Department of Health and Human Services July 2018 – Federal Register Recent Federal Regulation Documents

National Committee on Vital and Health Statistics: Meeting
Document Number: 2018-16361
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services
Emergency Use of Treatment for Uncontrolled Hemorrhage Due to Agents of Military Combat; Correction
Document Number: 2018-16331
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services
The Department of Health and Human Services is correcting a notice that appeared in the Federal Register on July 16, 2018. The notice announced the Secretary's Declaration Regarding Emergency Use of Treatment for Uncontrolled Hemorrhage During an Emergency Involving Agents of Military Combat pursuant to section 564 of the Federal Food, Drug & Cosmetic (FD&C) Act. On July 9, 2018, the Secretary declared that circumstances exist justifying the authorization of emergency use of freeze dried plasma (FDP) for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section. This notice is correcting the July 16, 2018 notice to correctly state the Secretary's declaration.
Patient Safety Organizations: Voluntary Relinquishment From Diagnostic Quality Assurance
Document Number: 2018-16327
Type: Notice
Date: 2018-07-31
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Patient Safety Rule authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, when a PSO chooses to voluntarily relinquish its status as a PSO for any reason, or when a PSO's listing expires. AHRQ has accepted a notification of voluntary relinquishment from Diagnostic Quality Assurance of its status as a PSO, and has delisted the PSO accordingly. Diagnostic Quality Assurance, PSO number P0170, submitted this request for voluntary relinquishment after receiving a Notice of Preliminary Finding of Deficiency.
Biosimilar User Fee Rates for Fiscal Year 2019
Document Number: 2018-16312
Type: Notice
Date: 2018-07-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the rates for biosimilar user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development; review of certain applications for approval of biosimilar biological products; and each biosimilar biological product approved in a biosimilar biological product application. BsUFA II directs FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year. These fees apply to the period from October 1, 2018, through September 30, 2019.
Fogarty International Center; Notice of Meeting
Document Number: 2018-16299
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-16297
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-16296
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Meeting
Document Number: 2018-16295
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Meeting
Document Number: 2018-16294
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-16293
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2018-16292
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-16291
Type: Notice
Date: 2018-07-31
Agency: Department of Health and Human Services
Medicare Program: Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Requests for Information on Promoting Interoperability and Electronic Health Care Information, Price Transparency, and Leveraging Authority for the Competitive Acquisition Program for Part B Drugs and Biologicals for a Potential CMS Innovation Center Model
Document Number: 2018-15958
Type: Proposed Rule
Date: 2018-07-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would revise 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 proposed rule, we describe the proposed 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 proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. The proposed rule also includes requests for information on promoting interoperability and electronic health care information exchange, improving beneficiary access to provider and supplier charge information, and leveraging the authority for the Competitive Acquisition Program (CAP) for Part B drugs and biologicals for a potential CMS Innnovation Center model. In addition, we are proposing to modify 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.
Announcement of Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030
Document Number: 2018-16238
Type: Notice
Date: 2018-07-30
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) announces the next meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2030 (Committee). The meeting is open to the public and will be held in the Washington, DC metropolitan area. The Committee is working to accomplish its mission to provide independent advice to the Secretary of the U.S. Department of Health and Human Services or a designated representative for the implementation of Healthy People 2030.
Adoption of the Methodology for the HHS-Operated Permanent Risk Adjustment Program Under the Patient Protection and Affordable Care Act for the 2017 Benefit Year
Document Number: 2018-16190
Type: Rule
Date: 2018-07-30
Agency: Department of Health and Human Services
This final rule adopts the risk adjustment methodology that HHS previously established for the 2017 benefit year. In February 2018, a district court vacated the use of statewide average premium as a basis for the HHS-operated risk adjustment methodology for the 2014, 2015, 2016, 2017, and 2018 benefit years. Accordingly, HHS is issuing this final rule to allow charges to be collected and payments to be made for the 2017 benefit year. We hereby adopt the final rules set out in the publication in the Federal Register on March 23, 2012 and the publication in the Federal Register on March 8, 2016.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types
Document Number: 2018-16189
Type: Notice
Date: 2018-07-30
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.
