Department of Health and Human Services June 15, 2018 – Federal Register Recent Federal Regulation Documents
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Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry #246 entitled ``Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program.'' This draft guidance document, when finalized, will help animal food facilities comply with the requirements for the supply-chain program under our regulation ``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals.''
The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``The Declaration of Certain Isolated or Synthetic Non-Digestible Carbohydrates as Dietary Fiber on Nutrition and Supplement Facts Labels; Guidance for Industry.'' The guidance identifies eight specific, additional isolated or synthetic non-digestible carbohydrates that we intend to add to our regulatory definition of ``dietary fiber'' through our regular rulemaking process. In the interim, the guidance also advises manufacturers of our policy for when one or more of these eight non-digestible carbohydrates, present in a food, are included in the declared amount of ``dietary fiber,'' and for the use of a caloric value for polydextrose of 1 kilocalorie per gram (kcal/g).
Medicare Program; Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program; Correction
This document corrects technical and typographical errors that appeared in the final rule published in the Federal Register on April 16, 2018 titled ``Medicare Program; Contract Year 2019 Policy and Technical Changes to the Medicare Advantage, Medicare Cost Plan, Medicare Fee-for-Service, the Medicare Prescription Drug Benefit Programs, and the PACE Program.''
Medicare and Medicaid Programs: Application From the Community Health Accreditation Partner for Continued CMS Approval of Its Hospice Accreditation Program
This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.
Prospective Grant of Exclusive Patent Commercialization License: Streptococcus Pneumonia PSAA Peptide for Treatment of Sepsis and Infection
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, on behalf of the Centers for Disease Control and Prevention, Department of Health and Human Services, is contemplating the grant of an exclusive patent commercialization license to The University of Liverpool, located in Liverpool, UK, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-August 22, 2018
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, August 22, 2018. This meeting will focus on the state of evidence on Chimeric Antigen Receptor (CAR) T-cell therapies that are approved by the Food and Drug Administration (FDA). We are seeking the MEDCAC's recommendations regarding collection of patient reported outcomes (PRO) in cancer clinical studies. The MEDCAC will specifically focus on appraisal of evidence-based PRO assessments to provide information that impacts patients, their providers, and caregivers after a CAR T-cell therapy intervention for the patient's cancer. This meeting is open to the public in accordance with the Federal Advisory Committee Act.
Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal
The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal 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 fluid jet system for prostate tissue removal'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.
Agency Information Collection Activities; Submission for OMB Review; Public Comment Request; State Councils on Developmental Disabilities-Annual Program Performance Report (PPR) (OMB Control Number-0985-0033)
The Administration for Community Living is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the State Councils on Developmental DisabilitiesAnnual Program Performance Report (PPR) [Proposed Extension with Changes of a Currently Approved Collection (ICR Rev)].
Coronary, Peripheral, and Neurovascular Guidewires-Performance Tests and Recommended Labeling; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Coronary, Peripheral, and Neurovascular GuidewiresPerformance Tests and Recommended Labeling.'' This draft guidance provides recommendations for the information and testing that should be included in premarket submissions for guidewires intended for use in the coronary, peripheral, and neurovasculature. This draft guidance is not final nor is it in effect at this time.
Intravascular Catheters, Wires, and Delivery Systems With Lubricious Coatings-Labeling Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings Labeling Considerations.'' This draft guidance addresses labeling considerations for devices containing lubricious coatings that are used in the vasculature. The purpose of this draft guidance is to provide recommendations for information to be included in device labeling, as submitted in premarket applications (PMAs) or premarket notification submissions (510(k)s) for class III and class II devices, to enhance the consistency of information across these product areas as well as to promote the safe use of these devices in clinical settings. This draft guidance is not final nor is it in effect at this time.
Final National Occupational Research Agenda for Agriculture, Forestry, and Fishing
NIOSH announces the availability of the final National Occupational Research Agenda for Agriculture, Forestry, and Fishing.
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