led directly to introduction of the legislation authorizing Regional Medical Proarams. Many of the Commission's recommendations were significantly altered by the Congress in the legislative process, but The Act was clearly passed to meet needs and problems identified and given national recognition in the Commissionis report and in the Congressional hearings preceding passage in The Act# Some of these needs and problems were expressed as follows: A program is needed to focus the Nation's health resources for research, teaching and DRAFT DRAFT patient care on heart disease, cancer, stroke and related diseases, because together they cause 70 percent of the deaths in the United States. A significant number of Americans with these diseases die or are disabled because the benefits of present knowledge in the medical sciences are not uniformly available throughout the country. There is not enough trained manpower to meet the health needs of the American people within the present system for the delivery of health services. Pressures threatening the Nation's health resources are building because demands for health services are rapidly increasing at a time when increasing costs are posing obstacles for many who require these preventive, diagnostic, therapeutic and rehabilitative services. A creative partnership must be forged among the Nation's medical scientists, practicing physicians, and all of the Nation's other health resources so that new knowledge can be translated more rapidly into better patient care. This partnership should make it possible for every community's practicing physicians to share in the diagnostic, thera- peutic and consultative resources of major medical institutions. They should similarly be provided the opportunity to participate in the academic environment of research, teaching and patient care which stimulates and supports medical practice of the highest quality. Institutions with high quality research programs in heart disease, cancer, stroke, and related diseases are too few, given the magnitude of the problems, and are not uniformly distributed throughout the country. T',P A Fr .U@r L 6 There is a need to educate the public regarding health affairs. Education in many cases will permit people to extend their own lives by changing personal habits to prevent heart disease, cancer, stroke and related diseases. Such education will enable individuals to recognize the need for diagnostic, therapeutic or rehabilitative services, and to know where to find these services, and it will motivate them to seek such services when needed. During the Congressional hearings on this bill, representatives of major groups and institutions with an interest in the American health system were heard, particularly spokesmen for practicing physicians and community hospitals of the Nation. The Act which emerged turned away from the idea of a detailed Federal blueprint for action. Specifically, the network of "regional centers" recommended earlier by the President's Commission was replaced by a concept of regional cooperative arrangements" among existing health resources. The Act establishes a system of grants to enable representatives of health resources to exercise initiative to identify and meet local needs within the area of the categorical diseases through a broadly defined process. Recognition of geographical and societal diversities within the United States was the main reason for this approach, and spokesmen for the Nation's health resources who testified durin- the hearings strengthened the case for local initiative. Thus the degree to which the various Regional Medical Programs meet the objectives of The Act will provide a measure of how well local health resources can take the initiative and work together to improve patient care for heart disease, cancer, stroke and related diseases at the local level. The Act is intended to provide the means for conveying to the medical institutions and professions of the Nation the latest advances in medical science for diagnosis, treatment, and rehabilitation of patients afflicted with heart disease, cancer, stroke, or related diseases--and to prevent these diseases. The grants authorized by The Act are to encourage and assist in the establishment of regional cooperative arrangements among medical schools, research institutions, hospitals, and other medical institutions and agencies to achieve these ends by research, education, and demonstrations of patient care. Through these means, the programs authorized by The Act are also intended to improve generally the health manpower and facilities of the Nation. In the two years since the President signed The Act, broadly repre- sentative groups have organized themselves to conduct Regional Medical .UKALI I: 7 Programs in more than 50 Regions which they themselves have defined. These Regions encompass the Natio-n's population. They have been formed by the organizing groups using functional as well as geographic criteria. These Regions include combinations of entire states (e.g. the Washington-Alaska Region), portions of several states (e.g. the Intermountain Region includes Utah and sections of Colorado, Idaho, Montana,'Nevada and Wyoming), sincle states (e.g..'Georgia)., and portions of states around a metropolitan center (e.g. the Rochester Region which includes the city and 11 surrounding counties). Within these Regional Programs, a wide variety of organization structures have been developed, including executive and planning committees, categorical disease task forces, and community and other types of sub-regional advisory committees. Regions first may receive planning grants from the Division of Regional Medical Programs, and then may be awarded operational grants to fund activities planned with initial and,tubsequent planning grants. These operational programs are the direct means for Regional Medical Programs to accomplish their objectives. Planning moves a Region toward operational activity and is a continuing means for assuring the relevancy and appropriateness of operational activity. It is the effects of the operational activities, however, which will produce results by which Regional Medical Programs will be judged. On November 9, 1967, the President sent the Congress the @rt on Regional Medical Programs prepared by the Surgeon General of the Public Health Service, and submitted to the President through the Secretary of Health, Education, and Welfare, in compliance with The Act. The ort details the progress of Regional Medical Programs and recommends continuation of the Programs beyond the June 30, 1968, limit set forth in The Act. The President's letter transmitting the ort to the Congress was at once encouraging and exhortative when, it said, in part: "Because the law and the idea behind it are new, and the problem is so vast, the proaram is just emerging from the planning state. But this report gives encouraging evidence of progress--and it promises great advances in speeding research knowledge to the patient's bedside." Thus in the final seven words of the Presidentis message, the objective of Regional Medical Programs is clearly emphasized. DRAFT DRAFT 8 CHAPTER II THE NATURE AND POTEINTIAL OF REGIONAL MEDICAL PROGRAMS GOAL IMPROVED PATIENT CARE Chapter I places the Goal of Regional Medical Programs in its historical context and gives a fuller perspective to Section 900 of the Act (see Appendix I), which defines the Goal in detail. In abbre- viated form, the Goal is described in the Surgeon General's Report as 11 ... clear and unequivocal. The focus is on the patient. The object is to influence the present arrangements for health services in a manner that will permit the best in modern medical care for heart disease, cancer, stroke, and related diseases to be available to all.if MEANS THE PROCESS OF REGIONALIZATION Note: Regionalization can connote more than a regional cooperative arrangement, but for the purpose of Guidelines, the two terms will be used interchangeably. The Act uses "regional cooperative arran,,ement," but "regionalization" has become a more convenient synonym. A regional cooperative arrangement among the full array of available health resources is a necessary step in bringing the benefits of scientific advances in medicine to people wherever they live in a Region they themselves have defined. It enables patients to benefit from the inevitable specialization and division of labor which accompany the expansion of medical knowledge because it provides a system of working relationships among health personnel and the institutions and organ4-- zations in Vnich they work. This requires a commitment o f individual and institutional spirit and resources which must be worked out by each Regional- Medical Program. It is facilitated by voluntary agreements to serve, systematically, the needs of the public as regards the categorical diseases on a regional rather than some more narrow basis. Regionalization, or a regional cooperative arrangement, within the context of Regional Medical Programs has several other important facets: It is both functional and geographic in character. Functionally, regionalization DRAFT JJNRII I 9 is the mechanism for linking patient care with health research and education within the entire region to provide a mutually beneficial interaction. This interaction should occur within the operational activities as well as in the total program. The geographic boundaries of a region serve to define the population for which each regional program will be concerned and responsible. This concern and responsibility should be matched by responsiveness, which is effected by providing the population with a signifi- cant voice in the regional program's decision-making process. It provides a means for sharing limited health manpower and facilities to maxi- mize the quality and quantity of care and service available to the region's population, and to do this as economically as possible. In some instances, this may require inter-regional cooperation between two or among several regional programs. Finally, it also constitutes a mechanism for coordinating its categorical program with other health programs in the region so that their combined effect may be increased and so that they contribute to the creation and maintenance of a system of comprehensive health care within the entire region.1 It is not the intent of a Regional Medical Program grant to supplant either Federal or non-Federal sources of support for various activities related to achieving its purpose. Rather, the Regional Medical Program provides an opportunity to introduce activities which draw upon and effectively link activities already supported, or supportable in the future, through other sources. Current examples of other Federal pro- grams that provide essential inputs into the health resources of the Region are: other activities of the National Institutes of Health, particularly the National Heart Institute, National Cancer Institute, and National Institute of Neurological Diseases and Blindness; other constituents of the Department of Health, Education, and Welfare particularly the Comprehensive Health Planning and Services Proaram in the Office of the Surgeon General, the Bureau of Disease Prevention and Environmental Control, the Bureau of Health Manpower, the Bureau DRAFT -@-I @ 10 Because the advance of care, rationalization can best be viewed as a continuous process rather than a plan which Lt t then implemented. This process of regionalization, or cooperative arrangements, consists of at least the following elements: involvement, identification of needs and opportunities, assessment of resources, definition of objectives, setting of priorities, implementation, and evaluation. While these seven elements in the process will be described and dis- cussed separately, in practice they are interrelated, continuous and often occur simultaneously. Involvement - The involvement and commitment of individuals, organizations and institutions which will engage in the activity of a Regional Medical Proaram, as well as those which will be affected by this activity, must underlie a Regional Program. By involving in the steps of study and decision all those in a reyion who are essential to implementation and ultimate success, better solutions may be found, the opportunity for wider acceptance of decisions is improved, and implementation of decisions is achieved more rapidly. Other attempts to organize health resources on a regional basis have experienced difficulty or have been diverted from their objectives because there was not this voluntary involvement and commitment by the necessary individuals, institutions and organizations. The Act is quite specific to assure this necessary involvement in Regional Medical Programs: it defines, for example, the minimum composition of Regional Advisory Groups. The Act states these Regional Advisory Groups must include "practicing physicians, medica center officials, hospital administrators, repre- sentatives from appropriate medical societies, voluntary health agencies, and representatives of other organizations, institutions, and agencies concerned with activities of the kind to be carried on under the program and members of the public familiar with the need for the services provided under the program." To ensure a maximum opportunity for success, the composition of the Regional Advisory Group also should be reflective of the total spectrum of health interests and resources of the entire reaion. And it should be broadly representative of the geographic areas and all of the socioeconomic groups which will be served by the Regional Program.2 of Health Services, the Social Security Administration, the Office of Education, and the Social and Rehabilitation Service; and other Government agencies, particularly the Office of Economic Opportunity, the Model Citie@;Procram of the Department of Housing and Urban Develop- ment, and the Veterans Administration. New sources of possible support for activities related to a Re-ional Medical Program should be considered during both the planning and operational Dhases. 