Department of Health and Human Services December 2017 – Federal Register Recent Federal Regulation Documents

Results 201 - 250 of 254
Fostering Digital Health Innovation: Developing the Software Precertification Program; Public Workshop; Request for Comments
Document Number: 2017-26457
Type: Notice
Date: 2017-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Fostering Digital Health Innovation: Developing the Software Precertification Program.'' The purpose of the public workshop is to discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program. In its Digital Health Innovation Action Plan and as part of the Medical Device User Fee Amendments, FDA has committed to explore opportunities to establish streamlined regulatory pathways tailored for digital health technologies that take into account real world evidence while incorporating principles established through international harmonization.
Request for Information on the Office of Disease Prevention Strategic Plan for Fiscal Years (FY) 2019-2023
Document Number: 2017-26453
Type: Notice
Date: 2017-12-08
Agency: Department of Health and Human Services, National Institutes of Health
This Request for Information (RFI) is intended to gather broad public input on the FY 2019-2023 Strategic Plan for the Office of Disease Prevention (ODP) in the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI), National Institutes of Health (NIH). The ODP invites input from prevention researchers in academia and industry, health care professionals, patient advocates and advocacy organizations, scientific or professional organizations, federal agencies, and other interested members of the public. Organizations are strongly encouraged to submit a single response that reflects the views of their organization and membership as a whole.
Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-26442
Type: Notice
Date: 2017-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act.'' This draft guidance provides clarity on FDA's current thinking regarding changes made by the 21st Century Cures Act (Cures Act) to the definition of a medical device and the resulting effect on guidances related to medical device software. This draft guidance is not final nor is it in effect at this time.
Software as a Medical Device: Clinical Evaluation; International Medical Device Regulators Forum; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-26441
Type: Notice
Date: 2017-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Software as a Medical Device (SaMD): Clinical Evaluation.'' This guidance was prepared as part of the FDA's international convergence efforts under the auspices of the International Medical Device Regulators Forum (IMDRF), formerly the Global Harmonization Task Force. The guidance, informed by global and U.S. public comments, pertains to Software as a Medical Device (SaMD) and focuses on principles of clinical evaluation, which include establishing the scientific validity, clinical performance, and analytical validity for SaMD. The guidance is intended to provide globally harmonized principles of when and what type of clinical evaluation is appropriate based on the risk of the SaMD.
Oncology Center of Excellence Listening Session; Public Meeting; Request for Comments
Document Number: 2017-26440
Type: Notice
Date: 2017-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled ``Oncology Center of Excellence (OCE): Listening Session.'' The purpose of the public meeting and the docket for comments is for stakeholders to provide recommendations to the Agency regarding FDA's OCE. Specifically, the Agency solicits comments regarding what stakeholders desire of the OCE in terms of structure, function, regulatory purview, and activity.
Clinical and Patient Decision Support Software; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-26439
Type: Notice
Date: 2017-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Clinical and Patient Decision Support Software.'' This draft guidance provides clarity on the scope of FDA's oversight of clinical decision support software intended for healthcare professionals, and patient decision support software intended for patients and caregivers who are not healthcare professionals. This draft guidance is not final nor is it in effect at this time.
Prescription Drug User Fee Act VI Commitment To Assess Current Practices of the Food and Drug Administration and Sponsors in Communicating During Investigational New Drug Development; Establishment of a Public Docket; Request for Comments
Document Number: 2017-26437
Type: Notice
Date: 2017-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the statement of work to assess current practices of FDA and sponsors in communicating during investigational new drug (IND) development and identify best practices and areas of improvement. The independent assessment is part of FDA performance commitments under the recent reauthorization of the Prescription Drug User Fee Act (PDUFA). The independent assessment of current practices of FDA and sponsors in communicating during drug development is described in detail in the document entitled ``PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022'' available at https://www.fda.gov/downloads/forindustry/ userfees/prescriptiondruguserfee/ucm511438.pdf. As part of FDA performance commitments described in this document, the assessment will be conducted by an independent contractor. FDA is providing for public comment on the statement of work before revising and requesting contractor proposals.
Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin; Draft Guidance for Industry; Availability; Extension of Comment Period
Document Number: 2017-26436
Type: Notice
Date: 2017-12-08
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of October 3, 2017. In the notice of availability, FDA requested comments on the draft guidance for industry entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.'' The Agency is taking this action in response to public interest in the draft guidance and to allow interested persons additional time to submit comments.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2017-26399
Type: Notice
Date: 2017-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Draft-National Occupational Research Agenda for Traumatic Injury Prevention
Document Number: 2017-26359
Type: Notice
Date: 2017-12-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of a draft NORA Agenda entitled National Occupational Research Agenda for Traumatic Injury Prevention for public comment. To view the notice and related materials, visit https:// www.regulations.gov. and enter CDC-2017-0104 in the search field and click ``Search.''
Pediatric Rare Diseases-A Collaborative Approach for Drug Development Using Gaucher Disease as a Model; Draft Guidance for Industry; Availability
Document Number: 2017-26357
Type: Notice
Date: 2017-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Pediatric Rare DiseasesA Collaborative Approach for Drug Development Using Gaucher Disease as a Model.'' This draft guidance focuses on drug development for pediatric patients with Gaucher disease. In particular, it proposes for consideration a novel approach to improve the efficiency of drug development in pediatric rare diseases using Gaucher disease as an example. The emergence of concomitant trials for multiple investigational drug products for the treatment of rare diseases can pose significant challenges to effective drug development, because there are limited numbers of patients for any given rare condition worldwide. This approach discusses the feasibility of the development of multiple drug products in a time-efficient manner while minimizing the number of patients necessary to be treated with placebo.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Safety Survey
Document Number: 2017-26356
Type: Notice
Date: 2017-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, Agency, or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request
Document Number: 2017-26353
Type: Notice
Date: 2017-12-07
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2017-26325
Type: Notice
Date: 2017-12-07
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2017-26324
Type: Notice
Date: 2017-12-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-26323
Type: Notice
Date: 2017-12-07
Agency: Department of Health and Human Services, National Institutes of Health
Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry; Availability
Document Number: 2017-26226
Type: Notice
Date: 2017-12-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Blood and Blood Components; Guidance for Industry.'' The guidance document provides recommendations to blood collection establishments regarding the use of serological tests to reduce the risk of transmission of Trypanosoma cruzi (T. cruzi) infection in blood and blood components. The recommendations apply to the collection of blood and blood components, except Source Plasma, for transfusion or for use in manufacturing a product, including donations intended as a component of, or used to manufacture, a medical device. The guidance announced in this notice supersedes the guidance entitled ``Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'' dated December 2010 (2010 Chagas Guidance) and finalizes the draft guidance entitled ``Amendment to `Guidance for Industry: Use of Serological Tests to Reduce the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood and Blood Components Intended for Transfusion'; Draft Guidance for Industry'' dated November 2016 (2016 Draft Chagas Guidance). The guidance incorporates recommendations for blood donor testing, deferral, and donor reentry from the 2016 Draft Chagas Guidance.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2017-26210
Type: Notice
Date: 2017-12-06
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Neurological Disorders and Stroke; Notice of Meeting
Document Number: 2017-26209
Type: Notice
Date: 2017-12-06
Agency: Department of Health and Human Services, National Institutes of Health
Review of Existing Regulatory and Information Collection Requirements; Extension of Comment Period
Document Number: 2017-26199
Type: Proposed Rule
Date: 2017-12-06
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the Requests for Comments and Information that appeared in the Federal Register of September 8, 2017. In the Requests for Comments and Information, FDA requested comments and information from interested parties to help FDA identify existing regulations and related paperwork requirements that could be modified, repealed, or replaced, consistent with the law, to achieve meaningful burden reduction while allowing us to achieve our public health mission and fulfill statutory obligations. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2017-26196
Type: Notice
Date: 2017-12-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.'' FDA has developed this leapfrog guidance to provide FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. This guidance outlines technical considerations associated with additive manufacturing processes as well as testing and characterization for final finished devices fabricated using additive manufacturing.
Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid Services With Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff; Availability
Document Number: 2017-26195
Type: Notice
Date: 2017-12-05
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff.'' This guidance modifies the FDA's current policy on categorization of investigational device exemption (IDE) devices, which assists the CMS in determining whether or not an IDE device should be covered (reimbursed) by CMS. On December 2, 2015, FDA's Center for Devices and Radiological Health (CDRH) and CMS's Coverage and Analysis Group (CAG) executed a Memorandum of Understanding (MOU) to streamline and facilitate the efficient categorization of investigational medical devices in order to support CMS's ability to make Medicare coverage (reimbursement) determinations for those devices. This guidance document further explains the framework that FDA intends to follow for such categorization decisions.
