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 (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 or we) is extending for a second time the comment period for the proposed rule, and for the information collection related to the proposed rule, entitled ``Laboratory Accreditation for Analyses of Foods'' that appeared in the Federal Register of November 4, 2019. We are taking this action in response to a request from several food industry associations to extend open comment periods while their members focus on continuity of critical infrastructure operations due to the recent COVID-19 public health declaration. We also are taking this action to keep the comment period for the information collection provisions associated with the rule consistent with the comment period for the proposed rule.

The Council on Graduate Medical Education (COGME) meeting previously announced as in-person and webinar/conference call on Tuesday, April 28, 2020, and Wednesday, April 29, 2020, has changed its format, date, and time. The meeting will now be a one-day webinar and conference call only on Wednesday, April 29, 2020, from 12:00 p.m.-5:00 p.m. Eastern Time. The webinar link, conference dial-in number, meeting materials, and agenda will be available on the COGME website: https:// www.hrsa.gov/advisory-committees/graduate-medical-edu/meeting s/ index.html.

In accordance with the Federal Advisory Committee Act, this notice announces that the National Advisory Council on Nurse Education and Practice (NACNEP) has scheduled a writing subcommittee public meeting. Information about NACNEP, the agenda, and materials for this meeting can be found on the NACNEP website at https://www.hrsa.gov/ advisory-committees/nursing/.

This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the 2019 Novel Coronavirus (COVID-19). Recognizing the urgency of this situation, and understanding that some pre-existing Medicare payment rules may inhibit innovative uses of technology and capacity that might otherwise be effective in the efforts to mitigate the impact of the pandemic on Medicare beneficiaries and the American public, we are changing Medicare payment rules during the Public Health Emergency (PHE) for the COVID-19 pandemic so that physicians and other practitioners, home health and hospice providers, inpatient rehabilitation facilities, rural health clinics (RHCs), and federally qualified health centers (FQHCs) are allowed broad flexibilities to furnish services using remote communications technology to avoid exposure risks to health care providers, patients, and the community. We are also altering the applicable payment policies to provide specimen collection fees for independent laboratories collecting specimens from beneficiaries who are homebound or inpatients (not in a hospital) for COVID-19 testing. We are also expanding, on an interim basis, the list of destinations for which Medicare covers ambulance transports under Medicare Part B. In addition, we are making programmatic changes to the Medicare Diabetes Prevention Program (MDPP) and the Comprehensive Care for Joint Replacement (CJR) Model in light of the PHE, and program-specific requirements for the Quality Payment Program to avoid inadvertently creating incentives to place cost considerations above patient safety. This IFC will modify the calculation of the 2021 and 2022 Part C and D Star Ratings to address the expected disruption to data collection and measure scores posed by the COVID-19 pandemic and also to avoid inadvertently creating incentives to place cost considerations above patient safety. This rule also amends the Medicaid home health regulations to allow other licensed practitioners to order home health services, for the period of this PHE for the COVID-19 pandemic in accordance with state scope of practice laws. We are also modifying our under arrangements policy during the PHE for the COVID-19 pandemic so that hospitals are allowed broader flexibilities to furnish inpatient services, including routine services outside the hospital.

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 information collection provisions of reporting and recordkeeping requirements for firms that process acidified foods and thermally processed low-acid foods in hermetically sealed containers.

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) 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 information collection provisions in FDA's cosmetic labeling regulations and its Voluntary Cosmetic Registration Program (VCRP).

The Agency for Toxic Substances and Disease Registry (ATSDR), 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 an extension of an existing information collection titled ``ATSDR Communication Activities Survey (ACAS)'' which will continue to be used to assess the effectiveness of ATSDR site team members as they engage and inform members of communities in providing effective, clear, and consistent communication and information about protecting communities from environmental hazards.

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting a three-year extension of the forms OCSE- 21-U4: Transmittal and Notice of Approval of State Plan Material for: Title IV-D of the Social Security Act and OCSE-100: State Plan (OMB #0970-0017, expiration 7/31/2020).

The Food and Drug Administration (FDA or Agency) is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name ``hepatitis C virus (HCV) antibody tests'' along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (general controls and premarket approval) to class II (general controls and special controls) and reduce the regulatory burdens associated with these devices, as these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a premarket notification under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and obtain clearance before marketing their device.

