Department of Health and Human Services November 4, 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SCENESSE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ADAKVEO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DENGVAXIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

The Food and Drug Administration (FDA, Agency, or we) 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 information collection provisions of the Interstate Shellfish Dealer's Certificate as well as the collection of other records related to participation in the National Shellfish Sanitation Program (NSSP).

The National Biodefense Science Board (NBSB or the Board) is authorized under Section 319M of the Public Health Service (PHS) Act, as added by section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act. The Board is governed by the Federal Advisory Committee Act (5 U.S.C. app.), which sets forth standards for the formation and use of advisory committees. The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to the Department of Health and Human Services (HHS) regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Authority to manage and operate the NBSB, including to receive advice and recommendations from the Board, has been delegated by the Secretary of HHS to the Assistant Secretary for Preparedness and Response (ASPR). The NBSB will meet in public (virtually) on December 16, 2021, to provide advice and recommendations to ASPR regarding the development of the 2023-2026 National Health Security Strategy and to discuss other matters of current important for public health emergency preparedness, response, and recovery. A more detailed agenda will be available on the NBSB meeting website https://www.phe.gov/nbsb. Procedures for Public Participation: Members of the public may attend the meeting via a toll-free phone number or Zoom teleconference, which requires pre-registration. The meeting link to pre-register will be posted on the meeting website https://www.phe.gov/nbsb. Members of the public may provide written comments or submit questions for consideration by the NBSB at any time via email to NBSB@hhs.gov. Additionally, the NBSB invites those who are involved in or represent a relevant biodefense or health security industry, serve as faculty or conduct research at an academic institution, occupy a relevant health profession, or work for a hospital system or health care consumer organization; or those who serve in a state, Tribal, territorial or local government agency to request up to seven minutes to address the Board in person via Zoom. Requests to provide remarks to the NBSB during the public meeting must be sent to NBSB@hhs.gov by midnight on October 10, 2021. In that request, please provide the name, title, and position of the individual who will be speaking and a brief description of the planned topic. Presenters who are selected for the public meeting will have audio only during the meeting, thoughlides, documents, and other presentation material may be sent ahead; those will be provided directly to the board members. Topics and presentations with an obvious commercial bias, to include any form of advertising, marketing, or solicitation, will not be accepted.