Department of Health and Human Services November 6, 2018 – Federal Register Recent Federal Regulation Documents
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Meeting of the Tick-Borne Disease Working Group
The Department of Health and Human Services (HHS) announces the eighth meeting of the Tick-Borne Disease Working Group (Working Group) on December 3, 2018, from 1:00 p.m. to 4:00 p.m., Eastern Time. The eighth meeting will be an online meeting held via webcast. The Working Group will review the work of the public comments subcommittee, discuss the release of the 2018 Report to Congress, recognize the subcommittee members for their contributions to the 2018 Report, and address the next steps and transition to a new Working Group for the 2020 Report to Congress.
Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry and FDA staff entitled ``Questions and Answers Regarding Mandatory Food Recalls: Guidance for Industry and FDA Staff.'' The guidance provides information on the implementation of the mandatory food recall provisions of the FDA Food Safety Modernization Act (FSMA). The guidance is in the form of Questions and Answers and provides answers to common questions that might arise about the mandatory recall provisions and FDA's plans for their implementation.
Proposed Data Collection Submitted for Public Comment and Recommendations
The Agency for Toxic Substance and Disease Registry, 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 ATSDR Exposure Investigations (EIs) (OMB Control No. 0923-0048, Expiration Date 3/31/2019) ExtensionAgency for Toxic Substances and Disease Registry (ATSDR). To evaluate public health issues at a site resulting from environmental exposure, ATSDR EIs fill data gaps by conducting environmental and biological sampling.
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 ``Sudden Death in the Young (SDY) Case Registry''. The goal of the SDY Case Registry is to compile standardized data on sudden and unexpected deaths among infants, children, and young adults, which are not explained by homicides, suicides, overdoses, or the result of an external cause that was the only and obvious reason for the fatal injury, or terminal illnesses.
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 extension to information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on an information collection project titled ``National Quitline Data Warehouse.'' The National Quitline Data Warehouse (NQDW) collects a core set of information from the 50 U.S. states, the District of Columbia, Guam, Puerto Rico, and the Asian Smoker's Quitline regarding what services telephone quitlines offer to tobacco users as well as the number and type of tobacco users who receive services from telephone quitlines.
Prospective Grant of Exclusive Patent License: Therapeutics for Insulin Resistance and Non-Alcoholic Fatty Liver Disease/Non-Alcoholic Steatohepatitis (NASH/NAFLD)
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization patent license to Ovensa, Inc. headquartered in Ontario, Canada, to practice the inventions embodied in the patent application(s) listed in the Supplementary Information section of this notice.
Statement of Organization, Functions, and Delegations of Authority
This notice replaces all language in Part Q (Office of the Secretary) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS or the Department), Office of Inspector General (OIG) (81 FR 13807, as published March 15, 2016). The Statement of Organization, Functions, and Delegations of Authority conforms to and carries out the statutory requirements for operating OIG. The organizational changes reflected in this notice are primarily to realign the functions within OIG to better reflect the current work environment and priorities and to more clearly delineate responsibilities for the various activities within OIG's offices. OIG was established by law as an independent and objective oversight unit of the Department to carry out the mission of preventing fraud and abuse and promoting economy, efficiency, and effectiveness of HHS programs and operations. In furtherance of this mission, the organization: Conducts and supervises audits, investigations, evaluations, and inspections relating to HHS programs and operations; identifies systemic weaknesses giving rise to opportunities for fraud and abuse in HHS programs and operations and makes recommendations to prevent their recurrence; leads and coordinates activities to prevent and detect fraud and abuse in HHS programs and operations; detects wrongdoers and abusers of HHS programs and beneficiaries so appropriate remedies may be brought to bear, including imposing administrative sanctions against providers of health care under Medicare and Medicaid who commit certain prohibited acts; and keeps the Secretary of Health and Human Services and Congress fully and currently informed about problems and deficiencies in the administration of HHS programs and operations and about the need for and progress of corrective action. In addition, OIG works with the Department of Justice (DOJ), on behalf of the Secretary, to operate the Health Care Fraud and Abuse Control Program. In accordance with authority enacted in its annual appropriations, OIG also provides protection services to the Secretary and conducts criminal investigations of violations of Federal child support provisions. In support of its mission, OIG carries out and maintains an internal quality assurance system and a peer-review system with other Offices of Inspector General, including periodic quality assessment studies and quality control reviews, to provide reasonable assurance that applicable laws, regulations, policies, procedures, standards, and other requirements are followed, are effective, and are functioning as intended in OIG operations. Section Q, Office of Inspector GeneralOrganization
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