Supplements and other changes to an approved application. Final rule

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to an approved application to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effects of manufacturing changes on the identity, strength, quality, purity, and potency of a drug or biological product as those factors relate to the safety or effectiveness of the product. The final rule sets forth requirements for changes requiring supplement submission and approval before the distribution of the product made using the change, changes requiring supplement submission at least 30 days prior to the distribution of the product, changes requiring supplement submission at the time of distribution, and changes to be described in an annual report.     

The Impact of Gravity-Weighted Knowledge Spillovers on Productivity in Manufacturing

This paper tests for localized knowledge spillovers from out-of-state innovations in U.S. manufacturing from 1977 to 1997. The source of these spillovers is innovations categorized into six technologies based on U.S. patent classes and patent data. Using a gravity-weighting for out-of-state innovations, knowledge spillovers are found from mechanical technologies and drug and medical technologies for a broad group of manufacturing industries. Innovations from chemical-related technologies are found to generate spillovers for the Chemical and Allied Products Industry and for the Transportation Equipment Industry. Additionally, specialization of production at the two-digit Standard Industrial Classification of industry level is also found to increase state-level productivity in manufacturing.     

Revocation of regulation on positron emission tomography drug products--FDA. Final rule; revocation

The Food and Drug Administration (FDA) is revoking a regulation on positron emission tomography (PET) radiopharmaceutical drug products. The regulation permits FDA to approve requests from manufacturers of PET drugs for exceptions or alternatives to provisions of the current good manufacturing practice (CGMP) regulations. FDA is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). Elsewhere in this issue of the Federal Register, FDA is publishing a notice revoking two notices concerning certain guidance documents on PET drugs and the guidance documents to which the notices relate.     

The Transfer of Manufacturing Processes and Standards in U.S. Plants Operating in the U.K.

This paper finds that U.S. firms tend to utilize their manufacturing processes when operating in the U.K. but that they adopt the production standards of the host country. Three process technology variables are examined: MRP I (materials requirements planning), JIT (just in time), and TQM (total quality management). While significant differences are found between indigenous plants in each of the two countries, the adoption of these manufacturing technologies is similar for American firms operating in either country. In contrast, U.S. transplants are found to be enthusiastic adopters of ISO 9000, suggesting that host country effects are large when it comes to conforming to regional standards.     

Policy Issues for R&D Investment in a Knowledge-Based Economy

The Internet Revolution induced an unbalanced perspective on future economic growth strategies. Because information technology (IT) largely constitutes an infrastructure upon which other economic activity is based, its economic role is to facilitate the productivity of investment in a wide range of products and services that meet final demand. Other economies around the world can and are investing in the same infrastructure, so the efficiency advantages now being realized by the U.S. economy will be fleeting unless U.S. R&D efforts produce a new and broad range of innovative products and services that take advantage of this infrastructure. A deep and diverse technology-based manufacturing sector must be a core objective of a national R&D strategy. United States manufacturing contributes $1.5 trillion to GDP, employs 20 million workers, accounts for more than 70% of industrial R&D, and constitutes the main source of technology for the larger service sector. While knowledge-based services are the largest source of economic growth for the U.S. economy, their long-term performance is highly dependent on synergies with a domestic manufacturing sector. These synergies will be even more important in the future because services are increasingly exposed to foreign competition. Knowledge-based services can be supplied from anywhere in the world—as long as these foreign sources can rapidly access and assimilate the necessary technology components. This caveat is the critical point for economic growth policy. Considerable research supports the argument that hardware and software components are most efficiently supplied to services by a manufacturing sector that is geographically close and institutionally integrated with the service applications. Policy debates have raged for decades over the nature and magnitude of underinvestment in manufacturing R&D. The need to resolve the relevant policy issues has increased, as industry is funding less of the long-term, high-risk research that creates the technology platforms supporting new industries and future economic growth. Unfortunately, only about a third of U.S. manufacturing is high-tech by conventional definitions. Some of the remaining industries develop technologies internally, but most purchase a large proportion of their technology from the high-tech sector. Because a technology acquisition strategy can be more easily imitated by foreign competitors, traditional industries are much more susceptible to exchange rate variations, global economic cycles, and secular shifts in foreign competition. Thus, with global technological capabilities relentlessly increasing, the long-term prospects for the moderate and low R&D-intensive portions of U.S. manufacturing are not good. This paper presents a conceptual framework and available data as inputs for the analysis of Federal R&D investment strategies. Such strategies must recognize the full range of public and private technology assets constituting a national innovation system. A developed and efficient innovation system has characteristics making imitation by foreign competitors difficult and thereby enables sustained competitive advantage.     

