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

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.

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

The Food and Drug Administration (FDA, Agency, or we) is classifying the alternate controller enabled infusion pump 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 alternate controller enabled infusion pump'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.

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 Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $500,000 for Year 1 of funding to the Programme National de Lutte contre le VIH/SIDA (PNLS). The award will strengthen Strategic Information (SI) activities, laboratory quality assurance services, and surveillance of new infections in Democratic Republic of Congo (DRC). This support will enhance the antiretroviral therapy (ART) cohort monitoring and delivery of HIV/AIDS services for the epidemic control in DRC. 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 2022 Racial and Ethnic Approaches to Community Health (REACH) Lark Galloway-Gilliam for Advancing Health Equity Award Challenge (REACH Lark Award Challenge). This biennial challenge was established in 2019 to recognize extraordinary individuals, organizations, or community coalitions associated with the REACH program whose work has contributed to the implementation of culturally tailored interventions that advance health equity, reduce health disparities, and increase community engagement to address preventable risk factors (e.g., tobacco use, poor nutrition, physical inactivity, and inadequate access to clinical services).

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the award of approximately $10,000,000 for Year 1 of funding to the Ministerio de Salud de la Rep[uacute]blica de Panam[aacute] {MINSA{time} . The award will contribute to the achievement of 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) in Panama by introducing or scaling up high-impact HIV prevention, testing, linkage, and treatment models across the continuum of care and strengthening HIV laboratory and information systems. 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 Leptospirosis and Melioidosis Active Hospital-based Surveillance in Puerto Rico. The project aims to identify leptospirosis and melioidosis cases in Puerto Rico by establishing active surveillance for both diseases at four hospital sites for disease identification and treatment and to improve understanding of leptospirosis and melioidosis epidemiology and ecology in Puerto Rico for public health control and prevention planning.

The Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services seeks approval to collect information about how Head Start programs coordinate family support services. Information will be collected from Head Start staff members via surveys and focus groups.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the U.S. Repatriation Program forms (OMB #0970-0474, expiration 4/30/2022). There are several changes requested to the eight forms. Burden estimates have also been updated.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Assessment of Pressor Effects of Drugs.'' This draft guidance is intended to advise sponsors on the premarketing assessment of a drug's effect on blood pressure. Elevated blood pressure is known to increase the risk of stroke, heart attack, and death. The effect of a drug on blood pressure is, therefore, an important consideration in risk assessment and product labeling. This draft guidance revises the draft guidance for industry ``Assessment of Pressor Effects of Drugs'' issued on May 31, 2018.

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 (the 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 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates 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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a 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 via Zoom and teleconference; 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 at the meeting via Zoom/teleconference. Individuals who wish to send in their written public comment should send an email to CARB@hhs.gov. Registration information is available on the website https://www.hhs.gov/paccarb and must be completed by February 25, 2022 for the March 2, 2022 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.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 29 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of eight abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.