NATIONAL SWINE RESEARCH AND RESOURCE CENTER RELEASE DATE: December 17, 2002 (see addendum NOT-AI-03-011) RFA: RR-03-003 National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov) APPLICATION RECEIPT DATE: February 26, 2003 THIS RFA CONTAINS THE FOLLOWING INFORMATION o Purpose of this RFA o Research Objectives o Mechanism(s) of Support o Funds Available o Eligible Institutions o Individuals Eligible to Become Principal Investigators o Special Requirements o Where to Send Inquiries o Submitting an Application o Peer Review Process o Review Criteria o Receipt and Review Schedule o Award Criteria o Required Federal Citations PURPOSE The purpose of this Request for Applications (RFA) is to solicit proposals to establish a National Swine Research and Resource Center (NSRRC). This resource will be for depositing, maintaining, preserving, and distributing swine models for studies of human diseases, as well as cryopreservation, storage, and reconstitution of embryos and germplasm. These activities will be organized under the auspices of the NSRRC with the necessary administrative and quality control infrastructure. Through appropriate research investigations, the NSRRC also will advance research and technologies to improve the utility of swine models for biomedical research. RESEARCH OBJECTIVES Over the last several years, swine have become increasingly utilized as biomedical research models for human disease, partially replacing dogs and primates. As research swine populations have experienced rapid and significant increases during the past few years, investigators have requested more resources for improving husbandry and medical care of new swine strains created by genetic technologies. As experimental subjects, swine have a number of advantages over other animal species. They have a favorable reproductive capacity with a short gestation period, large litter size, and a poly-estrus cycle. Furthermore, swine anatomy and physiology are similar to humans, especially in cardiovascular, pulmonary, skeletal, and integumentary systems. These similarities have made the swine the primary species of interest as organ, tissue, and cell donor species for xenograft transplantation procedures. Genetically altered pigs for potential use in clinical xenotransplantation are now technically feasible as precise genetic modifications in the pig genome are achieved. Thus, establishing a resource to supply needed swine organs would greatly support and advance these specific research goals. The development and increased use of purpose-bred swine strains (i.e., inbred strains, various hybrid lines, and lines with genetically selected or altered genes) in biomedical research by investigators from around the world generate increased demands on animal breeding programs, specifically for specific-pathogen free (SPF) quality animals. These special swine models are often made available to other investigators by the researchers who generated a strain, but the demands for distribution and maintenance of swine are frequently beyond the physical or financial resources of these individual investigators. This may impose undesirable restrictions on the availability of potentially valuable purpose-bred swine strains and their scientific use. The objective of this RFA is to establish a National Swine Research and Resource Center (NSRRC) to ensure that biomedical investigators have enhanced access to critically needed swine models for studies involving human health and disease. Besides numerous breeds of the domestic swine, Sus scrofa domestica, there are miniature breeds, such as the Yucatan minature, Sinclair, Pitman-Moore, and Hanford, as well as several genetically altered strains that are used in biomedical research. The NSRRC will maintain purpose-bred swine strains and make them widely available to the national and international research community. The swine resource center will eliminate the requirement of individual laboratories to maintain and distribute swine strains thereby ensuring the highest-level quality and uniformity of genetic and microbiological monitoring. Additionally, the NSRRC will serve as a central repository for materials (e.g., germ line and somatic cells, antibodies, gene probes and markers) and information (computer databases accessible via the World Wide Web, WWW) and make them available to the scientific community. Another important objective of the NSRRC will be to develop methods for improving health of swine strains by establishing standards and procedures for generating specific-pathogen free and more vigorous swine strains and characterizing diseases endemic to laboratory swine stocks. The NSRRC will have a well-integrated and coordinated research program with active investigators who will effectively utilize swine models to generate new information that is relevant to the resource. Furthermore, because the resource is expected to maintain swine strains for xenograft transplantation procedures, it is essential that the center be able to accommodate the specific needs for isolation, growth, preservation, expansion, and distribution of cells, tissues and organs from these animals. Plans for training and educational activities must be integrated in the proposed center. Examples of appropriate training activities include: special training at the resource facilities for individual collaborators and users of the resource; potential routine training and education on the available technologies or methodologies through hands-on experience, seminars, or lectures; and short courses, symposia, and workshops involving multi-disciplinary areas for participants from academic