Department of Health and Human Services March 9, 2018 – Federal Register Recent Federal Regulation Documents
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Advisory Committee on Interdisciplinary, Community-Based Linkages
In accordance with the Federal Advisory Committee Act, notice is hereby given that two orientation meetings are scheduled for the Advisory Committee on Interdisciplinary, Community-Based Linkages (ACICBL). These meetings will be open to the public. Information about the ACICBL and the agenda for these meetings can be obtained by accessing the ACICBL website at: https://www.hrsa.gov/advisory- committees/interdisciplinary-community-linkages/meetings/inde x.html.
Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments; Correction
The Food and Drug Administration is correcting a notice entitled ``Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments'' that appeared in the Federal Register of February 22, 2018. The document was published with the incorrect docket number. This document corrects that error.
Equivalence Determination Regarding the European Union Food Safety Control System for Raw Bivalve Molluscan Shellfish
The Food and Drug Administration (FDA or we) is inviting public comment on a proposed determination that the European Union (EU) food safety control system for raw bivalve molluscan shellfish (``shellfish'') intended for export into the United States, as administered by the European Commission (EC), provides at least the same level of sanitary protection as the United States' system and is therefore equivalent. If finalized, this determination would permit the importation of shellfish harvested from certain production areas and processed by establishments that have been listed by FDA on the Interstate Certified Shellfish Shippers List (ICSSL). This notice also briefly describes the processes whereby other EU Member States (EUMS) may be approved in the future.
Determination That DORYX MPC (Doxycycline Hyclate), Delayed-Release Tablets, 60 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for DORYX MPC (doxycycline hyclate), delayed-release tablets, 60 mg, if all other legal and regulatory requirements are met.
Draft National Institute of Environmental Health Sciences 2018-2023 Strategic Plan
The NIEHS is updating its 2012-2017 NIEHS Strategic Plan, which can be viewed at www.niehs.nih.gov/2012plan. The goal of the current strategic planning process is to define Strategic Objectives to anticipate, set, and meet priorities in environmental health sciences research, training, and translation in support of the NIEHS mission and vision, as well as to identify key focus areas for implementation of such Strategic Objectives. NIEHS requests comment from researchers in academia and industry, health care professionals, patient advocates and advocacy organizations, scientific or professional organizations, federal agencies, and other interested members of the public on these new Strategic Objectives and focus areas, which are detailed in ``NIEHS Strategic Plan 2018-2023: Advancing Environmental Health Science, Improving Health 2.0.'' The draft plan may be viewed online at www.niehs.nih.gov/strategicplan.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Request for Public Comments on Head Start Program Information Report
The Office of Head Start invites public comment on several major changes to the Head Start Program Information Report (PIR) to better align with the comprehensive revision of the Head Start Program Performance Standards (HSPPS), reduce reporting burden, and improve the data collection. Major changes include proposals to remove, add, and significantly update PIR questions. To view proposed changes to the PIR to go into effect for the 2019-20 PIR, please visit https:// eclkc.ohs.acf.hhs.gov/sites/default/files/pdf/summary-of-prop osed- changes-to-the-pir-for-public-comment.pdf.
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