Department of Health and Human Services July 19, 2007 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Physicians' Perceptions of the Impact of Early Risk Communication About Medical Products
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Threshold of Regulation for Substances Used in Food-Contact Articles
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Threshold of Regulation for Substances Used in Food-Contact Articles'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Voluntary Registration of Cosmetic Product Establishments
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 theFederal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the voluntary registration of cosmetic product establishments with FDA.
Draft Guidance for Industry and Food and Drug Administration Staff; Pulse Oximeters-Premarket Notification Submissions [510(k)s]; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Pulse Oximeters Premarket Notification Submissions [510(k)s].'' The draft guidance describes FDA's recommendations about the content of premarket notification submissions (510(k)s) for pulse oximeter devices.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Possible Footnotes and Cueing Schemes to Help Consumers Interpret Quantitative Trans Fat Disclosures on the Nutrition Facts Panel'' 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; Experimental Study of Trans
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Experimental Study of Trans Fat Claims on Foods'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Food Additives Permitted in Feed and Drinking Water of Animals; Selenium Yeast
The Food and Drug Administration (FDA) is amending the regulations for food additives permitted (FAP) in feed to provide for the safe use of selenium yeast as a source of supplemental selenium in feed supplements for limit feeding for beef cattle and in salt mineral mixes for free-choice feeding for beef cattle. This action is in response to an amendment of a food additive petition filed by Alltech, Inc.
Draft Guidance for Industry and Food and Drug Administration Staff; Premarket Notification Submissions for Medical Devices That Include Antimicrobial Agents; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Premarket Notification (510(k)) Submissions for Medical Devices That Include Antimicrobial Agents.'' This draft guidance is intended to assist device manufacturers interested in preparing premarket notification (510(k)) submissions for their medical devices that include antimicrobial agents. This guidance recommends testing and labeling for 510(k) submissions for devices that include antimicrobial agents. It is intended as a supplement to other device-specific guidance issued by the Center for Devices and Radiological Health (CDRH).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; FDA Survey of Current Manufacturing Practices in the Food Industry
The Food and Drug Administration (FDA) is reopening until September 17, 2007, the comment period for a notice that published in the Federal Register of May 8, 2007 (72 FR 26132). In the notice, FDA announced that a proposed collection of information had been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA). FDA is reopening the comment period in light of continued public interest in this collection of information and in response to a request for an extension of the comment period for this notice.
Determination That Brethine (Terbutaline Sulfate) Injection Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) is announcing its determination that Brethine (Terbutaline Sulfate) Injection was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for terbutaline sulfate injection if all other legal and regulatory requirements are met.
Irradiation in the Production, Processing and Handling of Food
The Food and Drug Administration (FDA) is responding to objections and is denying the requests that it has received for a hearing on the final rule that amended the food additive regulations to authorize the use of a machine source of high energy x-rays to inspect cargo containers that may contain food. After reviewing the objections to the final rule and the requests for a hearing, the agency has concluded that the objections do not raise issues of material fact that justify a hearing or otherwise provide a basis for revoking or modifying the amendment to the regulation.
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