institutions, hospitals, and industry. Training can be offered periodically or in conjunction with meetings that the user community is likely to attend. Funds to support courses given for credit may not be requested. Individuals involved in the training experiences may not be paid a stipend nor may the training experience be a requirement for receipt of an academic degree. Educational activities aimed at the general public and community about research activities performed at the NSRRC should be planned as part of the center's outreach program. MECHANISM OF SUPPORT This RFA will use the NIH "Animal Models, and Animal and Biological Materials Resource Cooperative Agreement" (U42). The U42 is a cooperative agreement award mechanism in which the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with NIH staff being substantially involved as a partner with the Principal Investigator, as described under the section "Cooperative Agreement Terms and Conditions of Award." Applicants are solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation. Future unsolicited, competing-continuation applications based on this project will compete with all investigator- initiated applications and will be reviewed according to the customary peer review procedures. The anticipated award date is September 2003. This RFA uses just-in-time concepts. All applications with annual direct costs of $250,000 or more must follow the instructions for non- modular research grant applications (https://grants.nih.gov/grants/funding/modular/modular.htm). FUNDS AVAILABLE In response to this RFA, it is anticipated that one U42 Research Center Grant will be funded. An applicant may request a project period of up to five years and a budget for direct costs of up to $1,000,000 per year. Because the nature and scope of the proposed center and research will vary from application to application, it is anticipated that the size of each application will vary. Although the financial plans of the ICs 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 meritorious applications. ELIGIBLE INSTITUTIONS Eligible institutions include domestic: o Non-profit or for-profit organizations o Public or private institutions, such as universities, colleges, hospitals, and laboratories o Units of State and local governments o Agencies of the Federal government INDIVIDUALS ELIGIBLE TO BECOME PRINCIPAL INVESTIGATORS Any individual with the skills, knowledge, training, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs. SPECIAL REQUIREMENTS In response to the need for making swine models available to the biomedical research community, the NCRR will establish a National Swine Research and Resource Center (NSRRC). The proposed NSRRC must have three basic characteristics. First, the NSRRC must serve the needs of investigators in a variety of research areas where work is sponsored by NIH categorical Institutes. Second, the NSRRC must be willing to make swine strains available to investigators on a local, regional, and national basis. Third, the NSRRC must have a research component to generate new information that is relevant to the resource. It is expected that some of the costs specifically associated with the establishment, improvement, or expansion of supply and long-term swine resource maintenance will be recovered from users through a charge schedule acceptable to the NIH. Applicants are encouraged to contact NCRR Program staff well in advance of the application submission date, to discuss the proposed research program, budget, organization of the resource, and its potential biomedical impact. These contacts help to assure that applicants have a clear understanding of current program policies and priorities, especially with respect to any special situations, such as the maintenance and distribution of highest-quality swine strains, research activities, training and educational program, etc. They also will allow staff to assess responsiveness to this RFA and provide appropriate guidance as needed. This RFA will not cover any costs for facility construction or renovation for a swine resource. Applications for funds for facility construction or renovation may be submitted to the Division of Research Infrastructure, NCRR, utilizing the extramural Research Facilities Improvement Program (https://grants.nih.gov/grants/guide/pa-files/PAR-01-130.html) where they will compete with all other construction applications. Cooperative Agreement Terms and Conditions of Award These special Terms of Award are in addition to and not in lieu of otherwise applicable OMB administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS, PHS, and NIH Grant Administration policy statements. The administrative and funding instrument used for this program is a cooperative agreement (U42), an "assistance" mechanism (rather than an "acquisition" mechanism) in which substantial NIH scientific and/or programmatic involvement with the awardee is anticipated during 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 role in the activity. Consistent with this concept, the dominant role and 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 among the awardee and the funding ICs project scientist(s). 