Department of Health and Human Services November 2023 – Federal Register Recent Federal Regulation Documents

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Peace Corps for ``Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act through a Peace Corps Health Benefit Plan.''

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a virtual meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB). The meeting will be open to the public and will be streamed live on hhs.gov/live. A pre-registered public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to present their comments live during the virtual meeting. Individuals who wish to provide written public comment should send an email to CARB@hhs.gov that includes their written comments. Registration information is available on the website https:// www.hhs.gov/paccarb and should be completed by December 18, 2023 for the December 20, 2023 virtual Public Meeting. Additional information about registering for the meeting and providing public comment can be obtained at https://www.hhs.gov/paccarb on the Upcoming Meetings page. HHS is also giving notice of the appointment of 16 new PACCARB councilmembers that will be sworn-in in preparation of the December 20, 2023 virtual public meeting.

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.

The Food and Drug Administration (FDA, Agency, or we) are proposing to classify certain types of wound dressings and liquid wound washes containing antimicrobials and/or other chemicals (unclassified, preamendments devices) as solid wound dressings; wound dressings formulated as a gel, cream, or ointment; and liquid wound washes. FDA currently regulates these unclassified devices as devices requiring premarket notification (510(k) requirements), with the product codes FRO, GER, MGP, MGQ, and EFQ, but FDA intends to create new product codes for these proposed classifications upon finalization of this classification action. FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a high level of antimicrobial resistance (AMR) concern (i.e., medically important antimicrobials) into class III. In addition, FDA is proposing to classify certain wound dressings and liquid wound washes containing antimicrobials with a medium or low level of AMR concern and/or other chemicals, into class II (subject to special controls and 510(k) requirements).

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry #284 entitled ``Using Relative Supersaturation to Support ``Urinary Tract Health'' Claims for Adult Maintenance Cat Food.'' FDA's Center for Veterinary Medicine (CVM) has evaluated the use of relative supersaturation (RSS) methodology to support urinary tract health claims for certain adult maintenance cat food. RSS is a measurement that estimates the potential for crystal formation and bladder stone growth, which is a common affliction in cats. This draft guidance provides recommendations for how pet food manufacturers can use RSS methodology to substantiate general structure or function claims that an adult maintenance cat food supports urinary tract health by promoting a healthy mineral content in the urinary tract.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Qelbree 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 Amondys 45 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 Office of Early Childhood Development (ECD), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting Office of Management and Budget (OMB) approval of the Tribal Early Childhood Facilities Combined Application Guide for joint applications for construction and major renovation projects using both Head Start and Child Care and Development Fund (CCDF) resources.

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.

In compliance with the Paperwork Reduction Act of 1995, HRSA submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Azstarys 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 Orgovyx 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 Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Empaveli 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 Korsuva 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 Tavneos 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 claim that human drug product.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for Zeposia 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, 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 information collections associated with Shortages Data Collections and with notifications to FDA of an interruption or permanent discontinuance in manufacturing of certain medical devices as required by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is seeking nominations for membership on the World Trade Center (WTC) Health Program Scientific/Technical Advisory Committee (WTCHP-STAC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010. The WTCHP-STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, and mental health, and representatives of WTC responders as well as representatives of certified-eligible WTC survivors.

The Food and Drug Administration (FDA, we, or the Agency) 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 Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the renewal of the charter of the Board of Scientific Counselors Infectious Diseases (BSC ID); (formerly known as the Board of Scientific Counselors, Deputy Director for Infectious Diseases (BSC, DDID)).

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 Blood Lead Surveillance System (BLSS). The National Center for Environmental Health (NCEH) is leading a three-year Extension for two CDC information collections, one for childhood blood lead surveillance by NCEH and another for adult blood lead surveillance by the National Institute for Occupational Safety and Health (NIOSH).