2 The Regional Advisory Group should provide overall advice and guidance in the planning and operational Program, from the initial steps onward. DRAFT DRAFT Identification of Needs and Opportunities A Regional Medical Program must identify the needs regarding heart disease, cancer, stroke and related diseases within the entire Region. Further, these needs must be stated in terms which offer opportunities for solution. This process of identification of needs and opportunities for solution requires a continuing analysis of the problems in delivering the best medical care for the target diseases on a regional basis, and it must go beyond a generalized statement to definitions which can be translated into operational activity.. Particular opportunities may be defined by: ideas and approaches generated within the Region, extension of activities already present within the Reaion, and approaches and activities developed elsewhere which might be applied with the Region. Among various identified needs there also are often relationships which, when perceived, offer even greater opportunities for solutions. The danger of "project vision," which is akin to tunnel vision, must be guarded against. In examining the problem of coronary care units throughout its Region, for example, a Regional Program may recognize that the more effective approach would be to consider the total problem of the treatment of myocardial infarction patients within the Region. This broadened approach on a regional basis enables the Regional Program to consider the total array of resources within its Region in relationship to a comprehensive program for the care of the myocardial infarction patient. Thus, what was a concern of individual hospitals about how to introduce coronary care units has been transformed into a project or group of related projects with much greater potential for effective and efficient utilization of the Region's resources to improve patient care. Assessment of Resources - As part of the process of regionalization, a Region must have continuously updated inventory of existing resources and capabilities in terms of function, size, number and quality. Every effort should be made to identify and use existing inventories, filling in the gaps as needed, rather than setting out on a long, expensive It should be actively involved in the review and guidance and in the coordinated evaluation of the ongoing plannino, and operatilia functions. It should be constituted to encourage cooperation among the institutions, organizations, health personnel, and state and local health agencies such as the health plannina bodies beina established under the Compre- hensive Health Planning Program, Public Law 90-174. It should be concerned with continuing review of the degree of relevance of the planning and operational activities to the objectives of the,Regional Medical Program and particularly with the effectiveness of these activities in attaining the goal of improved patient care. The Advisory DRAFT 12 process of creating an entirely new inventory. IInformation sources include state and local health planning agencies, hospital and medical associations, and voluntary agencies. The inventory provides a basis for informed judgments and priority settinc, on activities proposed for development under the Regional Program. It can also be used to identify missing resources--voids requiring new investment--and to develop new configurations of resources to meet needs. Definiti on of Objectives - A Regional Program must be continuously- involved in the process of settina operational objectives to meet identified needs and opportunities. Objectives are interim steps toward the Goal defined at the beginning of this Chapter, and achievement of these objectives should have an effect in the Region felt far beyond the focal points of the individual activities. This can be one of the greatest contributions of Regional Medical Programs. The completion of a new project to train nurses to care for cancer patients undergoing new combinations of dru- and radiation therapy, for example, should benefit cancer patients and should provide additional trained manpower for many hospitals in the Region. But the project also should have challenged the Region's nursing and hospitals communities to improve the continuing and in-service education opportunities for nurses within the Region. Setting of Priorities - Because of limited manpower, facilities, financing and other resources, a Region must assign some order of priority to its objectives and to the steps to achieve them. Besides the limitations on resources, factors to consider include: 1) balance between what should be done first to meet the Region's needs, in absolute terms, and what can be done using existing resources and compe- tence; 2) the potentials for rapid and/or substantial progress toward the Goal of Regional Medical Programs and progress toward regionalization of health resources and services; and 3) Program balance in terms of disease categories and in terms of emphasis on patient care, education and research. I!npleriientation - The purpose of the preceding steps has been to provide a base and imperative for action. In the creation of an initial Group does not have direct administrative responsibility for the Pro- gram, but the clear intent of the Congress was that the Advisory Group would insure that the Regional Medical Program is planned and developed with the continuing advice and assistance of a group which is broadly representative of the health interests of the Region. The Advisory Group is expected to prepare an annual statement giving its evaluation of effectiveness of the regional cooperative arrangements established under the Regional Medical Proaram. DRAFT DRAFT 13 operational program, no Region can attempt to determine all of the program objectives possible, design appropriate projects to meet all the objectives and then assign priorities before seeking a grant to implement an operational program which encompasses all or even most of the projects. Implementation can occur with an initial operational program encompassing even a small number of w.ell-designed projects which will move the Reaion toward the attainment of valid program objectives. Because regionalization is a continuous process, a Region is expected to continue to submit supplemental and additional operational proposals as they are developed. After the implementation of an operational procram, there are two potential threats to be avoided. One is that projects will lose their regional identities by becoming institutional projects, and thereby cancel the opportunity for the operational program to have Regional scope and effect. The other threat is that projects will lose the relationships one to another which maintain the interaction of patient care, education and research. Preventin- these breakdowns requires project and program administration-of a high order; it also requires sustained communications, involvement, and the application of evaluation procedures. Evaluation - Each planning and operational activity of a Region, as well as the overall Regional Program, should receive continuous, quantitative and qualitative evaluation wherever possible. Evaluation should be in terms of attainment of interim objectives, the process of regionalization, and the Goal of Regional Medical Programs. Objective evaluation is simply a reasonable basis upon which to determine whether an activity should be continued or altered, and, ultimately, whether it achieved its purposes. Also, the evaluation of one activity may suggest modifications of another activity which would increase its effectiveness. Evaluation implies carryina out whatever is feasible within the state of the art and appropriate for the activity being evaluated. Thus, evaluation can range in complexity "Prom simply counting numbers of people at meetings to the most involved determination of behavioral changes in patient management. As a first step, however, evaluation entails a realistic attempt to design activities so that, as they are implemented an fina y conc u e some data will result which wil be useful in deter-mining t e dearee o success attained by the activity. DRAFT DRAFT 14 Criteria - Evaluation of Re2i'onal Medical Prog ram The criterion for judging the success of a Region in implementing yh'e process of regionalization is the degree to which it can be demonstrated that the Regional Program has implemented the seven essential elements discussed in this Chapter: involvement, identification of needs and opportunities, assessment of resources, definition of objectives, settina of priorities, implementation, and evaluation. Ultimately, the success of any Regional iledical Program must be judged by the extent to which it can be demonstrated that the Reaional Program has assisted the providers of health services in developing a system which makes available to everyone in the Reaion improved care for heart disease, cancer, stroke, and related diseases. 15 CHAPTER III GRANT 'POLICIES I. ELIGIBLE APPLICANT Public or nonprofit private universities, medical schools,- research'institutions and other public or nonprofit private agencies and institutions are eligible to apply for a grant to plan and/or operate a Regional Medical Program. Each applicant must be authorized to represent the agencies and institutions which propose to cooperate in plannin,a for and development of the Regional Program. Additionally, each applicant must be able to exercise program coordination and fiscal responsibility (see agreement of affiliation, Chapter III, p. 26,). Finally, each applicant in order to be eligible must have designated a Regional Advisory Group to advise the applicant (and those agencies and institutions which propose to cooperate in the Regional Medical Program) in the planning and operation of the Program. It may be necessary for the agencies and institutions pro- posing to cooperate in the the Program to create a nonprofit corporation to act for them as the applicant, to maximize the extent to which effective program and fiscal coordination can be exercised in the implementation of the Regional Program. II. TYPES OF GRANTS Planning - Section 903 of The Act authorizes the Surgeon General, upon recommendation of the National Advisory Council on Regional Medical Programs, to make grants to assist in the planning and development of Regional Medical Programs. Operational - Section 904 of The Act authorizes the Surgeon General, upon recommendation of both the Regional Advisory Group and the National Advisory Council on Regional Medical Programs, to make grants to assist in the establishment and operation of Regional Medical Programs. The planning activities which are initially funded under the provisions of Section 903 may be continued and expanded as an integral part of the operational activities of each Region and as such may become a part of the Region's operational grant under Section 904. However, operational activities may not be supported from planning grant funds. n-D A rlr 16 Recognizing the necessity for each Region to,plan ahead, the various Regional Medical Programs are encouraged to consider their phasing according to the nature and