Department of Health and Human Services November 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or we) is announcing that Alzchem Trostberg GmbH has filed a petition proposing that the food additive regulations be amended to provide for the safe use of guanidinoacetic acid as a precursor of creatine in poultry feeds.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (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 If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing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.

This notice announces the 2020 meetings of the Physician- Focused Payment Model Technical Advisory Committee (PTAC). These meetings will include deliberation and voting on proposals for physician-focused payment models (PFPMs) submitted by individuals and stakeholder entities. All meetings are 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 (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 Intergovernmental Reference Guide (IRG) is a centralized and automated repository of state and tribal profiles that contains high-level descriptions of each state and tribal child support enforcement (CSE) program. These profiles provide state, tribal, and foreign country CSE agencies with an effective and efficient method for updating and accessing information needed to process intergovernmental child support cases.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring James R. Casey for a period of 5 years from importing articles of food or offering such articles for importation into the United States. FDA bases this order on a finding that Mr. Casey was convicted, as defined in the FD&C Act, of a felony count under Federal law for conduct relating to the importation into the United States of an article of food. Mr. Casey was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of June 30, 2019 (thirty days after receipt of the notice), Mr. Casey had not responded. Mr. Casey'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 or the Agency) has determined the regulatory review period for CRYSVITA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of patents which claim that human biological product.

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

The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations of individuals to serve as non-federal public members on the Interagency Autism Coordinating Committee (IACC).

The Food and Drug Administration's (FDA or Agency or we) Center for Devices and Radiological Health (CDRH or Center) is announcing its Ethylene Oxide Sterilization Master File Pilot Program (``EtO Pilot Program''). The EtO Pilot Program is voluntary and intends to allow companies (``sterilization providers'') that sterilize single- use medical devices using fixed chamber ethylene oxide (EtO) to submit a Master File when making certain changes between sterilization sites or when making certain changes to sterilization processes that utilize reduced EtO concentrations. Under this voluntary program, manufacturers (``PreMarket Application (PMA) holders'') of Class III devices subject to premarket approval that are affected by such changes may, upon FDA's permission, reference the Master File submitted by their sterilization provider in a postapproval report in lieu of submission of a premarket approval application (PMA) supplement. The EtO Pilot Program seeks to help ensure patient access to safe medical devices while encouraging new, innovative ways to sterilize medical devices that reduce the potential impact of EtO on the environment and on the public health while providing a regulatory approach that would address potential device shortages.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a final guidance for industry entitled ``Compliance Policy for Limited Modifications to Certain Marketed Tobacco Products.'' This guidance describes FDA's compliance policy for premarket review requirements for two types of limited modifications to new tobacco products that were on the market as of August 8, 2016, specifically, modifications to battery-operated tobacco products solely to comply with UL 8139 and modifications to liquid nicotine products solely to comply with the Child Nicotine Poisoning Prevention Act of 2015 (CNPPA) flow restrictor requirements for liquid nicotine containers. This guidance will enable tobacco manufacturers to upgrade their battery-operated tobacco products to UL 8139. It will also enable manufacturers to comply with the CNPPA requirements for flow restrictors for liquid nicotine containers. FDA is issuing this guidance to address battery safety concerns and youth exposure to liquid nicotine toxicity.

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 HHS Office of the Secretary is hosting the National Biodefense Science Board (NBSB) Public Meeting in Washington, DC, December 3, 2019. The purpose of the meeting is to gather information to develop expert advice provided by NBSB and guidance to the Secretary on scientific, technical, and other matters of special interest to HHS regarding current and future chemical, biological, nuclear, and radiological agents, whether naturally occurring, accidental, or deliberate. Retiring NBSB board members will also be presented with certificates and a signed letter of appreciation.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Health Statistics BSC, NCHS. This meeting is open to the public; however, visitors must be processed in accordance with established federal policies and procedures. For foreign nationals or non-U.S. citizens, pre-approval is required (please contact Gwen Mustaf, 301-458-4500, glm4@cdc.gov or Sayeedha Uddin, 301-458-4303, isx9@cdc.gov at least 4 weeks in advance for requirements). All visitors are required to present a valid form of picture identification issued by a state, federal in international government. As required by the Federal Property Management Regulations, Title 41, Code of Federal Regulations, Subpart 101-20.301, all persons entering in or on Federal controlled property and their packages, briefcases, and other containers in their immediate possession are subject to being x-rayed and inspected. Federal law prohibits the knowing possession or the causing to be present of firearms, explosives and other dangerous weapons and illegal substances. The meeting room accommodates approximately 78 people.

