February 4, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Immunogenicity Information in Human Prescription Therapeutic Protein and Select Drug Product LabelingContent and Format.'' This draft guidance provides recommendations for incorporating clinically relevant immunogenicity information into the labeling of products having immunogenicity assessments. Appropriate inclusion and consistent placement of immunogenicity information in the Prescribing Information helps to make clinically relevant information accessible to the health care practitioner and promotes the safe and effective use of prescription drug and biological products. When finalized, the recommendations in this guidance will supersede the immunogenicity labeling-specific recommendations in the guidances for industry entitled ``Labeling for Biosimilar Products'' and ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.''

In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior Bureau of Land Management's (BLM) Southeast Oregon Resource Advisory Council (RAC) will meet as follows.

The plats of surveys for the lands described in this notice are scheduled to be officially filed in the Bureau of Land Management (BLM) Montana State Office, Billings, Montana, 30 calendar days from the date of this publication. The surveys, which were executed at the request of the BLM Billings Field Office are necessary for the management of these lands.

The Secretary of Health and Human Services (Secretary) announces a meeting of the Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). The ISUDCC is open to the public and members of the public can attend the meeting via telephone or webcast only, and not in person. Agenda with call-in information will be posted on the SAMHSA website prior to the meeting at: https://www.samhsa.gov/about-us/advisory- councils/meetings. The meeting will include information on establishing ISUDCC working groups support for the mission and work of the Committee; federal advances to address challenges in substance use disorder (SUD); and non-federal advances to address challenges in SUD. Committee Name: Interdepartmental Substance Use Disorders Coordinating Committee (ISUDCC). Date/Time/Type: March 16, 2022, 1:00 p.m.-4:00 p.m. (EDT)/Open.

In accordance with the Paperwork Reduction Act of 1995, ED is proposing a new collection.

The Office of the Assistant Secretary for Health in the Department of Health and Human Services (HHS) seeks public comment regarding a proposed revision to the 2020 PHS Guideline Assessing Solid Organ Donors and Monitoring Transplant Recipients for Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Infection (1). The Organ Procurement and Transplantation Network (OPTN) implemented a policy change related to organ transplant candidate assessment and testing on March 1, 2021, to align OPTN policy with the new Guideline recommendations (2). Previous PHS Guideline recommendations did not include a specific timeframe during which pre- transplant testing for HIV, HBV, and HCV infections among organ transplant candidates should occur. In order to more accurately assess pre-transplant infection status and to enable the investigation of possible solid organ donor transmission of infection, the 2020 Guideline specified that pre-transplant HIV, HBV, and HCV testing of transplant candidates should occur during hospital admission for transplant surgery but prior to the implantation of the organ. In May 2021, HHS reviewed communications from members of the public to the OPTN, outlining concerns that the additional amount of blood drawn for infectious disease testing (when added to the relatively large amount of blood required for immediate preoperative laboratory testing) during the admission for transplantation poses potential risks for some pediatric organ transplant candidates. Potential risks due to blood volume loss include those related to preoperative low body weight (and low blood volume), anemia, or exacerbation of underlying co-morbid conditions. HHS conducted a review of the most recent HIV, HBV, and HCV surveillance data in the United States as stratified by age group. Additionally, HHS engaged with relevant stakeholders during May- November 2021, to understand implications of policy changes on organ transplantation and organ utilization. In December 2021, findings from these analyses were presented to the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA). The committee considered whether a revision to the Guideline recommendation pertaining to pre- transplant testing of candidates

This action proposes special conditions for the Robinson Helicopter Company (RHC) Model R66 helicopter. This helicopter will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for normal category helicopters. This design feature is a pressure refueling system. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a meeting of the Massachusetts Advisory Committee to the Commission will convene by conference call on Tuesday, February 22, 2022, at 2:00 p.m. (ET). The purpose of the meeting is to discuss the next civil rights project.

The Food and Drug Administration (FDA or we) is classifying the system for detection of microorganisms and antimicrobial resistance using reporter expression into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the system for detection of microorganisms and antimicrobial resistance using reporter expression's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices.

This action deletes product(s) and service(s) from the Procurement List that were be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Comprehensive Child Welfare Information System (CCWIS) information collection (OMB #0970-0463, expiration 8/31/2022). The CCWIS information collection includes the Automated Function List and the Data Quality Plan. There are no required instruments associated with the data collection and no changes to the data collection.

