MOUSE METABOLIC PHENOTYPING CENTERS FOR MODELS OF DIABETES AND ITS COMPLICATIONS Release Date: February 8, 2000 RFA: DK-00-014 (This RFA has been renewed, see RFA-DK-05-008) National Institute of Diabetes and Digestive and Kidney Diseases Letter of Intent Receipt Date: June 12, 2000 Application Receipt Date: July 12, 2000 PURPOSE This Request for Applications (RFA) solicits applications to establish national centers for the purpose of detailed metabolic phenotyping of knock-out mice and other mouse models potentially useful for understanding diabetes, its complications, obesity and related metabolic diseases or conditions. These facilities are expected to provide a range of standardized procedures to characterize metabolism, body composition, feeding behavior, activity, tissue pathology, and other physiologic, anatomic or pathological alterations that may occur in these mice. The user group for these centers is expected to be NIH grantees and others, both inside and outside the institution, who wish to submit their various mice for detailed metabolic and physiologic phenotyping beyond what would be possible or cost-effective in their individual laboratories. Because the mice to be characterized will have been developed on a variety of genetic backgrounds, characterization must be applicable to the major mouse strains used for research. Applicants should propose plans to prioritize use of the facility and for cost recovery from users. Coordination among the Mouse Metabolic Phenotyping Centers established in response to this RFA will be required. Finally, Centers are expected to develop improved methods to characterize the mice using a Pilot and Feasibility Project mechanism. 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, (Mouse Metabolic Phenotyping Centers for Models of Diabetes and Its Complications), is related to the priority area of Diabetes and Chronic Disabling Conditions. Potential applicants may obtain a copy of "Healthy People 2010" at ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic for-profit and nonprofit organizations, public and private, such as universities, colleges, hospitals, units of State and Local governments, and eligible agencies of the Federal government. Foreign institutions are not eligible, although they may apply for Pilot and Feasibility funds from the Mouse Metabolic Phenotyping Centers. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) cooperative agreement (U24) award mechanism. The cooperative agreement is used when participation by NIH staff is warranted to support and/or stimulate the recipients' activities by working jointly with the award recipients as a partner. However, NIH staff will not assume prime responsibility or take a dominant role in the activity. Details of the responsibilities, relationships, and governance of the studies funded under cooperative agreements are discussed below in "Terms and Conditions of Award" under SPECIAL REQUIREMENTS. Except as otherwise stated in this announcement, awards will be administered under National Institutes of Health (NIH) grants policy as stated in the NIH Grants Policy Statement. This RFA is a one-time solicitation. The total project period for an application submitted in response to this RFA may not exceed five years. The anticipated award date is March 1, 2001. FUNDS AVAILABLE The NIDDK intends to commit approximately $3,000,000 in FY 2001 to fund up to 4 new cooperative agreements in response to this RFA. An applicant may request a project period of up to 5 years and a budget for direct costs of up to $750,000 per year. Budget requests should make explicit the anticipated operating costs including fees charged to users for services. Because the nature and scope of the proposed research may vary, it is anticipated that the size of the awards will also vary. 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 this RFA will be reissued. RESEARCH OBJECTIVES Background Mutant mouse models, generated either by directed knock-out or transgenic techniques or by large-scale mutagenesis, are important tools for understanding the role of specific genes in health and disease. Genetic factors are thought to underlie the initiation, progression, and severity of complex diseases of interest to NIDDK: diabetes, obesity, and the devastating micro- and macrovascular complications of diabetes, such as nephropathy, neuropathy, retinopathy, and atherosclerosis. These diseases have proven difficult to study, partly due to lack of very good animal models and partly due to the complexity of the problem. Good animal models may allow for more rapid development and assessment of therapies and preventive measures. Candidate genes for diabetes and related disorders are being identified and mutated in directed research projects. These new mice include animals containing multiple altered genes or genes altered in specific tissues. Heterozygous knock-out mice are also potentially useful models for complex metabolic disease. New large-scale mutagenesis programs are expected to generate animal models of complex metabolic diseases in addition to other disorders. The resultant mice from both these approaches may have subtle phenotypes that could be particularly difficult to detect with simple high throughput tests, or with data taken at a