Department of Health and Human Services July 27, 2006 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Medical Devices; Immunology and Microbiology Devices; Classification of Fecal Calprotectin Immunological Test Systems
The Food and Drug Administration (FDA) is classifying fecal calprotectin immunological test systems into class II (special controls). The special control that will apply to these devices is the guidance document entitled, ``Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.'' The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for these devices.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.'' This guidance document describes a means by which fecal calprotectin immunological test systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify fecal calprotectin immunological test systems into class II (special controls). This guidance document is immediately in effect as the special control for fecal calprotectin immunological test systems, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).
Request for Comment From the Field on the Substance Abuse and Mental Health Services Administration's (SAMHSA) Addiction Technology Transfer Center (ATTC) Program
This notice is to request comments from interested stakeholders in the substance use disorders treatment field regarding SAMHSA's ATTC Program. SAMHSA will be issuing a Request for Applications (RFA) for a new round of competitive cooperative agreement awards under the ATTC program in Federal fiscal year (FFY) 2007. To assist SAMHSA in developing the RFA, SAMHSA is seeking input from stakeholders and interested parties on a number of issues relating to these cooperative agreements. Program Title: Addiction Technology Transfer Centers (ATTC) Program. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.
Office of the National Coordinator of Health Information Technology; American Health Information Community Confidentiality and Security Workgroup Meeting
This notice announces the first meeting of the American Health Information Community Confidentiality and Security Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
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