Department of Health and Human Services December 7, 2011 – Federal Register Recent Federal Regulation Documents

Biologics Price Competition and Innovation Act of 2009; Proposed Recommendations for a User Fee Program for Biosimilar and Interchangeable Biological Product Applications for Fiscal Years 2013 Through 2017; Notice of Public Meeting; Request for Comments
Document Number: 2011-31499
Type: Notice
Date: 2011-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the proposed recommendations for a user fee program for biosimilar biological products for fiscal years (FYs) 2013 through 2017.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-31449
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2011-31445
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Request for Nominations of Candidates To Serve on the Board of Scientific Counselors (BSC), Office of Infectious Diseases (OID)
Document Number: 2011-31429
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2011-31407
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2011-31391
Type: Notice
Date: 2011-12-07
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Comparing Data Obtained From Landline Telephone and Cell Phone Surveys
Document Number: 2011-31389
Type: Notice
Date: 2011-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a study entitled ``Experimental Study on Comparing Data Obtained From Landline Telephone and Cell Phone Surveys.''
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; MedWatch: The Food and Drug Administration Medical Products Reporting Program
Document Number: 2011-31341
Type: Notice
Date: 2011-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Medical Loss Ratio Rebate Requirements for Non-Federal Governmental Plans
Document Number: 2011-31291
Type: Rule
Date: 2011-12-07
Agency: Department of Health and Human Services
This interim final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to establish rules governing the distribution of rebates by issuers in group markets for non-Federal governmental plans.
Medical Loss Ratio Requirements Under the Patient Protection and Affordable Care Act
Document Number: 2011-31289
Type: Rule
Date: 2011-12-07
Agency: Department of Health and Human Services
This final rule with comment period revises the regulations implementing medical loss ratio (MLR) requirements for health insurance issuers under the Public Health Service Act in order to address the treatment of ``mini-med'' and expatriate policies under these regulations for years after 2011; modify the way the regulations treat ICD-10 conversion costs; change the rules on deducting community benefit expenditures; and revise the rules governing the distribution of rebates by issuers in group markets.
Medicare Program; Availability of Medicare Data for Performance Measurement
Document Number: 2011-31232
Type: Rule
Date: 2011-12-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule implements Section 10332 of the Affordable Care Act regarding the release and use of standardized extracts of Medicare claims data for qualified entities to measure the performance of providers of services (referred to as providers) and suppliers. This rule explains how entities can become qualified by CMS to receive standardized extracts of claims data under Medicare Parts A, B, and D for the purpose of evaluation of the performance of providers and suppliers. This rule also lays out the criteria qualified entities must follow to protect the privacy of Medicare beneficiaries.
Office of Planning, Research and Evaluation Advisory Committee on Head Start Research and Evaluation
Document Number: 2011-31196
Type: Notice
Date: 2011-12-07
Agency: Department of Health and Human Services
This notice announces a forthcoming meeting of a public advisory committee of ACF. The meeting will be open to the public. Name of Committee: Advisory Committee for Head Start Research and Evaluation. General Function of Committee: The Advisory Committee for Head Start Research and Evaluation will provide feedback on the published final report for the Head Start Impact Study, offering interpretations of the findings, discussing implications for practice and policy, and providing recommendations on follow-up research, including additional analysis of the Head Start Impact Study data. The Committee will also be asked to provide recommendations to the Secretary regarding how to improve Head Start and other early childhood programs by enhancing the use of research-informed practices in early childhood. Finally, the Committee will be asked to provide recommendations on the overall Head Start research agenda, includingbut not limited tohow the Head Start Impact Study fits within this agenda. The Committee will provide advice regarding future research efforts to inform HHS about how to guide the development and implementation of best practices in Head Start and other early childhood programs around the country.
Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)
Document Number: 2011-31109
Type: Notice
Date: 2011-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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