The Administration for Children and Families (ACF) is requesting to renew approval of the ACF-196 Temporary Assistance for Needy Families (TANF) Financial Reporting Form. The ACF-196 is the form used by states to estimate funding needs and request grant awards under the TANF program. In addition, the form is used to report data in substantiation of state claims and to certify the availability of the legislatively mandated state match. ACF will use the financial data provided by states to estimate quarterly funding needs, calculate award amounts, and assess compliance with statutory and regulatory requirements relating to administrative costs and state matching requirements. No changes are proposed to the form.

This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. A hospice that participates in Medicaid must also meet the Medicare conditions for participation.

The Centers for Disease Control and Prevention (CDC) in the Department of Health and Human Services (HHS) proposes to amend two provisions within its foreign quarantine regulations to provide additional clarity and safeguards to address the risk to public health from the importation of human remains into the United States.

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 Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with certain Freedom of Information Act and Privacy Act requests.

This gives notice under (specific statutes and regulations citations and) the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, Center for Preparedness and Response (BSC, CPR); (formerly known as the Board of Scientific Counselors, Office of Public Health Preparedness and Response (BSC, OPHPR)), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021.

This gives notice under the Federal Advisory Committee Act of October 6, 1972, that the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC), Centers for Disease Control and Prevention, Department of Health and Human Services, has been renewed for a 2-year period through November 5, 2021.

The Food and Drug Administration (FDA, the Agency, 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 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/revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on ``General Licensing Provisions; Section 351(k) Biosimilar Applications; Formal Meetings Between the FDA and Sponsors or Applicants.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of additional draft and revised draft product-specific guidances. The guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled ``Bioequivalence Recommendations for Specific Products'' that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The guidances identified in this notice were developed using the process described in that guidance.

This document corrects the information provided for [Document Identifier: CMS-10718] titled ``Model Medicare Advantage and Medicare Prescription Drug Plan Individual Enrollment Request Form.''

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 the availability of a draft guidance for industry entitled ``Transdermal and Topical Delivery SystemsProduct Development and Quality Considerations.'' This guidance provides recommendations to applicants and manufacturers of transdermal and topical delivery systems (TDS) regarding the pharmaceutical development and quality information to include in new drug applications (NDAs) and abbreviated new drug applications (ANDAs). Specifically, the guidance discusses FDA's current thinking on product design and pharmaceutical development, manufacturing process and control, and finished product control. It also addresses special considerations for areas where quality is closely tied to product performance and potential safety issues, such as adhesion failure and the impact of applied heat on drug delivery.

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program.'' The purpose of the public meeting is to help ensure that as standard core sets of clinical outcome assessments (COAs) are developed as part of the FDA pilot grant program, the identified concepts, COAs, and endpoints reflect what is most important to patients and relevant to regulatory and potentially other stakeholder decision making. To facilitate this, stakeholders including patients, care partners, FDA reviewers, drug developers, other government and academic researchers, health care providers, health technology assessors and health payers are encouraged to attend the meeting.

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GFI) #256 entitled ``Compounding Animal Drugs from Bulk Drug Substances.'' The draft guidance, if finalized, will describe FDA's current thinking about compounding animal drugs from bulk drug substances. FDA has generally exercised enforcement discretion with regard to animal drug compounding from bulk drug substances under certain circumstances when no other medically appropriate treatment options exist. This draft guidance, a continuation of this practice, is intended to provide additional information and clarity to veterinarians and pharmacists about FDA's current thinking with respect to animal drug compounding from bulk drug substances. FDA previously published draft guidance on this issue for public comment in May 2015 (Draft GFI #230, ``Compounding Animal Drugs from Bulk Drug Substances''). We received over 150 comments on that draft guidance. Based on those comments, we decided to withdraw the May 2015 draft guidance and publish this draft guidance for public comment.

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 Institute of Neurological Disorders and Stroke (NINDS), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

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 Office of Planning, Research, and Evaluation (OPRE) is proposing a data collection activity as part of the Evaluation of the National Human Trafficking Hotline (NHTH) Program. This data collection activity will examine the experiences of individuals who seek assistance from the NHTH after their interactions with the NHTH. The study will collect information via voluntary phone and Web-based surveys at two time points: (1) Immediately after an individual has contacted the NHTH by phone, text, or live online chat; and (2) two weeks later.

