Department of Health and Human Services November 25, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Agency Information Collection Activities: Submission for OMB Review; 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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Certificates of Confidentiality; Draft Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``Certificates of Confidentiality; Guidance for Sponsors, Sponsor-Investigators, Researchers, Industry, and Food and Drug Administration Staff.'' This draft guidance is intended to explain FDA implementation of the revised statutory provisions applicable to the request for, and issuance of, a Certificate of Confidentiality (CoC). The 21st Century Cures Act (Cures Act) amended the statutory provisions relating to the issuance of CoCs. A CoC is intended to help protect the privacy of human subject research participants from whom sensitive and identifiable information is being collected or used in furtherance of the research. Historically, a CoC generally protected a researcher from being compelled in a legal proceeding to disclose identifiable sensitive information about the research participant, created or compiled for the research. As amended, a CoC prohibits a researcher from disclosing such information unless a specified exception applies.
National Biodefense Science Board: Public Meeting
The HHS Office of the Secretary is hosting the National Biodefense Science Board (NBSB) Public Meeting in Washington, DC, December 3, 2019. The purpose of the meeting is to gather information to develop expert advice provided by NBSB and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Retiring NBSB board members will also be presented with certificates and a signed letter of appreciation.
Medicaid Program; Covered Outpatient Drug; Further Delay of Inclusion of Territories in Definitions of States and United States
The Covered Outpatient Drug final rule with comment period was published in the February 1, 2016 Federal Register. As part of that final rule with comment period, we amended the regulatory definitions of ``States'' and ``United States'' to include the U.S. territories (American Samoa, the Commonwealth of the Northern Mariana Islands, Guam, the Commonwealth of Puerto Rico, and the Virgin Islands of the United States) beginning April 1, 2017. Subsequently, in the November 15, 2016 Federal Register, we published an interim final rule with comment period (IFC) to further delay the inclusion of the U.S. territories in the regulatory definitions of ``States'' and ``United States'' until beginning April 1, 2020. This IFC further delays the inclusion of the territories in the definitions of ``States'' and ``United States'' until beginning April 1, 2022.
Board of Scientific Counselors, National Center for Health Statistics (BSC, NCHS)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics BSC, NCHS. This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500, glm4@cdc.gov or Sayeedha Uddin, 301-458-4303, isx9@cdc.gov at least 4 weeks in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal in international government. As required by the Federal Property Management Regulations, Title 41, Code of Federal Regulations, Subpart 101-20.301, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 78 people.
Proposed Information Collection Activity; Form ACF-196, TANF Financial Reporting Form for States
The Administration for Children and Families (ACF) is requesting to renew approval of the ACF-196 Temporary Assistance for Needy Families (TANF) Financial Reporting Form. The ACF-196 is the form used by states to estimate funding needs and request grant awards under the TANF program. In addition, the form is used to report data in substantiation of state claims and to certify the availability of the legislatively mandated state match. ACF will use the financial data provided by states to estimate quarterly funding needs, calculate award amounts, and assess compliance with statutory and regulatory requirements relating to administrative costs and state matching requirements. No changes are proposed to the form.
Medicare Program; Application From Accreditation Commission for Health Care for Initial CMS-Approval of Its Home Infusion Therapy Accreditation Program
This proposed notice acknowledges the receipt of an application from Accreditation Commission for Health Care for initial recognition as a national accrediting organization for suppliers of home infusion therapy services that wish to participate in the Medicare program. The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
Medicare and Medicaid Programs; Continued Approval of the Accreditation Commission for Health Care Accreditation Program
This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare conditions for participation.
Control of Communicable Diseases; Importation of Human Remains
The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) proposes to amend two provisions within its foreign quarantine regulations to provide additional clarity and safeguards to address the risk to public health from the importation of human remains into the United States.
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