extent of the activities involved up to a maximum of five years. The counittment for support beyond June 30, 1969, is based upon anticipated renewal of the Regional Medical Program's authorizing legislation and is predicated on the annual appropriation of.funds by the Congress. Commitments beyond the terminal dates of legislation-- both appropriations and authorizing legislation--are delimited by the phrase, irwithin the limits-of available funds," written into the regulations and on the award statements issued by the Division. III. THE REGIOIN-AL ADVISORY GROUP The Act specifies that an applicant for a planning grant must designate a Recional Advisory Group. The Act also specifies that the Advisory Group must approve an application for an operational grant under Section 904. The Advisory Group must include practicing physicians, medical center officials, hospital administrators, representatives from appropriate medical societies, other health professions, voluntary health agencies, and representatives of other organizations, institutions, and agencies and members of the public familiar with the need for the services provided under the Program ' It should also be broadly representative of the geographic area and of the social groups who will be served by the Regional Medical Program. The Regional Advisory Group should provide overall advice and guidance to the grantee in the planning and operational program from the initial steps onward. It should be actively involved in the development of the Regional objectives, as well as the review, guidance, and coordinated evaluation of the ongoing planning and operating functions. It should be constituted to encourage cooperation among the institutions, organizations, health personnel, state and local health aaencies. It should be concerned with continuing review of the degree of relevance of the planning and operational activities to the objectives of the Regional Medical Program and particularly with the effectiveness of these activities in attaining the objective of ,improved patient care. Therefore, Advisory Group members should be chosen who will provide a broad background of knowledge, attitudes and experience. To serve these purposes, the Advisory Group should operate under established procedures which insure continuity and appropriate independence of function and advice. It should formally consider what its specific duties and responsibilities shall be, including such things as the frequency of its meetings and appropriate methods for the replacing of retiring members. DRAFT 17 The Advisory Group, through the grantee, must submit to the Division of Regional Medical Programs an annual statement giving its independent evaluation of effectiveness of the regional cooperative arrangement (regionalization) established under the Regional Medical Program. IV. ASSURANCES General Responsibilities - The grantee is obligated, both for itself and each affiliated institution, to administer the grant in accordance with regulations (Appendix II) and policies of the Division of Regional Medical Programs. lqhere a policy is not stated or where the institutional policy is more restrictive than the Regional Medical Program policy, institutional policy prevails in that institution. ,General Assurances - Specific attention is directed to the requirement to honor the assurances provided in The Act. The recipient of a planning grant must comply with the assurances in Section 903(b), namely: reasonable assurances that Federal funds paid pursuant to any such grant will be used only for the purposes for which awarded and in accordance with the applicable provisions of The Act and the regulations thereunder, reasonable assurances that the applicant. will provide for such fiscal control and fund accounting procedures as are required by the Surgeon General to assure proper. disbursement of and accounting for such Federal funds. reasonable assurances that the grantee will make such reports in such form and containing such information as the Surgeon General may from time to time reasonably require, and will keep such records and afford such access thereto as the Surgeon General may find necessary to assure the correctness and veri- fication of such reports, and 18 a satisfactory showino, that the applicant has designated an advisory group to advise the applicant (and the institutions and agencies participating in the resulting Regional Medical Program) in formulating and carrying out the plan for the establish- ment and operation of such Regional Medical Program, which advisory group includes practicing physicians, medical center officials, hospital administrators, repre- sentatives from appropriate medical societies, voluntary health agencies, and representatives from other organizations, institutions and agencies concerned with activities of the kind to be carried on under the Program and members of the public familiar with the needs for the services provided under the Program. The recipient of an operational grant must comply with the assurances under Section 904(b), namely: Federal funds paid pursuant to any such grant (A) will be used only for the purposes for which paid and in accordance with the applicable provisions of this title and the regulations thereunder, and (B) will not supplant funds that are otherwise available for establishment or operation of the Regional Medical Program with respect to which the grant is made; the applicant will provide for such fiscal control and fund accounting procedures as are required by the Surgeon General to assure proper disbursement of and accounting for such Federal funds; the applicant will make such reports, in such form and containing such information as the Surgeon General may from time to time reasonably require, and will keep such records and afford such access thereto as the Surgeon General may find necessary to assure the correctness and verification of such reports; and any laborer or mechanic employed by any contractor or subcontractor in the performance of work on any construction aided by payments pursuant to any grant under this section will be paid wages at rates not less than those prevailing on similar construction in the locality as determined by the Secretary of Labor in accordance with the Davis--Bacon Act, as amended (40 U.S.C. 276a--276a-5); and the Secretary of Labor shall have, with respect to the labor 19 standards specified in this paragraph, the authority and functions set forth in Reorganization Plan Numbered 14 of 1950 (15 F.R. 3176; 5 U.S.C. 133z-15) and section 2 of the Act of June 13, 1934, as amended (40 U.S.C. 276c). V. ELIGIBLE ACTIVITIES Categorical Emphasis - The focus of Regional Medical Programs under the authorizing legislation is on problems of heart disease, cancer, stroke and related diseases.- This broad categorical approach must be a consideration in the development of specific Program elements under a Regional Medical Program. Because of the broad scope of heart disease, cancer, and stroke, it would be difficult and perhaps detri- mental to some types of medical services and educational. activities if a ri-idly categorical approach were adopted for all relevant Program elements. The emphasis of the Program does require that the component elements be shown to have significance for combating heart disease, cancer, stroke and related diseases throu-h a regional effort intended to improve the care of all those persons within the region suffering from one of these diseases. However, in some instances, activities which have a more general impact extending beyond the specific problems of heart, cancer, stroke and related diseases may need to be supported. because they are essential to the achievement of the purposes of Regional Medical Programs. The objective of improved patient care for those suffering from these categorical diseases will require the full development of the process of regionalization, particularly in the Program's operational phases. Therefore, individual, categorical activities should be designed and implemented in ways which will insure their regional rather than organizational or institutional identity. 'Core Support - The central administration and coordination of a Regional Medical Program represents the administrative heart of the Program, and as such is an activity eligible for grant support. The salaries of the Proaram Coordinator and his staff as well as other costs incident to the central administration and coordination of the Program may be charged to the grant. Research - Research activities which are integral to the purposes and objectives of the Regional Medical Program are eligible for support i DRAFT 20 and their costs may be paid by grant funds. Such research activities in order to be eligible must contribute to the process of regionalization and the goal of improved patient care the Program seeks to achieve. Demonstrations of Patient Care - Demonstrations of patient care may be supported when related to the objectives of the Regional Medical Program. The Act provides that the costs of patient care may be supported-only when such care is incident to research, training, or demonstration activities encompassed by the purposes of the Program and only if the patient has been referred by a practicing physician. Such demonstrations must contribute to the process of regionalization and the goal of improved patient care which the Regional Program is seeking to achieve. Grant funds may be used to pay the other costs incident to the demonstration activity, including staff and equipment. Training and Continuing Education - Continuing education and training programs for medical., allied health personnel and associated professions which are part of integrated comprehensive approaches of enhancing regional capability for the daignosis and treatment of heart disease, cancer, stroke, and related diseases are eligible for support. However, it should be emphasized that the primary intent of the leais- latio-n in this area is the support of those activities that are beyond those normally accepted as basic preparation for work in the health field. Thus, if one is to make assessment of needs for educations programs, this assessment must be based on the system of health care, the role of the learner, and his needs. In medical education, attenti6n must be focused directly on the questions: "Will this effort to change behavior result, in fact, in the patient receiving the maximum benefit of modern knowledge?" Grant funds may be used for innovative training approaches and the development of new types of health personnel or new arrangements of health personnel to meet the Region's goal of improved patient care for those suffering from heart disease, cancer, stroke, or related diseases. Systems Analysis - The use of systems analysis methodologies in Regional Medical Programs is eligible for crant support, but only to such an extent as it is considered applicable as an essential integral component of the individual Program proposed by the applicant. The applicant should emphasize the development of innovative, adequately formulated studies of realistically restricted problems involving the application of "systems" methodologies rather than submit an application dominated by general proposals for the utilization of large scale systems" approaches for the desi,,n of a Regional Program. These methodologies may be applied to either or both planning and operational activities. Communications and Public Information - A communications and pu lic information component can be included as an integral part of a Regional Medical ProQram. A qualified communications and public information specialist and necessary supporting staff may be employed to utilize all established commun4cations and informational techniques to assist in the development of Regional Proaram activities which will achieve understanding, DRAFT acceptance, support and cooperation of institutions, organizations and individuals in the initial growth period of the Regional Program. Then, in the operational phase, this staff can mount an additional effort toward these same ends which will not only maintain these relationships, but expand them to include all participating and benefitting publics. Activities that do not specifically advance understanding, acceptance, support and cooperation, or which would appear to provide only for publicity for the Prooram and ag-randisenient of its officials, shou d not be included. VI. SPECIFIC REQUIREINIENTS Discrimination Prohibited Section 601 of Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d, provides that no person in the United States shall, on the ground of race, color, or national