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-26190
Type: Notice
Date: 2017-12-05
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-26189
Type: Notice
Date: 2017-12-05
Agency: Department of Health and Human Services, National Institutes of Health
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2017-26151
Type: Notice
Date: 2017-12-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2017-26150
Type: Notice
Date: 2017-12-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2017-26149
Type: Notice
Date: 2017-12-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Statement of Organization, Functions, and Delegations of Authority
Document Number: 2017-26148
Type: Notice
Date: 2017-12-05
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Information Collection Activities; Proposed Collection; Public Comments Request; New Data Collection; National Center on Law and Elder Rights (NCLER)
Document Number: 2017-26116
Type: Notice
Date: 2017-12-05
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from legal and aging/disability service professionals. 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 and to allow 60 days for public comment in response on the proposed action. This notice solicits comments on proposed information collection requirements relating to ACL funded training, case consultation, and technical assistance for aging/disability networks assisting older adults in social or economic need facing legal issues.
Proposed Information Collection Activity; Comment Request
Document Number: 2017-26061
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services, Administration for Children and Families
Site Visit Training Program for Office of Pharmaceutical Quality Staff; Information Available to Industry
Document Number: 2017-26055
Type: Notice
Date: 2017-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Center for Drug Evaluation and Research (CDER) in the Food and Drug Administration (FDA) is announcing the 2018 CDER Office of Pharmaceutical Quality (OPQ) Staff Experiential Learning Site Visit Program. The purpose of this document is to invite pharmaceutical companies interested in participating in this program to submit a site visit proposal to CDER's OPQ.
Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 048
Document Number: 2017-26043
Type: Notice
Date: 2017-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 048'' (Recognition List Number: 048), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Establishing and Maintaining Lists of United States Manufacturers/Processors With Interest in Exporting Center for Food Safety and Applied Nutrition-Regulated Products to China
Document Number: 2017-26042
Type: Notice
Date: 2017-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
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; Public Comment Request; Revision of a Currently Approved Information Collection (OMB Approval Number 0985-0048); State Grants for Assistive Technology Program State Plan for Assistive Technology
Document Number: 2017-26018
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services
The Administration for Community Living (ACL) is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995 (the PRA). This 30-day notice requests comments on the information collection requirements related to a proposed Revision of a Currently Approved Information Collection (ICR-Rev). The revision will allow ACL to continue to collect information necessary to determine grantee compliance with Section 4 of the Assistive Technology Act of 1998, as Amended (AT Act).
Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies
Document Number: 2017-26016
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
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.
Food and Drug Administration Fiscal Year 2017 Performance Review Board Members
Document Number: 2017-26015
Type: Notice
Date: 2017-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the names of the members who will serve on its Performance Review Board (PRB). The purpose of the PRB is to provide fair and impartial review of senior executive service (SES), senior professional and Title 42(f) SES Equivalents performance appraisals, bonus recommendations, and pay adjustments.
Receipt of Notice That a Patent Infringement Complaint Was Filed Against a Biosimilar Applicant
Document Number: 2017-26013
Type: Notice
Date: 2017-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing notice that an applicant for a proposed biosimilar product notified FDA that a patent infringement action was filed in connection with the applicant's biologics license application (BLA). Under the Public Health Service Act (PHS Act), an applicant for a proposed biosimilar product or interchangeable product must notify FDA within 30 days after the applicant was served with a complaint in a patent infringement action described under the PHS Act. FDA is required to publish notice of the complaint in the Federal Register.
Obstetrical and Gynecological Devices; Reclassification of Single-Use Female Condom, To Be Renamed Single-Use Internal Condom
Document Number: 2017-26011
Type: Proposed Rule
Date: 2017-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is proposing to reclassify single-use female condoms, renaming the device to ``single- use internal condom,'' a postamendments class III device (product code MBU), into class II (special controls) subject to premarket notification (510(k)). FDA is also identifying the proposed special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is proposing this reclassification on its own initiative based on new information. FDA is also proposing to amend the existing device identification for ``female condom,'' a preamendments class III device (product code OBY), by renaming the device ``multiple- use female condom,'' to distinguish it from the ``single-use internal condom.'' If finalized, this order will reclassify single-use female condoms from class III to class II and reduce regulatory burdens on industry as these types of devices will no longer be required to submit a premarket approval application (PMA) but can instead submit a less burdensome 510(k) before marketing their device.
