Department of Health and Human Services September 13, 2017 – Federal Register Recent Federal Regulation Documents

National Center for Health Statistics (NCHS), ICD-10 Coordination and Maintenance (C&M) Committee Meeting
Document Number: 2017-19444
Type: Notice
Date: 2017-09-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee meeting. This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 240 people. We will be broadcasting the meeting live via Webcast at https://www.cms.gov/live/.
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
Document Number: 2017-19443
Type: Notice
Date: 2017-09-13
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC), announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the teleconference at the USA toll-free, dial-in number at 1-866-659-0537; the pass code is 9933701. The conference line has 150 ports for callers.
Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations; Draft Guidance for Industry; Availability
Document Number: 2017-19435
Type: Notice
Date: 2017-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendations.'' This draft guidance is intended to assist developers of microdose radiopharmaceutical diagnostic drugs on the nonclinical studies recommended to support human clinical trials and marketing authorization. The draft guidance discusses how to refine nonclinical study recommendations for this class of drug given its unique characteristics. This draft guidance is intended to provide recommendations for a pathway to full drug development (marketing authorization) for microdose radiopharmaceutical diagnostic drugs.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption; Extension of Compliance Dates for Subpart E
Document Number: 2017-19434
Type: Proposed Rule
Date: 2017-09-13
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is proposing to extend, for covered produce other than sprouts, the dates for compliance with the agricultural water provisions in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule. We are proposing to extend the compliance dates to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to achieve our regulatory objectives, in keeping with the Administration's policies.
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-19411
Type: Notice
Date: 2017-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2017-19367
Type: Notice
Date: 2017-09-13
Agency: Department of Health and Human Services, Administration for Children and Families
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2017-19363
Type: Notice
Date: 2017-09-13
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-19362
Type: Notice
Date: 2017-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-19361
Type: Notice
Date: 2017-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2017-19315
Type: Notice
Date: 2017-09-13
Agency: Department of Health and Human Services, National Institutes of Health
Government owned intellectual property covering HIV-1 reverse transcriptase inhibitors available for licensing and commercialization.
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