Department of Health and Human Services March 2023 – Federal Register Recent Federal Regulation Documents

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the rescission of the Order requiring negative pre-departure COVID-19 test result or documentation of recovery from COVID-19 for aircraft passengers traveling to the United States from the People's Republic of China, including the Special Administrative Regions of Hong Kong and Macau.

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 annual reporting for custom devices.

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use during the COVID-19 pandemic. FDA has issued one Authorization for the drug product KINERET (anakinra) as requested by Swedish Orphan Biovitrum AB (Sobi). The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS-CoV- 2, causes the illness COVID-19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Evaluation of Gastric pH-Dependent Drug Interactions With Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications.'' This guidance focuses on specific recommendations pertinent to pH-dependent drug-drug interaction (DDI) assessment and describes the current recommendations of FDA regarding when clinical DDI studies with acid-reducing agents (ARAs) are needed, design of the clinical studies, interpretation of study results, and options for managing pH-dependent DDIs in patients. This guidance finalizes the draft guidance of the same title issued on December 1, 2020.

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 continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Standardized National Hypothesis Generating Questionnaire (NHGQ). This questionnaire collects exposure information from ill people involved in a suspected multistate foodborne outbreak, and aids public health investigators in identifying the potential source of infection.

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 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 issuance of Emergency Use Authorizations (EUAs) (the Authorizations) for certain medical devices related to the Coronavirus Disease 2019 (COVID-19) public health emergency. FDA has issued the Authorizations listed in this document under the Federal Food, Drug, and Cosmetic Act (FD&C Act). These Authorizations contain, among other things, conditions on the emergency use of the authorized products. The Authorizations follow the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves the virus that causes COVID-19, and the subsequent declarations on February 4, 2020, March 2, 2020, and March 24, 2020, that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the virus that causes COVID-19, personal respiratory protective devices, and medical devices, including alternative products used as medical devices, respectively, subject to the terms of any authorization issued under the FD&C Act. These Authorizations, which include an explanation of the reasons for issuance, are listed in this document, and can be accessed on FDA's website from the links indicated.

The Office of Refugee Resettlement (ORR) is requesting a three-year extension with revisions of the Unaccompanied Refugee Minors (URM) Program Application and Withdrawal of Application or Declination of Placement Form (OMB #0970-0550, expiration 08/31/2023). Proposed revisions include additional instructions, a small number of new questions, dropping a few questions, and rephrasing existing questions.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC). The general function of the committee is to provide advice and recommendations to FDA on regulatory issues related to tobacco products. This meeting will be held to discuss and provide an opportunity for recommendations on the Requirements for Tobacco Product Manufacturing Practice (TPMP) proposed rule. The meeting will be open to the public.

The Food and Drug Administration (FDA, we, or Agency) is proposing to establish tobacco product manufacturing practice requirements for manufacturers of finished and bulk tobacco products. This proposed rule, if finalized, would set forth the requirements with which finished and bulk tobacco product manufacturers must comply in the manufacture, preproduction design validation, packing, and storage of finished and bulk tobacco products, to assure that the public health is protected and that tobacco products are in compliance with chapter IX of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Babson Diagnostics, Inc., for the Babson Diagnostics aC19G1, and Twist Bioscience Corporation for the SARS-CoV-2 NGS Assay. FDA revoked these Authorizations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) as requested by each Authorization holder. The revocations, which include an explanation of the reasons for each revocation, are reprinted at the end of this document.

This notice informs submitters who reported COVID-19 data in 2020 for the High-Impact Area Distribution that HRSA received a Freedom of Information Act (FOIA) request for data reported to HHS that was used in determining COVID-19 High-Impact Area Distribution payments under the Provider Relief Fund. Specifically, the request seeks certain information pertaining to providers who did not receive COVID-19 High- Impact Area Distribution payments. This notice seeks input from these providers so that HRSA can respond to the FOIA request.

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 Genitourinary Syndrome of Menopause, 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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

HRSA is seeking nominations of qualified candidates for consideration for appointment as members of the National Advisory Council on Migrant Health (NACMH). NACMH advises, consults with, and makes recommendations to the Secretary of HHS concerning the organization, operation, selection, and funding of migrant health centers (MHCs) and other entities, under grants and contracts under the Public Health Service (PHS) Act. HRSA is seeking nominations to fill two positions on NACMH.

The CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board). This meeting is open to the public, limited only by the space available and without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcomed to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug application (ANDA) 075286 for pemoline tablets, 18.75 milligrams (mg), 37.5 mg, and 75 mg, held by Fosun Pharma USA Inc. (Fosun), 104 Carnegie Center, Princeton, NJ 08540. Fosun requested that approval of this application be withdrawn and has waived its opportunity for a hearing.

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

The Food and Drug Administration (FDA) is publishing notice that an applicant for a biologics license application (BLA) for a biosimilar or interchangeable biosimilar product submitted under the Public Health Service Act (PHS Act) (a ``subsection (k) applicant'') notified FDA that an action for patent infringement was filed in connection with the applicant's BLA. Under the PHS Act, within 30 days after the subsection (k) applicant is served with a complaint in an action for patent infringement described under the PHS Act, the subsection (k) applicant shall provide the Secretary of HHS with notice and copy of such complaint. FDA is required to publish notice of the complaint in the Federal Register.

The Food and Drug Administration (FDA or Agency) has determined that lithium citrate oral solution, 8 milliequivalents (mEq)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

This 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.

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) 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) located within the Department of Health and Human Services (HHS) has amended the select agents and toxins regulations to add SARS-CoV/SARS-CoV-2 chimeric viruses resulting from any deliberate manipulation of SARS- CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors to the list of HHS select agents and toxins. With this final rule, regulated entities are required to obtain prior approval from CDC to conduct deliberate manipulation of SARS-CoV-2 to incorporate nucleic acids coding for SARS-CoV virulence factors because these chimeric viruses have the potential to pose a severe threat to public health and safety.

The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the next meeting of the Community Preventive Services Task Force (CPSTF) on April 19-20, 2023.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the SUPPLEMENTARY INFORMATION section of this notice to BrickBio, Inc. (``BrickBio'') located in Woburn, Massachusetts.

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 convene the 76th full council meeting on Wednesday, March 29 and Thursday March 30, 2023. The meeting will convene in Washington, DC and it will also utilize virtual technologies. The meeting will be open to the public. Due to limited space, pre-registration is encouraged for members of the public who wish to attend the meeting in-person. Please email your name to PACHA@hhs.gov by close of business Wednesday, March 22, 2023 to pre-reigster. There will be a public comment session during the meeting; pre-registration is required to provide public comment. To pre-register to provide public comment, please send an email to PACHA@hhs.gov and include your name, organization, and title by close of business March 22, 2023. 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 April 5, 2023. 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.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

Before using an electronic signature in an electronic record required by the Food and Drug Administration (FDA or Agency), a person must submit a letter of non-repudiation to FDA. Letters of non- repudiation are required to certify that a person's electronic signatures are intended to be the legally binding equivalent of traditional handwritten signatures. FDA is amending its regulations to update the address for submission of a certification in paper form and to provide an option for electronic submission. This amendment is to ensure accuracy and clarity in the Agency's regulations. This technical amendment is nonsubstantive.

The Office of the Assistant Secretary for Health published a document in the Federal Register of February 23, 2023, announcing the solicitation of rritten comments on the Physical Activity Guidelines Midcourse Report on Older Adults. The document announces the availability of the draft Physical Activity Guidelines Midcourse Report on Older Adults (Midcourse Report) and solicits written public comment on the draft report by March 10, 2023. The published Notice did not include the comment deadline.

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 analysis of Senior Medicare Patrol Grantees' Program Implementation.

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 meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 20, 2023, is cancelled. This meeting was announced in the Federal Register of January 30, 2023. The meeting is no longer needed.

This notice sets forth the Statement of Organization of the Office for Civil Rights (OCR) of the Department of Health and Human Services.

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

The Food and Drug Administration (FDA or the Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of individuals on its advisory committees regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups.

In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VERZENIO 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 human drug product.

The Food and Drug Administration (FDA or the Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.