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

This final rule advances CMS' efforts to streamline the Medicaid and Children's Health Insurance Program (CHIP) managed care regulatory framework and reflects a broader strategy to relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care. These revisions of the Medicaid and CHIP managed care regulations are intended to ensure that the regulatory framework is efficient and feasible for states to implement in a cost-effective manner and ensure that states can implement and operate Medicaid and CHIP managed care programs without undue administrative burdens.

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.

This notice announces Medicare's Hospital Insurance (Part A) premium for uninsured enrollees in calendar year 2021. This premium is paid by enrollees age 65 and over who are not otherwise eligible for benefits under Medicare Part A (hereafter known as the ``uninsured aged'') and by certain individuals with disabilities who have exhausted other entitlement. The monthly Part A premium for the 12 months beginning January 1, 2021 for these individuals will be $471. The premium for certain other individuals as described in this notice will be $259.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collections of information in the regulations for in vivo radiopharmaceuticals used for diagnosis and monitoring.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Malnutrition in Hospitalized Adults, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.

The final rules set forth requirements for group health plans and health insurance issuers in the individual and group markets to disclose cost-sharing information upon request to a participant, beneficiary, or enrollee (or his or her authorized representative), including an estimate of the individual's cost-sharing liability for covered items or services furnished by a particular provider. Under the final rules, plans and issuers are required to make this information available on an internet website and, if requested, in paper form, thereby allowing a participant, beneficiary, or enrollee (or his or her authorized representative) to obtain an estimate and understanding of the individual's out-of-pocket expenses and effectively shop for items and services. The final rules also require plans and issuers to disclose in-network provider negotiated rates, historical out-of- network allowed amounts, and drug pricing information through three machine-readable files posted on an internet website, thereby allowing the public to have access to health coverage information that can be used to understand health care pricing and potentially dampen the rise in health care spending. The Department of Health and Human Services (HHS) also finalizes amendments to its medical loss ratio (MLR) program rules to allow issuers offering group or individual health insurance coverage to receive credit in their MLR calculations for savings they share with enrollees that result from the enrollees shopping for, and receiving care from, lower-cost, higher-value providers.

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 we) is announcing the availability of a revised final guidance for industry entitled ``Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017,'' which supersedes the now withdrawn final guidance issued in May 2018 (May 2018 guidance). This revised final guidance concerns FDA's implementation of the Prescription Drug User Fee Amendments of 2017. In particular, this revised final guidance removes section VI.B. contained in the May 2018 guidance, regarding the ``same product as another product'' prescription drug program fee exception for certain prescription drug products under the Federal Food, Drug, and Cosmetic Act.

The United States Department of Health and Human Services (HHS) is proposing to issue regulations guiding implementation of the Buy Indian Act, which provides IHS with authority to set-aside procurement contracts for Indian-owned and controlled businesses.

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.

This notice announces the public meeting of the Advisory Council on Alzheimer's Research, Care, and Services (Advisory Council). The Advisory Council provides advice on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Advisory Council will next meet on Monday, November 9, and Tuesday, November 10. On November 9, federal representatives will provide updates on efforts to address Alzheimer's disease since January and a panel will present the results of two VA programs, STAR-VA and REACH-VA. On November 10, an invited panel will discuss past and current initiatives to expand access to long-term services and supports.

The Food and Drug Administration (FDA or we) is extending the comment period for the notification entitled ``Request for Information and Comments on Consumption of Certain Uncommon Produce Commodities in the United States'' that appeared in the Federal Register of August 10, 2020. We are taking this action in response to a request from stakeholders to extend the comment period to allow additional time for interested persons to develop and submit data, information, and/or comments for this Request for Information.

The Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR) is requesting a 3-year extension of the ACF form ORR-0135 State Plan for Grants to States for Refugee Resettlement (OMB #0970-0351, expiration 3/31/2021). ORR is proposing changes to the form.

HHS published a document on October 29, 2020, announcing a public hearing to receive information and views on the notice of proposed rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.'' The deadline to give oral notice of participation when there may be insufficient time to submit the required information in writing has changed from October 26, 2020, to November 5, 2020.

The National Heart, Lung and Blood Institute (NHLBI) and the National Human Genome Research Institute (NHGRI), both of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an exclusive patent license to Inversago Pharma Inc., located in Montreal, Quebec, Canada, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.

