Department of Health and Human Services August 15, 2018 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Agency Information Collection Activities; Proposed Collection; Comment Request; Data Collection Materials for the Annual Performance Reporting of the Administration for Community Living's American Indian, Alaskan Natives and Native Hawaiian Programs
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the Revision of a Currently Approved Collection (ICR Rev) and solicits comments on the information collection requirements related to the annual Program Performance Report (PPR) for the American Indian, Alaskan Natives and Native Hawaiian Programs under Title VI of the Older Americans Act.
Statement of Organization, Functions, and Delegations of Authority
Statement of Organizations, Functions, and Delegations of Authority The Administration for Children and Families (ACF) has realigned the Office of Human Services Emergency Preparedness and Response (OHSEPR). OHSEPR will be a direct report to the Deputy Assistant Secretary for External Affairs. ACF will transfer the U.S. Repatriation Program from the Office of Refugee Resettlement (ORR) to OHSEPR. The OHSEPR mission statement has been revised to include the Repatriation Program and responsibility for business continuity planning. It renames the Division of Disaster Case Management to the Division of Response and Recovery Operations and the Division of Emergency Planning, Policy and Operations to the Division of Emergency Policy and Planning. Lastly, it changes the reporting relationship of the Office of Communications from a direct report to the Deputy Assistant Secretary for External Affairs to a direct report to the Assistant Secretary for Children and Families.
Announcement of Intent To Issue One OPDIV-Initiated Supplement to BCFS Health and Human Services Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132
ACF, ORR, announces the intent to issue one OPDIV-Initiated Supplement to BCFS Health and Human Services, San Antonio, TX in the amount of up to $19,011,218. ORR has been identifying additional capacity to provide shelter for potential increases in apprehensions of Unaccompanied Children at the U.S. Southern Border. Planning for increased shelter capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to provide shelter for Unaccompanied Alien Children referred to its care by the Department of Homeland Security (DHS). To ensure sufficient capacity to provide shelter to unaccompanied children referred to HHS, BCFS proposed to provide ORR with 700 beds in an expedited manner.
Issuance of Priority Review Voucher; Rare Pediatric Disease Product
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that CRYSVITA (burosamab-twza), manufactured by Ultragenyx Pharmaceutical, Inc., meets the criteria for a priority review voucher.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information entitled ``Guidance for Industry on Postmarketing Adverse Event Reporting for Nonprescription Human Drug Products Marketed Without an Approved Application.''
Elemental Impurities in Animal Drug Products-Questions and Answers; Draft Guidance for Industry; Availability; Reopening of the Comment Period
The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice of availability that published in the Federal Register on March 27, 2018. In that document, FDA requested comments on the draft guidance for industry (GFI) #255 entitled ``Elemental Impurities in Animal Drug ProductsQuestions and Answers.'' The Agency is taking this action in response to requests for an extension to allow interested parties additional time to develop and submit comments.
Pharmaceutical Science and Clinical Pharmacology Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Medicare and Medicaid Programs: Application From the Joint Commission (TJC) for Continued Approval of its Psychiatric Hospital Accreditation Program
This proposed notice acknowledges the receipt of an application from the Joint Commission (TJC) for continued recognition as a national accrediting organization for psychiatric hospitals that wish to participate in the Medicare or Medicaid programs.
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