1. Awardee Rights and Responsibilities The awardee will have primary authorities and responsibilities for the following elements: o Maintenance and distribution of the highest health status inbred swine strains, various hybrid and inbred lines, and swine lines with genetically selected or altered genes (subsequently all called swine strains) that will be housed in the NSRRC. Establishment and maintenance of an animal barrier facility (SPF swine strains), and developing procedural and managerial husbandry techniques and practices appropriate for a state-of-the-art facility for various swine strains. o Phenotypic characterization of swine strains with regard to development, function, and pathology, including surveillance for infectious agents in both animals and germplasm. o Maintenance of a local electronic database for live animals and for cryopreserved materials (such as embryos, DNA, antibodies). This local NSRRC database should provide access to an NSRRC swine strain catalog and appropriate strain detail pages, information about requesting swine strains, application forms for submission of candidate strains to the NSRRC, and information on standard supply levels and pricing of NSRRC swine strains. The local database must be connected to a web site and accessible from the WWW to allow investigators access to the database. o Development of capabilities for cryopreservation of embryo and sperm, storage facilities, and expertise for the reconstitution of cryopreserved embryos and gametes. o Implementing licensing terms, use-restrictions including patent technology, and material transfer agreements (MTAs). The NSRRC will distribute strains under the least restrictive terms possible, resulting in minimal administrative delays. Outgoing MTAs for all recipients of NSRRC strains or cryopreserved material will be established. NSRRC swine strains will be distributed to all non-profit and for-profit institutions for internal, non-commercial biomedical research purposes under the supervision of an appropriate oversight body (e.g., an IACUC). o Cost-recovery for supplies and long-term maintenance of the resource. The NSRRC will establish a distribution fee schedule that is intended to defray the costs associated with specialized swine breeding for swine stains and lines, genetic quality control, animal health monitoring, cryopreservation, customer service, and technical information and support that is acceptable to the NIH. o Conducting research related to the improvement of the resource activity. Examples of such research would include the development of emerging technologies such as genotyping and phenotyping of swine animal models, infectious disease monitoring and prevention, production of new transgenic and knockout models, or investigations into optimal cryopreservation methods for germ cells and embryos. These examples are not intended to be limiting. o The Principal Investigator for the resource is required to attend the annual meeting of resource directors of the Division of Comparative Medicine, NCRR, which is held at one of the resource funding sites. 2. NIH Staff Responsibilities Program Officers from each contributing NIH Institute or Center (IC) will appoint a member to the Steering Committee (as defined below), and, as determined by that committee, its subcommittees. The NCRR Program Officer will be responsible for normal stewardship of the award, including monitoring progress and reviewing progress reports, and may recommend withholding, suspension, or termination of support for lack of progress. Each NIH IC that provides funding for the NSRRC, through its liaison on the Steering Committee as defined below, reserves the right to terminate or curtail the project in the event of substantial shortfall in effectively maintaining and distributing SPF inbred swine strains, research activities, collaborative efforts, data reporting, or any other major breach of protocol. The NCRR Scientific Coordinator, who may also be the NCRR Program Officer, will be substantially involved in establishing the NSRRC infrastructure including the following responsibilities above and beyond normal programmatic stewardship: o Participation in all NSRRC Steering Committee meetings as a voting member o Assistance with facilitating the coordination and management of the resource ensuring that overall management of the Center is in compliance with NIH policies o Coordination of and assistance with the establishing of operating procedures relating to sharing of swine models and related research data for use by other researchers o Facilitating the development of networks among researchers, commercial interests, community interests, and governmental entities 3. Collaborative Responsibilities o Training and collaborative research capacity. To ensure the broadest possible access for investigators to SPF swine strains, the NSRRC is responsible for collaborating with investigators nationwide. Such collaborations include advising on maintenance and breeding of particular swine strains as well as on-site collaborative research procedures, as appropriate. The NSRRC may explore the future expansion potential of the center in terms of establishing R01-type research collaborations. Additionally, education of the general public about research activities performed at the NSRRC should be planned. o Establishing a Steering Committee (SC) as defined below. The SC is responsible for reviewing the final standard operating procedures (SOPs) for quality control in husbandry, veterinary care, maintenance of the animal facility, shipping and receiving of animals and germplasm, maintenance of the electronic database, administrative directions, and reporting procedures. The SC will also be responsible for selecting members and coordinating activities of the NSRRC Advisory Panel (AP) as described below. The SC initially will consist of the Principal Investigator, up to two additional investigators associated with the NSRRC, one representative each from every IC contributing to the funding of the NSRRC, one expert scientist representing another NCRR-funded resource, and a qualified