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

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.

The Administration for Children and Families (ACF) proposes to extend data collection under the existing overarching generic clearance for Financial Reports used for ACF Mandatory Grant Programs (OMB #0970- 0510). There are no changes to the proposed types of information collection or uses of data.

The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new wave of the Head Start Family and Child Experiences Survey (FACES).

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.

This document corrects technical errors in the final rule that appeared in the December 28, 2020, Federal Register entitled, ``Medicare Program; CY 2021 Payment Policies under the Physician Fee Schedule and Other Changes to Part B Payment Policies; Medicare Shared Savings Program Requirements; Medicaid Promoting Interoperability Program Requirements for Eligible Professionals; Quality Payment Program; Coverage of Opioid Use Disorder Services Furnished by Opioid Treatment Programs; Medicare Enrollment of Opioid Treatment Programs; Electronic Prescribing for Controlled Substances for a Covered Part D Drug; Payment for Office/Outpatient Evaluation and Management Services; Hospital IQR Program; Establish New Code Categories; Medicare Diabetes Prevention Program (MDPP) Expanded Model Emergency Policy; Coding and Payment for Virtual Check-in Services Interim Final Rule Policy; Coding and Payment for Personal Protective Equipment (PPE) Interim Final Rule Policy; Regulatory Revisions in Response to the Public Health Emergency (PHE) for COVID-19; and Finalization of Certain Provisions from the March 31st, May 8th and September 2nd Interim Final Rules in Response to the PHE for COVID-19'' (hereinafter referred to as the CY 2021 PFS final rule).

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) (the Secretary) 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[supreg], Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open 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.

HHS proposes rescinding the final rule entitled ``National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table,'' published in the Federal Register on January 21, 2021. That final rule, if it were to go into effect, would amend our regulations by removing Shoulder Injury Related to Vaccine Administration (SIRVA), vasovagal syncope, and the new vaccines category (Item XVII) from the Vaccine Injury Table (Table). HHS seeks comments on this proposed rescission.

The Office of Family Assistance (OFA), Administration for Children and Families, is requesting a 3-year extension of the form ACF-4125: Annual Report on Children in Foster Homes and Children in Families Receiving Payment in Excess of the Poverty Income Level from a State Program Funded Under Part A of Title IV of the Social Security Act (OMB #0970-0004, expiration 3/21/2021). There are no changes requested to the form.

The Administration for Children and Families (ACF) is requesting a revision to the Social Services Block Grant (SSBG) Post- Expenditure Report, Pre-Expenditure Report, and Intended Use Plan (OMB #0970-0234, previously titled, ``Social Services Block Grant (SSBG) Post-Expenditure Report''). ACF is proposing to expand the information collection to include the collection of states' Intended Use Plans and retitle the information collection to clarify the role of the Pre- Expenditure Report.

The Food and Drug Administration (FDA or Agency) has determined the regulatory review period for OCS LUNG SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Potential Medication Error Risks with Investigational Drug Container Labels.'' This public meeting is being convened and supported by a partnership between the Reagan-Udall Foundation and FDA. The purpose of the public meeting is to solicit input from stakeholders (e.g., sponsors, clinical sites, entities that supply or otherwise label investigational drugs) on the risk of medication errors potentially related to the content and format of information on investigational drug container labels, the prevalence and nature of such errors, and to gather information on practices that minimize the potential for medication errors.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 19 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.

In compliance with the Paperwork Reduction Act of 1995, HRSA 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 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 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 ``Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types.''

The Food and Drug Administration (FDA or Agency) is reopening the comment period for the notice entitled ``Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of December 9, 2020. The Agency is taking this action to allow interested persons additional time to submit comments.

The Agency for Healthcare Research and Quality published a document in the Federal Register of March 5, 2021, concerning request for information on the Use of Clinical Algorithms That Have the Potential To Introduce Racial/Ethnic Bias Into Healthcare Delivery. The document was missing a URL link to the Effective Health Care website.

The National Institute of Allergy and Infectious Diseases, 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 U.S. and European Patents and Patent Applications listed in the Supplementary Information section of this Notice to Ridgeback Biotherapeutics, L.P., located in Miami, Florida.

