Health Information Technology Advisory Committee 2019 Schedule
The Health Information Technology Advisory Committee (HITAC) was established in accordance with section 4003(e) of the 21st Century Cures Act and the Federal Advisory Committee Act. The HITAC, among other things, identifies priorities for standards adoption and makes recommendations to the National Coordinator for Health Information Technology (National Coordinator). The HITAC will hold public meetings throughout 2019. See list of public meetings below.
Medicare and Medicaid Programs; Risk Adjustment Data Validation
This document extends the comment period for the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled ``Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021'' that was published in the November 1, 2018 Federal Register. The comment period for the RADV provision of this proposed rule, which would end on April 30, 2019, is extended by 120 days until August 28, 2019. This document also announces that CMS will be releasing additional data underlying the FFS Adjuster Study released October 26, 2018.
Agency Information Collection Request. 30-Day Public Comment Request
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
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.
Administration for Community Living; Notice of Intent To Award a Sole Source Supplement to the Christopher and Dana Reeve Foundation
The Administration for Community Living (ACL) is announcing the award of single-source supplement for the National Paralysis Resource Center (PRC) that was included in the 2019 Congressional budget appropriations. The National Paralysis Resource Center is operated by the Christopher and Dana Reeve Foundation, which offers important programmatic opportunities for persons with disabilities and older adults. The PRC provides comprehensive information for people living with spinal cord injury, paralysis, and mobility-related disabilities and their families. Resources include information and referral by phone and email in multiple languages; a peer and family support mentoring program; a military and veterans program; multicultural outreach services; multiple quality of life grants; and a national website. The administrative supplement for FY2019 will be in the amount of $1,000,000, bring the total award for FY 19 to $7,761,661. Program Name: National Paralysis Resource Center. Recipient: Christopher and Dana Reeve Foundation. Period of Performance: The supplement award will be issued for the second year of a three year project a project period, July 1, 2019 through June 30, 2020. Award Amount: $1,000,000. Award Type: Cooperative Agreement. Statutory Authority: This program is authorized under Section 317 of the Public Health Service Act (42 U.S.C. 247(b-4)); Consolidated and Further Continuing Appropriations Act, 2016, Public Law 114-113 (Dec. 18, 2015). CFDA Number: 93.325 Discretionary Projects.
Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties
This notification is to inform the public that the Department of Health and Human Services (HHS) is exercising its discretion in how it applies HHS regulations concerning the assessment of Civil Money Penalties (CMPs) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as such provision was amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act. Current HHS regulations apply the same cumulative annual CMP limit across four categories of violations based on the level of culpability. As a matter of enforcement discretion, and pending further rulemaking, HHS will apply a different cumulative annual CMP limit for each of the four penalties tiers in the HITECH Act.
Medicare and Medicaid Programs; Quarterly Listing of Program Issuances-January Through March 2019
This quarterly notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2019, relating to the Medicare and Medicaid programs and other programs administered by CMS.
Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The general function of the committees 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; YESCARTA
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for YESCARTA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Detention and Banned Medical Devices
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.
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
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 http:// www.samhsa.gov/workplace.
Unique Device Identification: Convenience Kits; 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 ``Unique Device Identification: Convenience Kits; Guidance for Industry and Food and Drug Administration Staff.'' The unique device identification system regulations require that the label and device package of a device must bear a unique device identifier (UDI), unless an exception or alternative applies. An exception is provided for devices packaged within the immediate container of a convenience kit, if the label of the convenience kit bears a UDI. This guidance document describes FDA's interpretation of the definition of ``convenience kit.'' This guidance does not apply to in vitro diagnostic (IVD) devices that are subject to IVD labeling requirements nor does it apply to combination products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device User Fee Small Business Qualification and Certification
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
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 information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.
Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions; 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 ``Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.'' FDA has developed this document to describe relevant information that should be included in test report summaries, test protocols, and complete test reports for non-clinical bench performance testing provided in a premarket submission (i.e., premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, premarket notification (510(k)) submissions, investigational device exemption (IDE) applications, and De Novo requests).
Characterization of Ultrahigh Molecular Weight Polyethylene Used in Orthopedic Devices; 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 ``Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices.'' The guidance identifies the types of UHMWPE commonly in use in orthopedic implants, as well as the recommended information and testing that should be included in premarket submissions for such devices.
Final Action Under the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
This notice sets forth final changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to streamline oversight for human gene transfer clinical research protocols and reduce duplicative reporting requirements already captured within the existing regulatory framework, as initially outlined by the NIH Office of Science Policy (OSP) in a Federal Register notice issued on August 17, 2018. Following the solicitation of public comment on its original proposal, the NIH is amending the NIH Guidelines to: (A) Delete the NIH protocol registration submission and reporting requirements under Appendix M of the NIH Guidelines, and (B) modify the roles and responsibilities of entities that involve human gene transfer and the Recombinant DNA Advisory Committee (RAC).
Advisory Board on Radiation and Worker Health (ABRWH or the Advisory Board), National Institute for Occupational Safety and Health (NIOSH)
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting of the Advisory Board on Radiation and Worker Health (ABRWH). This meeting is open to the public, but without a public comment period. The public is welcome to submit written comments in advance of the meeting, to the contact person below. Written comments received in advance of the meeting will be included in the official record of the meeting. The public is also welcome to listen to the meeting by joining the audio conference (information below). The audio conference line has 150 ports for callers.
