Department of Health and Human Services 2020 – Federal Register Recent Federal Regulation Documents

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 Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This guidance revises the guidance by the same title issued November 5, 2018, and describes FDA's intention with respect to the enforcement of unique device identification (UDI) requirements for class I and unclassified devices, other than implantable, life-sustaining, or life- supporting (I/LS/LS) devices. In this revised guidance, FDA clarifies that, at this time, in light of the considerations described in the guidance, it does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2022. The guidance is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.

The National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. Due to the coronavirus pandemic the NCI is providing an extension of the previously published notice in the Federal Register on March 11, 2020 to allow candidate more time to submit LOIs. NCI-ComboMATCH trial leadership invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next-Generation Sequencing (NGS) assays to participate in the NCI-ComboMATCH trial. In order to support this trial, the designated laboratories participating in NCI-ComboMATCH will identify patients for the specific variants needed for trial eligibility. Laboratories will be required to contact any of the NCTN sites that have activated NCI-ComboMATCH if a specimen sent from one of these sites has a variant(s) that would potentially make the patient eligible for one of the treatment arms.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

This proposed rule would update the home health prospective payment system (HH PPS) payment rates and wage index for calendar year (CY) 2021. This proposed rule also proposes to make permanent the changes to the home health regulations regarding the use of technology in providing services under the Medicare home health benefit as described in the Medicare and Medicaid Programs; Revisions in Response to the COVID-19 Public Health Emergency interim final rule with comment period. This proposed rule also proposes to remove provisions related to test transmission of OASIS data by a new HHA, because the provision is now obsolete due to changes in our data submission system. This proposed rule discusses policies finalized in the CY 2020 HH PPS final rule with comment period regarding the permanent home infusion therapy services benefit for CY 2021, and proposes conforming regulations text changes excluding home infusion therapy services from coverage under the Medicare home health benefit. Additionally, this proposed rule discusses Medicare enrollment policies for qualified home infusion therapy suppliers.

The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on specific questions pertaining to the use of codeine for analgesia in children under 12 years of age, and the use of cytochrome P450 2D6 (CYP2D6) testing in children under 12 years of age prior to treatment with codeine-containing analgesics. These questions are posed in section II.

The Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) seeks an update to the existing data collection for the Annual Survey of Refugees. The Annual Survey of Refugees is a yearly sample survey of refugee households entering the U.S. in the previous five fiscal years. The requested update is based upon results of a multi-year effort in instrument redesign and field testing. ACF estimates the proposed changes will increase response burden from 30 to 48 minutes per respondent.

The Children's Bureau (CB), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new descriptive studythe Cost Study of Trauma-Specific Evidence-Based Programs used in the Regional Partnership Grants (RPG) Program.

The Administration for Children and Families (ACF), within the U.S. Department of Health and Human Services (HHS), is proposing to collect data on the child welfare workforce as part of the third cohort of children and families for the National Survey of Child and Adolescent Well-Being (NSCAW III). Previous and current data collections for NSCAW have been approved by OMB under OMB #0970-0202. This request is for additional data collection.

The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID-19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID-19-related guidances. The guidances identified in this notice address issues related to the COVID-19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidance documents have been implemented without prior comment, but they remain subject to comment in accordance with the Agency's good guidance practices.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has 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 Administration for Children and Families (ACF) within the U.S. Department of Health and Human Services (HHS) is proposing to collect data on child welfare agencies' efforts to identify human trafficking and subsequent service delivery. The goal of the study is to better understand child welfare practice in screening for human trafficking, and the degree to which screening is related to subsequent referrals for, access to, and delivery of specialized services for children identified as trafficking victims or at high-risk of trafficking.

The Food and Drug Administration (FDA, the Agency, or we) is hosting a virtual public meeting entitled ``Generic Drug User Fee Amendments (GDUFA) of 2017.'' At the end of September 2022, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that before FDA begins negotiations with the regulated industry on GDUFA reauthorization, we publish a notice in the Federal Register requesting public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, including specific suggestions for changes to the goals referred to in the GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2018-2022 (i.e., the GDUFA II Commitment Letter), provide a period of 30 days after the public meeting to obtain written comments from the public, and publish the comments on FDA's website. FDA invites public comment on the GDUFA program and suggestions regarding the features FDA should propose for the next GDUFA program cycle. These comments will be published and available on FDA's website.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Community- Acquired Bacterial Pneumonia: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of antibacterial drugs for the treatment of community- acquired bacterial pneumonia (CABP) based on comments that were received and current recommendations. This guidance finalizes the draft guidance of the same title issued on January 10, 2014.

