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

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 the Proposed Revision for the information collection requirements related to Evaluation of the Administration for Community Living's American Indian, Alaska Natives and Native Hawaiian Programs (OAA Title VI).

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding the 67th full Council meeting utilizing virtual technology. The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for both public participation and comment. Individuals who wish to participate in the meeting and/or provide public comment should pre-register by sending an email to PACHA@hhs.gov. Individuals will be required to provide their name, organization, and email address to pre-register. Agenda items will include discussing the 2019 novel coronavirus (COVID-19) and the impact on people living with, or at risk of, HIV and implementing the Ending the HIV Epidemic initiative post COVID-19. The meeting agenda will be posted on the PACHA website at https://www.hiv.gov/federal-response/ pacha/about-pacha as soon as it becomes available.

HRSA is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by 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.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.'' On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV). Rapid detection of Coronavirus Disease-2019 (COVID-19) cases in the United States requires wide availability of SARS-CoV-2 testing. This guidance was revised on March 16, 2020, May 4, 2020, and May 11, 2020. The guidance describes four policies intended to help facilitate the development and use of SARS-CoV-2 tests during the public health emergency: Two policies for accelerating the development of certain laboratory tests for COVID-19one leading to an Emergency Use Authorization (EUA) submission to FDA and the other not leading to an EUA submission when the test is developed under the authorities of the State in which the laboratory resides and the State takes responsibility for COVID-19 testing by laboratories in its State; a policy for commercial manufacturers to more rapidly distribute their SARS-CoV-2 diagnostics to laboratories for specimen testing after validation while an EUA submission is being prepared for submission to FDA; and a policy regarding the use of serological testing. In addition, FDA has included a reference to the availability, on FDA's website, of templates for commercial manufacturers and laboratories intended to facilitate EUA submissions for molecular, antigen, and serology tests. 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 Committee on Infant Mortality (ACIM) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisory-committees/infant-mortality/ind ex.html.

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 Infant Feeding Practices Study III to understand the current state of mothers' intentions, behaviors, feeding decisions, and practices from pregnancy through their child's first two years of life and how these change.

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 ``Emerging Infections Program (EIP) Tracking of SARS-CoV-2 Infections among Healthcare Personnel''. Through this project, EIP staff will collect data to: (1) Determine the extent of COVID-19 among HCP working in U.S. healthcare facilities; (2) describe characteristics of HCP exposed to or infected with SARS-CoV-2, including clinical activities and personal protective equipment use; and (3) compare exposures and other characteristics of HCP cases and exposed HCP that do not become cases to identify risk factors or protective factors for COVID-19.

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

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 16 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.

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

The Food and Drug Administration (FDA or we) 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 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 Senti Bio (``Senti''), located in South San Francisco, CA.

This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters and cost-sharing reductions; and user fees for Federally-facilitated Exchanges and State-based Exchanges on the Federal platform. It also finalizes changes related to essential health benefits and will provide states with additional flexibility in the operation and establishment of Exchanges. The rule includes changes related to cost sharing for prescription drugs; notice requirements for excepted benefit health reimbursement arrangements offered by non- Federal governmental plan sponsors; Exchange eligibility and enrollment; exemptions from the requirement to maintain coverage; quality rating information display standards for Exchanges; and other related topics. This final rule also repeals regulations relating to the Early Retiree Reinsurance Program.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Board of Scientific Counselors (BSC), National Institute for Occupational Safety and Health (NIOSH), National Firefighter Registry Subcommittee. This meeting is open to the public via webcast and by teleconference. If you wish to attend by webcast or teleconference, please register at the NIOSH website https:/ /www.cdc.gov/niosh/bsc/nfrs/registration.html or call (513-841-4203) at least five business days in advance of the meeting. Adobe Connect webcast will be available at https://odniosh.adobeconnect.com/nfrs/ for participants wanting to connect remotely, and teleconference is available toll-free at (855) 644-0229, Participant Pass Code 9777483. This meeting is open to the public, limited only by the number of adobe license seats available, which is 100. The public is welcome to participate during the public comment period, from 11:15 a.m. to 12:00 p.m., EDT, on May 15, 2020. Please note that the public comment period ends at the time indicated above.

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 FDA's guidance for industry entitled ``Channels of Trade Policy for Commodities With Residues of Pesticide Chemicals, for Which Tolerances Have Been Revoked, Suspended, or Modified by the Environmental Protection Agency Pursuant to Dietary Risk Considerations.''

