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

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.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National HIV Behavioral Surveillance among Transgender Women (NHBS-Trans). CDC is requesting approval to continue collecting standardized HIV-related behavioral data from transgender women at risk for HIV.

In accordance with the Federal Advisory Committee Act of 1972, HHS is hereby giving notice that the National Advisory Committee on Rural Health and Human Services (NACRHHS) has been renewed. The effective date of the charter renewal is October 29, 2021.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 procedure by which both domestic and foreign bottled water manufacturers that sell bottled water in the United States maintain records of microbiological testing and corrective measures, in addition to existing recordkeeping requirements.

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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Text Analysis of Proprietary Drug Name Interpretations.''

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing a data collection activity as part of the Integrating Financial Capability and Employment Services Project. The objective of this project is to better understand financial capability interventions offered in the context of delivering employment and training services for low-income adults. This descriptive study intends to use this information to build more evidence about the extent, forms, and practices of incorporating financial capability interventions into organizations delivering employment and training services for low-income adult populations, and to help establish a basis for future research and evaluation in this area. This project will focus on organizations delivering employment and training services that also offer financial capability services to low-income adults.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VYONDYS 53 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 drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SPINRAZA 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 patents which claims that human drug product.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

In accordance with the Federal Advisory Committee Act, CDC announces the following virtual meeting for the World Trade Center Health Program Scientific/Technical Advisory Committee (WTCHP STAC). A notice of this WTCHP STAC meeting has also been posted on the committee website at: https://www.cdc.gov/wtc/stac_meeting.html.