DOCSLIB.ORG

Proquest Dissertations

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Proquest Dissertations INTEGRATION OF HIV AND REPRODUCTIVE HEALTH SERVICES: PRODUCTION PROCESSES IN FAMILY HEALTH OPTIONS KENYA CLINICS by Carol Atieno Obure Submitted in partial fulfilment of the requirements for the degree of Master of Development Economics at Dalhousie University Halifax, Nova Scotia June 2009 © Copyright by Carol Atieno Obure, 2009 Library and Archives Bibliotheque et 1*1 Canada Archives Canada Published Heritage Direction du Branch Patrimoine de I'edition 395 Wellington Street 395, rue Wellington OttawaONK1A0N4 OttawaONK1A0N4 Canada Canada Your file Votre reference ISBN: 978-0-494-56307-6 Our file Notre reference ISBN: 978-0-494-56307-6 NOTICE: AVIS: The author has granted a non­ L'auteur a accorde une licence non exclusive exclusive license allowing Library and permettant a la Bibliotheque et Archives Archives Canada to reproduce, Canada de reproduire, publier, archiver, publish, archive, preserve, conserve, sauvegarder, conserver, transmettre au public communicate to the public by par telecommunication ou par I'lnternet, prefer, telecommunication or on the Internet, distribuer et vendre des theses partout dans le loan, distribute and sell theses monde, a des fins commerciales ou autres, sur worldwide, for commercial or non­ support microforme, papier, electronique et/ou commercial purposes, in microform, autres formats. paper, electronic and/or any other formats. The author retains copyright L'auteur conserve la propriete du droit d'auteur ownership and moral rights in this et des droits moraux qui protege cette these. Ni thesis. Neither the thesis nor la these ni des extraits substantiels de celle-ci substantial extracts from it may be ne doivent etre imprimes ou autrement printed or otherwise reproduced reproduits sans son autorisation. without the author's permission. In compliance with the Canadian Conformement a la lot canadienne sur la Privacy Act some supporting forms protection de la vie privee, quelques may have been removed from this formulaires secondaires ont ete enleves de thesis. cette these. While these forms may be included Bien que ces formulaires aient inclus dans in the document page count, their la pagination, il n'y aura aucun contenu removal does not represent any loss manquant. of content from the thesis. 1*1 Canada DALHOUSIE UNIVERSITY To comply with the Canadian Privacy Act the National Library of Canada has requested that the following pages be removed from this copy of the thesis: Preliminary Pages Examiners Signature Page (pii) Dalhousie Library Copyright Agreement (piii) Appendices Copyright Releases (if applicable) DEDICATION This thesis is dedicated to the loving memory of my father the late Allan Obure who always believed in me. Daddy, I wish you had lived to see this day. To my mother, Florence Obure, Uncle, Joshua Mallet and Aunt, Elom Dope Akoumani. Thank you for your prayers and encouragement throughout this journey. To my brothers Roy and Carl, this is to inspire you that with God all things are possible. IV TABLE OF CONTENTS LIST OF TABLES vii LIST OF FIGURES viii ABSTRACT ix LIST OF ABBREVIATIONS USED x ACKNOWLEDGEMENTS... xii CHAPTER 1: INTRODUCTION 1 1.1 Background 1 1.2 Economics of Integrating HIV and SRH Services 3 1.3 Aims and Objectives of the Thesis 4 CHAPTER 2: CONCEPTUAL APPROACH TO INTEGRATION 6 2.1. Production Theory 6 2.2 Costs of Production 10 2.3 Joint Production 12 2.4 Economies of Scope 13 2.5 Transaction Costs Theory 14 2.6 Conclusion 19 CHAPTER 3: LITERATURE REVIEW 20 3.1. Defining Integration 20 3.2. Forms of Integration 21 3.3. History of Integration of Health Care Services 25 3.4 Rationale for Integrating HIV and SRH Services 27 3.5 Organization of HIV and SRH Services 30 3.6 Models of Integrated HIV and SRH Services 32 3.7 Challenges to Integration 36 3.8 Results of Integration Studies 37 3.9 Conclusion 51 v CHAPTER 4: BACKGROUND AND