In accordance with the Federal Advisory Committee Act, the CDC and the Health Resources and Services Administration (HRSA), announces the following meeting for the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment (CHACHSPT). This business meeting is open to the public, limited only by audio and web conference lines (1000 audio and web conference lines are available). The public is welcome to listen to the meeting by accessing the telephone number 1-669-254-5252, and the passcode is 55572151 (1000 lines are available). The web conference access is https://cdc.zoomgov.com/j/ 1606419940?pwd=V2krVkVXbGtvVFdLbXV3N25PbTV4UT09, webinar ID: 160 641 9940 and passcode: ZeTt@2VL. Due to the nature and time limitations of the meeting, members of the public will not have an opportunity to provide oral comments, although written comments may be submitted prior to the meeting, or up to 10 business days after the meeting, to Staci Morris at smorris4@cdc.gov.

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 information collection associated with prescription drug marketing under the Prescription Drug Marketing Act of 1987 and the Prescription Drug Amendments of 1992.

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that AMONDYS 45 (casimersen), manufactured by Sarepta Therapeutics Inc., meets the criteria for a priority review voucher.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic 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 Administration for Children and Families (ACF) is requesting a 3-year extension of the form CB-496: Title IV-E Programs Quarterly Financial Report. This form is currently approved under the ACF Generic Clearance for Financial Reports (OMB #0970-0510, expiration 5/31/2021), and ACF is proposing to reinstate the previous OMB number under which this form had been approved (OMB # 0970-0205). There are no substantial changes requested to the 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 Medical Monitoring Project (MMP). The purpose of this data collection is to describe the health-related behaviors, experiences and needs of adults diagnosed with HIV in the United States. Data will be used to guide national and local HIV- related service organization and delivery, and monitor receipt of HIV treatment and prevention services and clinical outcomes.

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 Behavioral Risk Factor Surveillance System (BRFSS). BRFSS is an annual state-based health survey, designed to produce state- or sub-state jurisdiction-level data about health-related risk behaviors, chronic health conditions, use of preventive services, and emerging health issues.

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 continuing information collection project titled Assisted Reproductive Technology (ART) Program Reporting System. This study is designed to collect information on ART cycles to publish information on pregnancy success rates as required under Section 2(a) of the Federal Clinic Success Rate and Certification Act (FCSRCA).

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 Venous Thromboembolism Prevention Practices in U.S. Hospitals. This proposed study is designed to support a framework for improving hospital venous thromboembolism (VTE) prevention practices through the evaluation of current VTE prevention practices in U.S. adult general medical and surgical hospitals.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on December 11, 2020. The document announced the withdrawal of approval (as of January 11, 2021) of 10 abbreviated new drug applications (ANDAs) from multiple applicants. The document indicated that FDA was withdrawing approval of the following two ANDAs after receiving a withdrawal request from VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771: ANDA 040323, Prednisolone Syrup, 15 milligrams (mg)/5 milliliters (mL); and ANDA 075782, Valproic Acid Syrup, 250 mg/5 mL. Before FDA withdrew the approval of these ANDAs, VistaPharm, Inc., informed FDA that it did not want the approval of the ANDAs withdrawn. Because VistaPharm, Inc., timely requested that approval of these ANDAs not be withdrawn, the approval of ANDAs 040323 and 075782 are still in effect.

This is a primary data collection request for the Infant and Toddler Teacher and Caregiver Competencies (ITTCC) study to examine, using qualitative case studies, different approaches to implementing competency frameworks and assessing competencies of teachers and caregivers of infants and toddlers who work in group early care and education (ECE) settings (centers and family child care homes). Each case study will focus on a specific competency framework used by states, institutions of higher education, professional organizations, or ECE programs. This study aims to present an internally valid description of the implementation of competency frameworks and assessment of competencies for up to seven purposively selected cases, not to promote statistical generalization to different sites or service populations.

