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

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.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the opening of a public docket to obtain comment and review of proposed additional data collection fields and reporting requirement modification for reporting of pregnancy success rates from assisted reproductive technology (ART) programs. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA).

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 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.

This document provides the methodology and data sources necessary to determine federal payment amounts for program years 2019 and 2020 to states that elect to establish a Basic Health Program under the Affordable Care Act to offer health benefits coverage to low-income individuals otherwise eligible to purchase coverage through Affordable Insurance Exchanges.

The Department of Health and Human Services is updating its regulations to reflect required annual inflation-related increases to the civil monetary penalties in its regulations, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and is making a technical change to correct an error in the regulation.

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 Airline and Traveler Information Collection: Domestic Manifests and the Passenger Locator Form that enables CDC to collect contact information and facilitate public health follow-up of at-risk travelers in the event a sick person is confirmed on board an aircraft.

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 Management Information Systems for Comprehensive Cancer Control Programs. This information collection aims to facilitate the monitoring of National Comprehensive Cancer Control Program awardee performance and submission of timely and accurate responses to inquiries from Congress and other stakeholders.

The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Evaluation of the Effectiveness of the Training and Education Modules in the North American Fatigue Management Program, which is an observational study evaluating 180 long-haul and regional truck drivers in a naturalistic driving study over eight months. Questionnaires, in-vehicle monitor system, Actigraphy devices, and smartphones will be used in the data collection.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Cardiovascular and Renal 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 Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Office of Minority Health and Health Equity Public Meeting on Strategies to Improve Health Equity Amidst the Opioid Crisis.'' The purpose of this public meeting is to share information and obtain the public's perspectives on the current opioid crisis and how it specifically affects racial and ethnic minority, underrepresented, and underserved populations across the country, approaches to prevent and treat opioid use disorder, and emerging research to improve care, and explore how FDA can support those efforts.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in all phases of development of antiviral drugs for the treatment of chronic hepatitis D virus (HDV) infection. This guidance is intended to provide consistent FDA advice to stakeholders regarding HDV drug development strategies.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Assessing User Fees under the Generic Drug User Fee Amendments of 2017.'' This draft guidance provides stakeholders information regarding the implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) and policies and procedures surrounding its application. This draft guidance revises and replaces FDA's draft guidance for industry entitled ``Assessing User Fees under the Generic Drug User Fee Amendments of 2017,'' published in October 2017.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) reapprove the proposed information collection project: ``Medical Expenditure Panel SurveyInsurance Component.'' This proposed information collection was previously published in the Federal Register on August 8, 2019, and allowed 60 days for public comment. AHRQ received no comments from members of the public. The purpose of this notice is to allow an additional 30 days for public comment.

In accordance with the Federal Advisory Committee Act (FACA), HHS is hereby giving notice that the National Advisory Committee on Rural Health and Human Services (NACRHHS or Committee) has been renewed. The effective date of the renewed charter is October 29, 2019.

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 the Director, Office of Acquisitions and Logistics Management (OALM), Small Business Program Office (SBPO), 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 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 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.

The Food and Drug Administration (FDA or we) is classifying the continuous glucose monitor data management system into class I (general controls). We are taking this action because we have determined that classifying the device into class I (general controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

This final rule rescinds the adopted standard unique health plan identifier (HPID) and the implementation specifications and requirements for its use and the other entity identifier (OEID) and implementation specifications for its use. This final rule also removes the definitions for the ``Controlling health plan'' (CHP) and ``Subhealth plan'' (SHP).

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 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 Xsto BioSciences, Inc. (Xsto), located in San Carlos, California.

The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research (CDER) is proposing to withdraw approval of an abbreviated new drug application (ANDA) for trandolapril tablets and is announcing an opportunity for the holder of the ANDA to request a hearing on this proposal. The basis for the proposal is that the holder of the ANDA has repeatedly failed to submit the required data to support a finding of bioequivalence for this ANDA.

The Food and Drug Administration (FDA or we) is issuing this final rule to revise the type size labeling requirements when front-of- pack (FOP) labeling is used to meet the calorie declaration requirements for articles of food sold from glass-front vending machines. We are taking this action to reduce the regulatory burden on industry, increase flexibility for the labeling of certain articles of food sold from glass-front vending machines, and ensure that consumers continue to have visible FOP calorie information for articles of food at the point of purchase.

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 Data Collection for the Residential Care Community and Adult Day Services Center Components of the National Post-Acute and Long-Term Care Study. The purpose is to collect data for the residential care community and adult day services center components for the 2020 wave of the National Post-Acute and Long-Term Care Study (formerly the National Study of Long-Term Care Providers).

