Department of Health and Human Services November 7, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA), in the Department of Health and Human Services, and the Food Safety Inspection Service (FSIS), in the United States Department of Agriculture (USDA), are jointly announcing a public meeting to discuss and solicit information on an approach for providing consistency and predictability with respect to which of the two agencies should have jurisdiction over certain types of food products that contain meat and poultry as ingredients, as well as the opening of a joint agency docket to receive written comments. This notice outlines that approach and solicits comments on it and on the specific questions asked in section II below.

This notice is to advise the public of ACF's plan to replace the six national data measures used for the CFSR with six data composites addressing the child welfare domains of maltreatment recurrence, maltreatment in foster care, timeliness of adoptions, timeliness of reunifications, placement stability, and permanency for children. The plan to develop data composites is a response to a recommendation made by a consultant under contract with ACF to study the CFSR process. The recommendation is based on input from a CFSR workgroup convened by the consultant at the end of the first round of CFSRs to assist in identifying areas needing improvement. ACF expects that each data composite will incorporate multiple performance areas and measures relevant to a specific domain. ACF plans to use State performance on the data composites as part of its evaluation of a State's substantial conformity with specific outcomes assessed through the CFSR. National standards will be developed for each of the domains represented by the six data composites. ACF's plan to replace existing measures with data composites is consistent with the final CFSR regulation at 45 CFR 1355.34(b)(4) and (5), which authorizes the Secretary of HHS to add, amend, or suspend any of the statewide data indicators when appropriate, and to adjust the national standards when appropriate. The proposed plan also complies with the requirements of section 1123A of the Social Security Act (the Act) for ACF to assess State child welfare agencies' compliance with titles IV-B and IV-E of the Act as implemented in 45 CFR 1355.31 through 1355.37. We invite the public to comment on the data composites, performance areas, and measures proposed in this announcement.

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.'' This guidance document has been developed as a special control guidance document to support the classification of the low energy ultrasound wound cleaner into class II (special controls). The device is intended for the cleaning and maintenance debridement of wounds. This guidance document describes a means by which the low energy ultrasound wound cleaner 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 the low energy ultrasound wound cleaner into class II (special controls). The guidance document is immediately in effect as the special control for the low energy ultrasound wound cleaner, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).

This final rule adopts standards for an electronic prescription drug program under Title I of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). These standards will be the foundation standards or the first set of final uniform standards for an electronic prescription drug program under the MMA, and represent the first step in our incremental approach to adopting final foundation standards that are consistent with the MMA objectives of patient safety, quality of care, and efficiencies and cost savings in the delivery of care.