RFA-DK-99-008: CLINICAL RESEARCH USING ENDOSCOPIC DATABASES

Department of Health
and Human Services (HHS)

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CLINICAL RESEARCH USING ENDOSCOPIC DATABASES Release Date: January 12, 1999 RFA: DK-99-008 (Reissued as RFA-DK-08-506) P.T. National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: February 24, 1999 Application Receipt Date: March 24, 1999 PURPOSE The Division of Digestive Diseases and Nutrition of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites applications for cooperative agreements (U01) from institutions or consortia to perform clinical research in digestive diseases using an endoscopic database. Over 10 million diagnostic and therapeutic gastrointestinal endoscopic procedures are performed yearly and the number has been increasing at a rapid rate. An increasing number of clinical entities are diagnosed and treated through ever more sophisticated endoscopic techniques. The frequency and severity of many of these conditions in the general community is unknown. Evaluations of the utility and effectiveness of many endoscopic procedures have come only from referral centers and highly skilled practitioners. Other procedures have not been evaluated at all. The purposes of this RFA are to use an existing endoscopic database for the following: to characterize the frequency, severity, and natural history of endoscopically diagnosed digestive conditions, to determine the effectiveness of endoscopic procedures in the prevention, diagnosis, management, and outcomes of persons with digestive diseases, and to evaluate non-endoscopic therapies in diseases that are typically diagnosed and followed with endoscopy. An award will be made to support the research activities of an existing Endoscopic Data Center that has an established relationship with a number of Clinical Affiliates providing endoscopic reports. It is essential for applicant institutions to possess an already established endoscopic database that contains information on diverse patient populations at various sites. Applications are requested from offerors who are capable of developing, adapting, and expanding an existing database to provide clinically significant and generalizable answers to hypothesis driven research in digestive diseases. Awards will be made as cooperative agreements, which create an assistance relationship with substantial NIDDK programmatic involvement with the recipients during the performance of the project, as outlined in this RFA. The cooperative agreement mechanism is used to stimulate investigator interest and proposes to advise or assist in an important and opportune area of research. Although the National Cancer Institute (NCI) will not formally participate in this solicitation, it has strong interests in databases of potential use in esophageal, stomach, and colon cancers and in the evaluation of laparoscopic surgery compared to standard surgery in the management of colon cancer. Applications addressing these areas but submitted outside of this RFA will be of interest to the NCI, commensurate with established referral guidelines. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), CLINICAL RESEARCH USING ENDOSCOPIC DATABASES, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2000" at http://www.crisny.org/health/us/health7.html. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible to apply. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. Prior to submission, the institution must have established or control a multicenter endoscopic database with centralized data storage and retrieval. This eligibility criterion is not the sole or major criterion upon which applicants will be evaluated. MECHANISM OF SUPPORT Support of this program will be through the cooperative agreement (U01), an assistance mechanism in which substantial NIDDK programmatic involvement with the awardee is anticipated during the performance of the activity. Under the cooperative agreement, the NIH purpose is to support and/or stimulate the recipient"s activity by involvement in and otherwise working jointly with the award recipient in a partner role, but it is not to assume direction, prime responsibility, or a dominant role in the activity. The nature of staff involvement is described below. Applicants will be responsible for the planning, direction, and execution of the proposed project. Details of the responsibilities, relationships, and governance of a study funded under the cooperative agreement are discussed later in this document under the section Terms and Conditions of Award. Applicants from institutions that have a General Clinical Research Center (GCRC) funded by the NIH National Center for Research Resources may wish to identify the GCRC as a resource for conducting the proposed research. If so, a letter of agreement from either the GCRC program director or principal investigator should be included with the application. This RFA is a one-time solicitation. If it is determined that there is a sufficient continuing program need, the NIDDK will invite the recipient of the award under this RFA to submit a competitive continuation cooperative agreement application for review according to the procedures described below. FUNDS AVAILABLE The NIDDK intends to commit to fund one new cooperative agreement in FY 1999 in response to this RFA. In order to help meet the goals of NIDDK for managing the costs of biomedical research, applicants must limit their requests to not more than $500,000 direct costs and approximately $750,000 total costs for the initial budget period. An applicant may request a project period of up to 5 years. Although the financial plans of the NIDDK provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications of outstanding scientific and technical merit. At this time, it is not known if competing continuation applications will be accepted or if this RFA will be reissued. RESEARCH OBJECTIVES A. Background In recent years, multi-user endoscopic databases that create and archive endoscopy reports have become more useful and practical to the practicing gastroenterologist. These databases use a common terminology and a central relational database of individual reports. Such databases could have important research uses. They can bridge a gap in knowledge between detailed information gained at considerable expense in small clinical studies and very large but superficial administrative databases, such as those used primarily for reimbursement. An endoscopic database containing sufficient information can be used to address clinical research questions that are too complex for administrative databases, but require more patients than can easily be provided from referral centers. Because the patients and the practitioners are diverse, the