origin, be'excluded from Darticipation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance. Regulations implementing the statute have been issued as Part 80 of Title 45, Code of Federal. Regulations. The Regional Medical Programs provide Federal Regulations. The Regional Medical Programs provide Federal financial assistance subject to the Civil Rights Act and the regu ations. It is the responsibility of the grantee to insure that each affiliated agency (institution) which proposes to cooperate in the Regional Medical Program is in compliance with Section 601 of Title VI of the Civil Rights Act of 1964. The grantee shall maintain a copy of the form which insures that each affiliated agency (institution) is in compliance. Each grant for construction (alterations and renovations) is subject to the condition that the grantee shall comply with the requirements of the Executive Order 11246, 30 F.R. 12319 and the applicable rules, regulations, and procedures as prescribed by the Secretary of Labor. Institutional Assurance Involving Human Subjects - An application for a Regional Medical Program grant which includes investigations involving human subjects will not be accepted for review unless the Public Health Service has approved a plan (known as Institutional Assurance on Investigations Involving Human Subjects, Including Clinical Research and Investigations in the Behavioral and Social Sciences) for insuring that the institution conducting the research has complied with the Public Health Service policy concerning research involving human subjects. It will be the responsibility of the grantee to insure that the individual affiliated institutions) which will be involved in these investigations secure the approval from the Public Health Service and to provide a copy of the approval to the Division of Regional Medical Proarams. C, 22 A copy of the Instructions 'for obtaining Public Health Service approval may be obtained by writina the Grants Review Branch, Division C, of Regional Medical Programs, National Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20014. Surveys or Questionnaires - Surveys or questionnaires arising from and supported by a grant should include a positive.statement clearly setting forth that the contents are in no way the responsi- bility of the Public Health Service. Publications - Grantees and/or their affiliated institutions may publish materials relating to their Regional Medical Program without prior review provided that such publications carry a footnote acknowledging assistance from the Public Health Service, and indicating that findings and conclusions do not necessarily represent the views of the Service. Patents and Inventions - The Department of Health, Education and Welfare regulations (945 F.R., Part 6 and 8) provide as a condition that all inventions arising out of the activities assisted by Public- Health Service Grants must be promptly and fully reported to the Public Health Service. Any process, art or method, machine manufacture or improvement thereof, may constitute an invention if it is new and useful and would not have been obvious to a person havina skill in the art to which it relates. In order for the Public Health Service to carry out its responsi- bility under these patent regulations, it is essential that the Service be advised before awarding Government fun s of any commitments or obligations made by the institutions or by the professional personnel to be associated with the activities carried on under the grant which would be in conflict with the inventions agreement. When submitting an application for Regional Medical Programs, the grantee must provide in letter form either: a. a statement indicating no previous commitments or obligations have been made, or b. a detailed explanation of such commitments or obligations where they do exist. DRAFT DRAFT 23 One such letter will suffice for the named grantee and all affiliated institutions receiving support under the grant. It is the responsibility of the institution named as the grantee on the application to ascertain the facts relating to patents and to report these on behalf of all affiliated organizations in the Regional Medical Proaram. 0 In subsequent years an annual invention statement form PHS-3945 must be filed whether or not an invention has occurred. Where there are no inventions to report, a single form PHS-3945 is all that is required for the institution named on the application as the grantee and for all affiliated institutions. Where there are inventions to report, a separate annual invention statement must be filed for each one. Here again, it is the responsibility of the grantee to report on behalf of itself and all other affiliated organizations in the Regional Medical Program. The Regional Medical Program grant for the next year will not be issued until the invention statement form PHS 3945 has been received by the Division.of Regional Medical Programs. Animal Care - Each person assigned or appointed to an activity receiving any Public Health Service support is required to exercise every precaution to assure proper care and humane treatment of research animals. The booklet, Guide for Laboratory Animals, Facilities and Care (PHS Publication #1024) should be obtained from the Division of Research Grants, Information Office, National Insti- tutes of Health, Bethesda, Maryland, 20014. The Public Health Service endorses the following guiding principles in the care and use of animals: (1) Animals should be acquired, retained, and used in compliance with applicable state and local law. (2) Animals should receive every consideration for their bodily comfort, be kindly treated and properly fed, be kept in sanitary facilities, and be provided with suitable medical care. (3) -With any operation likely to cause greater discomfort than that attending anesthetization, the animal should first be rendered incapable of perceiving pain and should be maintained in that condition until the operation is ended. Exceptions should be made only when anesthesia would defeat the ob4ective of the experiment. j In such cases, the anesthesia should be discontinued only so long as it is absolutely essential for the necessary observations. (4).If the nature of the study requires survival of the animal, aseptic precautions should be observed during the operation, and care should be taken to minimize discomfort durina convalescence T'it) A LIrl DRAFT 24 comparable to precautions taken in a hospital for human beings. If the animal is severely incapacitated and survival is not a requirement of the experiment, the animal should be sacrificed in a humane manner immediately following final observation. Changes in Approved Program - The Division of Reaional Medical Programs does not intend to interfere with administrative or program flexibility which serves the objectives of the Regional Medical Programs. If, however, a change is determined by the arantee to be desirable, and if that change would constitute a substantial change in the nature of the Proc,ram originally approved, the arantee must consult with the Division of Regional Medical Programs staff. No substantial change in the approved Program can be made without the specific written approval of the Division of Regional Medical Programs. Requests for such approva must e su - mitted in an Application for Revision (page 42). ChanRe in Program Period - The Program period may be extended up to 12 months without additional funds, if requested by the grantee before the end of the ProQram period. Change of Pro.2ram Coordinator - A change of Program Coordinator or other key official directing the Program requires the written approval by the Division of Regional Medical Programs. Notification,to the Division of Regional Medical Programs of such a proposed chan-e must be signed by at least one of the two persons who signed the original appli- cation. A curriculum vitae for the newly appointed official should accompany the notification of chance. Chan.2e of Grantee Organization - If for any reason the grantee organization proposes to relinquish its responsibility for a Regional Medical Program grant, it must immediately notify the Division of Regional Medical Programs. For example, a region may wish to create a non-profit corporation especially for the purpose of becoming the grantee organization. Any change of grantee organization requires that a terminal progress report, an expenditures report, and an invention statement (PHS 3945) be submitted to the Division of Reaional Medical Programs. If the grantee terminates its responsibility for the Regional- Medical Program, the new institution/corporation must submit a new grant application for the remainder of the program period. The application should include the reasons for transferring the Program and the probable effect of the move on the Regional Proaram. Administrative approval may be given by the Division of Regional Medical ProQrams to continue the Proc,ram with a new arantee. Applications, however, that reflect major Program changes will be referred to the National Advisory Council on Regional Medical Programs for recommendation. DRAFT 'U@r I 25 Early Termination of Grant.- (1) By the Grantee - A grant may be terminated or cancelled at any time by the grantee upon written notification to the Division of Regional Medical Programs stating the reasons for termination. (2) By the Public Health Service - A grant in whole or in part, may be revoked or terminated by the Surgeon General at any time within the program period whenever it is determined that the grantee has failed in a material respect to comply with the terms and conditions of the grant. Single Grantee - In order to insure regional cooperation, there can be only a sin(,le grantee organization for each Regional Medical Program. Reports - All reports required to be submitted to the Public Health Service should be sent to the Division of Regional Medical Programs, Public Health Service, Bethesda, Maryland 2obl4. A. Progress Reports - The grantee is required to submit an annual progress report for each grant. This report(s) should contain sufficient detail to inform the reader of the accomplishments with particular respect to the objectives and must be submitted with the application for continued support. in addition, grantees may be required to supply other information needed for guidance and development of the national program and are encouraged to report significant . developments promptly at any time. A terminal progress report must be submitted to the Division of Regional Medical Programs within three months of the termination of the program period. Specifically, the report must describe the ways in which the process of regionalizat4-on as described in Chapter II has moved the Regional Program toward its goal of improved patient care for all those within the Region,suffering from heart disease, cancer, stroke, or related diseases. The report must also include: (1') principal staff members - names and positions (2) organization of the Regional Medical Program (3) membership and functions of the Regional Advisory Group (4) names of all cooperating agencies/institutions and their relationship to the Regional Medical Program (5) description of planning activities (6) description of operational activities, if any (7) description of interregional activities, if any (8) the extent to which the planning and operational activitieslof the Program are supported by non- Federal funds DRAFT 26 B. Regional Advisory Group PeDorts - The Regional Advisory Group is expected to prepare an annual statement on the effectiveness of the regional cooperative arran-e.