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General Hospital and Personal Use Devices; Reclassification of Sharps Needle Destruction Device
Federal Register · Proposed Rule · Nov 7, 2017
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 8, 2018. … (2) Validation of cleaning and disinfection instructions must demonstrate that the device can be safely and effectively reprocessed after use per the recommended cleaning and disinfection protocol in
82 FR 51585Health and Human Services DepartmentFood and Drug AdministrationRequest for Information; Essential Health Benefits
Federal Register · Proposed Rule · Dec 2, 2022
Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. … Please allow sufficient time for mailed comments to be received before the close of the comment period.
87 FR 74097Health and Human Services DepartmentMedicare and Medicaid Programs; Regulation To Require Drug Pricing Transparency
Federal Register · Proposed Rule · Oct 18, 2018
Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. … SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable
83 FR 52789Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesProposed Data Collections Submitted for Public Comment and Recommendations
Federal Register · Notice · Sep 24, 2010
the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention … (CDC) will publish periodic summaries of proposed projects.
75 FR 58391Health and Human Services DepartmentCenters for Disease Control and PreventionFederal Register · Proposed Rule · Jun 25, 2012
Paperwork Reduction Act D. Small Business Regulatory Enforcement Fairness Act E. Unfunded Mandates Reform Act of 1995 F. Executive Order 12988 (Civil Justice) G. … Paperwork Reduction Act of 1995 The Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., requires an agency to invite public comment on and to obtain OMB approval of any regulation that requires
77 FR 37862Health and Human Services DepartmentMedicare Program; Payment for Respiratory Assist Devices With Bi-level Capability and a Back-up Rate
Federal Register · Proposed Rule · Aug 22, 2003
the Act). … • Other than monthly replacement of the air inlet filter on the front of the system, there is no routine maintenance required.
68 FR 50735Health and Human Services DepartmentCenters for Medicare & Medicaid ServicesFederal Register · Notice · Feb 21, 2018
The agenda allows for one oral public comment period (12 commenters, up to 5 minutes per speaker). … The authority for NTP panels is provided by 42 U.S.C. 217a; section 222 of the Public Health Service Act, as amended. The panel is governed by the Federal Advisory Committee Act, as amended (5 U.S.C.
83 FR 7488Health and Human Services DepartmentNational Institutes of HealthFederal Register · Notice · Sep 30, 2024
However, the Federal Food, Drug, and Cosmetic Act (FD&C Act) does not preclude FDA from using performance criteria to facilitate this comparison. … Act (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)).
89 FR 79615Health and Human Services DepartmentFood and Drug AdministrationDiseases Transmitted Through the Food Supply
Federal Register · Notice · Nov 17, 2008
The failure of food-handlers to wash hands (in situations such as after using the toilet, handling raw meat, cleaning spills, or carrying garbage, for example), wear clean gloves, or use clean utensils … Bacterial pathogens in this category often require a period of temperature abuse to permit their multiplication to an infectious dose before they will cause disease in consumers.
73 FR 67871Health and Human Services DepartmentCenters for Disease Control and PreventionDiseases Transmitted Through the Food Supply
Federal Register · Notice · Nov 6, 2003
SUMMARY: Section 103(d) of the Americans with Disabilities Act of 1990, Pub. … The failure of food-handlers to wash hands (in situations such as after using the toilet, handling raw meat, cleaning spills, or carrying garbage, for example), wear clean gloves, or use clean utensils
68 FR 62809Health and Human Services DepartmentCenters for Disease Control and PreventionDiseases Transmitted Through the Food Supply
Federal Register · Notice · Sep 10, 2001
The failure of food-handlers to wash hands (in situations such as after using the toilet, handling raw meat, cleaning spills, or carrying garbage, for example), wear clean gloves, or use clean utensils … Bacterial pathogens in this category often require a period of temperature abuse to permit their multiplication to an infectious dose before they will cause disease in consumers.
66 FR 47030Health and Human Services DepartmentCenters for Disease Control and PreventionDiseases Transmitted Through the Food Supply
Federal Register · Notice · Sep 26, 2006
The failure of food-handlers to wash hands (in situations such as after using the toilet, handling raw meat, cleaning spills, or carrying garbage, for example), wear clean gloves, or use clean utensils … Bacterial pathogens in this category often require a period of temperature abuse to permit their multiplication to an infectious dose before they will cause disease in consumers.
71 FR 56152Health and Human Services DepartmentCenters for Disease Control and PreventionDiseases Transmitted Through the Food Supply
Federal Register · Notice · Oct 4, 2004
SUMMARY: Section 103(d) of the Americans with Disabilities Act of 1990, Pub. … The failure of food-handlers to wash hands (in situations such as after using the toilet, handling raw meat, cleaning spills, or carrying garbage, for example), wear clean gloves, or use clean utensils
69 FR 59237Health and Human Services DepartmentCenters for Disease Control and PreventionFederal Register · Proposed Rule · Aug 17, 2018
Once the comment period ends, we will consider the comments and publish in the Federal Register a final action classifying such suitable accessories into class I. II. … apparatus accessory (FYD) Supplementary device that is intended to be used with an air-handling apparatus for a surgical operating room.
83 FR 41023Health and Human Services DepartmentFood and Drug AdministrationEnhancing Coverage of Preventive Services Under the Affordable Care Act
Federal Register · Proposed Rule · Jan 15, 2025
The comment period on the proposed rules closed on December 27, 2024, and the Departments received 268 comments to review. … Appropriations Act, 2021 (RIN 0938-AU98); Independent Dispute Resolution Operations (RIN 0938-AV15); Requirements Related to Air Ambulance Services, Agent and Broker Disclosures, and Provider Enforcement
90 FR 3728Treasury DepartmentInternal Revenue ServiceCurrent Good Manufacturing Practice for Positron Emission Tomography Drugs
Federal Register · Proposed Rule · Sep 20, 2005
Proposed § 212.70(e) would allow the 30-hour period to be exceeded in certain cases, such as weekends or holidays, provided it is shown that the extended period will not affect the stability or viability … (c) Record retention period .
70 FR 55038Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 7, 2016
Section 1271.200(e) requires documentation of all equipment maintenance, cleaning, sanitizing, calibration, and other activities. … and section 351 of the PHS Act (42 U.S.C. 262), that have registered and listed with FDA.
81 FR 61685Health and Human Services DepartmentFood and Drug AdministrationProposed Data Collection Submitted for Public Comment and Recommendations
Federal Register · Notice · May 6, 2015
ACTION: Notice with comment period. … on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
80 FR 26055Health and Human Services DepartmentCenters for Disease Control and PreventionFederal Register · Notice · Jun 15, 1995
DATES: Written comments by August 14, 1995. … Under the Federal Food, Drug, and Cosmetic Act, and FDA labeling regulations (21 CFR 801.5), a device is required to bear adequate directions for use.
60 FR 31484Health and Human Services DepartmentFederal Register · Notice · Mar 31, 2017
DATES: Fax written comments on the collection of information by May 1, 2017. … and section 351 of the PHS Act (42 U.S.C. 262), that have registered and listed with FDA.
82 FR 16040Health and Human Services DepartmentFood and Drug Administration
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