Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.'' This guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device investigational device exemption (IDE) applications, premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, evaluation of automatic class III designations (De Novo requests), premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications, Dual 510(k) and CLIA Waiver by Application Submissions, Accessory Classification Requests, and certain investigational new drug (IND) applications and biologics license applications (BLAs).
Medicare Program; Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures
This final rule revises the regulations setting forth the appeals process that Medicare beneficiaries, providers, and suppliers must follow in order to appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B or determinations for prescription drug coverage under Part D. These changes help to streamline the appeals process and reduce administrative burden on providers, suppliers, beneficiaries, and appeal adjudicators. These revisions, which include technical corrections, also help to ensure the regulations are clearly arranged and written to give stakeholders a better understanding of the appeals process.
Advisory Committee; Medical Imaging Drugs Advisory Committee; Renewal
The Food and Drug Administration (FDA) is announcing the renewal of the Medical Imaging 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 Medical Imaging Drugs Advisory Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 18, 2021.
Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.
Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Attention Deficit Hyperactivity Disorder: Developing Stimulant Drugs for Treatment.'' The purpose of this draft guidance is to assist sponsors in the clinical development of stimulant drugs for treatment of attention deficit hyperactivity disorder (ADHD) in pediatric and adult patients. Specifically, this draft guidance addresses the Agency's current recommendations regarding the development programs for methylphenidate and amphetamine products, as well as for novel (i.e., new molecular entity (NME)) stimulant drugs.
Submission for OMB Review; Child Care and Development Fund Plan for Tribes for FY 2020-2022 (ACF-118A)
The Administration for Children and Families (ACF) is requesting revision of the ACF-118A (OMB # 0970-0198, with expiration 06/30/2019), with minor modifications.
Medicaid Program; Reassignment of Medicaid Provider Claims
This final rule removes the regulatory text that allows a state to make Medicaid payments to third parties on behalf of an individual provider for benefits such as health insurance, skills training, and other benefits customary for employees. We have concluded that this provision is neither explicitly nor implicitly authorized by the statute, which identifies the only permissible exceptions to the rule that only a provider may receive Medicaid payments. As we noted in our prior rulemaking, section 1902(a)(32) of the Social Security Act (the Act) provides for a number of exceptions to the direct payment requirement, but it does not authorize the agency to create new exceptions.
Request for Information Regarding State Relief and Empowerment Waivers
This request for information (RFI) solicits public comment on ideas for innovative programs and waiver concepts that states could consider in developing a 1332 waiver plan. The Department of the Treasury and the Centers for Medicare & Medicaid Services in the Department of Health and Human Services (collectively, the Departments) are seeking feedback and ideas on how states might take advantage of new flexibilities provided in recently published October 2018 guidance. The overarching goal of section 1332 waivers is to give all Americans the opportunity to gain high value and affordable health coverage regardless of income, geography, age, gender, or health status while empowering states to develop health coverage strategies that best meet the needs of their residents. The Departments are committed to empowering states to innovate in ways that will strengthen their health insurance markets, expand choices of coverage, target public resources to those most in need, and meet the unique circumstances of each state.
Request for Information (RFI): Developing an STD Federal Action Plan
To help inform the development of the Sexually Transmitted Diseases (STD) Federal Action Plan, HHS seeks input from stakeholders on what strategies can be implemented by federal agencies to improve the efficiency, effectiveness, coordination, accountability, and impact of our national response to increasing rates of STDs.
National Toxicology Program Board of Scientific Counselors; Announcement of Meeting; Request for Comments
This notice announces the next meeting of the National Toxicology Program (NTP) Board of Scientific Counselors (BSC). The BSC, a federally chartered, external advisory group composed of scientists from the public and private sectors, will review and provide advice on programmatic activities. The meeting is open to the public and registration is requested for both attendance and oral comment and required to access the webcast. Information about the meeting and registration are available at http://ntp.niehs.nih.gov/go/165.
Prospective Grant of Exclusive Patent License: Scopolamine Therapeutics for Depression and Bipolar Disorder
The National Institute of Mental Health (NIMH), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Repurposed Therapeutics, Inc. (``Repurposed Therapeutics'') located in Tampa, Florida, to practice the inventions embodied in the patent application listed in the Supplementary Information section of this notice.
List of Patient Preference-Sensitive Priorities; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing the availability of the list of patient preference-sensitive priorities on FDA's website entitled, ``Patient Preference-Sensitive Areas: Using Patient Preference Information (PPI) in Medical Device Evaluation.'' As part of FDA's commitments for the reauthorization of the Medical Device User Fee Amendments of 2017 (MDUFA IV), the Center for Devices and Radiological Health (CDRH) committed to publish a list of priority areas where preference-sensitive data can inform regulatory decision making. FDA is also establishing a docket to solicit public input on this list of preference-sensitive areas that may impact the design and conduct of premarket medical device clinical studies, benefit-risk assessments, and postmarket evaluation.