findings of studies should be more generalizable than studies from a single or even multiple academic referral centers. B. Research Goals and Scope The objective of this RFA is to select and enhance an existing Endoscopic Data Center to perform the following research functions: to characterize the frequency, severity, and natural history of endoscopically diagnosed digestive conditions, to determine the effectiveness of endoscopic procedures in the prevention, diagnosis, management, and outcomes of persons with digestive diseases, and to evaluate non-endoscopic therapies in diseases that are typically diagnosed and followed with endoscopy. Several types of research studies could be performed by an Endoscopic Data Center that controls a large, active endoscopic database. Most require patients to be followed over time. It is envisioned that over the five-year period, a number of individual studies will be developed and implemented by the awardee. Types of such studies include, but are not limited to, the following: o The frequency and severity of various conditions in a large population and diverse practice settings. Such descriptive studies would be strengthened by inclusion of populations encompassing a broad range of age groups and consisting of appropriate gender and minority representation. Patients with a broad range of disease severity should also be included. o The value of endoscopic surveillance in prevention and early detection of malignant and non-malignant diseases. o Special or more intensive investigation conducted among subgroups of patients. Investigators might develop a strategy to systematically determine what has happened to a sample of patients in terms of treatment satisfaction or quality of life. o Formal case-control and cohort epidemiological studies using endoscopically diagnosed cases and negative controls. o Development of pilot clinical trials that may lead to full scale trials. Because the data are frequently uploaded from diverse study sites, it might be possible to use the database to rapidly screen and recruit for clinical trials. A full-scale efficacy trial would most likely require separate funding, but could still be done more efficiently and economically than projects without such information. SPECIAL REQUIREMENTS A. Existing Endoscopic Database The applicant is expected to demonstrate experience in working cooperatively with Clinical Affiliates and sponsoring organizations in multi-center studies. To meet the goals of the study, it is required that the offeror have control of an existing endoscopic database that has the following features: o Both upper and lower endoscopic records. Records of endoscopic cholangiopancreatic and endoscopic ultrasound examinations are highly desirable but not required. o Sufficient quality control measures to ensure all aspects of data accuracy and completeness. o Attractiveness of the database to current and potentially new Clinical Affiliates, including a short learning curve, ease of data entry and transmission, and ability of centers to retrieve information on their own patients. o Ease of retrieval and analysis of individual patient data by the Endoscopic Data Center. o Assured confidentiality of patient information, including protection from identification of individual patients by users of the database. o Evidence of the use of the database as a research tool, including presentations and publications. o Racially, ethnically and geographically diverse patient populations. o A large and diverse number of Clinical Affiliates that include gastrointestinal endoscopists representing multiple practice types, such as gastroenterology and multispecialty group private practices, health maintenance organizations, Veteran’s Administration and other Federal facilities, and academic centers. o Incorporation in the database of endoscopic images and clinical, pathological, and laboratory data or the ability to include such information. o Participating Clinical Affiliates must be committed to full participation throughout the study. Additional centers may be added after the study begins with the same stipulation of full participation. o It is desirable, although not required, that the Endoscopic Data Center have on site an endoscopy unit as one of the Clinical Affiliates. B. Personnel A Director and a Deputy Director for the Project must be designated. The Director should be either a gastroenterologist or a biostatistician/epidemiologist and the Deputy Director should have the complementary qualifications. These individuals should have experience in directing collaborative multi-center clinical investigations or large-scale epidemiological research projects or both. The application must describe the expertise of key scientific, technical and administrative personnel and include a mechanism for replacing key professional or technical personnel should the need arise. Staff needs may be modified as the study progresses, however, statisticians, systems analysts, computer programmers, study coordinators, statistical assistants, clerks, and administrative assistants must be available. Adequate support staff should be designated to manage routine tasks. Scientific Proposals Applicants should propose two specific examples (conducted either concurrently or sequentially) of clinical protocols requiring multicenter participation that they consider important. For each example, applicants should submit concept documents not more than four pages long that briefly outline the rationale and background of the proposed project, study design, type of patients to be included in the protocol, eligibility criteria, and baseline and outcome measures. For each of the clinical protocols, applicants should discuss the characteristics and number of potential participants needed. The scientific merit of these proposals will be evaluated in review of the application, actual projects will be determined once the project has begun (See Terms and Conditions). The actual number of projects conducted will be dependent upon availability of funds. All studies will be strengthened by complete data collection and, if required, follow up ascertainment. Of particular interest are studies that capture information from all endoscopic procedures from populations within a geographically defined area. Protocol Development Process Applicants should propose a process for developing individual protocols in keeping with the Terms and Conditions of the Award. This process should include a mechanism for independent review and approval of such protocols that are sent to the Steering Committee or are developed by Steering Committee members. E. Budget The budget is to be used to address the scientific clinical research issues identified by the Steering Committee. It should include