Privacy Act of 1974; annual publication of systems of records--PHS

This preamble summarizes significant changes to systems of individually identifiable records which have occurred since the 1982 annual publication. Notices of modified systems of records currently maintained by HRSA follow this preamble. The notices include modifications for the purpose of clarity, timeliness, and correctness, as of August 19, 1983. None of the modifications being made at this time meet the OMB criteria for a new or altered system report, or a period of public comment.     

Privacy Act of 1974; proposed new routine uses--PHS. Notification of new routine uses permitting disclosure of information from four Privacy Act systems of records

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish new routine uses permitting disclosure of information from four Privacy Act systems of records maintained by the National Institutes of Health (NIH): 09-25-0008, "Administration: Radiation Workers Monitoring, HHS/NIH/ORS"; 09-25-0010, "Research Resources: Registry of Individuals Potentially Exposed to Microbial Agents, HHS/NIH/NCI"; 09-25-0077, "Clinical Research: Biological Carcinogenesis Branch Human Specimen Program, HHS/NIH/NCI"; and 09-25-0099, "Clinical Research: Patient Medical Records, HHS/NIH/CC." The NIH Office of Research Services (ORS) is responsible for the first of these systems. The National Cancer Institute (NCI), a component of NIH, maintains the second and third systems of records. The NIH Clinical Center (CC) maintains the fourth system. The new routine uses will allow disclosure to contractors for routine records keeping and processing activities. These disclosures will be wholly compatible with the purposes of these systems, as discussed below.     

Privacy Act of 1974; new system of records--Public Health Service. Notification of establishment of a new Privacy Act system of records, 09-25-0151

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new Privacy Act system of records, 09-25-0151, "Administration: Alert Records Concerning Investigations or Determinations of Misconduct by Current or Potential Recipients of Funds for Biomedical Research," HHS/NIH/OD. We are also proposing routine uses for this system. The National Institutes of Health (NIH) will use this system to make informed decisions on appropriate actions regarding awards of research funds to individuals who are or have been subjects of investigations or determinations of misconduct. PHS invites interested persons to submit comments on the proposed routine uses on or before June 11, 1982.     

Privacy Act of 1974; altered system of records--PHS. Notification of altered Privacy Act system of records 09-25-0074

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to alter system of records 09-25-0074, "Clinical Research: Veterans Administration Bladder and Prostate Cancer Clinical Trials, HHS/NIH/NCI." The purpose of the alteration is to modify an existing system of records into an umbrella system by broadening both the categories of individuals under this system and the purposes for which the system is used. The names of the system of records is also being changed to reflect the alteration. The new name is "Clinical Research: Division of Cancer Biology and Diagnosis Patient Trials, HHS/NIH/NCI."     

Privacy Act of 1974; annual publication of systems of records--FDA

FDA is publishing this document to meet requirements of Pub. L. 97-375, the Congressional Reports Elimination Act. This new statute amends the Privacy Act (5 U.S.C. 552a, section 3(e)(4] to limit republication to revised system notices only. FDA has reviewed each of its system notices and has revised many of its system notices this year to enhance specificity and clarify the effects of reorganization. These revisions are minor and have no affect on the public's need-to-know. Therefore, FDA is not republishing any of its system notices at this time.     

Management of legal information in an international context: A conundrum of challenges and opportunities

Evolving technologies have created many exciting opportunities to increase the availability of legal information, and to facilitate the organization and publication of this information. With the globalization of almost all legal issues, increased access to primary and secondary resources in electronic format across jurisdictional lines has been a welcomed development by academics, lawyers, international business entities, and others. However, the myriad of legal systems and approaches to maintaining legislative and judicial records has led to a host of challenges in regard to coherent and efficient management of legal information. Focusing on development of legal information systems in China and the United States, this paper will open with a summary of the exciting current and emerging technological advances in legal research methodologies and in the electronic publication of cases, statutes, regulations and other critical resources. The paper will then analyze corresponding challenges, including authenticity, accuracy, currency and consistency. The analysis will include discussion of the varying quality of legal information resources proliferating in the Internet, as well as the host of issues surrounding electronic publishing of legal information by government entities and commercial enterprises. The paper will conclude with a prospective analysis of the manner in which emerging technologies can enhance knowledge management of legal information and strengthen legal systems in both common law and civil law jurisdictions.     

Public Health Service--Privacy Act of 1974. Notification of new system of records: "clinical research; records of subjects in intramural research, epidemiology, demography, and biometry studies on aging."

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to adopt a new system of records. "Clinical Research: Records of Subjects in Intramural Research, Epidemiology, Demography, and Biometry Studies on Aging." DHHS/NIH/NIA, 09-25-0142. These records will be used to accomplish scientific research conducted by intramural scientists employed by the National Institute on Aging (NIA), and by hospitals, universities, research centers and research foundation under contract with NIA. These research activities aim at determining the health status of individuals and changes in health status over time, the incidence and prevalence of certain diseases and problems of the aged in certain populations, and changes that take place as the individuals age who are under study.     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992, established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR part 493. This notice announces the fourth of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. After publication and close of comment period on the published partial lists, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, and responses to public comments received on the partial lists will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on the compilation will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or re-categorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After the effective date of 42 CFR part 493, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Privacy Act of 1974; system of records--PHS. Notification of establishment of a new Privacy Act system of records 09-25-0154, "Biomedical Research: Records of Subjects in Cancer Research

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new Privacy Act system of records 09-25-0154, "Biomedical Research: Records of Subjects in Cancer Studies of the Division of Resources, Centers and Community Activities," HHS/NIH/NCI. We are also proposing routine uses for this system. The Division of Resources, Centers and Community Activities (DRCCA) in the National Cancer Institute (NCI) will use this system of records to support research on the causes and prevention of cancer.     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the third of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. Additional lists of test systems, assays and examinations by complexity will be published periodically. A complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on the compilation list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation list, categorization or recategorization of laboratory test systems, assays and examinations will follow the procedures delineated in 42 CFR 493.17(c). After the effective date of 42 CFR 493, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Privacy Act of 1974; system of records--PHS

In accordance with the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to add a new routine use to system of records 00-37-0013. "Health Resources Utilization Statistics, HHS/OASH/NCHS." This system of records is maintained in the National Center for Health Statistics (NCHS) for the purposes of collecting statistics on the utilization of health services, processing and analyzing the data, and publication of the statistical findings. NCHS is proposing to add a new routine use to permit disclosure of information to a contractor. PHS invites interested persons to submit comments on or before January 11, 1984.     