veterinarian. The number of NIH voting members of the SC will be limited to a maximum of two; one vote will be represented by the NCRR Scientific Coordinator. NIH SC members may not chair the SC. The structure of the SC should be established at the first SC meeting, which should take place within the first six months of funding. The SC will elect a chairperson who will be responsible for SC activities, preparing meeting agendas, and for scheduling and chairing meetings. The SC will meet periodically to map strategies, to develop operating procedures, and to evaluate progress. The NSRRC AP will be responsible for reviewing and approving requests from investigators to have swine strains accepted into the center and deciding whether to maintain live animals or only cryopreserved germplasm. The AP also will review and decide on requests for banked DNA, antibodies, or other materials. The SC will determine the composition of the AP. Members must have appropriate expertise in molecular genetics, laboratory or clinical research, animal care, or other areas as deemed necessary by the SC. Members of the SC may also serve on the AP, but may not constitute the majority. 4. Arbitration Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the funding ICs may be brought to arbitration. An arbitration panel will be composed of three members – one selected by the Steering Committee (with the funding ICs representing members not voting) or by the individual awardee in the event of an individual disagreement, a second member selected by the funding ICs, 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. WHERE TO SEND INQUIRIES We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues: o Direct your questions about scientific/research issues to: Franziska B. Grieder, DVM, PhD Division of Comparative Medicine National Center for Research Resources 6705 Rockledge Drive, Suite 6050 Bethesda, MD 20892-7965 Telephone: (301) 435-0744 FAX: (301) 480-3819 Email: email@example.com o Direct your questions about peer review issues to: John L. Meyer, PhD Office of Review National Center for Research Resources 6705 Rockledge Drive Bethesda, MD 20892-7965 Telephone: (301) 435-0807 FAX: (301) 480-3660 Email: firstname.lastname@example.org o Direct your questions about financial or grants management matters to: Irene Grissom Office of Grants Management National Center for Research Resources 6705 Rockledge Drive, Room 6086 Bethesda, MD 20892-7965 Telephone: (301) 435-0844 FAX: (301) 480-3777 Email: email@example.com SUBMITTING AN APPLICATION Applications must be prepared using the PHS 398 research grant application instructions and forms (rev. 5/2001). The PHS 398 is available at https://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. For further assistance contact GrantsInfo, Telephone (301) 710-0267, Email: GrantsInfo@nih.gov. The section entitled "RESOURCES" Form Page 8 of the PHS 398 for the overall NSRRC should be completed. Briefly describe the features of the institutional environment that are or would be relevant to the effective implementation of the proposed program. As appropriate, describe available resources, such as laboratory facilities, participating and affiliated units, geographical distribution of space and personnel, and consultative resources. Include information on the support and commitment of the parent institution for the center. Use continuation pages as needed. Include any supporting letters from the Institution. The application must include a plan to document users and all resource- related publications resulting from use of the resource on a yearly basis, to be submitted with the annual progress report. Users include both investigators depositing materials and investigators ordering materials. These results must be reported yearly to the Program Director, NCRR, to show activity of the resource with respect to materials deposited and investigators who have used the materials from the resource, as well as to demonstrate the impact of the resource on biomedical research. SUPPLEMENTAL INSTRUCTIONS: The review will include an assessment of the academic and physical environment. As part of the review process, a site visit may occur. The adequacy of facilities to implement the goals of the NSRRC to perform the proposed research, including laboratory and/or clinical facilities, will be a factor considered in the appraisal of the application. USING THE RFA LABEL: The RFA label available in the PHS 398 (rev. 5/2001) application form must be affixed to the bottom of the face page of the application. Type the RFA number on the label. 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 RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/label-bk.pdf. SENDING AN APPLICATION TO THE NIH: 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 and any appendices must be sent to: John L. Meyer, PhD Office of Review National Center for Research Resources 6705 Rockledge Drive Bethesda, MD 20892-7965 Bethesda, MD 20817 (for express/courier service) APPLICATION PROCESSING: Applications must be received by the application receipt date listed in the heading of this RFA. If an application is received after that date, it will be returned to the applicant without review. 