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 the Paperwork Reduction Act of 1995. This 30-day notice collects comments on the information collection requirements related to the proposed Extension with minor changes on the information collection requirements related to Prevention and Public Health Funds Evidence- Based Falls Prevention Program.

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.

The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information listed above. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a 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 a revision to the information collection requirements related to the National Ombudsman Reporting System and Older Americans Act Title VII.

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 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), 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 Contact Investigation Outcome Reporting Forms, a collection that facilitates CDC working with state and local health departments, and maritime vessels, in conducting contact investigations of individuals exposed to a communicable illnesses during travel.

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 ``American Academy of Pediatrics (AAP) Resident Training Program on Children with Fetal Alcohol Spectrum Disorders (FASD)''. This project will collect data to evaluate the efficacy of a newly developed pediatric resident training curriculum regarding identification, referral and care of children with fetal alcohol spectrum disorders (FASD) and their families.

The Food and Drug Administration (FDA or we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during April, May, and June 2020. FDA is informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being amended to improve the accuracy and readability of the regulations.

The Food and Drug Administration (FDA or we) is amending StarKist Seafood Company's temporary permit to market test canned tuna. The temporary permit is amended to add three additional manufacturing locations and to increase the amount of test product. This amendment will allow the applicant to continue to test market the test product and collect data on consumer acceptance of the test product.

As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID-19 Health Equity Task Force (Task Force) will hold a virtual meeting on March 26, 2021. The purpose of this meeting is to discuss equitable vaccine access and acceptance. This meeting is open to the public and will be live-streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/ healthequitytaskforce/ prior to the meeting.

The Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services (DHHS), announces the re- opening of a docket to obtain a public comment on the DRAFT Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Diphtheria, Group A Streptococcus, Meningococcal Disease, and Pertussis Sections (``Draft Guideline'').

The Agency for Healthcare Research and Quality (AHRQ) is seeking information from the public on clinical algorithms that are used or recommended in medical practice and any evidence on clinical algorithms that may introduce bias into clinical decision- making and/ or influence access to care, quality of care, or health outcomes for racial and ethnic minorities and those who are socioeconomically disadvantaged.

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the issuance of an Order requiring airlines and aircraft operators to collect designated information for passengers who are departing from, or were otherwise present in, the Democratic Republic of the Congo (DRC) or the Republic of Guinea (Guinea) within 21 days prior to their entry or attempted entry into the United States. This Order is based on the CDC Director's determination that such passengers are at risk of exposure to Ebola virus and that their accurate and complete contact information is needed to protect the health of fellow travelers and United States communities.

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.

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is modifying a department-wide system of records titled HHS Correspondence, Customer Service, and Contact List Records, system no. 09-90-1901, to make certain updates and to more clearly include records about individuals who provide comments and supporting documents to HHS in response to HHS rulemakings and other docketed proceedings. The modifications include changing the name of the system of records to HHS Correspondence, Comment, Customer Service, and Contact List Records.

The Food and Drug Administration (FDA or Agency) is requesting that any industry organization interested in participating in the selection of a nonvoting industry representative to serve on the Device Good Manufacturing Practice Advisory Committee (DGMPAC) in the Center for Devices and Radiological Health notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative to fill an upcoming vacancy on DGMPAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for an upcoming vacancy effective with this notice.

The Food and Drug Administration (FDA, Agency, or we) 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 information collection provisions of FDA's procedures for early food safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food use, including bioengineered food plants.

The Food and Drug Administration (FDA or 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 a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 054'' (Recognition List Number: 054), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Michael Gurry from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Mr. Gurry was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Gurry was given notice of the proposed permanent debarment and an opportunity to request a hearing to show why he should not be debarred. As of October 22, 2020 (30 days after receipt of the notice), Mr. Gurry had not responded. Mr. Gurry's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.

The Director of the Center for Drug Evaluation and Research (Center Director) of the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a new drug application (NDA) submitted by Lexicon Pharmaceuticals, Inc. (Lexicon) for sotagliflozin oral tablets, 200 milligrams (mg) and 400 mg, in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Lexicon an opportunity to request a hearing on the matter.