Medical Device User Fee Rates for Fiscal Year 2019
Document Number: 2018-16178
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2019. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019. To avoid delay in the review of your application, you should pay the application fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is recognized by the U.S. Treasury. If you want to pay a reduced small business fee, you must qualify as a small business before making your submission to FDA; if you do not qualify as a small business before making your submission to FDA, you will have to pay the higher standard fee. Please note that the establishment registration fee is not eligible for a reduced small business fee. As a result, if the establishment registration fee is the only medical device user fee that you will pay in FY 2019, you should not submit a Small Business Certification Request. This document provides information on how the fees for FY 2019 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
Center for Devices and Radiological Health: Experiential Learning Program
Document Number: 2018-16177
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2019 Experiential Learning Program (ELP). This training is intended to provide CDRH and other FDA staff with an opportunity to understand laboratory practices, quality system management, patient perspective/ input, and challenges that impact the medical device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities, and others to participate in this formal training program for CDRH and other FDA staff, or to contact CDRH for more information regarding the ELP.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
Document Number: 2018-16161
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) 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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2018-16156
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications; Temporary Stay of Effective Date
Document Number: 2018-16148
Type: Notice
Date: 2018-07-30
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is providing notice that the effective date of an April 2, 2018, order denying requests for a hearing and withdrawing approval of abbreviated new drug applications (ANDAs) for certain prescription laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350) is stayed until November 2, 2018.
Submission for OMB Review; Comment Request
Document Number: 2018-15987
Type: Notice
Date: 2018-07-30
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Neurological Disorders and Stroke, Muscular Dystrophy Coordinating Committee Call for Committee Membership Nominations
Document Number: 2018-16112
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
The Office of the Secretary of the Department of Health and Human Services (HHS) is seeking nominations for an individual to serve as a nonfederal public member on the Muscular Dystrophy Coordinating Committee.
Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Health Disparities Subcommittee (HDS)
Document Number: 2018-16103
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Advisory Committee to the Director, Centers for Disease Control and PreventionHealth Disparities Subcommittee (ACD, CDC-HDS). This meeting is open to the public, limited only by the 50 audio phone lines. The public is also welcome to listen to the meeting by teleconference. Please dial (866) 918-8397 and enter code 9346283. There are 50 lines available. The public comment period is from 3:15 p.m.-3:20 p.m.
National Center for Health Statistics (NCHS), ICD-10 Coordination and Maintenance (C&M) Committee Meeting
Document Number: 2018-16102
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The CDC, National Center for Health Statistics (NCHS), Classifications and Public Health Data Standards Staff, announces the following meeting of the ICD-10 Coordination and Maintenance (C&M) Committee meeting. This meeting is open to the public, limited only by the space available. The meeting room accommodates approximately 240 people. We will be broadcasting the meeting live via Webcast at hhtp:// www.cms.gov/live/.
Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC)
Document Number: 2018-16101
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
In accordance with the Federal Advisory Committee Act, the CDC announces the following meeting for the Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC).
Notice To Announce Commission of a Surgeon General's Report on Oral Health
Document Number: 2018-16096
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
On behalf of the United States Department of Health and Human Services, the Office of the Surgeon General, the National Institutes of Health, and the National Institute of Dental and Craniofacial Research, the U.S. Public Health Service's Oral Health Coordinating Committee announces the commission of a Surgeon General's Report presenting prominent issues affecting oral health. The report will document progress in oral health in the twenty years since the 2000 Surgeon General's Report on Oral Health, identify existing knowledge gaps, and articulate a vision for the future.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-16091
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-16090
Type: Notice
Date: 2018-07-27
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019
Document Number: 2018-16069
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the fiscal year (FY) 2019 fee rates for certain domestic and foreign facility reinspections, failures to comply with a recall order, and importer reinspections that are authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). These fees are effective on October 1, 2018, and will remain in effect through September 30, 2019.
Generic Drug User Fee Rates for Fiscal Year 2019
Document Number: 2018-16067
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the Food and Drug Administration (FDA, Agency, or we) to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year (FY) 2019 rates for GDUFA II fees.
Prospective Grant of Exclusive Patent License: Radiotherapy for Metastatic Castration-Resistant Prostate Cancer
Document Number: 2018-16066
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive commercialization patent license to Sinotau Pharmaceutical Group, headquartered in Beijing, China, to practice the inventions embodied in the patent application(s) listed in the Supplementary Information section of this notice.
Prospective Grant of Exclusive Patent License: Radiotherapeutics Against Somatostatin-Receptor Expressing Neuroendocrine Tumors
Document Number: 2018-16065
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Molecular Targeting Technologies, Inc. (MTTI); a Delaware corporation, with its principle place of business in West Chester, Pennsylvania, to practice the inventions embodied in the patent application listed in the SUPPLEMENTARY INFORMATION section of this notice.