the following: o Support for the minimum number of full-and/or part-time staff to successfully carry out the proposed studies. o Required new electronic equipment and software used at either the Endoscopy Data Center or Clinical Affiliates. o Support for transmission of accurate data from the Clinical Affiliates, such as software installation, training, electronic communication, postage, and long distance telephone expenses. o Provision for at least 3 two-day meetings per year (4 may be necessary in the initial year) at a central site (assume Washington D.C.) for the Steering Committee and other members of the investigating team to plan, execute, analyze, and publish the research. Travel, per diem, and other meeting costs should be included in the budget. F. Federally Mandated Regulatory Requirements Each center participating in a consortium arrangement is required to meet the DHHS/PHS regulations for the protection of human subjects. At a minimum, these include: o Methods for assuring that each participating institution has a current, approved assurance on file with the Office of Protection from Research Risks (OPRR), that study protocols are reviewed and approved by the responsible Institutional Review Board (IRB) prior to patient entry, that active protocols are reviewed at least annually by the IRB, and that all protocol amendments are approved by the IRB. o Methods for assuring or documenting that each patient gives fully informed consent to participation in a research protocol. All informed consent documents must be available for review upon request by the Steering Committee. G. Project Scientist The NIDDK will identify a Project Scientist for the study. The Project Scientist will assist the Steering Committee in carrying out the study (described in detail under Terms and Conditions of Award). H. Terms and Conditions of Award The administrative and funding instrument used for this program is a cooperative agreement (U01). This is an assistance mechanism for support of a research resource in which substantial NIH scientific and programmatic involvement with the awardee is anticipated during performance of the activity. Under the cooperative agreement, the NIH assists, supports and stimulates the recipient"s activities, by facilitating performance of the program effort in a partner role. Consistent with this concept, the prime responsibility for the activity resides with the awardee for the project as a whole, although specific tasks and activities in carrying out the studies will be shared between the awardee and the NIH Project Scientist. The specific Terms and Conditions of Award, below, will be included in any award issued as a result of this RFA. These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS grant administration regulations in 45 CFR Part 74 and 92, and other HHS and NIH grant administration policy statements. 1. Awardee Activities o The Awardee has the responsibility for maintaining and further developing the endoscopic database, including all aspects of timeliness, completeness, accuracy, and patient confidentiality. o The Awardee is responsible for all data processing, computer programming, and statistical analyses. o The Awardee has the primary authority and responsibility to define objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of its studies. o The Awardee has the primary responsibilities for obtaining institutional review board approval and patient consent for all studies that are not covered by the initial approval for this project. o The Awardee will retain custody of and have primary rights to the data developed under this award, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. o The Awardee will arrange all meetings of the Steering Committee and sub- committees. The Awardee shall be responsible for drafting and circulating minutes of Steering Committee meetings as well as distributing correspondence, as needed, among the Clinical Affiliates and committee members. 2. NIDDK Activities The NIDDK Project Scientist will have substantial scientific and programmatic involvement during conduct of this activity through technical assistance, advice and coordination above and beyond normal program stewardship for grants, as described below. o The NIDDK Project Scientist may provide appropriate assistance by participating in the design of research activities, review of protocols, establishment of priorities, data analysis advice, manuscript preparation, and review of progress. o The NIDDK Project Scientist will ensure that the chosen study questions address significant clinical research issues. o The NIDDK Project Scientist will have substantial involvement in generating hypotheses and in indicating study design, data quality assurances, and analytical approaches. o The NIDDK Project Scientist may contribute, through review, comment, analysis, and co-authorship, to reporting results of the study to the investigator community and other interested scientific and lay organizations. o The NIDDK Project Scientist will have voting membership on the Steering Committee and on those subcommittees he or she serves on. o The NIDDK reserves the right to terminate or curtail the study in the event of substantial shortfall in participant recruitment, required follow-up, data reporting, quality control, or other major breach. Failure to ensure patient confidentiality and other human subject ethical issues may also dictate a premature termination. 3. Collaborative Activities A Steering Committee shall be created to determine the specific research objectives and to direct resources towards accomplishing these objectives. The Steering Committee will be the governing board of the study and will have primary responsibility for developing common research designs, protocols and manuals, facilitating the conduct and monitoring of studies, and reporting study results. Protocols will define rules regarding access to data and publications. The Awardee will be required to accept and implement protocols and procedures approved by the Steering Committee. To assure impartiality and objectivity in the choice of research projects, such projects and their protocols must be independently reviewed and approved by members of the Steering Committee or others appointed by the Steering Committee who did not substantively participate in their development. At a minimum, the Steering Committee shall be composed of the Director and Co- director of the Endoscopy Data Center and the Project Scientist from the Division of Digestive Diseases and Nutrition, NIDDK. The Steering Committee shall also include at least one scientist who is not from the awardee institution or collaborating Clinical Affiliates. Additional representatives from the awardee Institution and collaborating Clinical Affiliates may be included with a maximum of 12. This number may vary depending on the number and types of collaborating Clinical Affiliates. The Director shall select Steering Committee members in consultation with the NIDDK Project Scientist. The chairperson, who will be someone other than the NIDDK Project Scientist, will be selected by the Steering Committee. All major scientific decisions will be determined by the Steering Committee, with each member of the committee, including the NIDDK representative, casting one vote. Sub-committees, including a protocol review committee, can be appointed as appropriate, the NIDDK Project Scientist will serve on subcommittees as he or she deems appropriate. 