Department of Health and Human Services January 17, 2014 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Reporting of Computational Modeling Studies in Medical Device Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Reporting of Computational Modeling Studies in Medical Device Submissions.'' Computational modeling and simulation (CM&S) studies are often used by sponsors as a tool to support medical device applications. The purpose of this draft guidance document is to provide recommendations to industry on the formatting, organization, and content of reports of CM&S studies that are used as valid scientific evidence to support medical device submissions, and to assist FDA staff in the review of computational modeling and simulation studies by improving the consistency and predictability of the review and facilitating full interpretation and complete review of those studies. This draft guidance is not final nor is it in effect at this time.
Effective Date of Requirement for Premarket Approval for Transilluminator for Breast Evaluation and Sorbent Hemoperfusion System (SHS) Devices for the Treatment of Hepatic Coma and Metabolic Disturbances; Reclassification of SHS Devices for the Treatment of Poisoning and Drug Overdose
The Food and Drug Administration (FDA) is issuing a final order to require the filing of a premarket approval application (PMA) for the transilluminator for breast evaluation and sorbent hemoperfusion system (SHS) devices for the treatment of hepatic coma and metabolic disturbances and to reclassify SHS devices for the treatment of poisoning and drug overdose, a preamendments class III device, into class II (special controls).
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reporting and Recordkeeping for Electronic Products-General Requirements
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Reporting and Recordkeeping for Electronic ProductsGeneral Requirements'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices-21 CFR Part 814
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Approval of Medical Devices21 CFR Part 814'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification Submission 510(k)
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Premarket Notification Submission 510(k), Subpart E'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Modified Policy on Freedom of Information Act Disclosure of Amounts Paid to Individual Physicians Under the Medicare Program
This notice sets forth a new policy regarding requests made under the Freedom of Information Act for information on amounts paid to individual physicians under the Medicare program in which CMS will make case-by-case determinations as to whether exemption 6 of the Freedom of Information Act applies to a given request for such information.
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