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

Results 201 - 250 of 3,334
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26635
Type: Notice
Date: 2018-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comments on a proposed information collection project titled ``Online training for law enforcement to reduce risks associated with shift work and long work hours''. This study will develop and pilot test a new, online, interactive training program tailored for the law enforcement community that relays the health and safety risks associated with shift work, long work hours, and related workplace sleep issues, and presents strategies for managers and officers to reduce these risks.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-26634
Type: Notice
Date: 2018-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: 2018-26633
Type: Notice
Date: 2018-12-10
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
Document Number: 2018-26626
Type: Notice
Date: 2018-12-10
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a forthcoming public advisory committee meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee (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. FDA is establishing a docket for public comment on this document.
National Eye Institute; Notice of Meeting
Document Number: 2018-26596
Type: Notice
Date: 2018-12-10
Agency: Department of Health and Human Services, National Institutes of Health
Patient Protection and Affordable Care Act; Adoption of the Methodology for the HHS-Operated Permanent Risk Adjustment Program for the 2018 Benefit Year Final Rule
Document Number: 2018-26591
Type: Rule
Date: 2018-12-10
Agency: Department of Health and Human Services
This final rule adopts the HHS-operated risk adjustment methodology for the 2018 benefit year. In February 2018, a district court vacated the use of statewide average premium in the HHS-operated risk adjustment methodology for the 2014 through 2018 benefit years. Following review of all submitted comments to the proposed rule, HHS is adopting for the 2018 benefit year an HHS-operated risk adjustment methodology that utilizes the statewide average premium and is operated in a budget-neutral manner, as established in the final rules published in the March 23, 2012 and the December 22, 2016 editions of the Federal Register.
Meeting of the Presidential Advisory Council on HIV/AIDS
Document Number: 2018-26568
Type: Notice
Date: 2018-12-07
Agency: Department of Health and Human Services
As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will be holding a meeting and will discuss recommendations regarding programs, policies, and research to promote effective, prevention, treatment and cure of HIV disease and AIDS. The meeting will be open to the public.
Submission for OMB Review; Head Start Child and Family Experiences Survey (FACES) (OMB #0970-0151)
Document Number: 2018-26563
Type: Notice
Date: 2018-12-07
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Planning, Research, and Evaluation (OPRE), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS), is proposing to collect data for a new round of the Head Start Family and Child Experiences Survey (FACES).
Food Handler Antiseptic Drug Products for Over-the-Counter Human Use; Request for Data and Information
Document Number: 2018-26561
Type: Notice
Date: 2018-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing the establishment of a docket to obtain data, information, and comments that will assist the Agency in assessing the safety and effectiveness of food handler antiseptic drug products (i.e., antiseptic hand washes or rubs intended for use in food handling settings) for over-the- counter (OTC) human use. We are asking manufacturers of food handler antiseptics and other interested parties to submit safety and effectiveness data on OTC food handler antiseptics marketed for use by food handlers in commercial or regulated environments where growth, harvest, production, manufacturing, processing, packaging, transportation, storage, preparation, service, or consumption of food occurs. We also are inviting comments and requesting data on definitions, eligibility, current conditions of use of food handler antiseptics; safety and effectiveness criteria; as well as test methods to demonstrate the effectiveness of food handler antiseptics. In general, we are seeking input on current use conditions of antiseptics used in the food handler setting and recommended testing to establish the effectiveness of OTC food handler antiseptics. This information and data will inform FDA's ongoing review of OTC antiseptic drug products and will specifically inform our review of food handler antiseptic products.
Laboratory Animal Welfare: Draft Report on Recommendations To Reduce Administrative Burden on Researchers
Document Number: 2018-26557
Type: Notice
Date: 2018-12-07
Agency: Department of Health and Human Services, National Institutes of Health
The National Institutes of Health (NIH) is seeking input on the draft report by the 21st Century Cures Act Working Group on Reducing Administrative Burden to Researchers for Animal Care and Use in Research. The draft report is a coordinated effort of the Director of the National Institutes of Health, in collaboration with the Secretary of Agriculture and the Commissioner of Food and Drugs. It describes the proposed actions that the working group has identified to reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Environmental Impact Considerations
Document Number: 2018-26556
Type: Notice
Date: 2018-12-07
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; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration's Research and Evaluation Survey for the Public Education Campaign on Tobacco Among the Lesbian Gay Bisexual Transgender Community
Document Number: 2018-26555
Type: Notice
Date: 2018-12-07
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.