single time point. Defects may be exposed only in the presence of physiologic or nutritional stress. Moreover, simple genetic manipulations could result in a very complex phenotype due to minor alterations in a large number of pathways and organs, or in their interaction. The types of experiments that are currently available to study metabolic processes-- glucose and insulin clamps, indirect calorimetry, or organ balance, PET, NMR and other tracer studies--are very difficult to do in tiny animals, and require specialized equipment and expertise. Characterization of diabetic complications via measurement of glomerular filtration rate, cardiac or renal hemodynamics also become technically challenging when done in mice. Therefore, researchers would benefit from a few centralized, well-equipped facilities to which they could submit their mice for detailed phenotyping. Objectives and Scope A national Mouse Metabolic Phenotyping Center must be an identifiable unit within a single institution such as a university, or a consortium of cooperating institutions including an affiliated university. An existing program of excellence in biomedical research in the area of diabetes or diabetes complications would be considered a strength. The center would be available to study mice generated by NIH-funded and other investigators from both outside and inside the institution. In general, Centers will be comprised of several components. Examples include a phenotyping laboratory and analysis core, an animal care core, a research and development program, and an administrative core. In addition, a Center may house an informatics core, a modeling project, or other cores deemed necessary. It is hoped that Centers will play a leadership role in the standardization of currently available phenotyping tests and in the development of new technologies. Centers are encouraged to propose a Pilot and Feasibility program capable of supporting small research projects within and outside the parent institution for the development of new technologies. The Centers funded by this RFA will be expected to interact with each other to maximize and coordinate service to the diabetes research community. A National Steering Committee comprised of funded principal investigators, NIH staff, and external advisors will be established in order to oversee and coordinate the funded Centers, and it is expected to meet about once a year. Applicants should propose a description of this body and its duties. A more thorough description of possible cores follows. A. Phenotyping Laboratory And Analysis Cores Centers will design or adapt and standardize a variety of tests that can be conducted on living animals or on body fluids and tissue samples. These tests would constitute a metabolic phenotyping 'exam' for potential mouse models of diabetes, diabetic complications, obesity and complex metabolic diseases. Emphasis will be placed on technologies that study live animals, although Centers may accept tissue samples (pancreas, kidney, heart, liver, fat) or body fluids (blood, plasma, urine) as well as whole live animals from users for phenotyping. Centers may choose to provide either standard or customized 'exams' for various animal models, and should propose a method to advise users in order to determine the appropriate series of tests. Phenotyping tests may be designed to identify: 1) metabolic, signaling or endocrine alterations that result in altered glucose metabolism, obesity or feeding behavior, insulin resistance, dyslipidemia, diabetes, or other metabolic diseases; 2) altered susceptibility to or progression of diabetes, obesity, etc.; 3) defects in hormone production, secretion, receptor recognition, or intracellular action; 4) developmental alterations leading to diabetes, alterations in severity of diabetic complications, obesity, or other metabolic disorders; or 5) susceptibility to the sequelae of diabetes such as nephropathy, macrovascular disease, retinopathy, or neuropathy. In addition, a series of high-throughput tests may be proposed to identify other possible disease models of interest to NIDDK. Applicants must carefully justify methodologies, technologies, statistical analytical tools, and costs, and describe the limitations of the approaches. Applicants must indicate the number of tests that can be performed each year. Potentially interesting mice will have been developed on a variety of genetic backgrounds. Therefore characterization must be applicable to the major mouse strains used for research. Centers will be required to establish 'normal' parameters for each test on the appropriate wild type background strains. A quality control method for establishing, maintaining, and documenting the reliability of all tests should be proposed. Many of the proposed tests are likely to require significant development and standardization during the funding period. A detailed plan for such development should be included in the application. Applicants are encouraged to work with members of other communities, specifically researchers that already have important techniques used in rats, in order to miniaturize or otherwise adapt these extant techniques for use in mice. Each funded center will have unique strengths, either because of the technologies available to it, or