Department of Health and Human Services September 14, 2017 – Federal Register Recent Federal Regulation Documents
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Medicare Program; Announcement of the Advisory Panel on Clinical Diagnostic Laboratory Tests Meeting
This notice announces the next public meeting date for the Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests (the Panel) on September 25, 2017. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (DHHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on issues related to clinical diagnostic laboratory tests (CDLTs).
Advisory Committee on Immunization Practices
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Advisory Committee on Immunization Practices (ACIP). This meeting is open to the public, limited only by the space available. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is October 11, 2017. Written comments must include full name, address, organizational affiliation, email address of the speaker, topic being addressed and specific comments. Written comments must not exceed one single-spaced typed page with 1- inch margins containing all items above. Only those written comments received 10 business days in advance of the meeting will be included in the official record of the meeting. Public comments made in attendance must be no longer than 3 minutes and the person giving comments must attend the public comment session at the start time listed on the agenda. Time for public comments may start before the time indicated on the agenda. The meeting will be webcast live via the World Wide Web; for instructions and more information on ACIP please visit the ACIP Web site: https://www.cdc.gov/vaccines/acip/.
Prescription Drug User Fee Rates for Fiscal Year 2018
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2017 (PDUFA VI), authorizes FDA to collect application fees for certain applications for the review of human drug and biological products, and prescription drug program fees for certain approved products. This notice establishes the fee rates for FY 2018.
Biosimilar User Fee Rates for Fiscal Year 2018
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2018. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2017, through September 30, 2018.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Focus Groups as Used by the Food and Drug Administration (All Food and Drug Administration-Regulated Products)
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Arcadia Biosciences, Inc.; Filing of Food Additive Petition (Animal Use)
The Food and Drug Administration (FDA or we) is announcing that Arcadia Biosciences, Inc. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of gamma-linolenic acid (GLA) safflower oil as a source of omega-6 fatty acids in dry food for adult cats in the maintenance life stage.
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