4. Arbitration Any disagreement that may arise on scientific or programmatic matters between the award recipient and the NIDDK may be brought to arbitration. An arbitration panel will be composed of three members one selected by the Steering Committee (with the NIDDK member not voting) a second member selected by NIDDK, and the third member selected by the two prior selected members. This special arbitration procedure in no way affects the awardee"s right to appeal an adverse action that is otherwise appealable in accordance with the PHS regulations at 42 CFR Part 50, Subpart D and HHS regulation at 45 CFR Part 16. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their subpopulations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43. All investigators proposing research involving human subjects should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," which was published in the Federal Register of March 28, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Vol. 23, No. 11, March 18, 1994, available on the web at: http://grants.nih.gov/grants/guide/notice-files/not94-105.html. INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines" on the Inclusion of Children as Participants in Research Involving Human Subjects that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html Investigators also may obtain copies of these policies from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. LETTER OF INTENT Prospective applicants are asked to submit, by February 24, 1999, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA to which the application is in response. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIDDK staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to: Chief, Review Branch Division of Extramural Activities National Institute of Diabetes and Digestive and Kidney Diseases 45 Center Drive, Room 6AS-37F, MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301/710-0267, email: [email protected]. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The application should address Special Requirements A through F and should agree to comply with Special Requirement H, Terms and Conditions of Award. Submit a signed, typewritten original of the application, including the Checklist, and three signed photocopies in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040, MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At the time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK Natcher Building, ROOM 6AS-37F 45 CENTER DRIVE MSC 6600 BETHESDA, MD 20892-6600 Telephone: (301) 594-8885 FAX: (301) 480-3505 Applications must be received by March 24, 1999. If an application is received after that date, it will be returned to the applicant without review. Similarly, supplemental documents containing significant revision or additions will not be accepted after this date. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. Incomplete and non-responsive applications will be returned to the applicant without further consideration. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIH in accordance with the review criteria stated below. As part of the initial merit review, a process will be used by the initial review group in which applications receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the NIDDK National Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. (1) Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? (2) Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? (3) Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? (4) Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? (5) Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research o The adequacy of the proposed protection for humans, animals or the environment, to the extent they may be adversely affected by the project proposed in the application. Additional scientific and technical merit criteria specific to the objectives of this RFA include the following: 1. Demonstration of a functional multi-center endoscopic database representing diverse patient and practitioner populations that can be used to answer clinical research questions. 2. Demonstration of commitment of Clinical Affiliates to participate fully throughout the study. 3. Documentation of the specific competence and experience of professional, technical, and administrative staff pertinent to the study. Experience with an endoscopic database, including the creation, maintenance, monitoring the quality and timeliness of data collected from multiple locations, and utilization should be demonstrated. Coordinating center experience in other multi-center clinical studies and epidemiological research projects is also relevant and desirable. 4. Suitability of the organizational structure and the data management and data analysis plans for the proposed program. 5. Ability to design, implement, and maintain a data entry system for endoscopic and other clinical information at the Clinical Affiliates, including specific plans for ensuring quality control of the data. 6. Merit of the two specific scientific proposals according to Review Criteria (1)-(5) above. AWARD CRITERIA The anticipated date of award is September 15, 1999. Award criteria that will be used to make award decisions include: o scientific merit (as determined by peer review) o availability of funds o programmatic priorities INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: James Everhart, M.D., M.P.H. Chief, Epidemiology and Clinical Trials Branch Division of Digestive Diseases and Nutrition, NIDDK Natcher Building, Room 6AN-12J 45 CENTER DR MSC 6600 BETHESDA MD 20892-6600 Tel: (301) 594-8878 Fax: (301) 480-8300 Email: [email protected] Direct inquiries regarding fiscal and administrative matters to: Ms. Donna Huggins Division of Extramural Activities, NIDDK Natcher Building, Room 6AS-49J 45 CENTER DR MSC 6600 BETHESDA MD 20892-6600 Telephone: (301) 594-8848 FAX: (301) 480-3504 Email: [email protected] AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.848. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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