Department of Health and Human Services August 23, 2018 – Federal Register Recent Federal Regulation Documents
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Privacy Act of 1974; System of Records
In accordance with the requirements of the Privacy Act of 1974, as amended (the Act), the Department of Health and Human Services (HHS) is providing notice of the establishment of a new system of records, System No. 09-90-1701, HHS Insider Threat Program Records. The new system of records will cover records about individuals, retrieved by personal identifier, which are compiled and used by the Department's Office of Security and Strategic Information (OSSI), within the Immediate Office of the Secretary (IOS), to administer the Department's insider threat program. Because the records in this system of records include investigatory material compiled for law enforcement purposes and information classified in the interest of national security, elsewhere in today's Federal Register HHS has published a Notice of Proposed Rulemaking (NPRM) to exempt this system of records from certain requirements of the Privacy Act, pursuant to subsections (k)(1) and (k)(2) of the Act. The system of records is more fully described in the SUPPLEMENTARY INFORMATION section of this notice and in the System of Records Notice (SORN) published in this notice.
Medicare Program; Certain Changes to the Low-Volume Hospital Payment Adjustment Under the Hospital Inpatient Prospective Payment Systems (IPPS) for Acute Care Hospitals for Fiscal Years 2011 Through 2017
This document announces changes to the payment adjustment for low-volume hospitals under the hospital inpatient prospective payment systems (IPPS) for acute care hospitals for fiscal years (FYs) 2011 through 2017 in accordance with section 429 of the Consolidated Appropriations Act, 2018.
Evaluating Inclusion and Exclusion Criteria in Clinical Trials; Workshop Report; Availability
The Food and Drug Administration (FDA or the Agency is announcing the availability of a summary report of a public workshop that was held on April 16, 2018, entitled ``Evaluating Inclusion and Exclusion Criteria in Clinical Trials.'' The FDA Reauthorization Act of 2017 (FDARA) requires that the Agency convene a public workshop to discuss clinical trial eligibility criteria to inform a guidance on this subject and to publish a report summarizing the topics discussed within 90 days of the public workshop. This summary report fulfills FDA's mandate under FDARA.
Announcement of Intent To Solicit and Issue One OPDIV-Initiated Supplement to Lutheran Immigration and Refugee Service, Inc. Under the Standing Announcement for Residential (Shelter) Services for Unaccompanied Children, HHS-2017-ACF-ORR-ZU-1132
ACF, ORR announces the solicitation and intent to issue one OPDIV-Initiated Supplement to Lutheran Immigration and Refugee Service, Inc., Baltimore, MD in an amount not to exceed $1,000,000. ORR has been identifying additional capacity for fingerprinting services for an expected increase in the number of sponsors (parents, guardians, or family friends to whom the UAC will be released) who will need to be fingerprinted. Planning for increased fingerprinting capacity is a prudent step to ensure that ORR is able to meet its responsibility, by law, to ensure that the sponsor has not engaged in any activity that would indicate a potential risk to the UAC.
Request for Nominations for Voting Members on Public Advisory Panels or Committees; Device Good Manufacturing Practice Advisory Committee and the Medical Devices Advisory Committee
The Food and Drug Administration (FDA) is requesting nominations for voting members to serve on the Device Good Manufacturing Practice Advisory Committee and device panels of the Medical Devices Advisory Committee in the Center for Devices and Radiological Health. This annual notice is also in accordance with the 21st Century Cures Act, which requires the Secretary to provide an annual opportunity for patients, representatives of patients, and sponsors of medical devices that may be specifically the subject of a review by a classification panel to provide recommendations for individuals with appropriate expertise to fill voting member positions on classification panels. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Osteoarthritis: Structural Endpoints for the Development of Drugs, Devices, and Biological Products for Treatment.'' The purpose of this draft guidance is to assist sponsors who are developing drugs, devices, or biological products to treat the underlying pathophysiology and structural progression of osteoarthritis (OA). This draft guidance does not address improvement of symptoms of OA, such as pain or functional impairment, which will be addressed in future guidances.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Health Document Submission
The Food and Drug Administration (FDA or Agency) 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 Tobacco Health Document Submissions.
Solicitation of Nominations for Appointment to the Board of Scientific Counselors (BSC), Office of Infectious Diseases (OID)
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, OID. The BSC, OID, consists of 17 experts in fields associated with the issues addressed by CDC's infectious disease national centers (e.g., respiratory diseases, antimicrobial resistance, foodborne diseases, zoonotic and vectorborne diseases, sexually transmitted diseases) and specialties, including clinical and public health practice (including state and local health departments), research and diagnostics, bioinformatics, health policy/communications, and industry. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases and related specialties. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BSC, OID, objectives (www.cdc.gov/ oid/BSC.html).
Mine Safety and Health Research Advisory Committee (MSHRAC), Metal Mining Automation and Advanced Technologies (MMAAT) Workgroup
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC), Metal Mining Automation and Advanced Technologies (MMAAT) Workgroup. This meeting is open to the public, limited only by the space available. 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.
Meeting of the Advisory Committee on Immunization Practices
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by room seating. The meeting room accommodates 400. Time will be available for public comment.
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 ``HIV prevention among Latina transgender women: Evaluation of a locally developed intervention''. The collection is part of a research study designed to evaluate the efficacy of a locally developed and culturally congruent two-session Spanish-language small-group intervention, ChiCAS (Chicas Creando Acceso a la Salud [Chicas: Girls Creating Access to Health]), which provides combination HIV prevention services to adult Hispanic/Latina transgender women at high risk for HIV infection.
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 Understanding multi-sectoral collaboration for strengthening public health capacities in Ethiopia. The goal of this study is to explore multi-sectoral collaboration in Ethiopia, in the context of strengthening public health capacities under the Global Health Security Agenda.
Final National Occupational Research Agenda for Wholesale and Retail Trade
NIOSH announces the availability of the final National Occupational Research Agenda for Wholesale and Retail Trade.
National Advisory Council on the National Health Service Corps
The National Advisory Council on the National Health Service Corps (NACNHSC) has scheduled a public meeting. Information about NACNHSC and the agenda for this meeting can be found on the NACNHSC website at https://nhsc.hrsa.gov/about/national-advisory-council-nhsc/ index.html.
Privacy Act; Implementation
In accordance with the Privacy Act of 1974, as amended (the Act), the Department of Health and Human Services (HHS or Department) is proposing to exempt a new system of records, System No. 09-90-1701, HHS Insider Threat Program Records, from certain requirements of the Act.
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