The "Archival Revolution" in Russia (1991-1996)

The radical changes in archival policy and practice and in the use and publication of documents that have occurred since August 1991 have required from the outset the development of new terms and concepts to describe them. This was obvious at least to active participants in the reforms. V.P. Kozlov, a professional historian who became one of the heads of the State Archival Service, applied the term "new space of archival information" in 1992. The ideal model of this "new space" consisted, according to Kozlov, above all in open access for users, as well as of becoming an integral part of international information systems and commercializing the use of archival information. In fact, this involved no less than revolutionary changes in archival policy (a new legal status for archives) and in archival practice (calls to reject the "hoarding ideology," etc.).     

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the second of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. Additional lists of test systems, assays and examinations as well as deletions and corrections will be published periodically. On or before September 1, 1992, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on that final list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or recategorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After September 1, 1992, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.     

Privacy Act of 1974; new system of records--Department of Health and Human Services; Public Health Service. Notification of a new system of records: 09-25-0143

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new system of records, 09-25-0143, Biomedical Research: Records of Subjects in Clinical, Epidemiologic and Biometric Studies of the National Institute of Allergy and Infectious Diseases, HHS/NIH/NIAID. We are also proposing routine uses for this system. This system will be used to support (1) epidemiologic, clinical and biometric investigations into the causes, nature (morbidity and mortality), outcome, therapy and cost of infectious, immunologic and related diseases; (2) review and evaluation of the progress of these research projects, and identification and planning for improvements or for additional research. The population and statistical studies supported by this system may be conducted or managed by Institute staff as well as others outside the Institute. This system comprises records maintained in a number of distinct research projects. The number and specific nature of projects will change over time as new ones are started and as work on existing projects is completed.     

Medical devices; reprocessed single-use devices; requirement for submission of validation data. Direct final rule

The Food and Drug Administration (FDA or we) is amending certain classification regulations for reprocessed single-use devices (SUDs) whose exemption from premarket notification (510(k)) requirements have been terminated and other reprocessed SUDs already subject to premarket notification for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a 510(k). Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under FDA's usual procedures for notice and comment, to provide a procedural framework to finalize the rule in the event we receive any significant adverse comment and withdraw the direct final rule. This action codifies actions taken in previous Federal Register notices in accordance with MDUFMA.     

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.     

Privacy Act of 1974; systems of records, table of contents/index for the annual republication--HHS

On October 13, 1982, the Department made its annual republication of notices of systems of records to meet the requirements of 5 U.S.C. 552(e)(4). In order to assist the public, the Department publishes a consolidated lists of systems numbers, names, and Federal Register (FR) page numbers for the October 13 issue, as well as a subject/key word index.     

Do consensus conferences work? A process evaluation of the NIH Consensus Development Program

The purpose of this evaluation study is to identify problems and suggest modifications in the NIH Consensus Development Program. The current program consists of three-day conferences in which experts assess medical technologies for issues of efficacy, safety, conditions of use, and other related topics (e.g., costs and social impact). Eight consensus conferences held between 1980 and 1982 were studied in depth using a variety of methods; five of the conferences were investigated concurrently. In addition, archival material was examined for all but one of the 33 conferences held up to that time, and four planning meetings for future conferences were observed. The delay in publishing our findings provided an opportunity to examine the changes introduced by NIH; it also allowed us to avoid the criticism of numerous prior evaluations for finding fault with programs that are still developing. NIH adopted many of the recommendations in our evaluation report and has investigated others. Based on our evaluation and more recent evidence, however, we conclude that the major problem that was uncovered--selection bias, particularly with respect to the choice of questions and panelists--remains a significant threat to the credibility of the consensus process. More specifically, the results indicate that controversial issues cannot be properly addressed within the present conference format, although that was one of its major purposes. Recommendations for improving the consensus process are presented, as are their implications for a larger set of consensus activities that are currently being conducted.     

Trends in Academic Research Spending, Alliances, and Commercialization

Widespread changes underway in the national R&D landscape are impacting how universities fund, conduct, and disseminate their own research efforts. The key components of these trends are revealed through a variety of indicators, including on financial resources, publishing and patenting metrics, and research partnerships. Many of the changes appear to be cost-driven. Particularly as funding increases from Government have slowed and expectations for cost-sharing increased during the past decade, universities increasingly have come to rely on nonfederal sources, notably industry and institutional self-funding. The shift in funding sources has impacted all major fields of study. As part of this system-wide transformation, universities have noticeably increased their collaborations with nonacademic researchers as evidenced by trends in publication data and information on the formation of centers, consortia, and cooperative agreements. Concurrently, and not coincidentally, the transfer of universities' research output also is expanding. Such transfers are increasing both indirectly (as indicated from patenting citation data) and directly (as documented by universities' own patenting/licensing commercialization endeavors). On all accounts are we unlikely to have yet reached the peak of such activities.