-Lerits (regionalization) established under the Regional Medical Program. The report, signed by the Chairman of the Regional Advisory Group, signifying its approval, shou'1 e submitted to the Division of Regional Medical ProaraTns by the grantee along with the annual progress report. Periodic reviews of grants by the staff.of the Division and the Advisory Council will include con- sideration of the effectiveness of the Advisory Group. VII. FINLNCIAL Mt@NAGFi%IENT General Requirements - Federal funds awarded pursuant to either a Planning or operational arant are to be used only for the purposes for which awarded and in accordance with the provisions of the Act (Appendix I), its regulations (Appendix II), and these Guidelines. Additionally, Federal funds awarded pursuant to an operational grant may not be used to supplant funds that are otherwise available for the establishment or operation of the Regional Medical Program with respect to which the grant is made. Funds granted @a be used only for services, materials and other y items required to carry out the approved program. Circular A"21 of the Bureau of the Budget should be used to the extent practicable in determining allowable costs related to the grants for Reaional Medical Programs. Where the Division of Regional Medical Programs requires prior approval for items not listed in the approved budget, a written request must be made by the grantee to the Division of Regional MedicaI Programs in advance of the performance of the act which requires the obligating or expenditure of funds. Agreement of Affiliation By accepting a Regional Medical Program grant, the grantee has accepted certain responsibilities enumerated on pages 17-19 of this Chapter. Fiowever, the Reaional Medical Program activities will necessitate the expenditure of arant funds by a.,number of different institutions, organizations, and a@encies in addition to the grantee. in order to assure appropriate accountability for expen- diture of grant funds by these additional aoencies, an agreement of affiliation must be signed by-each affilial@ii@o, agency and the grantee, w'no represents the Regional Medical Program. This agreement, at a mini- mum, must include provisions which will insure that the grantee can carry out the assurances required by the Act in Sections 903(b) and 904(b) and that the grant --Funds provided to each affiliated agency will be administered by that agency in accordance with the Act, the regulations, and applicable policies of the Division of Regional Medical Programs. Di'\.A-@T 27 The Division also encourages the Regional Medical Program to include in such agreement any provisions relating to the conduct and development of the Regional Medical Programs as may be appro- priate and desirable for the achievement of the purposes of the Program as outlined in these Guidelines. The advice and counsel of the Reaional Advisory Group should be sought in developing such provisions. Allowable Direct Costs A. Personnel Costs - Salaries, wages, and fringe benefits of personnel in proportion to the time or effort expended on activities of the Regional Medical Program may be charged to the grant. These costs must be in accordance with applicable institutional policies, and adequate time and effort records must be maintained in order to sub- stantiate these costs. Salaries of personnel whose full time is devoted to the Regional Medical Program should not exceed the salaries of full-time administrative personnel in positions of comparable responsibility in major medical institutions in the Region. Specifically, if a new corporation is organized to serve as the grantee, it must establish salary policies which apply to its personnel under the above policies and which do not exceed equivalent salaries in the major medical institutions in the Region. Any question concerning the appropriateness of particular salaries or exceptions to these polities should be discussed with the Division staff. B. Consultant Services - Re-ional Medical Program grant funds may be used to pay consultant fees and supporting costs such as travel, and per them in payment for services related to any Program element of a Regional Medical Procram, providing that these services are the most effective means of accomplishing a particular purpose. If consultation is obtained from a salaried staff member of the grantee or an affiliated institution, that institution may be reimbursed for a proportionate amount of his regular salary from -rant funds. Proaram records must indicate the total cost and include a statement of activities. Where ustified by unusual circumstances, a salaried staff member of the grantee or an affiliated institution who is not receiving salary support from the grant, DRAFT 28 may be engaged as a consultant, but only with the prior approval of the Division of Regional Medical Programs. The request for approval must be supported by a clear state- ment of services to be performed and the expected number of days of service involved. Grant funds may not be used to pay fees and supporting costs to U.S. Government.employees, regardless of their employment or pay status. C. Training Activities ,.(l)@Selection of Trainees - Selection of trainees is the responsibility of the Region. The Division of Reaional Medical Programs must be notified of the number and kinds of tra inees that start And complete a training program. Training activities are eligible for grant support according to the following general conditions: a. Training Confereiices'and Seminars: No sti ends may p be paid for presentations which are planned for full-time participation for periods from one full day to five consecutive days or intermittently on a regular basis. However, travel and other expenses associated with these presentations may be paid. b. Short-Term Training: These activities include full- time training programs for more than five consecutive days but not more than a single academic session (quarter or semester). For allied health trainees either a stipend may be paid or the trainee may be reimbursed in accordance with a maintenance of income principle which would have the effect o@l-re-:Lilbursing the trainee at the level of his individual salary. Physician and dentist trainees may be reimbursed at a rate not to exceed $50.00 per day. Travel and other expenses associated with §hort-term trainin- programs may be paid for any trainee. c. Long-Term Training: These activities include training programs requiring full-time participation for more than a single academic session (quarter or semester). Stipends and travel expenses may be paid DRAFT 29 to those enrolled in long-tern, training programs. These stinends vary according, to the level of training and are consistent with other equivalent Public Health Service training proarams. Detailed information and policies concerning all eligible training activities will be supplied upon request by the Division of Regional Medical Proarams. D. Patient Care Costs (Hospitalization) - The cost of hospital care of patients.is paya.ble.from grant funds only to the extent that such care is incident to research, training, or demon- stration activities supported by the grant (Chapter III, page 20). If grant funds are used to support costs associated with hospitalization the grantee must document -that the patient has-been referred by a- practicing physician, including his name, the name of the patient, and the date of referral. @The calculation of a rate of.reimbursement will be according to established Public Health Service policies which can be made available to the grantee upon request. E. Transportation of Patients - When justified as the most efficient means of carrying out the purpose of the Program, Qrant funds c' may be used to Day the costs of transportation of patients referred for diagnosis and treatment in other institutions as part of a research, training or demonstration program. The use of grant funds to pay transportat,ion,costs should be carefully weighed against the use of funds for other activities within the Regional Medical Program. F. Alterations and Renovations - To the extent that other sources of Federal and :non-Federal funds are not readily available to the applicant for such purposes, ninety percent of the costs of construction, i.e., alteration, remodeling and renovation of existin- buildings (including initial equipment thereof) and replacement of obsolete built-in equipment of the types customarily included in a construction contract, may be paid for by operational grant funds The applicant is required to furnish a narrative description to indicate the need, nature and purpose of the proposed alterations and renovations, and in appropriate instances, detail the-plans and specifications. The amount of the alteration and renovation costs requested as part of a Division of Regional Medical Pro-rams grant determines the types of supporting documents to be submitted by the applicant. Applicants are referred to the procedures and regulations set forth in-the "Regional Medical Programs--Alterations and Renovations Guide." G. Electronic Communication Systems - A grant may support the purchase or rental of electronic communication systems such as special telephone lines, radio and television, to be used for educational, diagnostic or other purposes. However, if such requests represent major .Uf@ll i 30 funding investments, they should include documentation of: the planned measurements of effectiveness of the activity; the numbers of people affected by the system; the dearee to which the proaram content and.experience micht be generalized to other Re,-ional Medical Pro,:,rams; and knowledge of related efforts already accomplished by others with indications as to how the proposed activity will extend those efforts. E. Telephone, Postage and Similar Services That portion of telephone, postace and other such services necessary to the planning or implementation of the Regional Program may be charged to the crant. In no case may institutional local and regular monthly telephone costs and normal postage.costs not related to the Regional Medical Programs be charged to the grant. I. Design, Printing and Reproduction The costs of pamphlets 'brochures and other necessary materials may be charged to the grant. J. Equipment - Rental and purchase of equipment, including diagnostic and treatment equipment, for the planning or implementation of a program may be charged to the grant. When acquiring equipment, consideration of the relative advantage of lease versus purchase should be considered. K. Computers - Grant funds may be used to purchase computer time, or if the needs of the proaram are sufficient, the rental-of a comDtter. As with all other activities, the costs of acquiring computer capability must be measured against the benefits to be derived. L. Travel - Per dierii reimbursements to travelers, personal transportation charges, and reimbursements for authorized use of personally owned automobiles are chargeable to the grant.. If a corporation is established.for the purpose of becoming the grantee, it must establish travel policies which apply to its personnel under the above policy and which do not exceed the equivalent travel policies of the major medical institutions in the Region. Less than first class travel accommodations shall be used except in extenuating circumstances. Automobile mileage and any foreian travel must be in accordance with institution policy. Any forei.@n travel must receive prior approval from the Division of Regional Medical Programs. M. Rent The expenses or rental of facilities not owned by the crantee or affiliated institution may be charged in proportion to the space actually utilized for the Regional Program activity Rental costs may not be in excess of comparable rentals in the parti- cul,-r locality, and must be in accordance with institution policy. D P-A. i'T DRAFT 31 Direct Costs Not Allo@qed - The following direct costs or charges are not allowable: (1) Honoraria as distinguished from consultant fees (2) Entertainment (cost of amusement, social activities, entertainment and incidental costs thereto, such as meals, lodging, rentals, transportation and gratuities) (3) Payment to Federal employees (4) Petty cash funds (5) Subgranting (a subgrant is any allocation of grant funds by the-grahtee to other individuals or organizations for purposes over which the grantee institution named on the application does not maintain scientific and financial responsibility. A grantee may contract for services, but may not subgrant). Indirect-Costs - Regional Medical Program indirect cost rates will be established by or in coordination with the Division of Grants Adminis- tration Policy of the Department of Health, Education, and Welfare utilizing either rates already established by that office or data taken directly from the grantee or affiliated institutions most recent annual financial report and immediately available supporting information will be utilized as a basis for determining the indirect cost rate applicable to a Re-ional Medical. Program grant at the institution. 