METHODOLOGY 53 4.1. Kenya 53 4.2. HIV in Kenya 55 4.3. National Response to HIV/AIDS 57 4.4 Organisation of HIV and SRH Services in Kenya 59 4.5 Thesis Aims and Objectives 60 4.6 Methodology of Study 61 4.7 Background on Family Health Options Kenya 63 4.8 Conclusion 64 CHAPTER 5: PRODUCTION PROCESS OF INTEGRATED HTV AND REPRODUCTIVE HEALTH SERVICES 66 5.1 Description of the Clinics 66 5.2 Output Data 72 5.3 Description of Production Processes 74 5.4 Output Data Analysis 78 5.5 Input Profiles 81 5.6 Discussion 85 5.7 Conclusion 88 CHAPTER 6: CONCLUSION 90 6.1 Background in Economic Theory 90 6.2 Literature Review 91 6.3 Background and Methodology 91 6.4 Production Processes of HTV and SRH Services 92 6.5 Conclusion 93 REFERENCES 96 APPENDIX A: PERIODIC ACTIVITY REVIEW TOOL 102 APPENDIX B: LIST OF KEY INFORMANTS INTERVIEWED 123 VI LIST OF TABLES TABLE 3.1 DEFINITIONS OF INTEGRATION 22 TABLE 3.2 SUMMARY OF INTEGRATION STUDIES 38 TABLE 5.1 DESCRIPTION OF OUTPUTS 67 TABLE 5.2 SUMMARY OF CLINICS INCLUDED IN STUDY 69 TABLE 5.3 CD4 REFERRAL SITES 76 TABLE 5.4 SUMMARY OF CLINICS OUTPUTS FOR JAN - JUNE 2008 80 TABLE 5.5 KEY STAFF INVOLVED IN PROVISION OF SRH AND HIV SERVICES 81 TABLE 5.6 SUMMARY OF CLINICS LABOUR INPUTS 84 Vll LIST OF FIGURES FIGURE 2.1 ISOQUANT MAP 9 FIGURE 3.1 STRUCTURAL INTEGRATION 24 FIGURE 3.2 COMPONENTS OF HIV AND SEXUAL REPRODUCTIVE HEALTH SERVICES ... 30 FIGURE 4.1 MAP OF KENYA'S HIV PREVALENCE BY PROVINCE 56 vm ABSTRACT Integration of HIV and Sexual Reproductive Health services (SRH) has been advocated as a means of curbing the spread of HIV in high HIV prevalence settings while meeting the reproductive health needs of people living with HIV/AIDS. However, despite the benefits associated with integrating HIV and SRH services, there remains a dearth of economic evaluations of such integrated service delivery. This lack of economic analysis can be attributed to the major gap in knowledge of how resources are combined to produce such integrated services. This thesis therefore aims to address this information gap by examining how resources are combined to produce integrated HIV and SRH services in six Family Health Options Kenya Clinics. The analysis of the production processes presented in this thesis is expected to inform future economic evaluations of various models of integrated HIV and SRH service delivery. IX LIST OF ABBREVIATIONS USED AIDS Acquired Immunodeficiency Syndrome ANC Ante Natal Care ARV Anti-Retroviral ART Anti-Retroviral Therapy CHW Community Health Worker COW Community Outreach Worker DRH Division of Reproductive Health ERSWEC Economic Recovery Strategy for Wealth and Employment Creation FACES Family AIDS Care and Education Services FP Family Planning FHOK Family Health Options Kenya FPAK Family Planning Association of Kenya GDP Gross Domestic Product HBC Home-Based Care HIV Human Immunodeficiency Virus ICPD International Conference on Population and Development IPPF International Planned Parenthood Federation IUD Intrauterine Contraceptive Device KAIS Kenya AIDS Indicator Survey KEMRI Kenya Medical Research Institute KNASP Kenya National AIDS Strategic Plan MCH Maternal and Child Health X MOC Models of Care for Integrating HIV/AIDS Prevention and Care into Reproductive Health services MOH Ministry of Health NACC National AIDS Control Council NASCOP National AIDS and STI Control Programme 01 Opportunistic Infections PAR Periodic Activity Review PITC Provider Initiated Testing and Counseling PLWHA People living with HIV and AIDS , PMTCT Prevention of Mother to Child Transmission PNC Post Natal Care PSS Psychosocial Support RH Reproductive Health RTI Reproductive Tract Infection SIDA Swedish International Development Cooperation Agency SRH Sexual and Reproductive Health STD Sexual Transmitted Disease STI Sexually Transmitted Infection UNAIDS Joint United Nations Programme on HIV/AIDS UNFPA United Nations Population Fund USAID United States Agency for International Development