Department of Health and Human Services January 2022 – Federal Register Recent Federal Regulation Documents

In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold public meetings for the 2022 calendar year (CY). Information about the ACCV, agendas, and materials for these meetings can be found on the ACCV website at https://www.hrsa.gov/advisory- committees/vaccines/.

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 Fire Fighter Fatality Investigation and Prevention Program Survey which will evaluate fire department implementation of the National Institute for Occupational Safety and Health (NIOSH) Fire Fighter Fatality Investigation and Prevention Program (FFFIPP) recommendations. The evaluation will assess whether NIOSH FFFIPP recommendations are utilized by fire departments, identify barriers to implementation of recommendations, and identify areas for potential intervention projects.

In accordance with 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. Time will be available for public comment. The meeting will be webcast live via the World Wide Web.

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 Assessment for the Be Antibiotics Aware Consumer and Healthcare Professional (HCP) Campaign. Individuals who have opted to be contacted for surveys will be screened for eligibility and given access to an online survey to assess the Be Antibiotics Aware campaign, which is designed to optimize antibiotic prescribing and use.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and FDA staff entitled ``Principles of Premarket Pathways for Combination Products.'' This guidance presents FDA's current thinking on principles for premarket review of combination products. This guidance includes general, high-level information regarding what combination products are, coordination within FDA and interaction between FDA and sponsors regarding combination product regulation, and how combination products are reviewed by FDA before they are marketed. The guidance also includes recommendations on how to determine which type of premarket submissions may be appropriate for combination products. FDA is publishing this guidance as part of its efforts to implement the 21st Century Cures Act (Cures Act) and in keeping with the Agency's long-standing commitment to transparency, efficiency, and regulatory consistency to facilitate development of safe and effective combination products. This guidance finalizes the draft guidance of the same title that published on February 6, 2019.

The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

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 recordkeeping requirements regarding animal proteins prohibited in ruminant feed.

The Food and Drug Administration (FDA, Agency, or we) 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.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of December 23, 2021. In the notice of availability, FDA requested comments on draft guidance for industry and FDA staff entitled ``Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.'' The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

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, 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 March 7, 2022, beginning at 12:30 p.m. Eastern time. ASPR invites stakeholders and the general public to attend and participate as appropriate. A detailed agenda and instructions to register to attend the meeting 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 stakeholders to request up to seven minutes to address the Board in-person during the meeting. The Board is interested in hearing from anyone involved in, or who represents, a relevant biomedical, biodefense, or health security industry; serves as faculty or conducts research at an academic institution; occupies a relevant health profession or works for a hospital system or health care consumer organization; or who serves in a relevant state, Tribal, territorial, or local government agency. Requests to provide remarks to the NBSB during the public meeting must be sent to NBSB@hhs.gov by March 1, 2022. In that request, please provide the speaker's name, title, and position, with a brief description of the topic that they will address. The number of speakers and topics will be based on relevance to the mission of the NBSB and amount of time available on the agenda. The charter of the NBSB may be reviewed on the ASPR/NBSB website. 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), located within the Department of Health and Human Services (HHS), announces the award of approximately $3.6 million funding with an expected total funding of approximately $18 million over a 5-year period to Michigan State University. The award will support activities related to the Flint Registry, a comprehensive public health registry of residents who were exposed to lead-contaminated water in Flint, Michigan.

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 requirements associated with our Foreign Supplier Verification Programs for Food Importers.

The Food and Drug Administration (FDA, Agency, or we) is announcing the following virtual public meeting entitled ``Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards.'' The purpose of the virtual public meeting and the request for comments is to fulfill FDA's commitment to seek stakeholder input related to data standards and the electronic submission system's past performance, future targets, emerging industry needs, and technology initiatives. FDA will use the information from the public meeting as well as from comments submitted to the docket to provide input into data standards and electronic submissions initiatives.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Revising ANDA Labeling Following Revision of the RLD Labeling.'' This guidance provides recommendations for updating labeling for abbreviated new drug applications (ANDAs) following revisions to the labeling of a reference listed drug (RLD), including information on how to identify RLD labeling updates and how to submit labeling updates to both unapproved and approved ANDAs to conform to RLD labeling updates. This draft guidance revises the guidance for industry entitled ``Revising ANDA Labeling Following Revision of the RLD Labeling'' issued in April 2000.

The U.S. District Court for the District of Columbia in Facing Foster Care et al. v. HHS, 21-cv-00308 (DDC Feb. 2, 2021), has postponed the effectiveness of portions of the final rulemaking amendments to the Uniform Administrative Requirements, promulgated on January 12, 2021. Those provisions are now effective April 18, 2022.