Developing and Labeling In vitro
Document Number: 2018-26554
Type: Notice
Date: 2018-12-07
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 ``Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products.'' This draft guidance describes considerations for the development and labeling of in vitro companion diagnostic devices (referred to as companion diagnostics in this document) to support the indicated uses of multiple drug or biologic oncology products (referred to as therapeutic products or oncology therapeutic products in this document), when appropriate. The draft guidance includes factors for considering when broader labeling (i.e., labeling that is expanded) of a companion diagnostic would be appropriate. Oncology companion diagnostics with broader evidence-based indications will optimally facilitate clinical use.
Framework for a Real-World Evidence Program; Availability
Document Number: 2018-26546
Type: Notice
Date: 2018-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is establishing a public docket to collect comments on a framework created by the Center for Drug Evaluation and Research and the Center for Biologic Evaluation and Research for implementing a program to evaluate the potential use of real-world evidence (RWE) in regulatory decision making. This framework is entitled ``Framework for the Real-World Evidence Program.'' The 21st Century Cures Act (Cures Act) was enacted on December 13, 2016, and requires that FDA establish a framework for implementing a program to evaluate the potential use of RWE to help support the approval of a new indication for a drug approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help support or satisfy postapproval study requirements. FDA has created this framework to satisfy the Cures Act mandate and is establishing a docket to receive public comments.
Submission for OMB Review; Comment Request
Document Number: 2018-26535
Type: Notice
Date: 2018-12-07
Agency: Department of Health and Human Services, Administration for Children and Families
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Family-to-Family Health Information Center Feedback Surveys, OMB Number: 0906-xxxx-New
Document Number: 2018-26524
Type: Notice
Date: 2018-12-07
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with the Paperwork Reduction Act of 1995, HRSA 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.
Medical Device De Novo Classification Process
Document Number: 2018-26378
Type: Proposed Rule
Date: 2018-12-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) proposes to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The proposed requirements establish procedures and criteria related to requests for De Novo classification (``De Novo request''). These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation, as well as to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval. The proposed rule, if finalized, would implement the De Novo classification process under the FD&C Act, as enacted by the Food and Drug Administration Modernization Act of 1997 and modified by the Food and Drug Administration Safety and Innovation Act and the 21st Century Cures Act.
Solicitation of Nominations for Membership To Serve on the Advisory Committee on Heritable Disorders in Newborns and Children
Document Number: 2018-26518
Type: Notice
Date: 2018-12-06
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA is seeking nominations of qualified candidates to be considered for appointment as members of the Advisory Committee on Heritable Disorders in Newborns and Children (Committee). The Committee provides advice, recommendations, and technical information about aspects of heritable disorders and newborn and childhood screening to the Secretary of HHS (Secretary). HRSA is seeking nominations of qualified candidates to fill up to five positions on the Committee.
Submission for OMB Review; Comment Request
Document Number: 2018-26508
Type: Notice
Date: 2018-12-06
Agency: Department of Health and Human Services, Administration for Children and Families
Medicare Program: Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures, Correction
Document Number: 2018-26497
Type: Proposed Rule
Date: 2018-12-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document corrects technical and typographical errors in the proposed rule that appeared in the Federal Register on October 2, 2018 entitled ``Medicare Program: Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures.''
Notice of Hearing: Reconsideration of Disapproval Washington Medicaid State Plan Amendment (SPA) 17-0002
Document Number: 2018-26495
Type: Notice
Date: 2018-12-06
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces an administrative hearing to be held on January 15, 2019, at the Department of Health and Human Services, Centers for Medicare & Medicaid Services, Division of Medicaid and Children's Health, Seattle Regional Office, 701 Fifth Avenue, Suite 1600, Seattle, WA 98104 to reconsider CMS' decision to disapprove Washington's Medicaid SPA 17-0002.
Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry; Availability
Document Number: 2018-26477
Type: Notice
Date: 2018-12-06
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 draft document entitled ``Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.'' The draft guidance document provides blood collection establishments and transfusion services with recommendations to control the risk of bacterial contamination of room temperature stored platelets intended for transfusion. The guidance provides recommendations for all platelet products, including platelets manufactured by automated methods (apheresis platelets), whole blood derived (WBD) platelets, pooled platelets (pre-storage and post- storage) and platelets stored in additive solutions. The draft guidance replaces the draft guidance of the same title dated March 2016.