VCT Voluntary Counseling and Testing YMEP Young Men as Equal Partners xi ACKNOWLEDGEMENTS This study is part of a research project on "Assessing the Benefits of Integrated HIV and Reproductive Health Services in Kenya, Swaziland and Malawi" funded by the Bill and Melinda Gates Foundation in collaboration with the International Planned Parenthood Federation (IPPF), the London School of Hygiene and Tropical Medicine and the Population Council. I would like to give special thanks to Professor Lilani Kumaranayake, academic supervisor, Dalhousie University for giving me the opportunity to be a part of this study and for her support throughout the completion of this thesis. Thank you to Ms. Fern Terris-Prestholt, London School of Hygiene and Tropical Medicine for her time and support throughout the course of this study and to all the Family Health Options Kenya staff who participated in the research, for their help and hospitality. I also thank Professor Mathieu Dufour and Dr. Barry Lesser for agreeing to be my readers and providing valuable feedback and suggestions. Their contributions have greatly enhanced the quality of this thesis. Finally I would like to thank my dearest friends, Ifeatu Nwafornso and Ferdinand Mito- Yobo. I couldn't have asked for better classmates. Thank you! xn CHAPTER 1: INTRODUCTION Almost thirty years since the discovery of the human immunodeficiency virus (HIV), HIV/AIDS remains one of the greatest challenges to development in sub-Saharan Africa. According to the Joint United Nations Programme on HIV/AIDS (UNAIDS), sub- Saharan Africa is the most affected region, with more than 67% of the 33 million people living with HIV worldwide (UNAIDS, 2008). In addition, UNAIDS estimated that by the end of 2007, women accounted for nearly 60% of the new HIV infections in sub-Saharan Africa. With the pandemic showing no signs of abating, governments have been forced to adopt more aggressive measures to ensure prevention of HIV transmission. Therefore, efforts to stop new HIV infections continue to be as important as providing testing; and treatment to those already living with HIV.
Load more

Recommended publications
  • Rules and Regulations Federal Register Vol
    57607 Rules and Regulations Federal Register Vol. 68, No. 193 Monday, October 6, 2003 This section of the FEDERAL REGISTER Unit 148, Riverdale, MD 20737–1231; that a firm does not have the equipment contains regulatory documents having general (301) 734–8245. necessary to conduct the test. applicability and legal effect, most of which In this final rule, we are adopting the SUPPLEMENTARY INFORMATION: are keyed to and codified in the Code of gravimetric method as the standard Federal Regulations, which is published under Background procedure for determining moisture 50 titles pursuant to 44 U.S.C. 1510. content. As a Standard Requirement The Virus-Serum-Toxin Act test, the gravimetric method should be The Code of Federal Regulations is sold by regulations in 9 CFR part 113 (referred the Superintendent of Documents. Prices of used whenever the test for moisture new books are listed in the first FEDERAL to below as the regulations) prescribe content is performed. However, we note REGISTER issue of each week. standard requirements for the that exemptions to the use of the preparation and testing of veterinary gravimetric method, like exemptions to biological products. Standard any test prescribed in the various DEPARTMENT OF AGRICULTURE requirements consist of test methods, standard requirements found in part procedures, and criteria that define the 113, may be granted for any valid reason Animal and Plant Health Inspection standards for purity, safety, potency, in accordance with § 113.4, Service and efficacy for a given type of ‘‘Exemptions to tests.’’ Exemption veterinary biologic product. When a requests are evaluated on a product-by- 9 CFR Part 113 standard procedure for testing product basis, and in our review of such [Docket No.
