Department of Health and Human Services February 21, 2014 – Federal Register Recent Federal Regulation Documents
Results 1 - 12 of 12
Statement of Organization, Functions, and Delegations of Authority; Office of the General Counsel
This document announces the Office of the Secretary (OS)'s Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Office of the General Counsel (OGC), is being amended to reflect title changes in several of its components.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 30, 2014
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, April 30, 2014. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of low dose computed tomography (LDCT) screening for lung cancer in adult smokers. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers; Extension of Comment Period
This document extends the comment period for the Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers proposed rule, which was published in the December 27, 2013 Federal Register (78 FR 79082 through 79200). The comment period for the proposed rule, which would have ended on February 25, 2014, is extended to March 31, 2014.
Training Program for Regulatory Project Managers; Information Available to Industry
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation GuideData Elements and Message Specification'' (the E2B(R3) implementation guidance) and an appendix to the guidance entitled ``ICSRs: Appendix to the Implementation GuideBackwards and Forwards Compatibility'' (the BFC appendix). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and the E2B(R3) implementation guidance.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Current Good Manufacturing Practice; Quality System Regulation
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Draft Environmental Impact Statement for the Roybal 2025 Master Plan; Re-Scheduling of Public Meeting and Extension of Public Comment Period
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the re- scheduling of a public meeting to obtain public comment on the Roybal Campus 2025 Master Plan Draft Environmental Impact Statement (DEIS) and the extension of the public comment period. A public meeting had been scheduled for Wednesday, January 29, 2014 but had to be cancelled due to adverse weather conditions. The new date for the public hearing is Thursday, March 20, 2014.
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