Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of vouchers as well as the approval of products redeeming a voucher. FDA has determined that AJOVY (fremanezumab-vfrm), approved September 14, 2018, meets the redemption criteria.
Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that a meeting is scheduled to be held for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (Advisory Council). The meeting will be open to the public; a public comment session will be held during the meeting. Pre-registration is required for members of the public who wish to attend the meeting and who wish to participate in the public comment session. Individuals who wish to attend the meeting and/or send in their public comment via email should send an email to CARB@hhs.gov. Registration information is available on the website http://www.hhs.gov/ash/carb/ and must be completed by January 23, 2019; all in-person attendees must pre-register by this date. Additional information about registering for the meeting and providing public comment can be obtained at http://www.hhs.gov/ash/carb/ on the Meetings page.
Notice of Request for Information; A Notice by the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria
The Presidential Advisory Council on Combating Antibiotic- Resistant Bacteria (Advisory Council) requests information from the general public and stakeholders related to efforts and strategies to combat Antibiotic Resistance (AR). Given the evolution of AR and the long-term nature of the problem, the Secretary of Health and Human Services (HHS) tasked the Advisory Council with identifying significant areas that have emerged since the release of the National Action Plan (NAP) for Combatting Antibiotic-Resistant Bacteria (CARB) in 2015. To aid in the process of developing its response to the Secretary's task, the Advisory Council has posted this Request for Information (RFI) to hear from a wide range of stakeholders and sectors relevant to the overall CARB effort. This RFI offers the opportunity for the public, including interested individuals, organizations, associations, industries, and others, to provide their input on new priority areas within each of the five goals of the NAP that should be considered by the United States Government (USG) for 2020-2025. Responses to the RFI must be received by 11:59 p.m. on January 7, 2019 to be considered. The questions in the RFI are available through an online form on the Advisory Council's web page at www.hhs.gov/ash/ carb. Individuals unable to submit their answers using the online platform should send an email to CARB@hhs.gov, indicating ``RFI Response'' in the subject line, along with the corresponding goal number(s) for which they are responding.
Medicare Program; Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; Provisions From the Medicare Shared Savings Program Accountable Care OrganizationsPathways to Success; and Expanding the Use of Telehealth Services for the Treatment of Opioid Use Disorder Under the Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act
This major final rule addresses changes to the Medicare physician fee schedule (PFS) and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services, as well as changes in the statute. This final rule also finalizes policies included in the interim final rule with comment period in ``Medicare Program; CY 2018 Updates to the Quality Payment Program; and Quality Payment Program: Extreme and Uncontrollable Circumstance Policy for the Transition Year'' that address the extreme and uncontrollable circumstances MIPS eligible clinicians faced as a result of widespread catastrophic events affecting a region or locale in CY 2017, such as Hurricanes Irma, Harvey and Maria. In addition, this final rule addresses a subset of the changes to the Medicare Shared Savings Program for Accountable Care Organizations (ACOs) proposed in the August 2018 proposed rule ``Medicare Program; Medicare Shared Savings Program; Accountable Care OrganizationsPathways to Success''. This final rule also addresses certain other revisions designed to update program policies under the Shared Savings Program. The interim final rule implements amendments made by the SUPPORT for Patients and Communities Act to the Medicare telehealth provisions in the Social Security Act and regarding permissible telehealth originating sites for purposes of treatment of a substance use disorder or a co-occurring mental health disorder for telehealth services furnished on or after July 1, 2019 to an individual with a substance use disorder diagnosis.
Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities
The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee's 2019 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.
Charter Renewal of the Advisory Committee on Blood and Tissue Safety and Availability
The Department of Health and Human Services is hereby giving notice that the charter for the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) has been renewed.
Fiscal Year (FY) 2019 Funding Opportunity
This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $500,000 (total costs) for up to five years to CADCA for the National Anti-Drug Coalitions Training and Workforce Development Grant. Under this initiative, CADCA will provide training to state and community prevention leaders, including members of anti-drug community coalitions from around the country who are committed to addressing the evolving needs of the behavioral health field, and promote workforce development. Training and workforce development activities supported through this grant include SAMHSA's Prevention Day, the CADCA National Leadership Forum, and CADCA's Mid-Year Training Institute. These activities aim to disseminate knowledge and transfer state-of-the-art information, assisting state and community leaders in developing and implementing evidence-based programs, practices, and policies aligned with the 21st Century Cures Act, the Comprehensive Addition and Recovery Act, the President's Commission on combating drug addiction and the opioid crisis, and other national substance abuse prevention goals, outcomes, and efforts, including underage drinking prevention. This is not a formal request for applications. Assistance will be provided only to CADCA based on the receipt of a satisfactory application that is approved by an independent review group. Funding Opportunity Title: SP-19-002. Catalog of Federal Domestic Assistance (CFDA) Number: 93.243. Authority: Section 516 of the Public Health Services Act, as amended.
Use of the Names of Dairy Foods in the Labeling of Plant-Based Products; Extension of Comment Period
The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of September 28, 2018. In the notice, FDA invited interested parties to provide information on specific topics related to the labeling of plant-based products with names that include the names of dairy foods such as ``milk,'' ``cultured milk,'' ``yogurt,'' and ``cheese.'' We are extending the comment period to give interested parties more time to comment.
Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2019 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, we are updating the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey measure under the Hospital Inpatient Quality Reporting (IQR) Program by removing the Communication about Pain questions; and retaining two measures that were proposed for removal, the Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure and Central Line-Associated Bloodstream Infection (CLABSI) Outcome Measure, in the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program beginning with the FY 2021 program year.
Activities Deemed Not To Be Research: Public Health Surveillance, 2018 Requirements
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health, is announcing the availability of a draft guidance document entitled, ``Activities Deemed Not to Be Research: Public Health Surveillance, 2018 Requirements.''
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Chimeric Antigen Receptor (CAR) Therapies for the Treatment of FMS-Like Tyrosine Kinase 3 (FLT3) Expressing Cancers
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 ElevateBio. (``Elevate''), located in Cambridge, MA.
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. to achieve expeditious commercialization of results of federally-funded research and development.
Government-Owned Inventions; Availability for Licensing
The invention listed below is owned by an agency of the U.S. Government and is available for licensing.
Determination That REGITINE (Phentolamine Mesylate) Injection, 5 Milligrams/Vial, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR). This meeting is open to the public, limited only by available seating. The meeting room accommodates approximately 60 people. The public is also welcome to listen to the meeting by calling 800-619-8521, passcode 7019704, limited by 100 lines. The deadline for notification of attendance is December 3, 2018. The public comment period is scheduled on December 12, 2018 from 2:30 p.m. until 2:45 p.m., EST and December 13, 2018 from 10:10 a.m. until 10:25 a.m., EST. Individuals wishing to make a comment during Public Comment period, please email your name, organization, and phone number by November 30, 2018 to Amanda Malasky at firstname.lastname@example.org.
National Biodefense Science Board Public Teleconference
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services is hereby giving notice that the National Biodefense Science Board (NBSB) will hold a public teleconference on December 13, 2018.
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the Agency's annual report entitled ``Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.'' Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA is required to report annually on the status of postmarketing requirements (PMRs) and postmarketing commitments (PMCs) required of, or agreed upon by, application holders of approved drug and biological products. The report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct is on the FDA's ``Postmarketing Requirements and Commitments: Reports'' web page (https://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/Post- marketingPhaseIVCommitments/ucm064436.htm).
Meeting of the Advisory Committee on Infant Mortality
The Advisory Committee on Infant Mortality (ACIM) has scheduled a public meeting.
National Vaccine Injury Compensation Program: Revised Amount of the Average Cost of a Health Insurance Policy
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).
Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued Approval of Its Ambulatory Surgical Center Accreditation Program
This final notice announces our decision to approve the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for continued recognition as a national accrediting organization for ambulatory surgical centers (ASCs) that wish to participate in the Medicare or Medicaid programs.
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2019
This notice announces a $586.00 calendar year (CY) 2019 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, 2019 and on or before December 31, 2019.
Solicitation of Nominations for Appointment to the Tick-Borne Disease Working Group
This notice will serve to announce that the U.S. Department of Health and Human Services (HHS) is seeking nominations of non-federal individuals who represent diverse scientific disciplines and views and are interested in being considered for appointment to the Tick-Borne Disease Working Group (Working Group). Resumes or curricula vitae from qualified individuals who wish to be considered for appointment as a member of the Working Group are currently being accepted.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA or Agency) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) and humanitarian device exemption applications (HDEs), that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the internet and the Agency's Dockets Management Staff.
Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: MCH Jurisdictional Survey Instrument for the Title V MCH Block Grant Program, OMB No. 0906-XXXX, New
In compliance with the requirement of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, 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, or any other aspect of the ICR related to the Maternal and Child Health (MCH) Jurisdictional Survey that is to be administered in the U.S. territories and jurisdictions (excluding the District of Columbia) for purposes of collecting information related to the well-being of all mothers, children, and their families.
Medicare and Medicaid Programs; Continued Approval of the Community Health Accreditation Partner's Hospice Accreditation Program
This final notice announces our decision to approve the Community Health Accreditation Partner (CHAP) 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 (CoPs).
Findings of Research Misconduct
Notice is hereby given that on October 22, 2018, the U.S. Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on an Administrative Law Judge's finding of research misconduct against Rakesh Srivastava, Ph.D., former Eminent Scholar and Professor, University of Kansas Medical Center (KUMC). Dr. Srivastava engaged in research misconduct in research proposed or reported in grant application 1 R01 CA175776-01, submitted to the National Cancer Institute (NCI), National Institutes of Health (NIH), on June 5, 2012. The administrative actions, including two (2) years of debarment, were implemented beginning on October 22, 2018, and are detailed below.
Electronic Submission of Adverse Event Reports to the Food and Drug Administration Adverse Event Reporting System Using International Council for Harmonisation E2B(R3) Standards; Public Meetings; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing three public meetings entitled ``Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) Using International Council for Harmonisation (ICH) E2B(R3) Standards.'' The purpose of these public meetings is to provide the pharmaceutical industry and other interested parties with information on the plans, progress, and technical specifications to upgrade electronic submission standards for drug, biological, and drug/ biologic-led combination products for the premarket and postmarket safety surveillance programs managed by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER). These meetings will focus on enhancements to electronic submission of Individual Case Safety Reports (ICSRs) in FAERS using ICH E2B(R3) standards. FDA is seeking input from stakeholders as it fulfills its commitment to implement ICH E2B(R3) standards by holding three public meetings. FDA will use the information provided by the public to inform the enhancements to FAERS required for the implementation of ICH E2B(R3) standards and relevant regional variations.