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 CDC Ideation Catalyst (I- Catalyst) Program and Customer Engagement Information Collection. CDC will collect qualitative information from potential customers and other stakeholders about their needs and preferred approaches to solving public health problems. Findings will be used to improve customer satisfaction with, and usability of, CDC's products, programs, and services.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for FDA staff and industry entitled ``Drug Products Labeled as Homeopathic.'' The revised draft guidance, like the original version, describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval that potentially pose higher risk to public health. In response to comments received, we have revised the draft guidance and are reissuing it in draft form to enable the public to review and comment before it is finalized.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Postmarketing Studies and Clinical TrialsImplementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance revises the guidance for industry of the same name issued April 1, 2011. The draft guidance is being revised to describe the multiple factors that FDA considers, before requiring a postmarketing study or clinical trial for the purposes described in the Federal Food, Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes. The draft guidance is also being revised to reflect certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act as they relate to postmarketing studies and clinical trials.

The Food and Drug Administration (FDA or the Agency) is announcing its intent to exempt a list of class II devices from premarket notification requirements, subject to certain limitations. The Agency has determined that, based on established factors, these devices no longer require premarket notification to provide reasonable assurance of safety and effectiveness. FDA is publishing this notice to obtain comments regarding the proposed exemptions, in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The Food and Drug Administration (FDA or we) is classifying the internal therapeutic massager into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the internal therapeutic massager's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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 for the guidance on planning for the effects of high absenteeism to ensure availability of medically necessary drug products.

The Food and Drug Administration's (FDA or the Agency) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient/ parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information).

The Food and Drug Administration (FDA or Agency) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA).

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 to 80 room seats and 100 ports for audio phone lines. Time will be available for public comment. The public is welcome to submit written comments in advance of the meeting. Comments should be submitted in writing by email to the contact person listed below. The deadline for receipt is Monday, December 9, 2019. Persons who desire to make an oral statement, may request it at the time of the public comment period on December 11, 2019 at 11:40 a.m., EST.

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

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control, (BSC, NCIPC). This meeting is open to the public limited only by the space and ports available. The meeting room accommodates 70 participants and there will be 2,000 ports available. Due to the limited availability of meeting space, we are encouraging the pubic to please register using the link provided: https://www.surveymonkey.com/r/TPPT2T2. There will be public comment periods at the end of each meeting day; from 3:35 p.m.-4:05 p.m. on December 4, 2019 and from 10:40 a.m.- 10:55 a.m. on December 5, 2019.

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Breast Implants Certain Labeling Recommendations to Improve Patient Communication.'' This draft guidance contains recommendations concerning the content and format for certain labeling information for saline and silicone gel- filled breast implants. FDA is seeking comments on all aspects of the draft guidance, including the respective benefits and risks of smooth and textured breast implants and applicability of the recommendations to both types. This draft guidance is not final nor is it in effect at this time.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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) 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, Medicare, Medicaid, and the Children's Health Insurance Program (CHIP). This meeting is open to the public.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

The Food and Drug Administration (FDA or Agency) has determined that PROAMATINE (midodrine hydrochloride) tablets, 2.5 milligrams (mg), 5 mg, and 10 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for midodrine hydrochloride tablets, 2.5 mg, 5 mg, and 10 mg, if all other legal and regulatory requirements are met.

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.

In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, Office of Infectious Diseases (BSC, OID). This meeting is open to the public, limited only by the space available; the meeting room will accommodate up to 100 people. The public is also welcome to listen to the meeting by telephone, limited only by the number of ports available (100); the toll-free dial-in number is 1-877-951-7311, with a pass code of 5421098.

This notice announces the request for nominations for membership on the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). Among other duties, the MEDCAC provides advice and guidance to the Secretary of the Department of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) concerning the adequacy of scientific evidence available to CMS in making coverage determinations under the Medicare program. The MEDCACs fundamental purpose is to support the principles of an evidence-based determination process for Medicare's coverage policies. MEDCAC panels provide advice to CMS on the strength of the evidence available for specific medical treatments and technologies through a public, participatory, and accountable process.

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled ``Health Canada and U.S. Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).'' The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Singapore scheduled for November 16 through November 20, 2019. The topics to be addressed at the public meeting are the current ICH guideline topics under development that will be discussed at the forthcoming ICH Assembly Meeting in Singapore.

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 Standardized National Hypothesis Generating Questionnaire. The information collected will be used to define a core set of data elements to be used for hypothesis generation once a given situation is determined to be a multistate foodborne outbreak investigation.

This document corrects the information provided for [Document Identifier: CMS-10344] titled ``Elimination of Cost-Sharing for Full Benefit Dual Eligible Individuals Receiving Home and Community-Based Services.''

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.