Proposed Information Collection Activity; Procedures for Requests From Tribal Lead Agencies To Use Child Care and Development Fund (CCDF) Funds for Construction or Major Renovation of Child Care Facilities (OMB #0970-0160)
The Administration for Children and Families (ACF) is requesting proposed revisions with a three-year extension to an approved information collection: Procedures for Requests from Tribal Lead Agencies to use Child Care and Development Fund (CCDF) Funds for Construction or Major Renovation of Child Care Facilities (OMB #: 0970- 0160, expiration date: 9/30/2019).
Proposed Information Collection Activity; Comprehensive Child Welfare Information System
The Administration for Children and Families (ACF) is requesting a revision of the CCWIS information collection authorized by the CCWIS Final Rule (81 FR 35450-35482). The Automated Function List and the Data Quality Plan are revised to be annual submissions of updates with no change to the burden hours per year. Initial submission of the Automated Function List, the Data Quality Plan, and the Notice of Intent have been removed, as we do not expect to receive more than the Paperwork Reduction Act (PRA) threshold in a single year. There are no required instruments associated with this data collection.
Request for Public Comment: 60 Day Information Collection: Indian Health Service Forms To Implement the Privacy Rule
In compliance with the Paperwork Reduction Act of 1995, the Indian Health Service (IHS) invites the general public to comment on the information collection titled, ``IHS Forms to Implement the Privacy Rule'' Office of Management and Budget (OMB) Control Number 0917-0030. This previously approved information collection project was last published in the Federal Register (81 FR 15347) on March 22, 2016, and allowed 30 days for public comment. No public comment was received in response to the notice. This notice announces our intent to submit the collection, which expires August 31, 2019, to OMB for approval of an extension, and to solicit comments on specific aspects of the information collection. A copy of the supporting statement is available at www.regulations.gov (see Docket ID IHS-2016-1). Title of Collection: 0917-0030, IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164). Type of Information Collection Request: Extension of the currently approved information collection, 0917-0030, IHS Forms to Implement the Privacy Rule (45 CFR parts 160 & 164). Form(s): IHS-810, IHS-912-1, IHS-912-2, IHS-913, and IHS-917. Need and Use of Information Collection: This collection of information is made necessary by the Department of Health and Human Services Rule entitled ``Standards for Privacy of Individually Identifiable Health Information'' (Privacy Rule) (45 CFR parts 160 and 164). The Privacy Rule implements the privacy requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996, creates national standards to protect individual's personal health information, and gives patients increased access to their medical records. 45 CFR 164.508, 164.522, 164.526 and 164.528 of the Rule require the collection of information to implement these protection standards and access requirements. The IHS will continue to use the following data collection instruments to meet the information collection requirements contained in the Rule. 45 CFR 164.508: This provision generally requires covered entities to obtain or receive a valid authorization for its use or disclosure of protected health information, unless otherwise permitted or required by the Privacy Rule. (See, e.g., 45 CFR 164.506 for a common exception to this general rule, which involves uses and disclosure for treatment, payment, or healthcare operations.) Individuals may initiate a written authorization permitting covered entities to release their protected health information to entities of their choosing. The form IHS-810 ``Authorization for Use or Disclosure of Protected Health Information'' is used to document an individual's authorization to use or disclose their protected health information. 45 CFR 164.522: Section 164.522(a)(1) requires a covered entity to permit individuals to request that the covered entity restrict the use and disclosure of their protected health information. The covered entity may or may not agree to the restriction, and with a limited exception, a covered entity is not required to agree to a requested restriction. 45 CFR 164.522(a)(1)(vi). The form IHS-912-1 ``Request for Restrictions(s)'' is used to document an individual's request for restriction of their protected health information, and whether the IHS agreed or disagreed with the restriction. Section 164.522(a)(2) permits a covered entity to terminate its agreement to a restriction under certain conditions. For example, termination may occur if the individual agrees to or requests the termination in writing. 45 CFR 164.522(a)(2)(i). The form IHS-912-2 ``Request for Revocation of Restriction(s)'' is used to document the individual's request, the individual's agreement, and/or the agency's decision to terminate a formerly agreed to restriction regarding the use and disclosure of protected health information. 45 CFR 164.528: This provision requires covered entities to provide an accounting of certain disclosures of protected health information made by the covered entity. See also, 45 CFR 5b.9(c). The form IHS-913 ``Request for an Accounting of Disclosures'' is used to document an individual's request for an accounting of disclosures of their protected health information and the agency's handling of the request. 45 CFR 164.526: Under this provision, individuals have a right to amend protected health information or a record about the individual in a designated record set, under certain conditions. 45 CFR 164.526(a). This provision further requires covered entities to permit an individual to request that the covered entity amend protected health information. 45 CFR 164.526(b). The covered entity must inform the individual if the covered entity accepts the requested amendment, in whole or in part. The covered entity must provide the individual with a written denial containing certain information if the covered entity denies the requested amendment, in whole or in part. 45 CFR 164.526(d)(1). The form IHS-917 ``Request for Correction/Amendment of Protected Health Information'' will be used to document an individual's request to amend his/her protected health information and the agency's decision to accept or deny the request. Completed forms used in this collection of information are filed in the IHS medical, health and billing record, a Privacy Act System of Records Notice. Affected Public: Individuals and households. Type of Respondents: Individuals. Burden Hours: The table below provides for this information collection: types of data collection instruments, estimated number of respondents, number of responses per respondent, average burden hour per response, and total annual burden hour(s).
