Department of Health and Human Services June 7, 2006 – Federal Register Recent Federal Regulation Documents

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.

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.

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.

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.