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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 https:// www.samhsa.gov/workplace.

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.