The Office on Trafficking in Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting to continue data collection with an increased number of respondents to the previously approved information collection, National Human Trafficking Training and Technical Assistance Center (NHTTAC) Evaluation Package (OMB #0970-0519, expiration 10/31/2021). This request was originally approved under expedited review and increased the estimated burden hours from 689 hours to 9,497 hours. In addition, the previously approved Stop, Observe, Ask, and Respond to human trafficking (SOAR) Online Participant Feedback Form was restructured into a long and short form to reduce burden for information collected on SOAR Online training participants outside of the NHTTAC learning management system. There are no changes requested to the items on any forms.

This notification is to inform the public that the U.S. Department of Health and Human Services (HHS) has determined that the rulemaking that resulted in the regulatory provisions promulgated on Dec. 12, 2016, regarding HHS's grant regulations, raises significant concerns about compliance with the Regulatory Flexibility Act. The provisions will not be enforced pending a repromulgation that complies with the Act.

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 withdrawing the approval of abbreviated new drug application (ANDA) 077062 for the fentanyl transdermal system held by Mayne Pharma Group Ltd. (Mayne) and ANDA 076709 for the fentanyl transdermal system held by Actavis Laboratories UT, Inc. (Actavis), an indirect wholly owned subsidiary of Teva Pharmaceuticals USA, Inc. (Teva). These drug products are both transdermal systems designed with a liquid reservoir. Mayne and Actavis have both requested withdrawal of their respective applications and have waived their opportunity for a hearing.

The Food and Drug Administration (FDA) is announcing the renewal of the Nonprescription Drugs Advisory Committee by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Nonprescription Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until August 27, 2021.

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.

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

The 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) 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.

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 Agency) is announcing the availability of a final guidance entitled ``Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices.'' FDA is issuing this guidance to comply with changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Reauthorization Act of 2017 (FDARA), which specifies the process afforded to persons denied a Certificate to Foreign Government (CFG) for a device. This guidance describes the information that the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER), in collaboration with the Office of Regulatory Affairs (ORA), will provide to a person whose request for a CFG for a device is denied, and the process for seeking review of such a denial.

Findings of research misconduct have been made against Deepti Malhotra, Ph.D. (Respondent), former Doctoral Student and Postdoctoral Fellow, Department of Environmental Health Sciences, Johns Hopkins Bloomberg School of Public Health (JHSPH). Dr. Malhotra engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), grants R01 HL081205, P50 HL084945, P50 HL084948-01, U01 HL105569-03, P50 HL107169-01, R01 HL066554-09, and R03 HL096931-02; National Institute of Environmental Health Sciences (NIEHS), NIH, grants P50 ES015903, P01 ES018176-01, and P30 ES003891-25; National Cancer Institute (NCI), NIH, grant P50 CA058184-18; and National Institute for Research Resources (NCRR), NIH, grant UL1 RR025005-02. The administrative actions, including debarment for a period of four (4) years, were implemented beginning on October 1, 2019, and are detailed below.

The National Clinical Care Commission (the Commission) will conduct its fifth meeting on Friday, November 22, 2019. The Commission is charged to evaluate and make recommendations to the U.S. Department of Health and Human Services (HHS) Secretary and Congress regarding improvements to the coordination and leveraging of federal programs related to awareness and clinical care for complex metabolic or autoimmune diseases that result from issues related to insulin that represent a significant disease burden in the United States, which may include complications due to such diseases.

The Secretary of Health and Human Services (Secretary) announces subcommittee meetings of the Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meetings are open to the public and can be accessed via telephone only. Agenda with call-in information will be posted on the SAMHSA website prior to the meetings at: https://www.samhsa.gov/about-us/advisory-councils/meetings. The meetings will include information on the following focus areas: Data, Access, Treatment and Recovery, Justice, and Finance. Committee Name: Interdepartmental Serious Mental Illness Coordinating Committee (subcommittee meetings). Date/Time/Type:

