Department of Health and Human Services February 4, 2022 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is announcing the withdrawal of the proposed rule ``Removal of Certain Requirements Related to the Prescription Drug Marketing Act; Opportunity for Public Comment,'' published in the Federal Register on July 14, 2011. FDA is taking this action because the proposed changes are duplicative of another FDA proposed rulemaking, which is also being published in this issue of the Federal Register, that is intended to conform with newly established definitions and requirements set out by the Drug Supply Chain Security Act of 2013 (DSCSA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Drug Product Tracing: The Effect of Section 585 of the FD&C ActQuestions and Answers.'' FDA is issuing this guidance to assist industry and State and local governments in understanding the effects of the uniform national policy set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) that was added by the Drug Supply Chain Security Act, which was enacted on November 27, 2013. This guidance is intended to help industry and States understand the law as it is currently in effect and clarify its effect on State product tracing. This guidance finalizes the draft guidance entitled ``The Effect of Uniform National Policy on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Standards: Questions and Answers'' issued on October 8, 2014.

The Children's Bureau, Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect additional data for an evaluation of the services provided to child welfare jurisdictions and Court Improvement Programs (CIPs) by the Child Welfare Capacity Building Collaborative. This new data collection is the second part of a data collection effort already underway (OMB #0970-0576, expiration 9/30/2024). This notice details the second group of instruments that will be used for data collection as part of this evaluation.

The Food and Drug Administration (FDA, Agency, or we) is classifying the photoplethysmograph analysis software for over-the- counter use 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 photoplethysmograph analysis software for over-the-counter use'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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Population Pharmacokinetics.'' This guidance assists sponsors in the application of population pharmacokinetics (population PK) during the drug development process to inform drug use and includes FDA's current thinking on the data and model requirements for population PK analyses submitted as part of new drug applications (NDAs), biologic license applications (BLAs), and abbreviated new drug applications (ANDAs). This guidance also provides expectations regarding the format and content of the population PK report, as well as any labeling recommendations resulting from such analyses. This guidance finalizes the draft guidance of the same title issued on July 12, 2019.

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.