National Institute of Neurological Disorders and Stroke Notice of Closed Meetings
Document Number: 2018-16061
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Arthritis and Musculoskeletal and Skin Diseases; Notice to Close Meeting
Document Number: 2018-16060
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
Prospective Grant of an Exclusive Patent License: Development and Commercialization of Cancer Immunotherapy
Document Number: 2018-16058
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
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 U.S. Patents and Patent Applications listed in the Supplementary Information section of this notice to Midissia Therapeutics (``Midissia'') located in San Francisco, CA.
Meeting of the President's Council on Sports, Fitness, and Nutrition
Document Number: 2018-16056
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness, and Nutrition (PCSFN) will hold its annual meeting. The meeting will be open to the public.
Proposed Collection; 60-Day Comment Request; Intramural Continuing Umbrella of Research Experiences (iCURE) Application (National Cancer Institute)
Document Number: 2018-16053
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of propose projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Submission for OMB Review; 30-Day Comment Request Collection of Customer Service, Demographic, and Smoking/Tobacco Use Information From the National Cancer Institute's Contact Center (CC) Clients (NCI)
Document Number: 2018-16048
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
In compliance with the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-16046
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2018-16045
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, Substance Abuse and Mental Health Services Administration
ICU Medical, Inc., et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
Document Number: 2018-16037
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 31 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.
Slowly Progressive, Low-Prevalence Rare Diseases With Substrate Deposition That Results From Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies; Draft Guidance for Industry; Availability
Document Number: 2018-16036
Type: Notice
Date: 2018-07-27
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 ``Slowly Progressive, Low-Prevalence Rare Diseases with Substrate Deposition That Results from Single Enzyme Defects: Providing Evidence of Effectiveness for Replacement or Corrective Therapies.'' This document is intended to provide guidance to sponsors on the evidence necessary to demonstrate the effectiveness of new drugs, including biological drugs, or new drug uses intended for slowly progressive, low-prevalence rare diseases that are associated with substrate deposition and are caused by single enzyme defects. This guidance applies only to those low-prevalence rare diseases with a well-characterized pathophysiology and in which changes in substrate deposition can be readily measured in relevant tissue(s).
Determination That Metaxalone Tablets, 640 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2018-16031
Type: Notice
Date: 2018-07-27
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) has determined that metaxalone tablets, 640 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for metaxalone tablets, 640 mg, if all other legal and regulatory requirements are met.
Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry; Availability
Document Number: 2018-16030
Type: Notice
Date: 2018-07-27
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 document entitled ``Recommendations for Reducing the Risk of Transfusion-Transmitted Babesiosis; Draft Guidance for Industry.'' The draft guidance document notifies blood establishments that collect blood and blood components that we have determined babesiosis to be a relevant transfusion-transmitted infection (RTTI) and provides recommendations for donor screening, donation testing, donor deferral, and product management to reduce the risk of transfusion-transmitted babesiosis (TTB). The recommendations contained in the guidance apply to the collection of blood and blood components, except Source Plasma.
Peripheral Vascular Atherectomy Devices-Premarket Notification Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2018-16029
Type: Notice
Date: 2018-07-27
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 ``Peripheral Vascular Atherectomy DevicesPremarket Notification [510(k)] Submissions.'' This draft guidance provides recommendations for premarket submissions for a new or modified peripheral vascular atherectomy device. This draft guidance is not final nor is it in effect at this time.
Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases; Guidance for Industry; Availability
Document Number: 2018-16027
Type: Notice
Date: 2018-07-27
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 final guidance for industry entitled ``Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases.'' FDA does not expect to grant any additional orphan-drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). This will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug in the non-orphan adult population of that disease, get a pediatric- subpopulation designation for the pediatric subset of the disease, and, due to this designation, be exempt from conducting the pediatric studies normally required under PREA when seeking approval of the adult indication.
National Cancer Institute; Notice of Closed Meetings
Document Number: 2018-16008
Type: Notice
Date: 2018-07-27
Agency: Department of Health and Human Services, National Institutes of Health
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; and Medicaid Promoting Interoperability Program
Document Number: 2018-14985
Type: Proposed Rule
Date: 2018-07-27
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This major proposed 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.
Scholarly and Journalistic Activities Deemed Not To Be Research: 2018 Requirements; Draft Guidance; When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 Through January 20, 2019: 2018 Requirements; Draft Guidance Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements; Draft Guidance
Document Number: 2018-15908
Type: Notice
Date: 2018-07-25
Agency: Department of Health and Human Services
The Office for Human Research Protections (OHRP), Office of the Assistant Secretary for Health is announcing the availability of three draft guidance documents titled, ``Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements,'' ``When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements,'' and ``Elimination of Institutional Review Board (IRB) Review of Research Applications and Proposals: 2018 Requirements,'' respectively.