The Food and Drug Administration (FDA, the Agency, or we) is amending its medical device regulations. These revisions are necessary to reflect changes to the Agency's Center for Devices and Radiological Health's organizational structure, including the reorganization of its offices. The revisions replace references to the obsolete offices and positions with the current information, update the physical addresses for such offices, and correct inaccurate citations. In addition, as part of this effort we made other editorial non-substantive changes to correct other addresses, references, and citations, as appropriate. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

This final notice announces our decision to approve the Utilization Review Accreditation Commission (URAC) for initial recognition as a national accrediting organization for home infusion therapy suppliers that wish to participate in the Medicare program. A home infusion therapy supplier that participates must meet the Medicare conditions for coverage (CfCs).

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Ophthalmic 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 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 October, November, and December 2019. 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 make technical amendments to improve the accuracy of the regulations.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service (PHS) Act, as amended. While the Secretary of HHS is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions.

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.''

The Administration for Children and Families (ACF) is requesting a 3-year extension of the Children's Justice Act Program Instruction (OMB #0970-0425, expiration 4/30/2020). There are no changes requested to the form.

The meeting of the Allergenic Products Advisory Committee scheduled for May 15, 2020, is canceled. The Allergenic Products Advisory Committee meeting scheduled for May 15, 2020, to discuss and make recommendations on the safety and efficacy of Peanut (Arachis hypogaea) Allergen Extract manufactured by DBV Technologies, S.A, has been canceled to allow time for the FDA to review outstanding issues. The Agency intends to continue evaluating the product and will schedule an Advisory Committee meeting in the future, as needed. The meeting was announced in the Federal Register on February 24, 2020.

The Secretary of Health and Human Services (HHS) is issuing this notice pursuant to section 564 of the Federal Food, Drug, and Cosmetic (FD&C) Act. On February 4, 2020, the Secretary determined pursuant to his authority under section 564 of the FD&C Act that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus (nCoV) first detected in Wuhan City, Hubei Province, China in 2019 (2019-nCoV). The virus is now named SARS-CoV-2, which causes the illness COVID-19. On the basis of this determination, he also declared that circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

The National Institute for Occupational Safety and Health (NIOSH), of the Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), is adding coronavirus disease 2019 (COVID-19), the disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), to the List of Potentially Life-Threatening Infectious Diseases to Which Emergency Response Employees May be Exposed. The list and companion guidelines are published by NIOSH pursuant to the Ryan White HIV/AIDS Treatment Extension Act of 2009. NIOSH encourages medical facilities to review the agency's guidelines describing the manner in which medical facilities should make determinations on whether an emergency response employee was exposed to COVID-19, the disease caused by SARS-CoV-2.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Lead Exposure and Prevention Advisory Committee (LEPAC). This meeting is open to the public by web conference; however, advance registration is needed by April 15, 2020, to receive the information to join the meeting. The registration link is https://rossstrategic.zoom.us/webinar/register/ WN_I76JZ04RT5SVinnqu_tSYw. The public comment period is scheduled on April 29, 2020, from 1:45 p.m. until 2:00 p.m., EDT. Individuals wishing to make a comment during the public comment period, please email your name, organization, and phone number by April 15, 2020, to LEPAC@cdc.gov.

The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2020. See list of public meetings below.

The Food and Drug Administration (FDA or we) is announcing the cancellation of following public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-14 Meeting.'' The purpose of the public meeting was to invite public input on various topics pertaining to the regulation of cosmetics.

This Request for Information (RFI) is intended to gather broad public input to assist the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in developing the NIDDK Strategic Plan. NIDDK invites input from: The scientific research community; patients and caregivers; health care providers and health advocacy organizations; scientific and professional organizations; federal agencies; and other stakeholders, including interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and their membership as a whole.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the ports available. There will be 2,000 telephone ports available. The public comment period will be at the end of the meeting from 3:00 p.m.-3:45 p.m., EDT. The public is encouraged to register to participate by telephone and/or provide public comment using the registration form available at the link provided: https://www.surveymonkey.com/r/P6ZN7QX. Written comments may also be submitted for the meeting record in advance using the registration form. Individuals registered to provide public comment will be called upon to speak based on the order of registration. After persons who have registered have spoken, any remaining time in the public comment period will be used for members of the public who have not registered, but wish to offer comment. Each individual making public comment during the meeting will have a 2-minute speaking limit to allow for as many comments as possible. Registered individuals may also request that their written comments be read during the meeting, but such comments will be subject to the same duration limit.

