Department of Health and Human Services September 1, 2006 – Federal Register Recent Federal Regulation Documents
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Annual Guidance Agenda
The Food and Drug Administration (FDA) is publishing its annual guidance document agenda. This list is being published under FDA's good guidance practices (GGPs) regulations. It is intended to seek public comment on possible topics for future guidance document development or revisions of existing ones.
Agency Information Collection Activities; Proposed Collection; Comment Request; Food Additive Petitions
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 food additive petitions regarding animal feed.
Implantation or Injectable Dosage Form New Animal Drugs; Lincomycin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for the use of lincomycin injectable solution in swine for the treatment of infectious arthritis and mycoplasma pneumonia.
Oral Dosage Form New Animal Drugs; Carprofen
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by IMPAX Laboratories, Inc. The supplemental ANADA provides for veterinary prescription use of carprofen caplets in dogs for the control of postoperative pain associated with soft tissue and orthopedic surgeries.
Current List of Laboratories Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// workplace.samhsa.gov and https://www.drugfreeworkplace.gov.
Medicare Program; Prohibition of Midyear Benefit Enhancements for Medicare Advantage Organizations Offering Plans in Calendar Year 2007 and Subsequent Calendar Years
This proposed rule would prohibit Medicare Advantage (MAs) organizations, including organizations offering employer/union group health plans (EGHPs) (that is, plans that enroll both beneficiaries and employer/union members (plans open to general enrollment) and plans that are not open to general enrollment), from making midyear changes to nondrug benefits, premiums, and cost-sharing submitted in their approved bids for a given contract year. Programs of all-inclusive care for elderly (PACE) would not be subject to the provisions of this proposed rule and could continue to offer enhanced benefits as specified in our guidance for PACE plans.
Office of the National Coordinator for Health Information Technology; American Health Information Community Biosurveillance Data Steering Group Meeting
This notice announces the sixth meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Office of the National Coordinator; American Health Information Community Biosurveillance Data Steering Group Meeting
This notice announces the fifth meeting of the American Health Information Community Biosurveillance Data Steering Group in accordance with the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.).
Medicare Program; Hospice Wage Index for Fiscal Year 2007
This notice announces the annual update to the hospice wage index as required by statute. This fiscal year 2007 update is effective from October 1, 2006 through September 30, 2007. The wage index is used to reflect local differences in wage levels. The hospice wage index methodology and values are based on recommendations of a negotiated rulemaking advisory committee and were originally published in the August 8, 1997 Federal Register.
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