Department of Health and Human Services March 6, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 7 of 7
Mitigation Strategies To Protect Food Against Intentional Adulteration; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry.'' The revised draft guidance supersedes the version of the intentional adulteration draft guidance that we announced on June 20, 2018. This draft guidance document, when finalized, will help food facilities that manufacture, process, pack, or hold food, and that are required to register under the Federal Food, Drug, and Cosmetic Act (FD&C Act) comply with the requirements of our regulation entitled ``Mitigation Strategies to Protect Food Against Intentional Adulteration.''
Medicare Program; Release of Data Underlying Risk Adjustment Data Validation Provisions
This document announces the release of data underlying the proposed policies regarding the use of extrapolation in Medicare Advantage (MA) Risk Adjustment Data Validation (RADV) audits and the Fee-for-Service (FFS) Adjuster.
Medical Devices; Obstetrical and Gynecological Devices; Classification of the Software Application for Contraception
The Food and Drug Administration (FDA or we) is classifying the software application for contraception into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the software application for contraception's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Environmental Assessment Reporting System (NEARS) to collect data from foodborne illness outbreak environmental assessments routinely conducted by local, state, territorial, or tribal food safety programs during outbreak investigations.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Study on Disparities in Distress Screening among Lung and Ovarian Cancer Survivors. The goal of this study is to understand the processes, facilitators, and barriers related to implementing distress screening in 50 healthcare facilities.
Medical Devices; Exemption From Premarket Notification: Class II Devices; Flow Cytometer Instruments; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing its intention to exempt certain flow cytometer instruments from premarket notification requirements, subject to conditions and limitations. The Agency has determined based on established factors that these devices, which are currently regulated by FDA under product code OYE, no longer require premarket notification to provide reasonable assurance of safety and effectiveness. All other class II devices classified under FDA's automated differential cell counter regulation would continue to be subject to premarket notification requirements. FDA is publishing this proposed order to obtain comments regarding this proposed exemption, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue
The Food and Drug Administration (FDA, we, or the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for chickens, turkeys, and swine, as well as to provide for the safe use of silicon dioxide as a carrier for selenomethionine hydroxy analogue. This action is in response to a food additive petition filed by Adisseo France S.A.S.
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