9 Total expenditures as taken from the most recent annual financial report will be adjusted by eliminating from further consideration the following items or categories of expenditure: (1) The costs of equipment, buildin-s, and repairs which materially increase the value or useful life of buildings or equipment. However, depreciation and use charges may be included in determine total expenditure. (2) Advertisiny other than for recruitment of personnel, 0 precureme-@it of scarce items-or.the disposal-of scrap or surplus material. (3) Bad debts @C4,-,Contingency reserves (5) Co@,encement and convocation costs k'6) Enterta@A-iment costs bP@FT DRAFT 32 (7) Fines and penalties (8) Interest, fund raising and investment management costs (9) Losses on other agreements or contracts (10) Profits and losses on disposition of plant, equipment, or other capital costs (11) Public information services costs (12) Scholarships and student aid costs (13) Special services costs incurred for general public relations (14) Student activity costs (15) Student dormitory costs (16) Student services costs (17) Costs used in arrivinc, at a hospitalization rate or interdepartmental charge (18) Unrelated hospital costs (19) Other inappropriate costs. Where any types of expense ordinarily treated as general administrati.b n and general expenses or departmental administration expenses are charged to a Division of Regional Medical Programs,grant as direct costs, the similar type of expenses applicable to other activities of the insti- tution must, through separate cost groupings, be excluded from the allowable indirect costs. The indirect cost rate will then be computed by dividing the total direct salaries and wages paid by the institution into the total adjusted indirect cost incurred by the institution. When, under an operational grant, the affiliated institutions are preparing their budgets for submission to the grantee, the institutions indirect cost rates, based on salaries and wages, should be stated in the budget. To substantiate this rate, the affiliated institutions should supply the grantee with adequate substantiating data, such as documents certifying that the overall institutional indirect cost rate has been audited and approved by the PHS, another Government agency, or an independent accounting firm. In addition, the total institutional i-ndirect cost, and direct salaries and wades should be stated as separate amounts. The institution should indicate whether fringe bene its are included in the salary and wage base or not. A detailed indirect cost DRAFT 33 proposal should accompany each new or continuing grant application. When an applicant is submitting a planning arant application to the Division of Regional Medical Programs, the above procedures also apply. Indirect costs are those which, because of their incurrence usually for common or joint objectives, are not readily identified with individual projects. -All costs re resenting char es associated p 9 with the activities of the grantee or affiliated institutions which are supportive of the conduct of the Regional Medical Program, except those which are specifically approved by the Division of Regional Medical Programs as direct costs, are classified as indirect costs. The general types of indirect costs are: (1) General administration and expenses which are incurred for the executive and administrative offices of an institution receiving grants, and other expenses of a general character which do not relate solely to any specific unit in the institution, or to any specific project in the institution; (2) Program administration expenses which apply to Program activities administered in whole or in part by a separate organization or an identifiable administrative unit. Examples of work relating to grant activities which are somet imes performed under such organizational arrangement are: grant administration, purchasing, personnel, accounting, etc.; (3) Operation and maintenance expenses incurred for operating and maintaining an institution's physical plant, including expenses normally incurred for administration or supervision of the physical plant; janitorial service; utilities, including telephone installation and maintenance costs; and other expenses customarily associated with the operation, maintenance, preservation, and protection of the institution's physical facilities-, (4) Reimbursements and other receipts from the Federal Government which are used by the institution to support directly, in whole or in part, any of the administrative or service (indirect) activities received pursuant to an institution's base grant or any similar contractual arrangement with t'ne-Federal Government shall be treated as a credit to the total indirect cost pool. Such set-off shall be made prior to the determination of the indirect cost rate submitted to the Division of Regional Medical Programs. These credits include indirect cost reimbursements conta 4ned in payments for hospitalization, interdepartmental charges and centralized facilities operated by the institution. R of Funds The grantee or affiliated institutions with the full knowledge and approval of the grantee may depart from the approved budget after retei-vin- the written approval of the Di.vis-i-on of i. -Regional Medical Programs and use the funds-for other items required for J)@k"i 34 the project, excep- for the 4ollowina restrictions: (1) Grant funds may not be used for any purpose contrary to the regulations and policies of the Division of Regional Medical Programs or the grantee or the affiliated institutions. (2) Grant funds may not be rebudgeted in the last 60 days of a budget period. (3) Plannin- grant funds may be transferred between budaet categories to the extent that no category is increased or decreased by more than 20 percent of the approved budget. Increases or decreases in a budget category in excess of 20 percent must be approved in writing by the Division of Regional Medical Programs. (4) Operational grant funds may be transferred between budget categories to the extent that no substantial proaram chan-e in 0 0 any project(s) is made by such a transfer (see cnanges in approved ram, page 24) and that the transfer-does not exceed $50,000. Refunds During the program period, refunds and rebates should be credited to the grant account. Credits received after the termination of the program period shall be returned to the Public Health Service. Checks should be made payable to National Institutes of Health, Public Health Service, Department of Health, Education, and Welfare, Bethesda, Maryland 20014. (1) Interest and Other Income - Interest or other income earned on arant funds must be returned to the Public Health Service. (2) Royalties and Profits When the costs of publishing material are provided from Public Health Service grants, any royalties or profits up to the amount charged to the grant for publishing the material shall be refunded to the Public Health Service. Unexpended Balance - No funds may be carried forward from one budget period to another unless: (1) Thev are included as part of the budget of the continu- ation grant application, and (2) The expansion of the Program beyond that upon which the commitment of funds was based is clearly justified in terms of the relevance of the expansion to the Proaram areas originally approved as part of the oriainal grant. Approval of such a request will frequently require approval by the National Advisory Council. Obligations or Expenditures - Obligations, commitments, encumbrances, or expenditures @ill normally be made within the period indicated on the notice of grant award. Grant funds may not be used to reimburse any such DRAFT 35 obligations, commitments or expenditures made prior to the beginning date of the initial gran+- for a new or renewal project In exceptional instances the grantee may, at its own risk, prior to the beginning date of a continuation award, incur expenditures which exceed existing Division of Regional Medical Programs authorization but which are considered essential to the conduct of the Program. The Division of Regional Medical Programs may allow reimbursement of such expenditures from the continuation grant. Accounting, Records,-and Audit (1) Accounting - Accounting for grant funds will be in accordance with the grantee and/or affiliated institution accounting practices consistently applied regardless of the source of funds. Itemization of all supporting expenditures must be recorded in sufficient detail to show the exact-nature of expenditures. Each recipient of grant funds shall keep such records as the Surgeon General may prescribe, including records which fullv disclose the amount and disposition by such recipient of the proceeds of such grant, the total cost of the program or undertaking in connection with which such grant is made or used, and the amount of the portion of the cost of the proaram or undertaking supplied by other sources, and to make such t, 0 records available as will facilitate an effective audit by authorized personnel. Such a system must meet the following criteria: a. A special grant account must be established for each Regional Medical Program grant and be maintained at the grantee institution-designated on the application. Responsibility for expen- diture of funds by affiliated institutions must be assumed by the- grantee. b. The grantee's accounting records shall provide the information needed to identify the receipt and expenditure of all program funds separately for each grant. Expenditures shall be recorded by the component pro(,ram and@budaet cost categories shown in the approved budget. c. Each entry in the accountin<- records at the grantee or affiliated institution shall refer to the documentation which supports the entry and the document.ation shall be filed in such a way that it can be readily located. d. The accounting records shall provide accurate and current financial reporting information. e. The accounting,system shall possess an adequat.e means of internal contr ol to safeguard the assets, check the accuracy and reliability of the acccuntinc- data, promote operational efficiency, and encourage adherence to prescribed management policies. 36 (2) Records The financial records, including all documents to support entries oi the accounting records, must be kept readily available for examination by authorized personnel. No such records shall be destroyed or otherwise disposed of within three years after the termination of the Drogram. Unless written approval is obtained from the Public Health Service to dispose of the records, they must be retained until-the audit has been completed and all questions about the expenditures are resolve . (3) Audit - The Department of Health, Education,,and Welfare follows generally accepted-auditing practices in determining .that there is a Droper accounting in Use of grant funds. Failure of a grantee to appeal a proposed audit disallowance within thirty davs after receint of a written notification will make the action con- .clusive. Equii)ment (Title and Accountability) - Title to equipment purchased with grant funds resides in the grantee and accountability may be waived at the termination of the grant by the Division of Regional Medical Programs as long as the bqui rhbnt is used to further p the objectives of the Public Health Service. The Division of Reaional 0 Medical Programs, however, reserves the right under unusual circumstances to transfer title of equipment to the Division of Regional Medical Pro- grams or to another grantee. Excess materials and supplies retained by the grantee upon termination of the program may be accounted for under the same terms as equipment. r-S - (1) Expenditures Report (Form NIH-925-3) A single expenditures report and a single narrative progress report is required to be submitted by the grantee on behalf of all affiliated institutions to the Division of Regional Medical Programs for each budget period of the program period. If the grantee fails to submit an expenditures report within 120 days after the end of each budget period, future awards for that activity may be withheld. A supplemental grant forms a part of the existing grant and only one expenditure report need be submitted on the combined grants. (2) Time or Effort Report - Charges for salaries and wages of 4Lnd-Lviduals other than members of the professional staff will be supported by time and attendance and payroll distribution records@. For members of theprofessional staff, qua rterly,estimates of the percentage distribution of their total effort must be used as support in the absence 37 of actual time records. Time and effort reports are not to be sent to the Division of Regional Medical Programs but must be retained by the grantee and must be made available for inspection by the Public Health Service staff. Miscellaneous (1) Safety Precautions - The Public Health Service assumes no responsibility with respect to accident, claims or illness arising out of any work undertaken with the assistance of a Public Health Service grant. The grantee institution is expected to take necessary steps to insure or protect itself and its personnel. (2) Federal Income Tax - Determinatioq of a tax status of an individual receiving compensation in any form from the Public Health Service grant is the responsibility of the Internal Revenue Service. (3) Military Service - The Public Health Service will not intercede on behalf of an-individual in relation to military status. 