This interim final rule with request for comments (IFC) discusses CMS's implementation of section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which established Medicare Part B coverage and payment for Coronavirus Disease 2019 (COVID-19) vaccine and its administration. This IFC implements requirements in the CARES Act that providers of COVID-19 diagnostic tests make public their cash prices for those tests and establishes an enforcement scheme to enforce those requirements. This rule also establishes an add-on payment for cases involving the use of new COVID- 19 treatments under the Medicare Inpatient Prospective Payment System (IPPS). This IFC provides for separate payment for new COVID-19 treatments under the Outpatient Prospective Payment System (OPPS) for the remainder of the PHE for COVID-19 when these treatments are provided at the same time as a Comprehensive Ambulatory Payment Classification (C-APC) service. This rule also interprets and implements the requirement to maintain Medicaid beneficiary enrollment in order to receive the temporary increase in Federal funding in the Families First Coronavirus Response Act (FFCRA). This IFC modifies policies of the Comprehensive Care for Joint Replacement (CJR) model and adds technical changes to accommodate these policy changes. Specifically, we are extending Performance Year (PY) 5 by adding 6 months, creating an episode-based extreme and uncontrollable circumstances COVID-19 policy, providing two reconciliation periods for PY 5, and adding DRGs 521 and 522 for hip and knee procedures. This rule also amends regulations regarding coverage of preventive health services to implement section 3203 of the CARES Act, which shortens the timeframe within which non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance coverage must begin to cover without cost sharing qualifying coronavirus preventive services, including recommended COVID-19 immunizations. This IFC also revises regulations to set forth flexibilities in the public notice requirements and post award public participation requirements for State Innovation Waivers under section 1332 of the Patient Protection and Affordable Care Act (PPACA) during the public health emergency for COVID-19.

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.

As part of the work by the Federal Government to address the opioid crisis, the Food and Drug Administration (FDA or the Agency) is announcing the following public workshop entitled ``Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation Strategy Education Program on Prescribing Behaviors and Patient Outcomes Exploring the Path Forward for Assessment.'' The purpose of the public workshop is to obtain scientific input on methods to evaluate the Opioid Analgesics Risk Evaluation and Mitigation Strategy (OA REMS) education program. To assist in the workshop discussion, FDA is making available an issues paper that provides a brief overview of the REMS background and challenges with evaluating the REMS education intervention.

The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on a proposal to publish a summary of FDA's review of Risk Evaluation and Mitigation Strategy (REMS) assessments. The purpose of the docket establishment is to increase Agency transparency and promote exchange of information regarding the assessment of REMS programs.

In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC), announces the following meeting of Advisory Council for the Elimination of Tuberculosis (ACET). This meeting is open to the public, limited only by audio and web conference lines (1,000 audio and web conference lines are available). The public may join by accessing the meeting information below. Time will be available for oral public comment.

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces a framework for a phased resumption of cruise ship passenger operations. CDC also announces requirements for the initial phases of this framework regarding testing of crew members for COVID-19, an integral part of the initial phases prior to resuming passenger operations. This Order applies to cruise ship operators with cruise ships operating in U.S. waters and cruise ship operators who are operating cruise ships outside of U.S. waters, but intend for their cruise ships to return to operating in U.S. waters while this Order remains in effect.

This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from July through September 2020, relating to the Medicare and Medicaid programs and other programs administered by CMS.

On March 13, 2020, the President declared a national emergency in response to the public health emergency (PHE) caused by the SARS- CoV-2 virus, otherwise known as COVID-19. The CARES Act was published in response to the PHE that requires ``every laboratory that performs or analyzes a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 shall report the results from each such test.'' The September 2, 2020 interim final rule with comment (CMS- 3401-IFC) requires laboratories to report SARS-CoV-2 test results in a manner and frequency specified by the Secretary. Consistent with the CARES Act laboratory reporting requirements, CMS made modifications to the CLIA regulations to meet the SARS-CoV-2 test result reporting provisions related to the Secretary's Public Health Emergency declaration with respect to COVID-19.

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 (PRA).

The Office of the Assistant Secretary for Health published a document in the Federal Register on October 6, 2020 seeking nominations of non-federal public individuals who represent diverse scientific disciplines and views and are interested in being considered for appointment to the Tick-Borne Disease Working Group (TBDWG). Due to requests to extend the nomination period, this document is announcing a 30-day extension. The October 6 notice can be accessed at https:// www.govinfo.gov/content/pkg/FR-2020-10-06/pdf/2020-22062.pdf.

The Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to extend approval for data collection using the current Refugee Data Submission System for Formula Funds Allocations (ORR-5) until January 31, 2021, and revise the current form for use after Fiscal Year (FY) 2020. The revised form will collect additional client-level data.

This final rule updates the home health prospective payment system (HH PPS) payment rates and wage index for calendar year (CY) 2021. This final rule also implements the changes to the home health regulations regarding the use of telecommunications technology in providing services under the Medicare home health benefit as described in the ``Medicare and Medicaid Programs, Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency'' interim final rule with comment period (March 2020 COVID-19 IFC). In addition, this rule implements the permanent home infusion therapy services benefit and supplier enrollment requirements for CY 2021 and finalizes conforming regulations text changes excluding home infusion therapy services from coverage under the Medicare home health benefit. This rule also finalizes a policy to align the Home Health Value-Based Purchasing (HHVBP) Model data submission requirements with any exceptions or extensions granted for purposes of the Home Health Quality Reporting Program (HH QRP) during the COVID-19 PHE and also finalizes a policy for granting exceptions to the New Measures data reporting requirements during the COVID-19 PHE, as described in the ``Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program'' interim final rule with comment period (May 2020 COVID-19 IFC).

HRSA is publishing an updated monetary amount of the average cost of a health insurance policy as it relates to the National Vaccine Injury Compensation Program (VICP).

The Administration for Children and Families (ACF) proposes to extend data collection under the existing overarching generic clearance for Formative Data Collections for ACF Research and Evaluation (OMB #0970-0356). There are no changes to the proposed types of information collection or uses of data, but the request does include an increase to the estimated number of respondents and, therefore, the overall burden estimate.

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 National HIV Prevention Program Monitoring and Evaluation (NHM&E). NHM&E collects standardized HIV prevention program evaluation data from health departments and community-based organizations (CBOs) who receive federal funds for HIV prevention activities.

In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Institutes of Health (NIH) Office of Intramural Training & Education (OITE) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 existing information collection project titled The Childcare Survey of Activity and Wellness (C-SAW) Pilot Study. The pilot study will determine the current practices and policies of early care and education (ECE) providers in four states around nutrition, physical activity, and wellness and will inform the development of a potential national surveillance system.

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.

NIOSH gives notice of a decision to evaluate a petition to designate a class of employees from the Pinellas Plant in Clearwater, Florida, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 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 Administration for Children and Families' (ACF) Office of Child Support Enforcement (OCSE) is requesting a 3-year extension of the currently approved Multistate Financial Institution Data Match with Federally Assisted State Transmitted Levy (MSFIDM/FAST Levy) (current OMB approval expires 1/31/2021).

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Nonclinical Testing of Orally Inhaled Nicotine-Containing Drug Products.'' The document provides guidance about the nonclinical information FDA recommends to support development and approval of orally inhaled nicotine-containing drug products, including electronic nicotine delivery systems intended for smoking cessation and related chronic indications. This guidance finalizes the draft guidance of the same name issued August 6, 2018.

This document announces a public hearing to receive information and views on the Notice of Proposed Rulemaking (NPRM) entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table.''

In accordance with regulations prescribed by the Office of Personnel Management, one or more Senior Executive Service (SES) Performance Review Boards (PRBs). The PRB shall review and evaluate the initial summary rating of a senior executive's performance, the executive's response, and the higher-level official's comments on the initial summary rating. In addition, the PRB will review and recommend executive performance bonuses and pay increases.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Referencing Approved Drug Products in Abbreviated New Drug Application Submissions.'' Any person is permitted to submit an abbreviated new drug application (ANDA) in order to seek approval to market a generic version of a previously approved drug product. The purpose of this guidance is to provide information to potential applicants on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an ANDA submission.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Necessary Automated External Defibrillator Accessories: Policy Regarding Compliance Date.'' FDA is issuing this guidance to revise its compliance policy regarding the deadline for filing premarket approval (PMA) applications for previously cleared accessories necessary to the operation of automated external defibrillator (AED) systems.

The Food and Drug Administration (FDA or the Agency) is announcing the following virtual public meeting entitled ``The Drug Supply Chain Security Act Pilot Project Program and Enhanced Drug Distribution Security.'' The purpose of the public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to discuss with FDA and provide input on strategies and issues related to the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) and the results of FDA's DSCSA Pilot Project Program.

