Department of Health and Human Services November 2, 2015 – Federal Register Recent Federal Regulation Documents
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Notice To Propose the Redesignation of the Service Delivery Area for the Wampanoag Tribe of Gay Head (Aquinnah)
This document extends the comment period for the notice to propose Redesignation of the Service Delivery Area for the Wampanoag Tribe of Gay Head (Aquinnah), which was published in the Federal Register on October 5, 2015. The comment period for the notice, which would have ended on October 23, 2015, is extended by 30 days.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy; Updated Guidance for Industry, Availability
The Food and Drug Administration (FDA or we) is issuing a revised guidance document that extends the compliance policy described in the guidance for industry entitled ``DSCSA Implementation: Product Tracing Requirements for DispensersCompliance Policy.'' This revised guidance announces FDA's intention with regard to enforcement of certain product tracing requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act) added by the Drug Supply Chain Security Act (DSCSA). FDA does not intend to take action against dispensers who, prior to March 1, 2016, accept ownership of product without receiving transaction information, transaction history, and transaction statements (product tracing information), prior to or at the time of a transaction, or do not capture and maintain the product tracing information, as required by the FD&C Act.
Information To Support a Claim of Electromagnetic Compatibility of Electrically Powered Medical Devices; 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 ``Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically- Powered Medical Devices.'' This guidance describes the types of information that should be provided to support a claim of electromagnetic compatibility (EMC) in a premarket submission for an electrically powered medical device. Electromagnetic disturbance is electronic product radiation that may interfere with the performance of an electrically powered medical device in its intended environment (i.e., cause an electromagnetic interference (EMI)). EMC assessment helps to ensure that a device is able to function in its intended environment without introducing excessive electromagnetic disturbances that might interfere with other devices. This draft guidance is not final nor is it in effect at this time.
Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay
The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Bioequivalence Recommendations for Progesterone; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on progesterone gel entitled ``Draft Guidance on Progesterone.'' The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for progesterone gel.
Medicaid Program; Methods for Assuring Access to Covered Medicaid Services
This final rule with comment period provides for a transparent data-driven process for states to document whether Medicaid payments are sufficient to enlist providers to assure beneficiary access to covered care and services consistent with section 1902(a)(30)(A) of the Social Security Act (the Act) and to address issues raised by that process. The final rule with comment period also recognizes electronic publication as an optional means of providing public notice of proposed changes in rates or ratesetting methodologies that the state intends to include in a Medicaid state plan amendment (SPA). We are providing an opportunity for comment on whether future adjustments would be warranted to the provisions setting forth requirements for ongoing state reviews of beneficiary access.
Medicaid Program; Request for Information (RFI)-Data Metrics and Alternative Processes for Access to Care in the Medicaid Program
In this request for information (RFI), we seek public input to inform the potential development of standards with regard to Medicaid beneficiaries' access to covered services under the Medicaid program. Specifically, we are interested in obtaining information on core access to care measures and metrics that could be used to measure access to care for beneficiaries in the Medicaid program (including in fee-for- service and managed care delivery systems) and used to develop local, state and national thresholds and goals to inform and improve access in the program. We are also interested in feedback on approaches to using the metrics, which could include setting access goals and thresholds and formal processes for beneficiaries to raise access concerns.
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