    [Show full text]
  • CFSC Brochure
    Feasibility Study A feasibility study typically is the response to some client-identified problem or opportunity. It reveals what is required to build a solid business case, allowing management to make an informed decision about funding or canceling the project. "To be, or not to be?" is the primary question a feasibility study answers. This primary question can be decomposed in three supporting questions: What is this project all about? Should we do this project? How should we go about this project? What is this feasibility all about? One primary reason for project restarts, or outright failure, is the lack of a project mission, which at this early point means a careful analysis of the problems or opportunities and their possible impact on the organization. Team members, customers, and other stakeholders need a good understanding of the project's fundamental components - goals, objectives, scope, problem statement, constraints, and vision. A good test of whether or not a project is understood is to walk around and ask various participants what they think it's all about. A crisp, business-oriented, non-technical answer usually means the project's groundwork is well established. The answer could be what we refer to as a project objective statement: a short, concise, high-level summary of the project. Should we do this project? The second major question answered by a good feasibility study is whether or not the project should proceed. The very name "feasibility" indicates one possible outcome is not to proceed. A significant portion of the multi-billion losses on software projects comes from projects that should never have gotten past the feasibility stage, but got caught up in corporate egos and politics.
    [Show full text]
  • A Manufacturing Business Process Reengineering Method: Design and Redesign of a Production Control Model
    A Manufacturing Business Process Reengineering Method: Design and Redesign of a Production Control Model J. O. Strandhagen, Dr.ing. T. Skarlo, Research Engineer SINTEF Production Engineering, N - 7034 Trondheim, Norway Telephone: +4773593138•, Telefax: +4773597117 e-mail: [email protected], [email protected] Abstract Design and Redesign of a Production Control Model are methods for business process reengineering of manufacturing companies. It is a practical approach to assist companies that want to make the way they control their manufacturing processes a competitive advantage in meeting future market and customer demands. It is based on application of a mixture of techniques and methods from well known control principles. It has been developed and tested in a dozen Norwegian companies. Keywords Business Process Reengineering, Production Planning and Control, Material Flow, Layout, Production Control Model. 1 INTRODUCTION In order to compete successfully, firms must achieve excellence in managing their manufacturing operations. Companies need to change the role of manufacturing from being “internal neutral” to “externally supportive” based on Hayes and Wheelwrights (1985) stages. Several studies on performance have been performed. The best known is probably "Made in America" (Dertouzos, et. al, 1989) which studied how the US industry should change in order to regain competitiveness over Europe and Japan. A stronger focus on manufacturing was one of the major findings. In the Norwegian TOPP project a study of the performance of 50 Norwegian industrial companies was performed. This study showed that product development, quality management, production control, procurement and internal material 1 flow all had a higher relative importance than performance, Bredrup et.
    [Show full text]
  • Indicator: Percentage of Land Cover Types in Ontario
    Pressures on Biodiversity INDICATOR: PERCENTAGE OF LAND COVER TYPES IN ONTARIO STRATEGIC DIRECTION: Reduce Threats TARGET: N/A THEME: Pressures on Biodiversity – Habitat Loss Background Information: Changes in land cover can provide critical information on broad-scale ecosystem changes and the causes and impacts of these changes. By using land cover mapping developed from satellite imagery, it is possible to track changes in land cover through time over broad areas. For this indicator, individual land cover classes were aggregated into broader land cover types with relevance to biodiversity: anthropogenic cover, aquatic cover, disturbance cover, natural disturbance cover and natural terrestrial cover. At the ecozone scale, anthropogenic cover reflects threats to biodiversity, under the assumption that human-modified landscapes experience greater habitat loss and fragmentation than more natural landscapes. While some disturbances are caused by human activities, it’s important to note that disturbances are a natural part of any ecosystem and are necessary to maintain biodiversity. This indicator shows trends in the proportion of broad land cover types in each of Ontario’s terrestrial ecozones over the period 2000-2011. Data Analysis: Classes of land cover from digital provincial data sets for the years 2000 and 2011 were aggregated into five broad land cover categories (Table 1). In the Mixedwood Plains Ecozone of southern Ontario (with the exception of Manitoulin Island), land cover information from the Southern Ontario Land Resource Information System was used (SOLRIS; OMNR 2008). SOLRIS version 2.0 (2011 land cover) was developed using a LandSat based change detection analysis process applied to woodlands and wetlands identified in SOLRIS version 1.0 (2000-2002 land cover).