Medical devices; 30-day notices and 135-day PMA supplement review--FDA. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing the submission and review of premarket approval (PMA) supplements to provide for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA).     

产品责任:北美视角的比较法评论

美国采纳严格产品责任的主要原因是:早期的法律不能给消费者提供充分的保护;调整保证的法律不是从消费者的角度出发的;美国的社会福利很大程度上不如其他西方国家。当今美国主要对于设计和信息性缺陷适用过失责任制度,严格产品制度仅适用于制造缺陷和非制造缺陷的销售者。欧洲和其他法域的严格产品制度远比美国严格。各种结构化和程序化的事务赋予美国公民更多诉至法院的机会。     

Medical use of byproduct material: issues and request for public input--NRC. Request for public input on rule development

The U.S. Nuclear Regulatory Commission (NRC) has developed a program for revising the regulations governing the medical use of byproduct material. The decision to revise this regulation resulted from the NRC Strategic Assessment and Rebaselining Initiative (SA), a process involving identification of the direction-setting issues and associated options for the future of NRC activities. This notice describes the NRC's program for revising the medical use regulation; notifies the public of the availability of documents associated with this action on the NRC Technical Conference Forum and through the NRC Public Document Room; and solicits informal public input on development of proposed rule language and associated documents. The Commission plans to formally propose specific rulemaking text for public comment during summer of 1998.     

The use of orthopedic surgical devices for forensic identification

Surgically implanted devices have become increasingly common in modern skeletal material. Therefore, having the knowledge of the variety of implanted orthopedic devices, their manufacturer, and where to find and how to use identifying numbers in such implants can assist in the identification process when traditional methods are not applicable. Orthopedic device manufacturers are required by the Safe Medical Devices Act of 1990 and the FDA Modernization Act of 1997 to track permanently implanted devices. Manufacturer information on orthopedic devices associates the orthopedic surgeon who implanted the device with the patient. By providing a current list of the most common orthopedic device manufacturers in the U.S.A. and the associated contact information, investigators will have updated tools for the individuation process. Despite numerous complicating factors regarding how device data are tracked, the information presented here can assist forensic professionals with obtaining presumptive and/or positive identifications.     

Medical devices; exemptions from premarket notification; class II devices--FDA, Final rule

The Food and Drug Administration (FDA) is codifying the exemption from premarket notification of all 62 class II (special controls) devices listed as exempt in a January 21, 1998, Federal Register notice, subject to the limitations on exemptions. FDA has determined that for these exempted devices, manufacturers' submissions of premarket notifications are unnecessary to provide a reasonable assurance of safety and effectiveness. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking implements new authorities delegated to FDA under the Food and Drug Administration Modernization Act (FDAMA).     

What Do Prosecutors Maximize? Evidence from the Careers of U.S. Attorneys

This study examines the performance of chief federal prosecutors(U.S. attorneys) and their subsequent careers. In a sample of570 attorneys in office from 1969 to 2000, the length of prisonsentences is positively related to subsequent favorable careeroutcomes for U.S. attorneys. In contrast, conviction rates donot appear to affect the careers of U.S. attorneys. These resultsare consistent with longer total prison sentences’ beingpersonally beneficial to prosecutors, and prosecutors’maximizing the length of prison sentences. Overall, the resultssuggest that sentence length, as opposed to convictions rates,is the relevant performance metric.     

Waste not, want not—A look at the impact of manufacturing extension centers

Manufacturing extension centers have helped small manufacturers improve performance on the shop floor and thereby reduce costs. This article presents a case study of a metal working firm that was able to increase productivity and profits by instituting measures recommended by a field agent working for the Florida Manufacturing Technology Center (FMTC). As a result of services provided, the company was able to boost manufacturing throughput and increase production efficiencies. Using a simulation model, the article explores how small changes in manufacturing performance can result in significant cost reduction. It then discusses the consequences of alternative strategies designed to enhance the value of goods sold, rather than lower the costs of production. It concludes by arguing that manufacturing extension centers should help companies become more distinctive as well as more efficient.     

