Department of Health and Human Services June 7, 2006 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Detention and Banned Medical Devices
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements for Administrative Detention and Banned Medical Devices.
Office of the National Coordinator for Health Information Technology; Nationwide Health Information Network Forum
This notice announces the first forum of the Office of the National Coordinator for Health Information Technology to address the Nationwide Health Information Network functional requirements. The Forum is open to the public and will discuss the requirements needed for a Nationwide Health Information Network that facilitates the accurate, appropriate, timely, and secure exchange of health information.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Olfactory Test Device; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Olfactory Test Device.'' This guidance document describes a means by which the olfactory test device may comply with the requirement of special controls for class II devices. It includes recommendations for validation of device performance and labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls).
Medical Devices; Ear, Nose, and Throat Devices; Classification of Olfactory Test Device
The Food and Drug Administration (FDA) is classifying the olfactory test device 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: Olfactory Test Device.'' 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 announcing the availability of the guidance document that is the special control for the device.
Medical Devices; Exception From General Requirements for Informed Consent
The Food and Drug Administration (FDA) is issuing this interim final rule to amend its regulations to establish a new exception from the general requirements for informed consent, to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. The agency is taking this action because it is concerned that, during a potential terrorism event or other potential public health emergency, delaying the testing of specimens to obtain informed consent may threaten the life of the subject. In many instances, there may also be others who have been exposed to, or who may be at risk of exposure to, a dangerous chemical, biological, radiological, or nuclear agent, thus necessitating identification of the agent as soon as possible. FDA is creating this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational.
2005 White House Conference on Aging
Pursuant to Section 10(a) of the Federal Advisory Committee Act as amended (5 U.S.C. Appendix 2), notice is hereby given that the Policy Committee of the 2005 White House Conference on Aging will discuss items related to the final report of the Conference during a conference call. The conference call will be open to the public to listen, with call-ins limited to the number of telephone lines available. Individuals who plan to call in and need special assistance, such as TTY, should inform the contact person listed below in advance of the conference call. This notice is being published less than 15 days prior to the conference call due to scheduling problems.
Agency Information Collection Activities: Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) allow the proposed information collection as part of an AHRQ contract for ``Privacy and Security Solutions for Interoperable Electronic Health Information Exchange'' (the Assessment). In accordance with the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), AHRQ is submitting a request to OMB for emergency review. AHRQ is requesting an emergency review of this collection because the information is needed for subsequent health information technology projects later this year. Because subcontracts were solicited and awarded to the States, it was not possible to accurately quantify the public burden earlier this year. Data collection subcontract proposals were solicited from States and until they were reviewed, selected, awarded and accepted, it was not possible to accurately quantify the public burden earlier.
The Data Measures, Data Composites, and National Standards To Be Used in the Child and Family Services Reviews
On November 7, 2005, the Administration for Children and Families (ACF) published a notice in the Federal Register soliciting comment regarding its proposal to replace the six data measures used as part of the assessment of State performance on the Federal Child and Family Services Review (CFSR) with six data composites (70 FR 67479). Based on the results of our data analyses and a review of comments from the field, ACF made the following decisions: The CFSR will use a State's performance on two individual data measures as part of the assessment of the State's substantial conformity with CFSR Safety Outcome 1Children are, first and foremost, protected from abuse and neglect. A national standard is established for each of these measures. The CFSR will use a State's performance on four data composites as part of the assessment of the State's substantial conformity with CFSR Permanency Outcome 1Children have permanency and stability in their living situations. A national standard is established for each of these data composites. This announcement presents the following information: The decisions made by the Children's Bureau regarding use of data composites for the Federal Child and Family Services Review (CFSR); The composites and additional data that will be used as part of the assessment of a State's substantial conformity with the CFSR requirements; and Descriptive statistics relevant to each composite and measure, including the score that will serve as the national standard for the second round of the CFSR. Where relevant, the announcement addresses key comments from the field in response to the Federal Register notice. The announcement also includes the following attachments: Attachment A: Data to be included in the CFSR State Data Profile. Attachment B: Methodology for Composite Construction.
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