Department of Health and Human Services March 10, 2005 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry and Food and Drug Administration Staff on Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' dated January 2005. The draft guidance document serves as the special control to support the reclassification from class III to class II of the automated blood cell separator device operating on a centrifugal or filtration separation principle intended for the routine collection of blood and blood components. This draft guidance document describes a means by which the automated blood cell separator device operating by centrifugal or filtration separation principle may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify these device types into class II (special controls).
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Drug Metabolizing Enzyme Genotyping System
The Food and Drug Administration (FDA) is classifying drug metabolizing enzyme (DME) genotyping test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System.'' This guidance document describes a means by which drug metabolizing enzyme genotyping systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify drug metabolizing enzyme genotyping systems into class II (special controls). This guidance document is immediately in effect as the special control for drug metabolizing enzyme genotyping systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Instrumentation for Clinical Multiplex Test Systems
The Food and Drug Administration (FDA) is classifying instrumentation for clinical multiplex test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.'' This guidance document describes a means by which instrumentation for clinical multiplex test systems may comply with the requirements of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify instrumentation for clinical multiplex test systems into class II (special controls). This guidance document is immediately in effect as the special control for instrumentation for clinical multiplex test systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Medical Devices; Hematology and Pathology Devices; Reclassification from Class III to Class II of Automated Blood Cell Separator Device Operating by Centrifugal Separation Principle
The Food and Drug Administration (FDA) is proposing to reclassify from class III to class II (special controls) the automated blood cell separator device operating on a centrifugal separation principle and intended for the routine collection of blood and blood components. This proposed rule would also modify the special control for the device with the same intended use but operating on a filtration separation principle. The reclassification is being proposed on FDA's own initiative under procedures set forth in FDA regulations and based on information provided to FDA. This action is being taken 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 SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency proposes this reclassification because special controls, in addition to general controls, are capable of providing reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a draft guidance document entitled ``Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle,'' which will serve as the special control if this proposal becomes final.
National Toxicology Program (NTP); NTP Liaison and Scientific Review Office; Announcement of Availability of NTP Roadmap for the 21st Century and NTP Celebration of its History
The National Toxicology Program (NTP) announces availability of the document, ``A National Toxicology Program for the 21st Century: A Roadmap for the Future,'' and invites attendance at the symposium, ``The National Toxicology Program: A Quarter Century of Toxicology for Public Health'' on May 10-11, 2005, at the National Academy of Sciences in Washington, DC. This meeting will reflect on the history of the NTP and its impact on public health since its establishment in 1978 and unveil the NTP's plans and directions for the future.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Proposed Collection; Comment Request; Assessment of the Use of Special Funding on Research on Type 1 Diabetes Provided by the Balanced Budget Act of 1997, the FY 2001 Consolidated Appropriations Act, and the Public Health Service Act Amendment for Diabetes
In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: Assessment of the Use of Special Funding for Research on Type 1 Diabetes Provided by the Balanced Budget Act of 1997 (Pub. L. 105-33), the FY 2001 Consolidated Appropriations Act (Pub. L. 106-554), and the Public Health Service Act Amendment for Diabetes (Pub. L. 107-360). Type of Information Collection Request: Revision, OMB control number 0925-0503; expiration date: 06/30/2005. Need and Use of Information Collection: This survey will be one source of input into a statutorily mandated assessment and report to the Congress on special funding for research on type 1 diabetes provided by the Balanced Budget Act of 1997, (Pub. L. 105-33), the FY 2001 Consolidated Appropriations Act, (Pub. L. 106- 554), and the Public Health Service Act Amendment for Diabetes, (Pub. L. 107-360). Collectively, these Acts provided $1.14 billion in special funds to the Department of Health and Human Services (HHS) for research aimed at understanding, treating and preventing type 1 diabetes and its complications. The Secretary of HHS subsequently designated to NIDDK the lead responsibility in the Department for developing a process for allocation of these funds. The primary objective of the survey is to gain information, via a brief questionnaire, from NIH research grantees, who were the primary recipients of these special funds, concerning their views on the impact of the type 1 diabetes research funding with respect to: (1) Advancing scientific accomplishments involving innovative, clinically relevant, and multidisciplinary research on type 1 diabetes; (2) developing resources or reagents useful for type 1 diabetes research; and (3) increasing the number and quality of type 1 diabetes investigators. The responses will provide valuable information concerning how the funds have facilitated research as intended by these Acts of Congress. The results will also help determine how research progress from these special congressional initiatives fits within the continuum of diabetes research, and how these funds have contributed to the field of type 1 diabetes research and NIH efforts to combat this challenging health problem. Information from this study will aid in evaluation of the process by which the research goals for use of the special type 1 diabetes funds have been developed and are being pursued. Responses already collected from this survey were analyzed as part of an interim program assessment that was published by the NIDDK in April, 2003 https://www.niddk.nih.gov/federal/ planning/type 1specialfund/. This revised survey will contribute to a statutorily mandated report, due to Congress on January 1, 2007, evaluating the process and efforts under this program and assessing research initiatives funded by these Acts of Congress. Frequency of Response: The initial survey will require a one time response; though, respondents may be contacted again in the event of future congressionally mandated reports on the use of the special type 1 diabetes research funds. Affected Public: Research scientists who received the special funds about which Congress has mandated in law the requirements for an evaluation report. Type of Respondents: Laboratory and clinical investigators who have received support from the special type 1 diabetes funds provided under the laws previously cited. The annual reporting burden is as follows: Estimated Number of Respondents: 500; Estimated Number of Responses per Respondent: 1 (Respondents will be given one questionnaire containing an estimated fifteen questions.); Average Burden Hours Per Response: 1; and Estimated Total Annual Burden Hours Requested: 500. The annualized total cost to respondents is estimated at: $25,000. It is expected that the respondents will be contacted vie e-mail and that their responses will be collected through an Internet-accessible questionnaire. These measures will reduce the burden on the respondents and the overall costs of administering the study. Because different types of awards have been made with the special type 1 diabetes funds, the questionnaire may be tailored such that respondents will only be asked to answer a subset of questions that pertain to their particular type of award(s). No respondent will be asked to answer more than a total of fifteen questions, at least one-third of which will be answered with a ``yes'' or ``no'' or a one- word response. There are no Capital Costs, Operating or Maintenance Costs to report. Request For Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) The accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
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