    [Show full text]
  • Veterinary Services Memo 800.116: Animal Safety Testing Exemption
    July 31, 2013 United States VETERINARY SERVICES MEMORANDUM NO. 800.116 Department of Agriculture Animal and Plant TO: Biologics Licensees, Permittees, and Applicants Health Inspection Directors, Center for Veterinary Biologics Service Veterinary Services Leadership Team Veterinary Services FROM: John R. Clifford /s/ John R. Clifford Washington, DC Deputy Administrator 20250 SUBJECT: Animal Safety Testing Exemption I. PURPOSE This Memorandum provides guidance so licensed firms may request an exemption under title 9, Code of Federal Regulations (9 CFR), part 113.4, to animal safety testing as required in section V.B. of the Outline of Production and 9 CFR 113.64, 113.100, 113.200, 113.300, and 113.450. The Center for Veterinary Biologics (CVB) will consider granting an exemption to animal safety testing for specific products with a documented history of acceptable safety results and controlled manufacturing processes that have ensured batch-to-batch consistency and sterility. II. BACKGROUND Safety testing in animals has been a component of the approval process for each serial of product released for marketing by the CVB since the program’s inception. This release testing provides assurance that each serial of product will not have unfavorable results in the target animal. General safety requirements for live bacterial vaccines are described in 9 CFR 113.64, inactivated bacterial products in 9 CFR 113.100, killed virus vaccines in 9 CFR 113.200, live virus vaccines in 9 CFR 113.300, and antibody products in 9 CFR 113.450. Depending on the type of product, animal safety testing may be conducted in mice (9 CFR 113.33), guinea pigs (9 CFR 113.38), or the host animal, i.e., cat (9 CFR 113.39), dog (9 CFR 113.40), calf (9 CFR 113.41), pig (9 CFR 113.44), sheep (9 CFR 113.45), poultry (9 CFR 113.100(b)(2)), or aquatic species or reptiles (9 CFR 113.100(b)(3)).
    [Show full text]
  • Asset Management of Public Facilities in an Era of Climate Change: Application of the Dynamic Computable General Equilibrium Model
    Sustainable Development and Planning V 553 Asset management of public facilities in an era of climate change: application of the dynamic computable general equilibrium model Y. Kunimitsu Department of Rural Planning, National Institute for Rural Engineering, NARO, Japan Abstract Agricultural production depends heavily on climate conditions; therefore, climatic uncertainty caused by global warming represents a significant threat not only to agriculture but also to entire economies. Furthermore, the drastic budget cuts after 2001 in Japan have reduced public capital stock and have placed the production capacities of various industries in jeopardy. This highlights the need for asset management to prolong the structural integrity of facilities. The present study uses the recursive dynamic computable general equilibrium (CGE) model to evaluate asset management measures (namely, those focusing on reinforcing old facilities) in the context of climatic uncertainty. Simulation results showed that the uncertainty of production induced by climate change is amplified through the market mechanism. The variation in the total production was much wider than the variation in agricultural production originally affected by the climate change. The public capital stock maintained by the asset management measures can ease such uncertainty. Therefore, asset management policy, which makes the deficit minimal leeway for increasing public investment, is critical in Japan. The dynamic CGE model can also measure such long-term comprehensive effects and is useful
    [Show full text]
  • The Study on Revitalization of Small and Medium Enterprises in Argentina
    Japan International Cooperation Agency Secretary of Industry, Commerce and Small and Medium Enterprise, Ministry of Economy and Production, Argentina Sub-Secretary of Industry Sub-Secretary of Small and Medium Enterprise and Regional Development National Institute of Industrial Technology The Study on Revitalization of Small and Medium Enterprises in Argentina Final Report (Summary) MARCH 2006 UNICO INTERNATIONAL CORPORATION INTI made a brochure of the Study, in which the transfer of soft technology to the local SMEs with the experts of the Study Team is presented. “Bolsa de PyME” (SME database) developed as a joint work of SSPyMEyDR and the Study Team was launched in the closing seminar of the Study. Procedure of the closing seminar of the Study on March 2, 2006 in Buenos Aires Abbreviations ADEFA Asociación de Fábricas de Automotores ADERR Agencia de Desarrollo Región Rosario (Rosario Regional Development Agency) ADIMRA Asociación de Industriales Metalúrgicos de la República Argentina AFAC Asociación de Fábricas Argentinas de Componentes AFIP Administración Federal de Ingresos Públicos AFYDREM Asociación Fabricantes y Distribuidores de Repuestos para Automotores de la República Argentina AGE Asesores en Gestión de Empresa AIM Asociación de Industriales Metalúrgicos de Rosario BICE Banco de Inversión y Commercio Exterior, SA BID Banco Interamericano de Desarrollo CAFMA Cámara Argentina de Fabricantes de Maquinaria Agrícola CAP Common Automotive Policy CDE Centro de Desarrollo Empresarial CDTI Centro para el Desarrollo Tecnológico Industrial