The Food and Drug Administration (FDA) is announcing the issuance of three Emergency Use Authorizations (EUAs) (the Authorizations) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), for use during the COVID-19 pandemic. FDA has issued one Authorization for a biological product as requested by AstraZeneca Pharmaceuticals LP (AZ), one Authorization for a drug product as requested by Pfizer, Inc. (Pfizer), and one Authorization for a drug product as requested by Merck Sharp & Dohme Corp. (Merck). The Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV-2, causes the illness COVID- 19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorizations, which include an explanation of the reasons for issuance, are reprinted in this document.

The Coast Guard is proposing to establish a temporary security zone for certain waters of the Gastineau Channel. This action is necessary to protect personnel, vessels, and the marine environment from potential hazards created by a Navy diving excercise involving remotely operated vehicles (ROVs) and accompanying divers on these navigable waters between the Juneau-Douglas Bridge and Savikko Park near Juneau, AK from March 6, 2022, through March 17, 2022. This proposed rulemaking would prohibit persons and vessels from being in the security zone unless authorized by the Captain of the Port Southeast Alaska or a designated representative. We invite your comments on this proposed rulemaking.

Notice is hereby given that Heather E. Liwanag, Ph.D., 1 Grand Avenue, San Luis Obispo, CA 93407-0401, has withdrawn her application for a major amendment and has applied for a revised amendment to Scientific Research Permit No. 22187-02.

This notice announces the availability of EPA's interim registration review decisions for the following chemicals: Creosote; and chromated arsenicals and dichromic acid, disodium salt, dehydrate. In addition, it announces the final registration review decision for pentachlorophenol.

The Surface Transportation Board (Board) will hold a public hearing in this docket, consisting of two phases. The first phase, which will involve comments from the public, will commence on February 15, 2022, and will continue on February 16, 2022, if necessary. The second phase will be an evidentiary hearing commencing on March 9, 2022, and will be limited to the four parties to this casethe National Railroad Passenger Corporation (Amtrak), CSX Transportation, Inc. (CSXT), Norfolk Southern Railway Company (NSR), and the Alabama State Port Authority and its rail carrier division, the Terminal Railway Alabama State Docks (collectively, the Port; and with Amtrak, CSXT, and NSR, the ``Parties''). Immediately following the first phase, the Board will hold a conference with the Parties on February 16, 2022, to discuss issues related to the second phase.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $1,500,000, for Year 1 of funding to the National Lung Hospital (NLH)/National Tuberculosis Program (NTP). The award will support high quality TB, multi-drug resistant TB (MDR-TB), and TB/HIV programs to strengthen and expand TB and MDR-TB quality- assured diagnostic capacity (clinical and laboratory testing); promote TB, MDR-TB, and TB/HIV prevention and integration into existing healthcare services; strengthen TB surveillance and monitoring and evaluation (M&E) and improve collaboration and coordination between TB and other programs, particularly HIV and COVID-19. Funding amounts for years 2-5 will be set at continuation.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $800,000, for Year 1 of funding to Ghana Health Service (GHS). Funding amounts for years 2-5 will be set at continuation. The award will build laboratory and Strategic Information (SI) capacity to improve the provision of HIV testing, treatment, and retention in line with HIV epidemic control and 95-95-95 targets (95% of HIV-positive individuals knowing their status, 95% of those receiving ART [Antiretroviral therapy], and 95% of those achieving viral suppression).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $450,000 for Year 1 of funding to the Sierra Leone (SL) Ministry of Health and Sanitation. The award will build laboratory and Strategic Information (SI) capacity to improve the provision of HIV testing, treatment, and retention in line with HIV epidemic control and 95-95-95(95% of HIV-positive individuals knowing their status, 95% of those receiving ART [Antiretroviral therapy], and 95% of those achieving viral suppression) targets. Funding amounts for years 2-5 will be set at continuation.

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 the National School COVID-19 Prevention Study. This information collection request is designed to obtain data from a nationally representative sample of K-12 public schools in the United States to describe the prevalence of COVID-19 prevention strategies (e.g., mask use, physical distancing) that K-12 schools are implementing, including changes over time and differences by school-level characteristics and examine associations between school-level COVID-19 prevention strategies and COVID-19 transmission related outcomes in the school and larger community.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies to take this 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 the extension of an existing collection of information titled Assessment of Outcomes Associated with the Preventive Health and Health Services Block Grant. This assessment will assess select cross-cutting outputs and outcomes of the Preventive Health and Health Services Block Grant and demonstrate the utility of the grant on a national level.