This notice announces the next meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM). SACATM is a federally chartered external advisory group of scientists from the public and private sectors, including representatives of regulated industry and national animal protection organizations. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the National Institute of Environmental Health Sciences (NIEHS) and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM. This SACATM meeting will be held by webcast only and available to the public for remote viewing. Registration is required to access the webcast and to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/32822.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 12 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.

The Food and Drug Administration (FDA or Agency) has determined that TENEX (guanfacine hydrochloride) tablets, 1 milligram (mg), 2 mg, and 3 mg, was 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 this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to the Proposed Revision and solicits comments on the information collection requirements related to the National Beneficiary Survey of State Health Insurance Assistance Program (SHIP) OMB# 0985-0057.

The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under section 506(c)(2)(A) of the Paperwork Reduction Act of 1995. This 30-Day notice collects comments on the information collection requirements related to Proposed new information collection requirements related to Evaluation of participants of an Annual SMP/SHIP National Training Conference hosted by the Office of Healthcare Information and Counseling.

The National Healthcare Preparedness Programs (NHPP) Branch of the Office of the Assistant Secretary for Preparedness and Response (ASPR), in the Department of Health and Human Services intends to provide a Single Source Cooperative Agreement to the American Red Cross. The Cooperative Agreement will support the stability of the American Red Cross blood operations and humanitarian services during the COVID-19 pandemic. The total proposed cost of the Single Source Cooperative Agreement is not to exceed $118,000,000 for a total of 12 months.

The Administration for Children and Families (ACF) in the U.S. Department of Health and Human Services (HHS) is requesting a 3-year extension of the National Child Abuse and Neglect Data System (NCANDS) collection (OMB #0970-0424, expiration 02/28/2021). There are no changes requested to this data collection.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of February 12, 2019. The document announced the withdrawal of approval of 12 abbreviated new drug applications (ANDAs) from multiple applicants. The document erroneously included ANDA 077736 for Polyethylene Glycol 3350 Powder for Oral Solution, 17 grams/scoopful, held by Breckenridge Pharmaceutical, Inc. (Breckenridge). This document corrects that error.

HRSA announces the award of a supplemental award of approximately $330,000 per year to the Education Development Center (EDC) for the Home Visiting Collaborative Improvement and Innovation Network 2.0 (HV CoIIN 2.0) for fiscal years (FY) 2020, 2021 and 2022. The supplement will allow the recipient to build a continuous quality improvement (CQI) health equity framework for the Maternal, Infant and Early Childhood Home Visiting Program (MIECHV).

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Emmaus Medical Inc. located in 21250 Hawthorne Boulevard, Suite 800, Torrance, CA, 90503.

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.

On May 1, 2020, the National Institute for Occupational Safety and Health (NIOSH), within the Center for Disease Control and Prevention (CDC), opened a docket to obtain public input on the following draft documents: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List), and (3) Managing Hazardous Drug Exposures: Information for Healthcare Settings. Comments were to be received by June 30, 2020. NIOSH is extending the comment period to close on July 30, 2020, to allow stakeholders and other interested parties additional time to respond.

This proposed rule would advance CMS' efforts to support state flexibility to enter into innovative value-based purchasing arrangements (VBPs) with manufacturers, and to provide manufacturers with regulatory support to enter into VBPs with payers, including Medicaid. To ensure that the regulatory framework is sufficient to support such arrangements and to promote transparency, flexibility, and innovation in drug pricing without undue administrative burden, we are proposing new regulatory policies and clarifying certain already established policies to assist manufacturers and states in participating in VBPs in a manner that is consistent with the law and maintains the integrity of the Medicaid Drug Rebate Program (MDRP). This proposed rule also proposes revisions to regulations regarding: Authorized generic sales when manufacturers calculate average manufacturer price (AMP); pharmacy benefit managers (PBM) accumulator programs and their impact on AMP and best price; state and manufacturer reporting requirements to the MDRP; new Medicaid Drug Utilization Review (DUR) provisions designed to reduce opioid related fraud, misuse and abuse; the definitions of CMS-authorized supplemental rebate agreement, line extension, new formulation, oral solid dosage form, single source drug, multiple source drug, innovator multiple source drug for purposes of the MDRP; payments for prescription drugs under the Medicaid program; and coordination of benefits (COB) and third party liability (TPL) rules related to the special treatment of certain types of care and payment in Medicaid and Children's Health Insurance Program (CHIP).

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this Notice to Ziopharm Oncology, Inc. (``Ziopharm''), headquartered in Boston, MA.