    [Show full text]
  • USDA Center for Veterinary Biologics Statistics Section
    USDA Center for Veterinary Biologics Statistics Section Work Instructions Document: STATWI0005.01 Title: Logistic Curve Parameterizations in Commercial Software Author: Christopher Tong and Marie Vendettuoli Approved by: David Siev on 2017.03.23 This document approved for the indicated purposes Internal use Yes External distribution Yes CVB public web site Yes STATWI0005.01 Cover Page – page 0 2017.03.23 Source document: CVB Quality Manual Chapter 5 Parameterizations of the four-parameter logistic curve in software for estimating relative potency Christopher Tong∗ and Marie Vendettuoliy Statistics Section Center for Veterinary Biologics (CVB) U.S. Department of Agriculture Ames, Iowa, USA 23 March 2017 Contents 1 Introduction 3 2 Scope 3 3 Conventions 4 3.1 Concentration and dilution . 4 3.2 Assay response type . 5 3.3 4PL curve . 6 3.4 Graphing . 7 3.5 Suitability Criteria . 8 3.6 Procedure for estimating relative potency . 8 4 Examples 10 5 Software Implementation 13 5.1 SoftMax Pro 6.3 [10] . 14 5.2 Gen5 2.01 [1] . 15 6 An alternate parameterization of the 4PL curve 18 ∗[email protected] [email protected] 1 STATWI0005.01 page 1 of 20 References 19 2 STATWI0005.01 page 2 of 20 1 Introduction In vitro enzyme immunoassays (eg, ELISAs) are often used as relative potency tests for lot release1 of biological products [2, 9]. In such assays, a single 96- well microtiter plate may contain serial dilution sequences of one or more test lots and a reference preparation. The measured response in each well is an Optical Density (OD) value.
    [Show full text]
  • The Intergovernmental Forum on Forests (IFF) - in the Swedish Context
    R A P P O R T 3 2 0 0 1 The proposals for action submitted by the Intergovernmental Panel on Forests (IPF) and the Intergovernmental Forum on Forests (IFF) - in the Swedish context Kajsa Nilsson Swedish University of Agricultural Sciences © The National Board of Forestry januari 2001 Facts Kajsa Nilsson Swedish University of Agricultural Sciences Paper brilliant copy Reproduction JV, Jönköping Number of copies 350 ex ISSN 1100-0295 PRODUCT NUMBER 1630 The National Board of Forestry S – 551 83 Jönköping Telephone + 46 36 - 15 55 92 The proposals for action submitted by the Intergovernmental Panel on Forests (IPF) and the Intergovernmental Forum on Forests (IFF) - in the Swedish context Kajsa Nilsson Swedish University of Agricultural Sciences A study initiated by the National Board of Forestry and elaborated with participation of Ministry of Industry, Employment and Communications, Ministry of the Environment, Ministry for Foreign Affairs, Swedish International Development Cooperation Agency, Swedish Forest Industries Federation, Federation of Swedish Farmers and Forest Owners and Swedish Society for Nature Conservation. Table of contents Summary__________________________________________________________________ 1 1. Introduction _____________________________________________________________ 3 1.1 The United Nations Conference on Environment and Development (UNCED)__________ 3 1.2 The Intergovernmental Panel on Forests (IPF) ____________________________________ 3 1.3 The Intergovernmental Forum on Forests (IFF) ___________________________________
    [Show full text]
  • Federal Register/Vol. 70, No. 81/Thursday, April 28, 2005
    Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Proposed Rules 21985 etc. Finally, this rule will ensure that § 214.2 Special requirements for Production. In addition, after a product employers have sufficient time to seek admission, extension, and maintenance of is licensed and its dating period a new beneficiary or beneficiaries in the status. confirmed, the licensee or permittee event a petition is denied. * * * * * would have to submit a plan to monitor (o) * * * the stability of the product and the Executive Order 13132 (2) * * * suitability of its dating period; that plan This rule will not have substantial (i) General. * * * The petition may would have to include regular testing of direct effects on the states, on the be filed up to one year, but not earlier serials for potency during and at the end relationship between the National than 6 months, before the actual need of dating. The proposed changes would Government and the states, or on the for the alien’s services. Exceptions may help clarify the distinction between distribution of power and be granted in emergency situations at specifying an expiration date for an responsibilities among the various the discretion of the USCIS Service individual serial of a product and levels of government. Therefore, in Center Director, and in special filing establishing the appropriate expiration accordance with section 6 of Executive situations as determined by USCIS dating period for the product. The effect Order 13132, it is determined that this Headquarters. * * * of these proposed changes would be to rule does not have sufficient federalism * * * * * establish a single uniform standard for implications to warrant the preparation (p) * * * determining expiration dates for of a federalism summary impact (2) * * * veterinary biological products.