Upper‐Bounding the Incidence Rate of Associations Between Camouflage Uniforms and Surveillance Images*

Abstract: Camouflage garments can be associated with surveillance images of a crime scene even in the absence of unique wear marks or very high‐quality images. However, the probability of an accidental association, or incidence rate, is significant. The present work describes and validates a method for estimating the incidence rate based on a statistical model of the garment manufacturing process. The model was developed primarily for use with the current U.S. Army Combat Uniform (ACU), but can be applied to any camouflage garment. Eight garment manufacturers were studied, and all sources of variation in the manufacturing process were characterized. The marking and spreading procedures were found to be dominant and consistent sources of variation. However, some sources of variation, in particular those because of human operators, were not consistent enough to accurately characterize. Sources of variation that could not be well‐characterized were ignored in the statistical model, yielding a worst‐case estimate that is an upper‐bound to the true incidence rate. The model was evaluated for a variety of cases. Depending on the quality of the surveillance image, the manufacturing parameters, and the local population, incidence rates range from about 3% to negligibly small. The model was validated by returning to one manufacturer, and sampling a large number of completed garments and estimating empirical match probabilities. The empirical probabilities validated the estimates of the worst‐case incidence rate and also demonstrated that typical incidence rates are significantly lower.     

Cardiovascular and neurological devices; reclassification of two embolization devices. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to reclassify two embolization device types from class III (premarket approval) into class II (special controls). The agency is also changing the names and revising the identifications of these devices. The vascular embolization device (previously the arterial embolization device) is intended to control hemorrhaging due to aneurysms, certain types of tumors, and arteriovenous malformations. The neurovascular embolization device (previously the artificial embolization device) is intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations. FDA is reclassifying these devices on its own initiative on the basis of new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for these devices.     

Small business innovation,research, and development

Historically, small businesses have been the innovation engine of the United States, with significantly more than half of the new technologies and products coming from small enterprises. In 1992, there were more than 21 million small businesses with fewer than 500 employees each in the United States, including 4.5 million small corporations, 1.6 million partnerships, and 15.1 million sole proprietorships. Although most small businesses have considerably fewer than 100 employees, they employ more than half the private U.S. work force, contribute more than half of all sales in the country, and are responsible for over half of the private sector's products. From 1976 to 1990, small firms also generated 65% of the net new jobs. From 1988 to 1990, all of the net new jobs in the U.S. economy were created by small firms. Indeed, small business is really big business in the United States.     

Network strategies of nineteenth century Hesse-Cassel emigrants

Between 1820 and 1930 over 5 million Germans emigrated to overseas destinations, most to the U.S. By the 1850s the number of German migrants living in the U.S. was large, a consequence partly of cumulative causation. I provide evidence for the dramatic increase in networks by using micro-level data for the German principality of Hesse-Cassel in the mid-nineteenth century. A conservative measurement of network relationships finds that after 25 years almost half of them were related to a previous family member from the same village. Migrants who used family networks tended to move in small units. Usually only a few years separated networked family members, but some links lasted over a decade. Women were unlikely to start a network but more likely than men to travel to the U.S. Within some families, migrants switched from continental destinations to the U.S., perhaps due to the failure of the 1848 March Revolution.     

Infrared quantitative evidential breath-alcohol analyzers: in vitro accuracy and precision studies

The in vitro accuracy and precision of four infrared breath-alcohol analyzers, the Alcotest 7010, BAC Verifier, Intoxilyzer 5000, and Intoximeter 3000, were studied with a protocol adapted from portions of the U.S. Department of Transportation's (DOT) "Standard for Devices to Measure Breath Alcohol." Statistical evaluation of these studies indicated that all instruments met or exceeded the performance requirements modified from the U.S. DOT Standard for quantitative evidential breath-alcohol analyzers.     

Measuring the performance of research and technology programs: A balanced scorecard approach

Research programs, like other government programs, are now being requested to demonstrate relevance and value added to national social and economic needs. Complexity, unpredictability and other factors make it difficult to define specific performance measures for R&D programs. This paper describes the performance measurement efforts of one technology development program within the U.S. Department of Energy and proposes a strategy for applying this balanced scorecard approach to a fundamental research organization. Simple logical models of the inputs, activities, outcomes and long term results of R&D programs are proposed. A critical few measures of performance that answer questions from multiple audiences are then chosen across this performance spectrum. This paper describes work performed by Sandia National Laboratories Energy Policy and Planning Department, Albuquerque, New Mexico 87185, with the support of the U.S. Department of Energy under contract DE-AC0494AL85000. The continued support and enthusiams of Darrell Beschen in the DOE Office of Energy Efficiency and Renewable Energy and Iran Thomas in DOE Office of Energy Research, Basic Energy Sciences, is appreciated. The authors also acknowledge the contributions of John Reed and the training in the logic chart and performance spectrum provided by Ron Corbeil and Steve Montague. The opinions expressed are those of the authors and do not represent the opinions of the U.S. Department of Energy.