38 CHAPTER IV PREPARATION AND REVIEW OF APPLICATIONS 1. TYPES OF APPLICATIONS A. New A-p-plications New applications are submitted by a Regional Medical. Programs for an initial planning grant or an initial operational grant. B. Supplemental Applications The supplemental application requests funds for a specific grant period for the expansion of activities already funded and/or the addition of new activities. The supplemental application may request expansion of central functions of the Regional Medical Proaram such as coordinating, planning, evaluation, and for administrative staff. The application may request funding for new operational projects for incorporation into the Regional Medical Program. Supplemental applications may be submitted at any time during the specific period of the grant they are to supplement. C. Continuatio li ations This application requests support for an additional budaet period C, included in the program period spe cified in the current statement or award. D. Renewal Applications This application requests support for an extension of a Regional Medical Program beyond the proaram period. 0 E. Applications for Revision These are applications which propose substantial program modification in already funded projects or activities. II. GENERAL FORMAT FOR ALL APPLICATIONS A. Form Application form NIH-925-1 (Revised Ilay '66) is used for all grant applications and may be obtained on request from the Grants Review Branch, DRAFT DRAFT 39 Division of Regional.- Medical Programs, Fiational institutes of:-Eealth, Bethesda, Maryland 20014. Specific instructions for completion accompany the for-,q. B. Budget A specific justification of the budget estimate must be supplied and must include enouah specific information to support the actual amount of funds requested. Allowable budget costs are described in Chapter III. Tfi&'presentation of the budget and its justification should be clear and well organized, and the computations carefully checked for accuracy. In all requests for sup'ort beyond one yea!--, the budget is presented in two p parts--the detailed presentation of the amounts requested for the first budget period (usually twelve months) and an estimated projection of funds needed for each of the subsequent budget periods for which a commitment of support is requested. The projections should be estimated as realistically as possible on the basis of the first year level less non-recurrina costs, such as fixed equipment and renovation and alteration costs. Increases to provide for program expansion, regular salary increments and phasing of projects should be fully explained. The budget for the initial year of a project should make realistic allowance for anticipated delays in recruiting staff for the project. C. Narrative The body of each application will consist of a narrative, which provides the full justification for the requst and relates the proposal to the objectives of the Re-ional Medical Program. D. Supporting Documents Applications will include necessary supporting documents, such as 0 statutory or regulatory assurances, curricula vitae of the persons involved, and other supplementary information. III. SPECIFIC FO-@IAT A. Planning Application The planninQ, grant application should include a narrative justi- fication for the proposed Re-i.on including appropriate demographic and descriptive data which support the preliminary delineation of the Region, background and history of the proposed Regional Medical Program, including a description of relationships of adjacent Peaions, descriptions of the proposed organizational structure and how it will function, the nature of the Regional Advisory Group and how it was selected, and a description of how the planning activities will contribute to the goal of the Recional C> Medical Program in terms of the seven elements of the process of regionali- zation described in Chapter !I. D c-@i T'T L)KAil,l: 40 B. Planning Supplemental Application The narrative in this application should include a description of plannina progress to date, why currently available planning funds are C> insufficient, and a description of the expanded planning activities which would result from the supplemental funding bein- requested. This application should be accompanied by current budget information about the ongoing-arant which gives expenditures to date and projected expen- C, ditures to the end of the bud-et period and which supports the need for additional funding. C. New Operational Grant An application for an operational grant must include notification of the approval of the Regional Advisory'Group as required by the kct. This notification must bear an original signature of the chairman and should be placed prominently in the application. Assurances such as--those having to do with civil rights, human experimentation, and other assurances not already on file with the Division should be attached as appendices and will be maintained on file by the Division of Regional Medical Programs. The narrative of the operational grant application should cover the following general Doints: 1. A restatement of the justification of the region and description of rodelineation if pertinent, for accomplishing the purposes of the operational Regional Medical Program. 2. Accomplishments under the program supported by the planning grant and the specific results of the planning process that led to the development and submission of the operational request. 3. A complete discussion of the conceptual strategy for carrying out the process of regionalization directed toward the goal of improved patient care as described in Chapter II. This description must include the relationship of the proposed operational program to the continued planning activities and to the extent possible, in the context of the specific elements described in Chapter II. 4. A description of Program organization, staffing, leadership capability, and decisi-on-making mechanisms should be included. 'In addition to these general considerations, the applications for operational grants should include descriptions of the individual projects. The general narrative should provide the basis for relating the specific projects to the overall development of the Proaram and should enable the review ,roups to reach the conclusion that the Program has a unified strategy and is not a group of unrelated projects. Separate budgets DRAFT DRAFT 41 should be included for each project with a budget justification and where appropriate an identification of the planning group or subcommittee within the Regional Medical Program that may have participated in developing the C:> particular project. The narrative description for the project should cover: 1. Justification of the contribution to the overall Regional Medical Program; 2. PelationshiD to planning and to other operational projects already undertaken, as well as continued planning and operational activities. 3. The anticipated rate of implementation of the project; 4. The contribution of the individual project to the process of regionalization described in Chapter II, 5. Supporting documents should be included for each project- such 5 as curricula vitae of principal staff members, project directors, their leading assistants. These should be brief and the list of publications should be limited to the past five years. D. Supplemental Operational Applications This application requests expansion of the activities or projects already funded under the operational grant or proposals for other projects integrated into the Regional Medical Procram. The supplemental application needs to relate the proposed additional activities or expansion to the general development of the Regional Medical Program as described in the narrative for the initial operational application. The supplemental appli- cation should summarize for the reviewers the developments in the Regional Medical Pro-ram since previous applications or progress reports were submitted to the Division. The detail of this summary will depend upon the time which has elapsed since such information was previously supplied to the Division. Projects proposed in the supplemental application should be described in the same terms that are outlined above (see C). Any additional assurances required because of new activities proposed should be included alorLc with the documentation of the approval of the Recional Advisory Group including the original si@nature of the chairman. E. Continuatilo-,i Application Application for continuation of Programs beyond the current budaet period into budget periods for which support was committed in the original grant award must be submitted not less than thirtv days prior to the end of each budget year within the approved pro,,ram period. Detailed instructions for completion of the continuation application will be supplied to the grantee by the Division staff approximately three months prior to expiration of the budget period. Such an application will- include: 1. The progress report (see Chapter III) DR-AFT DRAFT 42 2. The required annual report of the Regional Advisory Group (see Chapter III) 3. An Annual Invention Statement 4. An estimated Statement of Expenditures (NIH 925-3) for the current year based on the total budget as set forth in the current Notic6 of Grant Awarded (NIH 925-2) and on each project included within an operational grant Funds remainin- from a specific grant period may not be used unless: 1. They are justified as a part.of the budget of the continuation grant application, and 2. The expansion of the Program beyoni the original commitment of funds, is clearly justified in terms of its relevance to the program areas funded in the original grant. Such a request will frequently require approval by the National Advisory Council. F. ADDlication for Renewal Grant A renewal application must be submitted for continued support beyond the completion of the committed program period. These applications-are essentially identical to new applications except that the narrative must include a summary of the progress made during the. entire previous pro-ram period and an assessment of the stat:us of the Regional @ledical Program at the time of the application. G. APDlication- for Revisions Applications for revisions request permission to use already awarded grant funds for activities or projects which are substantially different from those presented in the application upon which the award was based4 The limitations on budget revisions are discussed in Chapter III. Any substantial revision in a Program approach or project content whether or not they require budaet revisions requires vritten approval of the Division of Regioial Medical Programs 'and must be discussed with the Division. If a substantial change is proposed, it should be presented in the format of a supplemental application. DRAFT DRAFT 43 IV. APPLICATION PRCCFDURE A. Schedule Applications to the Division of Regional Medical Programs may be submitted at any time. A date set approximately six weeks prior to each meeting of the Regional Medical Program Review Committee is set as the limit for receipt of applications for the review cycle initiated by that meeting. There are usually four such cycles each year. A calendar of these dates and the dates of all Review Committee and the National. Advisory Council meetings is kept current for at least one full year in advance and distributed regularly to all program coordinators. B. Number of Cop .e@ Applicants are requested to submit tiqenty copies of an application. C. Lt@le Applicants should adopt a typographic style which will permit stapling or binding in a three-ring binder. Each page should be suitable for photographic reproduction. The narrative snoula' be typed single spaced to conserve space. V. REVIEW PROCESS As has been described earlier, each region develops for itself a regional advisory group whose review and approval of projects contained in operational applications is required by statute. For other types of applications, while endorsement by the regional advisory group is not a statutory necessity, its inclusion in the application is highly recommended as evidence of the effective involvement of this group. A. Receipt of Application When the application is received by the Division of Regional Medical Programs, an initial review for accuracy and compliance with regulations and policies is undertaken. Copies'are routinely sent to designated liaison