Department of Health and Human Services December 9, 2009 – Federal Register Recent Federal Regulation Documents
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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).
Approved Tobacco Retailer Training Program; Request for Comments
The Food and Drug Administration (FDA) is establishing a public docket to obtain information on suggested elements for approved tobacco retailer training programs. FDA is establishing this docket in order to provide an opportunity for interested parties to provide information and share views on elements that should be included in an effective retailer training program as provided for in the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act).
Guidance for Industry on Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims.'' This guidance describes how FDA reviews and evaluates patient-reported outcome (PRO) instruments used to measure treatment benefit in medical product clinical trials. It also provides recommendations on how sponsors can use study results measured by PRO instruments to support claims in approved medical product labeling. This guidance finalizes the draft guidance published on February 3, 2006.
Medicare Program; Application of Certain Appeals Provisions to the Medicare Prescription Drug Appeals Process
This final rule will implement the procedures that the Department of Health and Human Services will follow at the Administrative Law Judge and Medicare Appeals Council levels in deciding appeals brought by individuals who have enrolled in the Medicare prescription drug benefit program. In addition, it will implement the reopening procedures that will be followed at all levels of appeal.
Medicare Program: Changes to the Medicare Claims Appeal Procedures
Under the procedures in this final rule, Medicare beneficiaries and, under certain circumstances, providers and suppliers of health care services can appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B pursuant to sections 1869 and 1879 of the Social Security Act (the Act). Section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) amended section 1869 of the Act to provide for significant changes to the Medicare claims appeal procedures. After publication of a proposed rule implementing the section 521 changes, additional new statutory requirements for the appeals process were enacted in Title IX of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). In March 2005, we published an interim final rule with comment period to implement these statutory changes. This final rule responds to comments on the interim final rule regarding changes to these appeal procedures, makes revisions where warranted, establishes the final implementing regulations, and explains how the new procedures will be put into practice.
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