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. PEER REVIEW PROCESS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NCRR. Incomplete and/or 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 NCRR in accordance with the review criteria stated below. As part of the initial merit review, all applications will: o Receive a written critique o 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 and assigned a priority score o Receive a second level review by the NCRR 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 your application to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals: o Significance o Approach o Innovation o Investigator o Environment o Research Component The scientific review group will address and consider each of these criteria in assigning the application's overall score, weighting them as appropriate for each application. An 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. (1) SIGNIFICANCE: Does your study address an important problem? If the aims of your application are achieved, how do they advance scientific knowledge? What will be the effect of these studies on the concepts or methods that drive this field? (2) APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics? (3) INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does your project challenge existing paradigms or develop new methodologies or technologies? (4) INVESTIGATOR: Are you appropriately trained and well suited to carry out this work? Is the work proposed appropriate to your experience level as the principal investigator and to that of other researchers (if any)? (5) ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Is an appropriate animal care and veterinary support program described? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? (6) RESEARCH COMPONENT: Does the center propose a research component to generate new information that is relevant to the resource and contributes to the improvement of the resource's value to the scientific community? ADDITIONAL REVIEW CRITERIA: In addition to the above criteria, your application also will be reviewed with respect to the following: o PROTECTIONS: The adequacy of the proposed protection for humans, animals, or the environment, to the extent they may be adversely affected by the project proposed in the application. o DATA SHARING: The NIH encourages the timely dissemination of research tools and results in support of further research and development. The NIH has issued a policy document that addresses these concerns (http://www.ott.nih.gov/policy/rt_guide_final.html). o BUDGET: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. o OTHER REVIEW CRITERIA: o Will this resource maintain and distribute the highest health status swine strains? Will the proposed animal barrier facilities and husbandry management techniques result in state-of-the-art SPF hybrid, inbred, and genetically altered swine strains? o Will the resource provide importation capabilities for live animals and cryopreservation of embryos and sperm that are based on the latest scientific knowledge? o Will the resource engage in phenotypic characterization of swine strains, including surveillance for infectious agents? o Will the resource be able to distribute efficiently animals and other materials to the scientific community? Are appropriate priorities planned for importation and distribution of swine strains? o Is the number of proposed swine strains to be maintained and distributed to the scientific community appropriate to the scope of the project? o Will the resource maintain an electronic database for live animals and cryopreserved germplasm that can be accessed by investigators in the scientific community to deposit and request swine strains? o Will the resource establish a Steering Committee and Advisory Panel as defined under Special Requirements? o Will the resource provide for licensing terms, use restrictions, and material transfer agreements to ensure that swine strains are distributed under the least restrictive terms possible? o Will the resource establish a cost-recovery system for supplies and long-term maintenance of the resource? o Will the resource engage in research activities related to the improvement of the resource and the scientific advancement of the swine strains? o Is the organizational, scientific, and operational framework reasonable, well-integrated and appropriate to the aims of the NSRRC? o Does the NSRRC employ novel approaches or methods for facilitating scientific interaction? o Is the NSRRC Director and leadership appropriately trained and well suited to the organizational and scientific responsibilities associated with this project? o If collaborative arrangements are proposed, is there a convincing demonstration that these interactions will be sufficiently consistent and feasible to meet the needs of the NSRRC? RECEIPT AND REVIEW SCHEDULE Application Receipt Date: February 26, 2003 Peer Review Date: June 2003 Council Review: September 2003 Earliest Anticipated Start Date: September 2003 AWARD CRITERIA 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. REQUIRED FEDERAL CITATIONS PUBLIC ACCESS TO RESEARCH DATA THROUGH THE FREEDOM OF INFORMATION ACT: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this RFA in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award. URLs IN NIH GRANT APPLICATIONS OR APPENDICES: All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010: The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This RFA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople. AUTHORITY AND REGULATIONS: This program is described in the Catalog of Federal Domestic Assistance No. 93.306, and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and administered under NIH grants policies described at https://grants.nih.gov/grants/policy/policy.htm and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. The PHS strongly encourages all grant recipients to provide a smoke- free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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