Medicare Program; Administrative Law Judge Hearing Program for Medicare Claim and Entitlement Appeals; Quarterly Listing of Program Issuances-January Through March 2019
This quarterly notice lists the OMHA Case Processing Manual (OCPM) instructions that were published from January through March 2019. This manual standardizes the day-to-day procedures for carrying out adjudicative functions, in accordance with applicable statutes, regulations, and OMHA directives, and gives OMHA staff direction for processing appeals at the OMHA level of adjudication.
21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and to the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Notice of 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 ULTOMIRIS (ravulizumab-cwvz) approved December 21, 2018, meets the redemption criteria.
Meeting of the Community Preventive Services Task Force (CPSTF)
The Centers for Disease Control and Prevention within the Department of Health and Human Services announces the next meeting of the Community Preventive Services Task Force (CPSTF) on June 12-13, 2019, in Atlanta, Georgia.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals
We are proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2020 and to implement certain recent legislation. We also are proposing to make changes relating to Medicare graduate medical education (GME) for teaching hospitals and payments to critical access hospital (CAHs). In addition, we are proposing to provide the market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2020. We are proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2020. In this proposed rule, we are including proposals to address wage index disparities between high and low wage index hospitals; to provide for an alternative IPPS new technology add-on payment pathway for certain transformative new devices; and to revise the calculation of the IPPS new technology add-on payment. In addition, we are requesting public comments on the substantial clinical improvement criterion used for evaluating applications for both the IPPS new technology add-on payment and the OPPS transitional pass- through payment for devices, and we discuss potential revisions that we are considering adopting as final policies related to the substantial clinical improvement criterion for applications received beginning in FY 2020 for IPPS (that is, for FY 2021 and later new technology add-on payments) and beginning in CY 2020 for the OPPS. We are proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). We also are proposing to establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. We are proposing to update policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.
Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients; Public Workshop; Request for Comments
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Antiviral Drugs for the Treatment of Adenoviral Infection in Immunocompromised Patients.'' The purpose of the public workshop is to discuss the scientific and clinical trial design considerations for development of antiviral products to treat adenoviral infection.
National Biodefense Science Board: In-Person Meeting
The HHS Office of the Secretary is hosting the National Biodefense Science Board (NBSB) at an In-Person Meeting in Washington, DC, on June 10-11, 2019. The purpose of the NBSB In-Person Meeting is to gather 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.
Medicare Program; Accrediting Organizations-Changes to Change of Ownership
This proposed rule would add requirements and a specified process to address changes of ownership as they relate to the sale, transfer, and/or purchase of assets of Accrediting Organizations (AOs) with the Centers for Medicare & Medicaid Services (CMS)-approved accreditation programs. This change is intended to provide CMS the ability to receive notice when an AO is contemplating undergoing or negotiating a change of ownership and the ability to review the AO's capability to perform its tasks after a change of ownership has occurred, in order to insure the ongoing effectiveness of the approved accreditation program(s) and to minimize risk to patient safety.
Preparation for International Cooperation on Cosmetics Regulation Thirteenth Annual Meeting; Public Meeting
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``International Cooperation on Cosmetics Regulation (ICCR)Preparation for ICCR-13 Meeting.'' The purpose of the public meeting is to invite public input on various topics pertaining to the regulation of cosmetics. We may use this input to help us prepare for the ICCR-13 meeting that will be held July 9 to 11, 2019, in Montreal, Canada.