Department of Health and Human Services December 5, 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Elanco Animal Health. The supplemental NADA removes the requirement for 30-day expiration on labeling of monensin Type C medicated feeds for several classes of cattle and goats.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval the information collection listed below. This proposed information collection was previously published in the Federal Register on September 12, 2007, page 52155, and allowed 60 days for public comment. One comment was received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, any information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The Cardiovascular Health Study. Type of Information Request: Reinstatement (OMB No. 0925-0334). Need and Use of Information Collection: This study quantifies associations between conventional and hypothetical risk factors and coronary heart disease (CHD) and stroke in people age 65 years and older. The primary objectives include quantifying associations of risk factors with subclinical disease; characterizing the natural history of CHD and stroke; and identifying factors associated with clinical course. The findings provide important information on cardiovascular disease in an older U.S. population and lead to early treatment of risk factors associated with disease and identification of factors that may be important in disease prevention. OBM clearance is being sought for data collection activities at only one of the four CHS field centers (the Pittsburgh field center), which are expected to end on May 31, 2008. Other data collection efforts in the CHS cohort are supported by various non-contract funding sources. Frequency of response: Twice a year (participants) or once per cardiovascular disease event (proxies); Affected public: Individuals. Types of Respondents: Individuals recruited for CHS and their selected proxies. The annual reporting burden is as follows: Estimated Number of Respondents: 467; Estimated Number of Responses per Respondent: 1.2; and Estimated Total Annual Burden Hours Requested: 281. The annualized cost to respondents is estimated at: $5,225. There are no capital, operating, or maintenance costs to report.

This rule with comment period finalizes the Medicare program provisions relating to contract determinations involving Medicare Advantage (MA) organizations and Medicare Part D prescription drug plan sponsors, including eliminating the reconsideration process for review of contract determinations, revising the provisions related to appeals of contract determinations, and clarifying the process for MA organizations and Part D plan sponsors to complete corrective action plans. In this final rule with comment period, we also clarify the intermediate sanction and civil money penalty (CMP) provisions that apply to MA organizations and Medicare Part D prescription drug plan sponsors, modify elements of their compliance plans, retain voluntary self-reporting for Part D sponsors and implement a voluntary self- reporting recommendation for MA organizations, and revise provisions to ensure HHS has access to the books and records of MA organizations and Part D plan sponsors' first tier, downstream, and related entities. Although we have decided not to finalize the mandatory self-reporting provisions that we proposed, CMS remains committed to adopting a mandatory self-reporting requirement. To that end, we are requesting comments that will assist CMS in crafting a future proposed regulation for a mandatory self-reporting requirement.