Department of Health and Human Services March 2021 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``FY 2021 Generic Drug Science and Research Initiatives Workshop.'' The purpose of the public workshop is to provide an overview of the status of science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA is seeking this input from a variety of stakeholdersindustry, academia, patient advocates, professional societies, and other interested partiesas it fulfills its commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its Fiscal Year (FY) 2022 GDUFA science and research initiatives.

The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.

The Food and Drug Administration (FDA or Agency) is publishing a list of premarket approval applications (PMAs) that have been approved from October 1, 2018, through December 31, 2020. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.

The Administration for Children and Families (ACF) is requesting a 3-year extension of the form ACF-696T: Child Care and Development Fund Annual Financial Report. This form is currently approved under the ACF Generic Clearance for Financial Reports (OMB #0970-0510; expiration May 31, 2021), and ACF is proposing to reinstate the previous OMB number under which this form had been approved. There are no changes requested to the form.

This final rule implements a further delay until July 20, 2021, of the effective date of the rule entitled ``Implementation of Executive Order on Access to Affordable Life-saving Medications'' published in the Federal Register on December 23, 2020. This rule was scheduled to take effect on March 22, 2021, after a delay from its original effective date of January 22, 2021. HHS is delaying the effective date of the rule to July 20, 2021, to ensure that implementation of the rule does not impede HHS's and health centers' immediate priority work, on a nationwide basis, of responding to and mitigating the spread of COVID-19, including ensuring widespread and equitable access to COVID-19 vaccines, and maintaining the delivery of comprehensive primary health services to medically underserved populations, while considering how to address administrative/ implementation issues raised by commenters and further address comments regarding the impact of the rule.

The Department of Health and Human Services (HHS or Department) is postponing, pending judicial review, the effective date of a final rule entitled ``Securing Updated and Necessary Statutory Evaluations Timely'' (SUNSET final rule) and published in the Federal Register of January 19, 2021. This document also corrects certain errors in the SUNSET final rule.

This document corrects an error that appeared in the notice published in the August 16, 2018, Federal Register entitled ``Opportunity to Co-Sponsor Office of Research Integrity Workshops.'' The document contained an incorrect suite number in the address of the Office of Research Integrity.

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau has a legislative requirement to collect and maintain client statistical records on the numbers and the characteristics of runaway and homeless youth, and youth at risk of family separation, who receive shelter and supportive services through the Runaway and Homeless Youth (RHY) Program funding. RHY data collection is integrated with the U.S. Department of Housing and Urban Development's (HUD) Homeless Management Information System (HMIS).

The subcommittees listed below are part of AHRQ's Health Services Research Initial Review Group Committee. Grant applications are to be reviewed and discussed at these meetings. Each subcommittee meeting will be closed to the public.

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.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the HICPAC. The HICPAC consists of 14 experts in fields including but not limited to, infectious diseases, infection prevention, healthcare epidemiology, nursing, clinical microbiology, surgery, hospitalist medicine, internal medicine, epidemiology, health policy, health services research, public health, and related medical fields. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of infectious diseases, infection prevention, healthcare epidemiology, nursing, environmental and clinical microbiology, surgery, internal medicine, and public health. Federal employees will not be considered for membership. Members may be invited to serve for four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of HICPAC objectives https:// www.cdc.gov/hicpac/.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Advisory Council for the Elimination of Tuberculosis (ACET), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through March 15, 2023.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), seeks approval of a standardized request form to collect information from state and tribal title IV-D child support agencies requesting administrative flexibilities under the Robert T. Stafford Disaster Relief and Emergency Assistance Act, (the ``Stafford Act''), due to the COVID-19 pandemic.

The Administration for Children and Families (ACF) is requesting reinstatement of the Low Income Home Energy Assistance Program (LIHEAP) Performance Measures (Office of Management and Budget (OMB) #0970-0449, expiration date March 31, 2021) with changes. Changes include a single addition of a field to capture a potential additional source of funding, and other minor changes to the most recent version of this form.

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 and Monitoring of Breastfeeding-Related Maternity Care Practices in Intrapartum Care Facilities in the United States and Territories. The Maternity Practices in Infant Nutrition and Care (mPINC) survey is a census of maternity care hospitals in the United States and territories, that CDC has administered nearly every two years since 2007 in order to monitor and examine changes in breastfeeding-related maternity care over time.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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.