In accordance with the Federal Advisory Committee Act, the CDC announces the following virtual meeting of the Board of Scientific Counselors, National Institute for Occupational Safety and Health (BSC, NIOSH). This meeting is open to the public via webcast and by teleconference. If you wish to attend, please see the NIOSH website to register (https://www.cdc.gov/niosh/bsc/) or call (404-498-2539) at least five business days in advance of the meeting. Teleconference is available toll-free; please dial (855) 644-0229, and the participant passcode 9777483. Adobe Connect webcast will be available at https:// odniosh.adobeconnect.com/nioshbsc/ for up to 100 participants. The public is welcome to participate during the public comment period, from 12:45 p.m., EDT to 1:00 p.m., EDT on April 28, 2020. Please note that the public comment period ends at the time indicated above. Each commenter will be provided up to five minutes for comment. A limited number of time slots are available and will be assigned on a first come-first served basis. Written comments will also be accepted from those unable to attend the public session via an on-line form at the following website: https://www.cdc.gov/niosh/bsc/contact.html.

The Administration on Children, Youth and Families (ACYF), Family and Youth Services Bureau (FYSB) is accepting mandatory formula grant applications and State Plans from states and territories for the development of and implementation for Title V State Sexual Risk Avoidance Education (SRAE) Program. The Title V State SRAE Funding Opportunity Announcement sets forth the application requirements for the receipt of the following documents from applicants and awardees: Application, State Plan, and Performance Progress Report.

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 ``Patient-Centered Outcomes Research Clinical Decision Support: Current State and Future Directions.''

The Office of Human Services, Emergency Preparedness and Response (OHSEPR) is the emergency management office of the U.S. Department of Health and Human Services' (HHS) Administration for Children and Families (ACF). OHSEPR is requesting a 3-year extension of the Immediate Disaster Case Management Intake Assessment tool (OMB #0970-0461). The content of the form has not changed. There is one modification to the proposed use of resulting aggregate data, to include a use to advance research with a goal of developing a Quality Assurance/Performance Improvement process.

This document is to inform the public that the Director of the Centers for Disease Control and Prevention, an agency of the Department of Health and Human Services, has issued an Order suspending the introduction of persons into the United States.

The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces the issuance of a No Sail Order and Suspension of Further Embarkation on March 14, 2020 for all cruise ships that are not voluntarily suspending operation.

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 meeting of the Blood Products Advisory Committee (BPAC) scheduled for April 2-3, 2020, is postponed. The Food and Drug Administration (FDA), like other government agencies, is taking the necessary steps to ensure the Agency is prepared to continue our vital public health mission in the event that our day-to-day operations are impacted by the COVID-19 public health emergency. Therefore, we are canceling or postponing all non-essential meetings through the month of April. We will reassess on an ongoing basis for future months. Therefore, this meeting is being postponed. The meeting was announced in the Federal Register on February 13, 2020.

This notice replaces all language in Part Q (Office of the Secretary) of the Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (HHS or the Department), Office of Inspector General (OIG), (published March 15, 2016).

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 to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the Customer Surveys Generic Clearance for the National Center for Health Statistics. This collection is used to assess NCHS customers' satisfaction with the content, quality and relevance of the information it produces.

