Department of Health and Human Services June 20, 2012 – Federal Register Recent Federal Regulation Documents
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Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis.'' This draft guidance document describes a means by which implanted blood access devices may comply with the requirement of special controls for class II devices. This draft guidance is not final nor is it in effect at this time.
Gastroenterology-Urology Devices; Reclassification of Implanted Blood Access Devices
The Food and Drug Administration (FDA) is proposing to reclassify the implanted blood access device preamendments class III device into class II (special controls). FDA is proposing this reclassification on its own initiative based on new information. FDA is taking this action under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food and Drug Administration Modernization Act of 1997 (FDAMA), and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Secure Supply Chain Pilot Program
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Disease Information in Branded Promotional Material
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.
Draft Guidance for Industry on Active Controls in Studies To Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 204 entitled ``Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for Use in Companion Animals.'' This draft guidance advises industry on the use of active controls in studies intended to provide substantial evidence of effectiveness of new animal drugs for use in companion animals. The intent of the guidance is to provide information to clinical investigators who conduct studies using active controls and have a basic understanding of statistical principles.
Agency Information Collection Activities; Proposed Collection; Comment Request
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Synthesis of AHRQ-Funded HAI Projects.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. This proposed information collection was previously published in the Federal Register on April 6th, 2012 and allowed 60 days for public comment. No substantive comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
Proposed Requirements-Race to the Top-Early Learning Challenge; Phase 2
The Secretary of Education and the Secretary of Health and Human Services (hereafter ``the Secretaries'') propose requirements for Phase 2 of the Race to the TopEarly Learning Challenge (RTT-ELC) program. In this phase (Phase 2 of the RTT-ELC program), we would make awards to certain States that applied for, but did not receive, funding under Phase 1 of the RTT-ELC competition held in fiscal year (FY) 2011 (FY 2011 RTT-ELC competition). Specifically, we would consider eligible the five highest-scoring applicants that did not receive funding in the FY 2011 RTT-ELC competition, each of which received approximately 75 percent or more of the available points under the competition. We take this action to fund down the slate of the FY 2011 RTT-ELC competition and to establish the information and assurances that the eligible applicants would need to provide in order to receive funding under Phase 2 of the RTT-ELC program.
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