The Centers for Disease Control and Prevention (CDC) is soliciting nominations for membership on the LEPAC. The LEPAC consists of 15 Federal and non-Federal experts in fields associated with lead screening, the prevention of lead exposure, and services for individuals and communities affected by lead exposure. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishment of the committee's objectives. Nominees will be selected based on expertise in the fields of epidemiology, toxicology, mental health, pediatrics, early childhood education, special education, diet and nutrition, and environmental health. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of LEPAC objectives.

The Department of Health and Human Services is hereby giving notice that the charter for the Secretary's Advisory Committee on Human Research Protection (SACHRP) has been renewed.

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 chapters and the template for the 2020 report to the HHS Secretary and Congress. 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.

The National Institutes of Health (NIH) Sexual & Gender Minority Research Office (SGMRO) will be holding its second annual listening session with Sexual & Gender Minority (SGM)-focused organizations. The primary objective of the NIH's listening session is to hear from community stakeholders about what issues are on their minds regarding SGM-related research and related activities at NIH. The goal is to hold an annual listening session every year, to provide different SGM focused organizations an opportunity to speak.

In compliance with the requirement of 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 Food and Drug Administration (FDA, the Agency, or we) is seeking requests for participation from members of the public, including owners of third-party human food safety standards, interested in participating in a voluntary pilot program to evaluate third-party food safety standards. On July 13, 2020, FDA announced the New Era of Smarter Food Safety Blueprint and the desire to explore the increased use of reliable third-party audits to help ensure safer food, including exploring the use of reliable audit data in risk-prioritization for FDA regulatory activities, for example, with respect to inspections of both imported and domestically produced foods. Under the pilot program, FDA will assess third-party food safety standards for alignment with certain FDA food safety regulations. Knowing that these third-party standards align with certain FDA food safety regulations would give those relying on audits conducted to those standards confidence that they are meeting certain FDA requirements for supplier verification audits. The pilot will enable FDA to gain information and experience that will allow the Agency to evaluate the resources and tools required to conduct alignment reviews.

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.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Phillip R. Carawan for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Carawan was convicted, as defined in the FD&C Act, of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Carawan was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of June 13, 2020 (30 days after receipt of the notice), Mr. Carawan has not responded. Mr. Carawan's failure to respond and request a hearing constitutes a waiver of Mr. Carawan's right to a hearing concerning this matter.

The Administration for Community Living 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 the Information Collection tools for information collection requirements related to Alzheimer's and Dementia Program Data Reporting Tool (ADP-DRT).

The Administration for Community Living 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 the proposed information collection requirements related to the State Health Insurance Assistance Program Annual Sub-Recipients Report.

This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. This meeting is by webcast only and is open to the public. Written comments will be accepted and registration is required to present oral comments. Information about the meeting and registration are available at https://ntp.niehs.nih.gov/go/165.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 69th full Council meeting utilizing virtual technology. PACHA members will be discussing HIV, the Ending the HIV Epidemic: A Plan for America (EHE) initiative, and the novel coronavirus (COVID- 19). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required to provide public comment. To pre-register to attend or to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business Friday November 20, 2020. If you decide you would like to provide public comment but do not pre- register, you may submit your written statement by emailing PACHA@hhs.gov by close of business Thursday, December 10, 2020. The meeting agenda will be posted on the PACHA page on HIV.gov at https:// www.hiv.gov/ federal-response/pacha/about-pacha prior to the meeting.

The National Eye 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 certain of the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to Connectyx Technologies Holdings Group located in Boca Raton, Florida.

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 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 draft guidance for industry entitled ``Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.'' Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and Biologics, are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on postmarketing requirements (PMRs) and postmarketing commitments (PMCs) in a consistent format. Forms FDA 3988 and 3989 are published in draft form in Appendix A and B of the draft guidance for comment and are not intended to be used until the forms are finalized. The forms were developed, in part, in response to the recommendations from the Government Accountability Office (GAO) and the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) regarding the need for comparable information across annual status reports (ASRs) on PMRs and PMCs, to eliminate manual data entry, and to enhance FDA's ability to track PMRs and PMCs. These forms are expected to result in improved accuracy and timeliness of FDA's identification and review of those submissions containing information on PMRs and PMCs. This draft guidance covers the purpose of each form, when to use these forms, and how to submit these forms. The draft guidance also explains where applicants will be able to find the forms and instructions for their completion once the forms and instructions are finalized.

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 Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. This Generic Information Collection enables the CDC to garner customer and stakeholder feedback on service delivery through routine surveys, focus groups, usability testing, and customer comment cards.