because of expertise in some aspect of metabolism, diabetes, diabetic complications, etc. It is expected that each center will work closely with the others through a National Steering Committee to take full advantage of these strengths and provide the best possible range of tests. Ongoing research to provide new tests, with an emphasis on novel technologies and miniaturization, should also be coordinated through this body. Examples of phenotyping tests include, but are not limited to: o Glucose and insulin clamps; o Carbon-13 NMR studies of metabolic pathway flux; o PET or other imaging measurements of regional nutrient uptake; o Whole body or organ balance tracer measurements of carbohydrate, protein, amino acid, or lipid uptake and production; o Body composition measurements; o Appetite, food intake, whole body energy balance and activity measurements; o Glomerular filtration rate, proteinuria, and renal hemodynamics; o Exercise stress testing; o Physiologic measurements, such as blood pressure, cardiac output, regional blood flow, or nerve function; o Anatomy and tissue pathology; o Hormone, cytokine, metabolite, ion, enzyme profiles in very small volumes of body fluids; o Physiologic and/or metabolic response to exogenous hormones or altered diet; o Alterations in development; o Immune parameters, especially those that are significant for development of type 1 diabetes and diabetic complications; or o Vulnerability of tissues to complications of diabetes. B. Animal Care Core Investigators will receive, house, feed, monitor and maintain the health of submitted mice for the duration required for the phenotyping exam. Proposals must include policies, procedures, and anticipated costs for these items. It is not anticipated that these animals will be returned to the users. C. Research and Development Core This RFA aims to foster the development of new technologies and tests that will enhance and enlarge the capability of the centers to characterize mouse models of diabetes, obesity and metabolic disorders, and diabetic complications. This might include, for example, novel technologies applied to living animals, miniaturization of existing assays, or contracting or collaborating with investigators from other areas to lend their expertise to develop new technologies or assays. A detailed plan for these projects should be submitted in the application. In addition to in-house research and development efforts that would take place under the auspices of the principal or co- investigators, the Centers are encouraged to propose a Pilot and Feasibility program. This would provide short-term grant support (1-2 years) to fund projects in new technology and test development and would provide a mechanism to draw upon technologies yet to be developed or expertise not found within the Center. Centers would be expected to dedicate at least $150,000 of direct costs during years 2-5 for these projects, which would be solicited from inside and outside the institution. This money would be competitively distributed to 1) develop new technologies or miniaturization of existing technologies for use in mice; 2) develop applications of existing technologies for mouse phenotyping; 3) provide new tests to meet identifiable, outstanding needs of the Center(s); 4) establish new types of mathematical models, informatics, databases or products that otherwise augment the Centers. These funds are not intended to support ongoing funded research of an investigator. They would in most cases not be renewable. Applications may contain examples of the sorts of Pilot and Feasibility projects that might be solicited. These might outline goals, experimental approach, and the difficulties that would need to be overcome, but they need not be fully developed. Each Center will be required to administer a finite portfolio of Pilot and Feasibility Projects, which will likely be a subset of those selected under the auspices of the National Steering Committee. These will be funded through the parent U24 awards as subcontracts to outside institutions, or as subprojects within the parent institution. It is expected that the Pilot and Feasibility programs will be overseen by the National Steering Committee, which will work with the NIH and all funded Centers to determine the appropriate methods for national solicitation, selection, and administration of these awards. The U24 application should propose methods by which these will be accomplished. D. Administrative Core Applicants must provide methods to maintain center records, establish, standardize, document and distribute protocols, and to provide for quality control and budgetary oversight. Applicants must also provide methods for establishing priorities among submitted mice, and a plan for full or partial cost recovery from users. The same priority criteria and reimbursement structure should be applied to submitted animals from all investigators, whether inside or outside the parent institution. Applicants should plan to advise users on the appropriate 'exam' for their particular animal model and research goals. They must plan to distribute funds for Pilot and Feasibility projects, and inform the research community of the available phenotyping exams. An internal advisory board consisting of the principal and