Proposed Information Collection Activity; Strengthening Relationship Education and Marriage Services (STREAMS) Evaluation (OMB#0970-0481)
Document Number: 2018-26450
Type: Notice
Date: 2018-12-06
Agency: Department of Health and Human Services, Administration for Children and Families
The Office of Family Assistance (OFA) within the Administration for Children and Families (ACF) at the U.S. Department of Health and Human Services has issued grants to organizations to provide healthy marriage and relationship education (HMRE) services. Under a previously approved data collection activity (OMB#0970-0481), the Office of Planning, Research, and Evaluation (OPRE) within ACF is conducting the Strengthening Relationship Education and Marriage Services (STREAMS) evaluation with five HMRE grantees. The purpose of STREAMS is to measure the effectiveness and quality of HMRE programs designed to strengthen intimate relationships. This data collection request is for an extension of previously approved data collection instruments and for two additional data collection instruments.
Submission for OMB Review; Comment Request
Document Number: 2018-26416
Type: Notice
Date: 2018-12-06
Agency: Department of Health and Human Services, Administration for Children and Families
National Institute of Diabetes and Digestive and Kidney Diseases; Cancellation of Meeting
Document Number: 2018-26386
Type: Notice
Date: 2018-12-06
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting
Document Number: 2018-26385
Type: Notice
Date: 2018-12-06
Agency: Department of Health and Human Services, National Institutes of Health
Findings of Research Misconduct
Document Number: 2018-26379
Type: Notice
Date: 2018-12-06
Agency: Department of Health and Human Services, Office of the Secretary
Findings of research misconduct have been made on the part of Rajendra Kadam, former Ph.D. student in pharmaceutical sciences, University of Colorado, Denver (UCD) (Respondent). Mr. Kadam engaged in research misconduct in research supported by National Eye Institute (NEI), National Institutes of Health (NIH), grants R01 EY018940, R01 EY017533, R24 EY017045, and RC1 EY020361. The administrative actions, including debarment for a period of three (3) years, were implemented beginning on November 13, 2018, and are detailed below.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26352
Type: Notice
Date: 2018-12-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Asthma Information Reporting System (AIRS)'' (OMB Control No. 0920-0853, expiration date 6/30/2019). The purpose of AIRS to collect performance measure and surveillance data spreadsheets designed to increase the efficiency and effectiveness of state asthma programs and to monitor the impact of the state and national programs.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26351
Type: Notice
Date: 2018-12-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled National Surveillance of Community Water Systems and Corresponding Populations with the Recommended Fluoridation Level. This surveillance collects the fluoridation status of the nation's approximately 52,000 community water systems (CWS) which serve the 50 states and the District of Columbia. It also collects fluoride level testing data for those CWS which adjust naturally occurring fluoride levels. The data are analyzed and published to inform the public and to support state and local governments' efforts to monitor community water fluoridation levels relative to the US Public Health Service recommended level to prevent tooth decay.
Proposed Data Collection Submitted for Public Comment and Recommendations
Document Number: 2018-26350
Type: Notice
Date: 2018-12-06
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled ``Web-based approaches to reach black or African American and Hispanic/Latino MSM for HIV Testing and Prevention Services.''
Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports
Document Number: 2018-26334
Type: Notice
Date: 2018-12-04
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces a 1-year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia.
Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
Document Number: 2018-26333
Type: Notice
Date: 2018-12-04
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 ``Noncirrhotic Nonalcoholic Steatohepatitis With Liver Fibrosis: Developing Drugs for Treatment.'' This draft guidance is intended to assist sponsors in the clinical development of drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Patient Protection and Affordable Care Act; Elimination of Internal Agency Process for Implementation of the Federally-Facilitated User Fee Adjustment
Document Number: 2018-26332
Type: Rule
Date: 2018-12-04
Agency: Department of Health and Human Services
The U.S. Department of Health and Human Services (HHS) is issuing this final rule to eliminate references to internal Executive Branch procedures provided for under Office of Management and Budget (OMB) circular A-25R in connection with an adjustment to the Federally- facilitated Exchange (FFE) user fee. HHS is amending these regulations because it has determined that an exception to OMB circular A-25R is not required to effectuate the FFE user fee adjustment. Thus, this final rule removes the language that refers to an exception under OMB circular A-25R as an aspect of reducing a participating issuer's FFE user fee obligation. This rule does not affect the ability of an issuer to obtain an applicable reduction in FFE user fee obligations, amend the calculation of the FFE user fee credit provided to a participating issuer, change the application of the monthly user fee adjustment, or alter any of the other standards that participating issuers must meet to qualify for the user fee adjustment.