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 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 (PRA).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Revised Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry.'' The revised guidance provides blood establishments that collect blood and blood components with FDA's recommendations to reduce the risk of transfusion-transmitted malaria. The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk. The guidance announced in this notice supersedes the guidance entitled ``Recommendations for Donor Questioning, Deferral, Reentry, and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria; Guidance for Industry'' dated August 2013 and updated August 2014.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products; Guidance for Industry.'' The revised guidance provides blood establishments that collect blood or blood components, including Source Plasma, with FDA's revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. FDA is also recommending that these blood establishments make corresponding revisions to their donor educational materials, donor history questionnaires, and accompanying materials, along with revisions to donor requalification and product management procedures. The guidance also incorporates certain other recommendations related to donor educational materials. The guidance announced in this notice supersedes the guidance of the same title dated December 2015.

The Food and Drug Administration (FDA or the Agency) is requesting nominations for members to serve on the Pharmacy Compounding Advisory Committee (the Committee), Division of Advisory Committee and Consultant Management, Center for Drug Evaluation and Research. The Committee provides advice on scientific, technical, and medical issues concerning human drug compounding under the Federal Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other product for which FDA has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs.

The U.S. Department of Health and Human Services (HHS) is hereby giving notice that the charter for the President's Council on Sports, Fitness, and Nutrition (hereafter referred to as the Council) has been renewed.

The Administration for Children and Families (ACF) is requesting a 3-year extension of form ACF-123: Guidance for Tribal Temporary Assistance for Needy Families (TANF) (OMB #0970-0157, expiration date: 6/30/2020). There are minor clarifying changes requested to the guidance.

This notice informs the public of the availability of the complete lists of all geographic areas, population groups, and facilities designated as primary medical care, mental health, and dental health professional shortage areas (HPSAs) as of May 1, 2020. The lists are available on HRSA's HPSAFind website.

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 ``Evaluation of Enhancing HIV Prevention Communication and Mobilization Efforts through Strategic Partnerships.'' This collection is designed to assess the extent to which partnership activities meet the overarching goals for dissemination, communication, and implementation of national engagement efforts in support of the U.S. Department of Health and Human Services' Ending the HIV Epidemic.

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 the CDC's National Healthcare Safety Network (NHSN). NHSN is a public health surveillance system that collects, analyzes, reports, and makes available data for monitoring, measuring, and responding to healthcare associated infections (HAIs), antimicrobial use and resistance, blood transfusion safety events, and the extent to which healthcare facilities adhere to infection prevention practices and antimicrobial stewardship.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``AHRQ Managing Unhealthy Alcohol Use in Primary Care Initiative.'' This proposed information collection was previously published in the Federal Register on March 30, 2020 and allowed 60 days for public comment. AHRQ did not receive any comments during the aforementioned public comment period. The purpose of this notice is to allow an additional 30 days for public comment.

In compliance with the requirement for opportunity for public comment on proposed data collection projects, the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This is to notify the public that the July 29-30, 2020, and November 4-5, 2020, meetings of the National Advisory Council on Migrant Health (NACMH) are canceled.

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 Administration for Children and Families' (ACF) Administration for Native Americans (ANA) is requesting a revision to the information collection: Ongoing Progress Report (OPR) and the Objective Work Plan (OWP) (OMB #0970-0452). Changes are proposed to reduce the burden on the public by combining ANA's Annual Data Report (OMB #0970-0475) with the OPR.

This notice announces a virtual public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, July 22, 2020. This meeting will focus on the home use of noninvasive positive pressure ventilation in patients with chronic respiratory failure (CRF) consequent to chronic obstructive pulmonary disease (COPD). We are seeking the MEDCAC's recommendations regarding the characteristics that define those patient selection and usage criteria, concomitant services, and equipment parameters necessary to best achieve positive patient health outcomes in beneficiaries with CRF consequent to COPD. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This notice announces the next meeting of the APOE (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of consumer education strategies concerning the Health Insurance Marketplace, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Voluntary Customer Survey Generic Clearance for the Agency for Healthcare Research and Quality.''

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Generic Clearance for Questionnaire and Data Collection Testing, Evaluation, and Research for the Agency for Healthcare Research and Quality.''

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: ``Evaluation of Learning Health Systems K12 Training Program.'' This proposed information collection was previously published in the Federal Register on March 12, 2020, and allowed 60 days for public comment. No comments were received from the public during this period. The purpose of this notice is to allow an additional 30 days for public comment.

As required by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the Tick-Borne Disease Working Group (TBDWG) will hold a virtual meeting. The meeting will be open to the public. For this meeting, the TBDWG will review the draft 2020 report to the HHS Secretary and Congress and review and approve graphics and images for the report. The 2020 report will address ongoing tick-borne disease research, including research related to causes, prevention, treatment, surveillance, diagnosis, diagnostics, and interventions for individuals with tick- borne diseases; advances made pursuant to such research; federal activities related to tick-borne diseases; and gaps in tick-borne disease research.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.