    [Show full text]
  • Animal and Plant Health Inspection Service, USDA § 114.7
    Animal and Plant Health Inspection Service, USDA § 114.7 (State) in storage at licensed establishments: [39 FR 16869, May 10, 1974, as amended at 60 Provided, That, if such ingredients, FR 48021, Sept. 21, 1995] components, or biological products are not so identified, they shall be disposed § 114.3 Separation of establishments. of as provided in § 114.15. (a) Each licensed establishment shall be separate and distinct from any other § 114.5 Micro-organisms used as seed. establishment in which a biological Micro-organisms used in the prepara- product is prepared. tion of biological products at licensed (b) No biological products authorized establishments shall be free from the to be prepared in a licensed establish- causative agents of other diseases or ment shall be prepared in whole or in conditions. A complete record of such part by another licensed establishment micro-organisms shall be kept cur- except as provided in paragraphs (c) rently correct and a list submitted to and (d) of this section. Animal and Plant Health Inspection (c) When a partially prepared biologi- Service upon request of the Adminis- cal product cannot be completed at a trator. licensed establishment due to failure of essential equipment, the Administrator (Approved by the Office of Management and may authorize the use of similar equip- Budget under control number 0579–0059) ment at another licensed establish- [39 FR 16869, May 10, 1974, as amended at 48 ment: Provided, That, such authoriza- FR 57473, Dec. 30, 1983; 56 FR 66784, Dec. 26, tion shall be limited to the duration of 1991] the emergency and to the phase of pro- duction affected by the equipment fail- § 114.6 Mixing biological products.
    [Show full text]
  • Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects
    Writing Assignment II Melissa Ann Snider DMP 895: Regulatory Aspects I. Outline of Regulatory Requirements for a Start-up Veterinary Biological Product Company in Regards to Establishing Itself and Licensing of First Vaccine with APHIS. Licensure Overview: First off, for new applicants, the facility should contact the Center for Veterinary Biologics (CVB) early in the production development process, so that a licensing reviewer can be assigned to help walk them through the regulatory process. This will help in preventing hang ups and unnecessary mistakes within the process. Obtain necessary permits, request to receive organism, product formulation: Veterinary Services Memorandum No. 800.50, gives guidance on the requirements for obtaining a U.S. Veterinary Biologics Establishment License, per title 9, Code of Federal Regulations (9 CFR), section 102.3(a), and a U.S. Veterinary Biological Product License, per 9 CFR 102.3(b). This document also specifies the information and documents needed to complete licensing actions for APHIS. For an Establishment License, the applicant must submit the following: 1. Application for U.S. Veterinary Biologics Establishment License: by submitting APHIS form 2001. 2. Articles of incorporation for the applicant and any subsidiaries, if applicable: 9 CFR 102.3. 3. Water quality statement (9 CFR 108.11): Submit a statement from local water authorities to verify that the facility is in compliance with regulations for effluent waste. 4. Application for at least one U.S. Veterinary Biological Product License and any applicable supporting documents (listed in the rest of the licensure overview): by submitting APHIS Form 2003. 5. Qualifications of Veterinary Biologics Personnel for key employees (9 CFR 114.7(a)): by submitting APHIS Form 2007.
    [Show full text]