Department of Health and Human Services March 14, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Modifications to Compliance Policy for Certain Deemed Tobacco Products.'' The draft guidance discusses changes to the compliance policies for premarket review requirements for certain deemed tobacco products and describes how FDA intends to prioritize its enforcement resources with regard to the marketing of certain deemed tobacco products that do not have premarket authorization.

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 Extension without Change (ICR Ext) solicits comments on the information collection requirements related to the Program Performance Reports for Title VI grants under the Older Americans Act.

The Food and Drug Administration (FDA, the Agency, or we) is re-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.

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 the Inspection by Accredited Persons Program.

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 051'' (Recognition List Number: 051), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC). The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. Consistent with FDA's regulations, notice is being published with less than 15 days prior to the date of the meeting based on a determination that an immediate meeting of the Vaccines and Related Biological Products Advisory Committee is needed. This Federal Register notice could not be published 15 days prior to the date of the meeting due to a delay by the World Health Organization (WHO) in recommending H3N2 strain for inclusion in the 2019-2020 seasonal influenza vaccines.