Solicitation of Nominations for Appointment to the Board of Scientific Counselors, National Center for Injury Prevention and Control BSC, NCIPC
The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the BSC, NCIPC. The BSC, NCIPC consists of 18 experts in fields associated with surveillance, basic epidemiologic research, intervention research, and implementation, dissemination, and evaluation of promising and evidence-based strategies for the prevention of injury and violence. Nominations are being sought for individuals who have expertise and qualifications necessary to contribute to the accomplishments of the committee's objectives. Nominees will be selected based on expertise in the fields of pertinent disciplines involved in injury and violence prevention, including, but not limited to, epidemiology, statistics, trauma surgery, rehabilitation medicine, behavioral science/psychology, health economics, program evaluation, political science, law, criminology, informatics and other aspects of injury management. Federal employees will not be considered for membership. Members may be invited to serve for up to four-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of BSC, NCIPC objectives https:// www.cdc.gov/injury/bsc/.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Environmental Information Documentation, OMB No. 0915-0324-Revision
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.
National Vaccine Injury Compensation Program: List of Petitions Received
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. While the Secretary of Health and Human Services 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.
Child Support Program Technical Corrections Notice of Proposed Rulemaking; Correction
This document corrects the regulatory identification number (RIN) that appeared in the heading of a notice of proposed rulemaking published in the Federal Register of December 18, 2018. Through that document, OCSE proposed to eliminate regulations rendered outdated or unnecessary and make technical amendments to the Flexibility, Efficiency, and Modernization in Child Support Enforcement final rule, published on December 20, 2016, including proposing to amend the compliance date for review and adjustment of child support orders.
Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics With Continuous Outcomes; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics with Continuous Outcomes.'' The draft guidance, when finalized, will represent the current thinking of FDA on adjusting for covariates in randomized clinical trials for drugs and biologics, focusing on randomized clinical trials with continuous endpoints.
Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles; Guidance for Government Public Health and Emergency Response Stakeholders; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for government public health and emergency response stakeholders entitled ``Extending Expiration Dates of Doxycycline Tablets and Capsules in Strategic Stockpiles.'' This document provides guidance to government stakeholders on testing to extend the expiration dateunder the Federal Food, Drug, and Cosmetic Act (FD&C Act)of stockpiled doxycycline tablets and capsules for public health emergency preparedness and response purposes for an anthrax emergency. This guidance has been prepared in response to requests from States asking FDA what would be necessary to provide confidence that stockpiled doxycycline tablets and capsules have retained their original quality beyond the manufacturer's labeled expiration date so the replacement of stockpiled product could be deferred. This guidance and any resulting expiration date extensions authorized by FDA do not apply to doxycycline available commercially or otherwise held for any other nonemergency purpose. This guidance finalizes the draft guidance issued in April 2017.
Medicare Program; FY 2020 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements
This proposed rule would update the hospice wage index, payment rates, and cap amount for fiscal year 2020. This rule proposes to rebase the continuous home care, general inpatient care, and the inpatient respite care per diem payment rates in a budget-neutral manner to more accurately align Medicare payments with the costs of providing care. In addition, this rule proposes to modify the election statement by requiring an addendum that includes information aimed at increasing coverage transparency for patient under a hospice election. Finally, this rule proposes changes to the Hospice Quality Reporting Program.
Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities; Updates to the Quality Reporting Program and Value-Based Purchasing Program for Federal Fiscal Year 2020
This proposed rule would update the payment rates used under the prospective payment system (PPS) for skilled nursing facilities (SNFs) for fiscal year (FY) 2020. We also propose minor revisions to the regulation text to reflect the revised assessment schedule under Patient Driven Payment Model (PDPM). Additionally, we propose to revise the definition of group therapy under the SNF PPS, and to implement a subregulatory process for updating the code lists (International Classification of Diseases, Tenth Version (ICD-10) codes) used under PDPM. We are also soliciting comments on stakeholder concerns regarding the appropriateness of the wage index used to adjust SNF payments. In addition, the proposed rule includes proposals for the SNF Quality Reporting Program (QRP) and the SNF Value-Based Purchasing (VBP) Program that will affect Medicare payment to SNFs.
Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2020
This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally- facilitated Exchanges (FFEs) and State-based Exchanges on the Federal Platform (SBE-FPs). It finalizes changes that will allow greater flexibility related to the duties and training requirements for the Navigator program and changes that will provide greater flexibility for direct enrollment entities, while strengthening program integrity oversight over those entities. It finalizes a change intended to reduce the costs of prescription drugs. This final rule also includes changes to Exchange standards related to eligibility and enrollment; exemptions; and other related topics.
Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry; Availability
The Food and Drug Administration (FDA or we) is announcing the availability of an update to the immediately in effect guidance for industry entitled ``Compliance Policy for Combination Product Postmarketing Safety Reporting.'' This guidance describes FDA's compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.
Natural Resources Defense Council et al.: Response to the Objections and Denial of the Requests for a Public Hearing
The Food and Drug Administration (FDA or we) is overruling the objections and is denying the requests for a public hearing, submitted by the Environmental Defense Fund, Natural Resources Defense Council, Center for Food Safety, Clean Water Action, Center for Science in the Public Interest, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group, and Improving Kids' Environment.
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting
The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public.
General and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify surgical staplers for internal use (currently regulated under the classification for ``manual surgical instrument for general use'' and assigned the product code GAG) from class I (general controls) into class II (special controls) and subject to premarket review. FDA is identifying the proposed special controls for surgical staplers for internal use that the Agency believes are necessary to provide a reasonable assurance of the safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. As part of this reclassification, FDA is also proposing to amend the existing classification for ``manual surgical instrument for general use'' to remove staplers and to create a separate classification regulation for surgical staplers that distinguishes between surgical staplers for internal use and external use.
Surgical Staplers and Staples for Internal Use-Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Surgical Staplers and Staples for Internal UseLabeling Recommendations.'' FDA is issuing this draft guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths. This draft guidance is not final nor is it currently in effect.