This notice announces the monthly actuarial rates for aged (age 65 and over) and disabled (under age 65) beneficiaries enrolled in Part B of the Medicare Supplementary Medical Insurance (SMI) program beginning January 1, 2020. In addition, this notice announces the monthly premium for aged and disabled beneficiaries, the deductible for 2020, and the income-related monthly adjustment amounts to be paid by beneficiaries with modified adjusted gross income above certain threshold amounts. The monthly actuarial rates for 2020 are $283.20 for aged enrollees and $343.60 for disabled enrollees. The standard monthly Part B premium rate for all enrollees for 2020 is $144.60, which is equal to 50 percent of the monthly actuarial rate for aged enrollees (or approximately 25 percent of the expected average total cost of Part B coverage for aged enrollees) plus $3.00 repayment amount required under current law. (The 2019 standard premium rate was $135.50, which included the $3.00 repayment amount.) The Part B deductible for 2020 is $198.00 for all Part B beneficiaries. If a beneficiary has to pay an income-related monthly adjustment, he or she will have to pay a total monthly premium of about 35, 50, 65, 80 or 85 percent of the total cost of Part B coverage plus a repayment amount of $4.20, $6.00, $7.80, $9.60 or $10.20 respectively.

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 (PRA).

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 Extension without Change and solicits comments on the information collection requirements related to Development Disabilities State Plan.

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 Extension without Change and solicits comments on the information collection requirements related to the National Maltreatment Reporting System (NAMRS).

The Food and Drug Administration (FDA or the Agency) is reopening the comment period for the proposed rule that appeared in the Federal Register of August 16, 2019. The Agency is providing additional information in the docket and reopening the public comment period for 15 days to afford the public an opportunity to comment on this additional information.

This notice announces a $595.00 calendar year (CY) 2020 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children's Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2020 and on or before December 31, 2020.

The National Institutes of Health (NIH) is seeking public comments on a DRAFT NIH Policy for Data Management and Sharing and supplemental DRAFT guidance. The purpose of this DRAFT Policy and supplemental DRAFT guidance is to promote effective and efficient data management and sharing to further NIH's commitment to making the results and accomplishments of the research it funds and conducts available to the public.

HHS gives notice of a decision to designate a class of employees from the West Valley Demonstration Project in West Valley, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000.

This final rule with comment period updates the home health prospective payment system (HH PPS) payment rates and wage index for CY 2020; implements the Patient-Driven Groupings Model (PDGM), a revised case-mix adjustment methodology, for home health services beginning on or after January 1, 2020. This final rule with comment period also implements a change in the unit of payment from 60-day episodes of care to 30-day periods of care, as required by section 51001 of the Bipartisan Budget Act of 2018, hereinafter referred to the ``BBA of 2018'', and finalizes a 30-day payment amount for CY 2020. Additionally, this final rule with comment period: Modifies the payment regulations pertaining to the content of the home health plan of care; allows therapist assistants to furnish maintenance therapy; and changes the split percentage payment approach under the HH PPS. For the Home Health Value-Based Purchasing (HHVBP) model, we are finalizing provisions requiring the public reporting of the Total Performance Score (TPS) and the TPS Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and Payment Adjustment Report for each home health agency in the nine Model states that qualified for a payment adjustment for CY 2020. This final rule with comment period also finalizes the following updates to the Home Health Quality Reporting Program (HH QRP): Removal of a measure; adoption of two new measures; modification of an existing measure; and a requirement for HHA's to report standardized patient assessment data beginning with the CY 2022 HH QRP. Additionally, we are finalizing our proposal to re-designate our current HH QRP regulations in a different section of our regulations and to codify other current policies in that new regulatory section with one substantive change as well as a few technical edits. We are not finalizing our proposal to remove question 10 from all of the HH Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys. Lastly, it sets forth routine updates to the home infusion therapy payment rates for CY 2020, payment provisions for home infusion therapy services for CY 2021 and subsequent years, and solicits comments on options to enhance future efforts to improve policies related to coverage of eligible drugs for home infusion therapy.

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.

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.

The Food and Drug Administration (FDA or Agency) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Allergenic Products Advisory Committee (APAC) for the Center for Biologics Evaluation and Research notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the APAC. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.

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 Office on Trafficking of Persons (OTIP), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is requesting expedited review of an information collection request from OMB for an increase in the number of respondents to the previously approved information collection, National Human Trafficking Training and Technical Assistance Center (NHTTAC) Evaluation Package (OMB #0970-0519, expiration 10/31/2021). This will increase the estimated burden hours from 689 hours to 9,495 hours. In addition, the previously approved SOAR Online participant feedback form has been restructured into a long and a short form to reduce burden for information collected on SOAR Online training participants outside of the NHTTAC learning management system. There are no changes requested to the items on any forms.