co-investigators and other important personnel should be proposed in order to oversee the daily operation of the center. The Applicant should describe how the center will fit into, augment, and be supported by the parent institution, and plan for designating an alternate or replacement Principal Investigator should it become necessary. E. Databases and Data Sharing Timely sharing of information, materials, protocols and technology will speed scientific discovery by permitting researchers access to well-characterized resources as quickly as possible. At the same time, data collected on submitted mouse models cannot be considered public information. Applicants are expected to propose appropriate means of recording data and interacting with the research community. They should comment regarding the confidentiality of data collected on submitted mouse models. It is hoped that databases, web sites, etc. will be able to serve the needs of all centers established by this initiative. SPECIAL REQUIREMENTS Applicants must indicate their willingness to be part of a National Steering Committee consisting of representatives of each Phenotyping Center, NIH staff, and members of the scientific community who are unaffiliated with funded centers, and who will act in an advisory capacity. The annual meetings will be held to encourage exchange of information among investigators who participate in this program. A major goal of these meetings is to facilitate progress by providing a forum that will lead to sharing skills, ideas, technology, data, and biological reagents. At the meetings, participants will also discuss quality assurance, informatics, coordination, sharing, means of informing the research community of services offered by the Phenotyping Centers, and training. Applicants must indicate their willingness to work together to develop a range of phenotyping tests that are complimentary. If duplication is absolutely necessary, centers should expect to use similar protocols. The National Steering Committee will also participate in administering the Pilot and Feasibility arms of the Centers. Applicants must include travel funds that will allow the Principal Investigator and at least one other key research scientist to participate each year for a one-day meeting in Bethesda, Maryland. During the course of the funding period, technologies will improve, and the rate of progress and focus of work supported by the cooperative agreement may change. It is expected that the Principal Investigator(s), in consultation with NIDDK program staff and the National Steering Committee, will make any necessary adjustments to accommodate the changing research environment, to remain focused on appropriate goals, to maintain excellent coordination with the other projects funded under this RFA, and to incorporate new technological advances. TERMS AND CONDITIONS OF AWARD The administrative and funding instrument used for the Centers is a cooperative agreement (U24), an "assistance" mechanism in which substantial NIH scientific and programmatic involvement with the awardee is anticipated during the performance of the agreement. Under the cooperative agreement, NIDDK's purpose is to work with the Center as a partner to assist and stimulate the Centers' planning and implementation. NIDDK will not assume primary direction, responsibility, or a dominant operating role in the Center. The primary role and total responsibility for Center programs resides with each Center. The Center and the NIDDK as noted below will share specific tasks and activities in completing the agreement. These special Terms of Award are in addition to and not in lieu of otherwise applicable U.S. Office of Management and Budget administrative guidelines, HHS Grant Administration Regulations at 45 CFR Parts 74 and 92, and other HHS and NIH Grant Administration policies. 1. Awardee Rights and Responsibilities The Awardee will have primary and lead responsibilities for the project as a whole, but is expected to collaborate and cooperate with the National Steering Committee, as well as with NIDDK staff. The Awardee is expected to administer the Center, design and provide mouse phenotyping tests for the diabetes and metabolic diseases research community, and facilitate and support research as outlined in the application. The Awardee will establish an Internal Advisory Committee to provide scientific and administrative oversight. The Advisory Committee will be composed of the lead center personnel, and other technical or research personnel. These individuals are not limited to center faculty. The committee is expected to meet at least monthly. Minutes of these meetings will be made available to NIH staff upon request. The Advisory Committee is charged with both prioritizing projects submitted to the Center and periodically reviewing Center activities to ensure that Center objectives, as outlined in the application, are being met. Data on normal mouse background strains shall become public and available. The users will retain custody of, and have primary rights to, the data taken on their particular mouse models, subject to Government rights of access consistent with current HHS and NIH policies. These data may be made public with permission of the investigator to whom the animals belong. 