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 Platelet-rich Plasma for Wound Care in the Medicare Population, 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 Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.'' Due to the Coronavirus Disease 2019 (COVID-19) pandemic, FDA has received a number of queries concerning compounding of alcohol-based hand sanitizers. The Agency is issuing this guidance to communicate its policy for the temporary compounding of certain alcohol-based hand sanitizer products by pharmacists in State-licensed pharmacies or Federal facilities and registered outsourcing facilities (referred to collectively in this notice and the guidance as compounders) for the duration of the public health emergency declared by the Secretary of Health and Human Services on January 31, 2020. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Council on Blood Stem Cell Transplantation (ACBSCT) has scheduled a public meeting. Information about ACBSCT and the agenda for this meeting can be found on the ACBSCT website at https://bloodstemcell.hrsa.gov/about/advisory- council

The Food and Drug Administration is announcing that certain meetings involving the Center for Drug Evaluation and Research (CDER) from March 10 through April 30, 2020, are postponed, cancelled, or modified to take place remotely.

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 Brenda Elise Edwards 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 Mrs. Edwards was convicted of a felony under Federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mrs. Edwards was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of January 2, 2020 (30 days after receipt of the notice), Mrs. Edwards had not responded. Mrs. Edwards's failure to respond and request a hearing constitutes a waiver of her right to a hearing concerning this action.

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 Gerald Tighe 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. Tighe 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. Tighe was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Mr. Tighe failed to respond. Mr. Tighe's failure to request a hearing within the prescribed timeframe constitutes a waiver of his right to a hearing concerning this action.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Restricted Delivery Systems: Flow Restrictors for Oral Liquid Drug Products.'' This guidance provides recommendations regarding the use of restricted delivery systems to limit unintentional ingestion of oral liquid drug products (e.g., oral solution, oral suspension) by children. The recommendations in this guidance apply broadly to oral liquid drug and biological products. FDA's recommendations are intended to minimize the potential for harm due to unintentional ingestions.

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) permanently debarring Charles Jeffrey Edwards 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. Edwards was convicted, as defined in the FD&C Act, of two felony counts under federal law for conduct that relates to the regulation of a drug product under the FD&C Act. Mr. Edwards was given notice of the proposed permanent debarment and was given an opportunity to request a hearing within the timeframe prescribed by regulation to show why he should not be debarred. As of November 15, 2019 (30 days after receipt of the notice), Mr. Edwards had not responded. Mr. Edwards's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this action.

In response to recently issued OPM guidance to agencies on reducing non-essential travel, this notice announces a change to a meeting of the National Advisory Council for Healthcare Research and Quality.

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ``Required Warnings for Cigarette Packages and Advertisements: Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with FDA's document entitled ``Tobacco Products: Required Warnings for Cigarette Packages and Advertisements,'' which establishes new required cigarette health warnings for cigarette packages and advertisements.

The Food and Drug Administration (FDA) is withdrawing approval of three new drug applications (NDAs) from multiple holders of those NDAs. The basis for the withdrawal is that these NDA holders have repeatedly failed to file required annual reports for those NDAs.

In accordance with section 351a of the Public Health Service Act, the Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS; hereafter referred to as HHS/CDC) has initiated a review of the HHS list of biological agents and toxins that have the potential to pose a severe threat to public health and safety (HHS select agents and toxins). This review was initiated within two years of the completion of the previous review. In reviewing the list, HHS/CDC is considering whether to propose amending the HHS list of select agents and toxins.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jagen Lewicki for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Lewicki was convicted, as defined in the FD&C Act, of one felony count under Federal law for conspiracy to distribute Human Growth Hormone (HGH) imported from China for a purpose other than the treatment of a disease or other recognized medical condition, the use of which had been authorized by the Secretary of Health and Human Services, and not pursuant to an order of a physician, in violation of the FD&C Act. The factual basis supporting this felony conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Lewicki was given notice of the proposed debarment and, in accordance with the FD&C Act and FDA's regulations, was given an opportunity to request a hearing to show why he should not be debarred. As of October 28, 2019 (30 days after receipt of the notice), Mr. Lewicki had not responded. Mr. Lewicki's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Richard Jodoin for a period of 5 years from importing any drug into the United States. FDA bases this order on a finding that Mr. Jodoin was convicted, as defined in the FD&C Act, of one felony count under Federal law for unlawfully importing and attempting to import a controlled substance into the United States. The factual basis supporting the conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Jodoin was given notice of the proposed debarment and, in accordance with the FD&C Act, was given an opportunity to request a hearing to show why he should not be debarred. As of November 9, 2019 (30 days after receipt of the notice), Mr. Jodoin had not responded. Mr. Jodoin's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.