Department of Health and Human Services June 8, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 22 of 22
Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB); Correction
This document corrects the information provided for [Document Identifier: CMS-10379] titled ``Rate Increase Disclosure and Review Reporting Requirements (45 CFR Part 154)'' that was published in the Federal Register on June 1, 2011 (76 FR 31613). FOR FURTHER INFORMATION CONTACT: William N. Parham, III, (410) 786-4669.
Quality Assurance Requirements for Respirators; Notice of Withdrawal
The Department of Health and Human Services (HHS) is withdrawing its proposed rule to update the quality assurance and control requirements for the manufacture of respirators approved under 42 CFR Part 84 by the National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention and the Mine Safety and Health Administration (MSHA). NIOSH has reviewed the comments it received to the proposed rule and determined that additional analysis is needed to assess the economic impact of its proposed rule. NIOSH plans to seek further information and to consider possible alternative approaches.
Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications
The Food and Drug Administration (FDA) is withdrawing approval of 70 new drug applications (NDAs) and 97 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period
The Food and Drug Administration (FDA) is extending the comment period for the notice of public meeting, that appeared in the Federal Register of August 9, 2010 (75 FR 47820). In the notice, FDA requested comments to gather stakeholder input on the development of a generic drug user fee program. The Agency is taking this action to allow interested persons additional time to submit comments.
Medicare Program; Accelerated Development Sessions for Accountable Care Organizations-June 20, 21, and 22, 2011; Corrections
This document corrects technical errors that appeared in the notice published in the May 19, 2011 Federal Register entitled ``Medicare Program; Accelerated Development Sessions for Accountable Care OrganizationsJune 20, 21, and 22, 2011.''
Medicare Program; Pioneer Accountable Care Organization Model, Request for Applications; Correction
This document corrects technical errors that appeared in the notice published in the May 20, 2011 Federal Register entitled ``Medicare Program; Pioneer Accountable Care Organization Model: Request for Applications.''
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Voluntary National Retail Food Regulatory Program Standards
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Voluntary National Retail Food Regulatory Program Standards'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Strengthen and Promote the Role of Local Health Departments in Retail Food Safety Regulation (U-50)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a cooperative agreement between the Center for Food Safety and Applied Nutrition (CFSAN) and the National Association of County and City Health Officials (NACCHO). The goal of the cooperative agreement for CFSAN is to have NACCHO conduct work that will strengthen the role of local health departments and help FDA/CFSAN promote effective city and county regulatory programs responsible for retail food protection in the United States.
Guidance for Industry on Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' The Food and Drug Administration Amendments Act (FDAAA) added new provisions to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) addressing the Agency's treatment of certain citizen petitions and petitions for stay of agency action (collectively, petitions), as well as related applications. The guidance describes how FDA will determine if the new provisions apply to a particular petition and how FDA will determine if a petition would delay approval of a pending abbreviated new drug application (ANDA) or 505(b)(2) application. The guidance also describes how FDA will interpret the requirements that such petitions include a certification and that supplemental information or comments to such petitions include a verification. The guidance also addresses the relationship between the review of petitions and pending ANDAs and 505(b)(2) applications for which the Agency has not yet made a decision on approvability.
Medicare Program; Availability of Medicare Data for Performance Measurement
This rule proposes to implement new statutory requirements regarding the release and use of standardized extracts of Medicare claims data to measure the performance of providers and suppliers in ways that protect patient privacy. 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 of services and suppliers.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