2. NIH Staff Responsibilities The NIDDK Program Officer will have substantial scientific and programmatic involvement in the Centers. NIDDK will designate a Program Officer and a Grants Management Specialist to provide administrative oversight of the cooperative agreement. The NIDDK and the awardees will jointly select members of the National Steering Committee. The NIDDK Program Officer will assist the awardees in coordinating activities among the Centers, providing information to researchers about the availability of services, and in developing policies for prioritization of use of these services. 3. Collaborative Responsibilities A National Steering Committee, composed of the principal investigators of each supported Metabolic Phenotyping Center, the NIDDK Program Officer, and external advisors, has the primary responsibility for developing and implementing common procedures, guidelines, and criteria across Centers. It will also be responsible for establishing common procedures and guidelines for Pilot and Feasibility programs, and for reviewing submitted applications. The Mouse Metabolic Phenotyping Centers agree to use any common guidelines and procedures set by the National Steering Committee (e.g., process for systematic review of quality control, protocols, record keeping, database management, report formats). 4. Arbitration Any disagreement that may arise on scientific and programmatic matters within the scope of the cooperative agreement and between award recipients and NIDDK may be brought to arbitration. An arbitration panel will be composed of three members: one selected by the Center Principal Investigator; a second member selected by NIDDK; and, the third member selected by the two prior selected members. This special arbitration procedure in no way effects the awardee's right to appeal an adverse action that is appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulation at 45 CFR Part 16. LETTER OF INTENT Prospective applicants are asked to submit by June 12, 2000 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 in response to which the application may be submitted. 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, NIDDK Room 653 6707 Democracy Boulevard MSC 5452 Bethesda, MD 20892-5452 (Bethesda, MD 20817 for express/courier service) 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 may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, MSC 7910, Bethesda, MD 20892-7910, telephone 301-710-0267, email: 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 sample RFA label available at: has been modified to allow for this change. Please note this is in pdf format. 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 time of submission, two additional copies of the application must be sent to: Chief, Review Branch Division of Extramural Activities, NIDDK Room 653 6707 Democracy Boulevard MSC 5452 Bethesda, MD 20892-5452 (Bethesda, MD 20817 for express/courier service) Applications must be received by July 12, 2000. If an application is received after this date, it will be returned to the applicant without review. Supplemental documents containing significant revision or additions will not be accepted, unless applicants are notified by the Scientific Review Administrator. 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 previously reviewed, but such applications must include an introduction addressing the previous critique. SPECIAL INSTRUCTIONS TO APPLICANTS Applicants must carefully describe methodologies, technologies, quality control measures, record keeping, statistical tools, costs and cost recovery strategies, and known limitations of proposed tests. Applicants should outline strategies for research and development of new tests, or implementation of tests that will take place during the funded period. Since new techniques are being developed rapidly, the applicant should discuss how they will take advantage of technical and methodological advances as they occur. Pilot and Feasibility Program: Applicants may include brief descriptions of sample Pilot and Feasibility studies to demonstrate the sort of projects likely to be solicited. Applicants should outline strategies for solicitation and review of Pilot and Feasibility applications, and for administering awards. It is expected that all awarded Centers will work with NIH, each other, and the National Steering Committee to finalize and implement policies regarding the Pilot and Feasibility programs. Each Center will be required to administer a subset of awarded Pilot and Feasibility Projects, either as subcontracts under the parent U24 award to other institutions, or as subprojects within the parent institution. Internal Advisory Committee: The application should describe the composition and functions of an Internal Advisory Committee that would establish priorities for the Center, discuss issues of quality control, cost recovery, record keeping, new technologies, etc. National Steering Committee: One external National Steering Committee will be established to oversee all funded Centers. Applicants should propose strategies for staffing this committee, and an outline of its duties. Annual Meetings: Applicants must include travel funds that will allow the Principal Investigator and at least one other key person to participate each year in a one-day meeting in Bethesda, Maryland. Applications should include a statement indicating willingness to participate in these meetings. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by the NIDDK. 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 the NIDDK in accordance with the review criteria stated below. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Applications for Mouse Metabolic Phenotyping Centers will be reviewed in the context of their ability to support and expand NIDDK's goals to study and treat diabetes and its complications, obesity, and other complex metabolic diseases. Specific review criteria are: o Proposed Phenotyping Tests: Will the proposed tests characterize a reasonable range of metabolic phenomena, and provide information that would otherwise be unavailable to most laboratories, or more cost- effective to conduct centrally? Do they utilize state-of-the-art technology? Is the necessary technical and analytical expertise available? Will the proposed tests help researchers characterize existing mouse models of disease and identify new ones? o Innovation: Does the application demonstrate potential for in-house development of important new tests and technologies that will expand the scope and quality of the available phenotyping exam? In addition, does it indicate a willingness to participate in a Pilot and Feasibility program that would also contribute new tests and technologies to the Center? Are adequate mechanisms proposed for collecting and reviewing applications and administering funds for this program? o Coordination: Is the applicant willing and able to provide a phenotyping service for the national diabetes, metabolism, and NIDDK research communities? Does the applicant state a willingness to work with the NIH, other awarded Centers and a National Steering Committee to develop the best possible set of phenotyping tests? Will this service be accessible to outside investigators, and are the criteria for prioritizing the testing of submitted mice fair and equitable? Is the applicant willing to share protocols and technology with the research public? Is the applicant willing to participate in developing a national database of test results on control animals from appropriate background strains, and other appropriate information? o Management: Are the applicant’s plans for oversight, animal care, quality control and record-keeping adequate? o Investigators: Are the investigators appropriately trained and well suited to carry out this work? Do they have experience with metabolic research, with mice, and with the proposed technologies? Is the proposed work appropriate to the experience level of the principal investigator and other researchers? o Resources and Environment: Does the institutional environment in which the work will be done contribute to the probability of success? Is there evidence of institutional support? Are there appropriate facilities and equipment, and will the Center have access to them? Is there an intellectual research community available to participate in test development? Are there candidate users at the applicant institution? In addition to the above criteria, in accordance with NIH policy, all applications will also be reviewed with respect to the following: o The reasonableness of the proposed budget. o The adequacy of the proposed protection of humans, animals, or the environment, to the extent that they may be adversely affected by the project proposed in the application. Schedule Letter of Intent Receipt Date: June 12, 2000 Application Receipt Date: July 12, 2000 Peer Review Date: November-December, 2000 Council Review: January, 2001 Earliest Anticipated Start Date: March 1, 2001 AWARD CRITERIA Award criteria that will be used to make award decisions include: o Merit of the proposed service and scientific projects as determined by peer review; o Programmatic priorities, including geographic location of the applicant organization, diversity of phenotyping tests, willingness to work with other institutions to minimize overlap between centers, and relevance of the phenotyping tests to advance the understanding of diabetes and diabetic complications; o Availability of funds; and o Total cost of the project. 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: Maren R. Laughlin, Ph.D. Division of Diabetes, Endocrinology and Metabolic Diseases NIDDK 45/5AN-24J 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8802 FAX: (301) 480-3503 E-mail: Robert A. Star, M.D. Division of Kidney, Urologic, and Hematologic Diseases NIDDK 45/6AS-13K 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-7715 FAX: (301) 480-3510 E-mail: Direct inquiries regarding fiscal matters to: Mary Kay Rosenberg Division of Extramural Activities NIDDK 45/6AS-49D 45 Center Drive MSC 6600 Bethesda, MD 20892-6600 Telephone: (301) 594-8891 FAX: (301) 480-3504 E-mail: AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.93.847, 93.848 and 93.849. Awards are 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 NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The NIH strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the NIH mission to protect and advance the physical and mental health of the American people.

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