Department of Health and Human Services November 16, 2018 – Federal Register Recent Federal Regulation Documents
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Solicitation of Nominations for Appointment to the Tick-Borne Disease Working Group
This notice will serve to announce that the U.S. Department of Health and Human Services (HHS) is seeking nominations of non-federal individuals who represent diverse scientific disciplines and views and are interested in being considered for appointment to the Tick-Borne Disease Working Group (Working Group). Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the Working Group are currently being accepted.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. 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.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs), that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: MCH Jurisdictional Survey Instrument for the Title V MCH Block Grant Program, OMB No. 0906-XXXX, New
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, or any other aspect of the ICR related to the Maternal and Child Health (MCH) Jurisdictional Survey that is to be administered in the U.S. territories and jurisdictions (excluding the District of Columbia) for purposes of collecting information related to the well-being of all mothers, children, and their families.
Medicare and Medicaid Programs; Continued Approval of the Community Health Accreditation Partner's Hospice Accreditation Program
This final notice announces our decision to approve the Community Health Accreditation Partner (CHAP) 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 (CoPs).
Findings of Research Misconduct
Notice is hereby given that on October 22, 2018, the U.S. Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on an Administrative Law Judge's finding of research misconduct against Rakesh Srivastava, Ph.D., former Eminent Scholar and Professor, University of Kansas Medical Center (KUMC). Dr. Srivastava engaged in research misconduct in research proposed or reported in grant application 1 R01 CA175776-01, submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH), on June 5, 2012. The administrative actions, including two (2) years of debarment, were implemented beginning on October 22, 2018, and are detailed below.
Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council for Harmonisation E2B(R3) Standards; Public Meetings; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing three public meetings entitled ``Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonisation (ICH) E2B(R3) Standards.'' The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for drug, biological, and drug/ biologic-led combination products for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. FDA is seeking input from stakeholders as it fulfills its commitment to implement ICH E2B(R3) standards by holding three public meetings. FDA will use the information provided by the public to inform the enhancements to FAERS required for the implementation of ICH E2B(R3) standards and relevant regional variations.
Regulatory Agenda
The Regulatory Flexibility Act of 1980 and Executive Order (E.O.) 12866 require the semiannual issuance of an inventory of rulemaking actions under development throughout the Department, offering for public review summarized information about forthcoming regulatory actions.
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