National Institute of Nursing Research; Notice of Meeting
Document Number: 2017-25986
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-25985
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2017-25984
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2017-25983
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services, National Institutes of Health
National Center for Advancing Translational Sciences; Notice of Closed Meeting
Document Number: 2017-25982
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-25981
Type: Notice
Date: 2017-12-04
Agency: Department of Health and Human Services, National Institutes of Health
Medicare, Medicaid, and Children's Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2018
Document Number: 2017-25972
Type: Notice
Date: 2017-12-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a $569.00 calendar year (CY) 2018 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, 2018 and on or before December 31, 2018.
Medicare Program; Town Hall Meeting on the FY 2019 Applications for New Medical Services and Technologies Add-On Payments
Document Number: 2017-25971
Type: Notice
Date: 2017-12-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a Town Hall meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss fiscal year (FY) 2019 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2019 new medical services and technologies applications meet the substantial clinical improvement criterion.
Availability of Draft Vessel Sanitation Program (VSP) Operations Manual and VSP Construction Guidelines
Document Number: 2017-25955
Type: Notice
Date: 2017-12-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), within the Department of Health and Human Services (HHS), announces the opening of a public docket to obtain comment on the draft Vessel Sanitation Program (VSP) Operations Manual and the VSP Construction Guidelines. Information about locating these documents can be found in the supporting materials section and on the VSP Web site. VSP established the public health standards found in the VSP Operations Manual and Construction Guidelines to target the control and prevention of gastrointestinal illnesses on cruise ships. The VSP Operations Manual and Construction Guidelines were last updated in 2011. New technology, advanced food science, and emerging pathogens require updates to these documents.
Medicare Program; Cancellation of Advancing Care Coordination Through Episode Payment and Cardiac Rehabilitation Incentive Payment Models; Changes to Comprehensive Care for Joint Replacement Payment Model: Extreme and Uncontrollable Circumstances Policy for the Comprehensive Care for Joint Replacement Payment Model
Document Number: 2017-25979
Type: Rule
Date: 2017-12-01
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final rule cancels the Episode Payment Models (EPMs) and Cardiac Rehabilitation (CR) Incentive Payment Model and rescinds the regulations governing these models. It also implements certain revisions to the Comprehensive Care for Joint Replacement (CJR) model, including: Giving certain hospitals selected for participation in the CJR model a one-time option to choose whether to continue their participation in the model; technical refinements and clarifications for certain payment, reconciliation and quality provisions; and a change to increase the pool of eligible clinicians that qualify as affiliated practitioners under the Advanced Alternative Payment Model (Advanced APM) track. An interim final rule with comment period is being issued in conjunction with this final rule in order to address the need for a policy to provide some flexibility in the determination of episode costs for providers located in areas impacted by extreme and uncontrollable circumstances.
Barr Laboratories, Inc. et al.; Withdrawal of Approval of 68 Abbreviated New Drug Applications
Document Number: 2017-25920
Type: Notice
Date: 2017-12-01
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 68 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Nominations to the Presidential Advisory Council on HIV/AIDS
Document Number: 2017-25915
Type: Notice
Date: 2017-12-01
Agency: Department of Health and Human Services
The Office of the Assistant Secretary for Health (OASH) is seeking nominations of qualified individuals to be considered for appointment as members of the Presidential Advisory Council on HIV/AIDS (PACHA). The PACHA is a federal advisory committee within the Department of Health and Human Services (HHS). Management support for the activities of this Council is the responsibility of the Office of HIV/AIDS and Infectious Disease Policy in the OASH. The qualified individuals will be nominated to the Secretary of Health and Human Services for consideration for appointment as members of the PACHA. Members of the Council, including the Chair, are appointed by the Secretary. Members are invited to serve on the Council for up to four- year terms. The Council was established to provide advice, information, and recommendations to the Secretary regarding programs and policies intended to promote effective prevention and care of HIV infection and AIDS. The functions of the Council are solely advisory in nature.