personnel in the related categorical institutes of the National Institutes of Health and toother bureaus of the Public Health Service. In the case of operational applications, individual projects are referred for specific technical evaluation to other proaram elements within, the Service and in other agencies. B. Review by ReSional Medical Program Review Committee Review by this multidisciplinary group constitutes the initial review of the application. Review Committee meetings are scheduled regularly to review and evaluate tLic professi.onql aspects of all. Regional. Medical Pro-ram applications, consider reports of staff, outside reviewers and site visit teams, and recommend time and amount of support to Council for its DF@FT 44 consideration at a subsequent meetina. The Review Committee participates in site visits to regions which are made frequently i.n the case of planning applications and routinely for operational. applications. In the more complex operational applications, the review cycle may not be complete until a second review'by the Committee has taken place. This may be occasioned by problems raised by technical reviewers, overlap with other programs, feasibility of proposals and other, relevant program considerations. C. Site V@Lsits Site visits are made routinely in the case of operational applications and as determined by the Committee or Council for other applications. The purpose is to permit a personal in-depth presentation of the appl.icant's proposals to a group of disinterested consultants. A site visit team is usually made up of members of the National Advisory Council 3 the Review Committee, staff representatives and consultants ,7ho represent specialized competencies. Site visits are arranged from four to six weeks in advance by staff of the Division of Regional lledical Progr8ms. In the case of .operational applications, the visits require from one to two days. At t@ie conclusion of the visit, the site visit team draws up a report which is presented at the next Review Conniittee meeting or to the National AdvisOr-,7 Council. D. Review by National, Advisory CoLli-ici.1 The final review of applications is by the National Advisory Council. The Council considers the recommendations and findings of the Review 'Committee and draws upon them the full array of material assembled during the entire review process. The, Counci.1's final recommendation, required by ,the law before a grant can be awarded, concerns the application as a whole and includes a recommendation of the overall grant amount. Where still further exchange ol' infor.7.ntion is considered necessary to resolve major questions, a further Council site visit is arranged. E. @roval and -Award After the Council's recommendations are Trade, Division of Regional. Medical- Program staff ueets representatives of the applicant region, and relates the Council's concerns and recommendations .n detail. The applicant will be iiformed if certain proposed projects have been specifically disapproved. If the recommended amount has been reduced below the amount requested for those pro-ects or activities not specifically disapproved. t,ie applicant has the opportunity to return to its own decisio-@i-,naki-ng group., to reassess priorities, and to submit a budget which redistributes the recommended arr@oul-it among its approved projects or component activities. It is on the basis of this resubmitted budget with the projects it covers that a grant is made and that the program for the btid-et period is set. DRAFT C L 0 S S A R Y 1. ACT (PUBLIC LAW 89-239 OR TITLE IX) is the Heart Disease Cancer, and Stroke amendments of 1965 to the Public Health Service Act. 2. AFFILIATED AGENCY (See Agency) 3. AGENCY (INSTITUTION) Cooperating is an a,-ency (institution) which has iiidi.catp-d,its willingness to cooperate in a Reai-oiial Medical Program. Affiliated is a -cooperating agency (institution) which is the recipient of Title IX grant funds from the grantee. AGREEMENT OF AFFILIATION is the written agreement between the grantee and each affiliated agency which asf;ures both the grantee and the Public Health Service that funds awarded under the Act will be used in accordance with Public Ilei Ith Service policies and procedures. 5. APPLICANT is the public or nonprofit corporate organization or institution which submits a request for funds under the Act and which proposes to become the grantee. 6. APPROVI@"D PROGRAM is coinpri,,4r-,d of the ictiviL-Ics which the applicant has submitted to the Federal Government for funding and which have been r2cormRended Lb tLe Sur3coii General for approviil-by thf-- National Advisory Council. on Regional @-Medical Programs. 7. BUDGET PERIOD is the period of time covered by a specific budget, usually twelve months. DRAFT DRAFT 8. CLINICAT RESEARCH CE14TER 11 is an institution (or part of an institution) the primary function of which is research, training of specialists, and demonstrations; and which, in connection therewith, provides specialized, high- quality diagnostic and treatment services for inpatients and outpatients. 9. CONSTRUCTION is alteration, major repair (including the restoration of an existin@ building to a sound state), and renovation of existing buildings (including initial equipment thereof) and replacement of obsolete, ,built-in equipment (equipment affixed to the facility and customarily included in the construction contract) of existing buildings. 10. CONTINUATION GRANT (See Grant) 11. COOPERATING AGENCY (See Agency) 12. DIVISION OF REGIONAL MEDICAL PROG@IS is the Division of the National Institutes of Health which is principally responsible for the administration of the Act. 13. FEASIBILITY STUDY are those activities, supported as a portion of a planning grant, the T)rincipal purpose of which is aimed at assessing the workability and utility of particular program elements. 14. GRANT Plar,-,iiTi@ is a grant authorized by Section 903 of the Act which is made to assist in "he planninQ and development of a Regional Medical Program. Operational is a grant authorized by Section 904 of the Act which is made to assist in the establishment or operation of a Recli-onal Medical Program. DRAFT DRAFT -T (Cont'd.) 14. G@ Supplemental is a grant which provides support for expansion of existing, previously fundedv or new program elements. Continuation is a grant which provides support for an additional budget period included in the program period specified in the current statement of award. Renewal. is a grant which provides for the extension of a Regional I-ledical Pro-ram beyond the program period. 15. GRANTEE is the public or nonprofit@institution, agency or corporation which is the recipient of grant funds under the Act. 16. IIOSPITAL is A general, till)crculo!jLs, or other type of llo,,-,I)Itlll and related facility, such ,i,4 i l,iil)oritory, C)titp@.Iti.Clit department, (iitirses' lioiiic facility and central service facility operated in connection with hospitals or other health facilities in which local- capability for diagnosis and treatment is supported and augmented by tire program under the Act, but does not include any hospital furnishing primarily domiciliziry care. 17. INSTITUTION (See Agency) 18. MAINTENANCE OF EFFORT is the principle, which applies to Federal funds paid pursuant to any operational grant, requiring that grant funds will not supplant funds that are otherwise available for establishment or operation of the Regional Medical Program. 19. MEDICAI, CENTER is a medical school or other ,,ic!cliciil institution involved in postgraduate medical- training and one or more hospitals -ffili,.it-2c, for teaching, research, and demonstration purposes. 20,7 NATIONAL ADVI SORY COUNCIL ON REGIONAL MEDICAL PPOGRA@IS is the body authorized by Section 905 of the Act which shall advise and assist the Surgeon General in the preparation of regulations for, and as to policy matters arising with respect to the adinini- stration of the Act. The Council shall be comprised of the Surgcoi General, who shall be the chairman, and twelve members who are leaders in the fields of the fundatocntal sciences, the medical sciences, or public affairs. At least two shall be practicing physicians, one shall be outstanding in the study, diagnosis or treatment of heart disease, one shall be outstanding in the study, diagnosis, oi- treatment of cancer, and one shall be outstanding in the study, diagnosis, or treatment of stroke. The Council shall consider all applications for grants under the Act and shall mikc recommendations to the Surgeon General with respect to approval of applications for and amounts of grants under the Act. 21. NO,\@PROI,'IT STATUS is any institution or agency which is o@viicd and operated by one or more nonprofit corporations or associations no part of the not earning of which inures, or may lawfully inure, to the benefit of any private shareholder or individual. -22. OPERATIO L GRANT (See Grant) 23. PLANNING GRANT (See Grant) 24. PRACTICING PHYSICIP.N is any physician licensed to practice viediciiic in accordance with applicable state laws and currently engaged in the diagnosis and treatment of patients. 25. PROGRAM COORDINATOR is t)ie person who bears the principal adminl.strat ve responsibility for the overall coordination of the Regional Medical Program. 26. PROGRAM PERIOD is the period of time for which new and/or continuing support under the Act has been recommended by. the National -Advisory Council on Re,-ional Medical. Programs, not exceeding five years. D,@FT DRAFT 27. PROGRESS REPORT is the annual report submitted to the Division of Regional Medical Progrims by the Fralitce which describes the progress,, ,Iccolnl)lisliiiieiits and problems of the Re-ioiial Medical Program. 28. PITOJECT is a particular activity which is undertaken by the Regional Medical Program as an integral pirt of its overall operational program. 29. REGION is a geographically and/or functionally defined area which the Surgeon General determines forms an economic and socially related region, taking into consideration such factors as present -ind future population trends and patterns of i;rowtli; location and extent of transportation and coiiuiiuili.ciLion facilities and systems; and presence and distribution of educational, medical, and health facilities and programs. 30. REGIONAL ADVISORY GROUP is the group designated by the al)plllcalit (and the insti- tutions cooperating in the Regional Medical Pro6ram) to advise them concerning the cstiblisliineiit and operation of their Regional Medical Program. Such groups sliall consist of practicing physicians, medical center officials, hospital administrators, representatives from appropriate medical societies, voluntary health agencies, and rcpre- sentatives of other agencies, organizations, and iiisti- tutions concerned with activities of the kind to be carried out under the Ilroi,!rtjiii, and of the public familiar with the need for the services provided under the Progrim. 31. REGIONAL COOPEIVITIVE ARRANGEMENT (See Regional.ization) 32. REGIONAL MEDICAL PROGRAM is the cooperative arrangement among the health resources of a region the purpose of which is to make available to all those persons within the region the best possible patient care for heart disease, cancer, stroke and related diseases through research, training, and demonstration of patient care. 33. REG10iiALIZATION@. (REGIO,@kL COOPEIKTIVE Al@',M@NGEMENT) is the process the region moves toward its i!oil of improved patient care for those suffering from heart disease, cancer, stroke, or related diseases. 34. RELATED DISEASES are those diseases which can reasonably be considered to bear a direct relationship to heart disease, cancer, stro'r-le. 35. RENEWAL GF@NT (See Grant) 36. REPORT is the Surgeon General.'s Report on Regional Medical Programs to the President and the Cono,ress required by Section 908 of the Act. C, 37. REVIEW COMMITTEE is a formally established Public Health Service review committee which performs the initial review of grant requests under the Act. 38. SITE VISIT is an official visit to a Region by persons from either or both the National Advisory Council on Regional Medical Programs and the Review Committee the principal purposes of which are to make judgments concerning proposed or ongoing activities of the Regional liedic@il. Program and to ciiibl.c-, both the site visitors and the Region Lo better understand Regional Medical Programs. 39. SUPPLEAENTAL GRANT (See Grant) 40. SURGEON GENERAL is the Surgeon General of the Public Health Service. 41. TITLE 1X (See Act) 42. UNEXPENDED BALANCE is the balance of funds remaining in the grant account at the end of each budget period. D ILA. F'f