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

The National Biodefense Science Board (NBSB) is authorized under Section 319M of the Public PHS Act, as added by Section 402 of the Pandemic and All-Hazards Preparedness Act of 2006 and amended by Section 404 of the Pandemic and All-Hazards Preparedness Reauthorization Act. The Board is governed by the Federal Advisory Committee, which sets forth standards for the formation and use of advisory committees. The NBSB provides expert advice and guidance on scientific, technical, and other matters of special interest to the Department regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Background: The May 13, 2020, NBSB public teleconference is dedicated to the discussion of recommendations on two topics: (1) NBSB Rapid medical countermeasures (MCM) for Disease X and (2) Integrating Clinical Disaster Response Training with Community and State Based Emergency Planning. We will post modifications to the agenda and/or topics on the NBSB meeting website, which is located at https:// www.phe.gov/nbsb. Availability of Materials: We will post all teleconference materials prior to the teleconference on May 13, 2020, on the website located at https://www.phe.gov/nbsb. Procedures for Providing Public Input: Members of the public may attend the public teleconference via a toll-free call-in phone number, which is available on the NBSB website at https://www.phe.gov/nbsb.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR have been 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 or Agency) is withdrawing approval of seven abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Notice is hereby given that the Indian Health Service has decided to expand the geographic boundaries of the Purchased/Referred Care (PRC) Delivery Area for the Havasupai Tribe in the State of Arizona to include Mohave County in the State of Arizona. The final PRC delivery area for the Havasupai Tribe is now the counties of Coconino and Mohave in the State of Arizona. The sole purpose of this expansion is to authorize Havasupai to cover additional Tribal members and beneficiaries under Havasupai's PRC.

This document corrects errors that appeared in the notice published in the April 29, 2020, Federal Register entitled ``Findings of Research Misconduct.'' The document contained an incorrect title and signature date.

The Food and Drug Administration (FDA or we) is announcing that Adisseo France S.A.S. has filed a petition proposing that the food additive regulations be amended to provide for the safe use of selenomethionine hydroxy analogue as a source of selenium in feed for beef and dairy cattle.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this notice has closed.

The U.S. Department of Health and Human Services, Administration for Children and Families (ACF) will host a virtual Tribal Consultation to consult on ACF programs and tribal priorities.

This interim final rule with comment period (IFC) gives individuals and entities that provide services to Medicare, Medicaid, Basic Health Program, and Exchange beneficiaries needed flexibilities to respond effectively to the serious public health threats posed by the spread of the coronavirus disease 2019 (COVID-19). Recognizing the critical importance of expanding COVID-19 testing, we are amending several Medicare policies on an interim basis to cover FDA-authorized COVID-19 serology tests, to allow any healthcare professional authorized to do so under State law to order COVID-19 diagnostic laboratory tests (including serological and antibody tests), and to provide for new specimen collection fees for COVID-19 testing under the Physician Fee Schedule and Outpatient Prospective Payment System, during the public health emergency (PHE) for the COVID-19 pandemic. Recognizing the urgency of this situation, and understanding that some pre-existing CMS 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 beneficiaries and the American public, we are amending several CMS policies and regulations in response to the COVID-19 PHE and recent legislation, as outlined in this IFC. These changes apply to physicians and other practitioners, hospice providers, federally qualified health centers, rural health clinics, hospitals, critical access hospitals (CAHs), community mental health centers (CMHCs), clinical laboratories, teaching hospitals, providers of the laboratory testing benefit in Medicaid, Opioid treatment programs, and quality reporting programs (QRPs) for inpatient rehabilitation facilities (IRFs), long-term care hospitals (LTCHs), skilled nursing facilities (SNFs), home health agencies (HHAs) and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers.

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.

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 ``Medical Expenditure Panel Survey (MEPS) Social and Health Experiences Self-Administered Questionnaire.''

The Office of Child Support Enforcement (OCSE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect expenditure estimates for the Tribal Child Support Enforcement Program through an optional financial reporting form, Tribal Budget and Narrative Justification Template. This optional template is designed for tribes operating an approved Tribal Child Support Enforcement Program to use in preparing their annual budget and narrative justification estimates in accordance with the tribal child support enforcement regulations.

The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Biomin GmbH, proposing that the food additive regulations be amended to provide for the safe use of fumonisin esterase to degrade fumonisins present in swine feed.