Final National Occupational Research Agenda for Oil and Gas Extraction
Document Number: 2018-26315
Type: Notice
Date: 2018-12-04
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Oil and Gas Extraction
Supplemental Evidence and Data Request on Interventions for Substance Use Disorders in Adolescents: A Systematic Review
Document Number: 2018-26304
Type: Notice
Date: 2018-12-04
Agency: Agency for Healthcare Research and Quality, Department of Health and Human Services
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Interventions for Substance Use Disorders in Adolescents: A Systematic Review, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Agency Information Collection Activities; Proposed Collection; Comment Request; Electronic Submission of Medical Device Registration and Listing
Document Number: 2018-26303
Type: Notice
Date: 2018-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
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 associated with electronic submission of medical device registration and listing.
Solicitation for Written Comments on Proposed Objectives for Healthy People 2030; Correction
Document Number: 2018-26299
Type: Notice
Date: 2018-12-04
Agency: Department of Health and Human Services
The Department of Health and Human Services published a document in the Federal Register of November 27, 2018, concerning request for comments on the proposed Healthy People 2030 objectives. The document contained an incorrect date.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
Document Number: 2018-26295
Type: Notice
Date: 2018-12-04
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ASPIRE ASSIST
Document Number: 2018-26290
Type: Notice
Date: 2018-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ASPIRE ASSIST 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; TRULANCE
Document Number: 2018-26289
Type: Notice
Date: 2018-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TRULANCE 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 drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; OCALIVA
Document Number: 2018-26288
Type: Notice
Date: 2018-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OCALIVA 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 drug product.
Post-Complete Response Letter Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants Under Generic Drug User Fee Amendments; Guidance for Industry; Availability
Document Number: 2018-26285
Type: Notice
Date: 2018-12-04
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 ``Post- Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA.'' This guidance is intended to clarify the criteria for granting post-complete response letter (CRL) meeting requests and the scope of discussions for granted meeting requests. This guidance provides procedures that will promote well-managed post-CRL meetings and help ensure that such meetings are scheduled and conducted in accordance with the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years 2018-2022 (GDUFA II).
Determination of Regulatory Review Period for Purposes of Patent Extension; EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM
Document Number: 2018-26282
Type: Notice
Date: 2018-12-04
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXABLATE NEURO MODEL 4000 TYPE 1.0 SYSTEM (EXABLATE) 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 medical device.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2018-26281
Type: Notice
Date: 2018-12-04
Agency: Department of Health and Human Services, National Institutes of Health
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: 2018-26279
Type: Notice
Date: 2018-12-04
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.
Evaluating the Therapeutic Potential of Cannabinoids: How To Conduct Research Within the Current Regulatory Framework
Document Number: 2018-26127
Type: Notice
Date: 2018-12-03
Agency: Department of Health and Human Services, National Institutes of Health
This workshop on December 8, 2018, sponsored by the National Center for Complementary and Integrative Health (NCCIH), a component of the National Institutes of Health (NIH), will bring together researchers, governmental officials, and industry representatives to discuss the processes and issues related to conducting cannabinoid research.
National Advisory Council on Nurse Education and Practice
Document Number: 2018-26123
Type: Notice
Date: 2018-12-03
Agency: Department of Health and Human Services, Health Resources and Services Administration
HHS is hereby giving notice that the charter for the National Advisory Council on Nurse Education and Practice (NACNEP) has been renewed. The effective date of the renewed charter is November 30, 2018.
Agency Information Collection Request; 60-Day Public Comment Request
Document Number: 2018-26122
Type: Notice
Date: 2018-12-03
Agency: Department of Health and Human Services
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.
National Institute of Nursing Research; Notice of Meeting
Document Number: 2018-26113
Type: Notice
Date: 2018-12-03
Agency: Department of Health and Human Services, National Institutes of Health
340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation
Document Number: 2018-26223
Type: Rule
Date: 2018-11-30
Agency: Department of Health and Human Services
The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), which is referred to as the ``340B Drug Pricing Program'' or the ``340B Program.'' HHS published a final rule on January 5, 2017, that set forth the calculation of the 340B ceiling price and application of civil monetary penalties. On June 5, 2018, HHS published a final rule that delayed the effective date of the 340B ceiling price and civil monetary rule until July 1, 2019, to consider alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. On November 2, 2018, HHS issued a proposed rule to solicit comments to change the effective date from July 1, 2019, to January 1, 2019, and to cease any further delay of the rule. HHS proposed this action because it determined that the January 5, 2017, final rule has been subject to extensive public comment, and had been delayed several times. HHS has considered the full range of comments on the substantive issues in the January 5, 2017, final rule. After consideration of the comments received on the effective date of the proposed rule, HHS is changing the effective date of the January 5, 2017, final rule, to January 1, 2019.