The Administration for Children and Families (ACF) is requesting a three-year extension of the collection of information under the Child and Family Services Plan (CFSP), the Annual Progress and Services Report (APSR), and the Annual Budget Expenses Request and Estimated Expenditures (CFS-101) collection (OMB #0970-0426, expiration 1/31/2021). There are minor changes to the APSR, the burden hours for the APSR, and CFS-101 form.

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 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.

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 accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without an oral public comment period. The public is welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.

This document reopens the comment period for the January 21, 2020 request for information entitled ``Coordinating Care From Out-of- State Providers for Medicaid-Eligible Children With Medically Complex Conditions''. That document requested information (RFI) to seek public comments regarding the coordination of care from out-of-state providers for Medicaid-eligible children with medically complex conditions. We wish to identify best practices for using out-of-state providers to provide care to children with medically complex conditions; determine how care is coordinated for such children when that care is provided by out-of-state providers, including when care is provided in emergency and nonemergency situations; reduce barriers that prevent such children from receiving care from out-of-state providers in a timely fashion; and identify processes for screening and enrolling out-of-state providers in Medicaid, including efforts to streamline such processes for out-of-state providers or to reduce the burden of such processes on them. We intend to use the information received in response to the RFI to issue guidance to state Medicaid directors on the coordination of care from out-of-state providers for children with medically complex conditions. The comment period for the RFI, which ended on March 23, 2020, is reopened for 30 days from the date of publication of this notice.

This notice announces a virtual public meeting to receive comments and recommendations (including data on which recommendations are based) on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System codes being considered for Medicare payment under the Clinical Laboratory Fee Schedule (CLFS) for calendar year (CY) 2021. This meeting also provides a forum for those who submitted certain reconsideration requests regarding final determinations made last year on new test codes and for the public to provide comment on the requests.

The Administration for Children and Families (ACF) proposes to revise the existing overarching generic clearance for Grant Reviewer Recruitment (GRR) forms to expand the focus from recruiting just grant reviewers to recruiting expert reviewers in general.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) announces the re-opening of this docket to obtain additional public comment on the proposed update of the 2006 Revised Recommendations for HIV Testing. CDC is re- opening this docket at the request of the public.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Mine Safety and Health Research Advisory Committee (MSHRAC). This is a virtual meeting. It is open to the public, limited only by web conference lines (500 web conference lines are available). If you wish to attend, please contact Marie Chovanec by email at MChovanec@cdc.gov or by telephone at 412-386-5302 at least 5 business days in advance of the meeting. She will provide you the Zoom web conference access.

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). A notice listing all currently HHS-certified laboratories and IITFs is published in the Federal Register during the first week of each month. If any laboratory or IITF certification is suspended or revoked, the laboratory or IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the internet at https:// www.samhsa.gov/workplace/resources/drug-testing/certified-lab -list.

In compliance with the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. OMB may act on HRSA's ICR only after the 30 day comment period for this Notice has closed.

This final rule is intended to move the health care ecosystem in the direction of interoperability, and to signal our commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve the quality and accessibility of information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected health care providers and payers.

The Food and Drug Administration (FDA) is postponing the meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory Committee scheduled for June 9, 2020. The meeting was announced in the Federal Register of April 1, 2020. 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 postponing this meeting and will reassess on an ongoing basis for future months. A future meeting date will be announced in the Federal Register.

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 requirements under the Postmarketing Safety Reporting Rule for Combination Product for Constituent Part Applicants to share specified adverse event information with one another.

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 is announcing that the following public workshop entitled ``FY 2020 Generic Drug Regulatory Science Initiatives'' announced in the Federal Register on March 10, 2020, is being modified to take place remotely.

The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a guidance for industry entitled ``Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule,'' which was issued in 2017. The guidance was intended to assist persons who manufacture, package, sell, offer to sell, distribute, or import for sale and distribution within the United States newly regulated tobacco products, roll-your-own (RYO) tobacco, and cigarette tobacco in complying with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), and FDA regulations. FDA is withdrawing the guidance because the compliance deadlines contained therein have passed, have been vacated or stayed, or are otherwise described in other guidance.

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 Office of Research on Women's Health (ORWH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Council for the Elimination of Tuberculosis Meeting (ACET). This meeting is open to the public, limited only by audio and web conference lines (100 audio and web conference lines are available) by accessing the following telephone number at 1-877-927-1433; the passcode is 12016435. The web conference access is https://adobeconnect.cdc.gov/r5p8l2tytpq/.

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.