Department of Health and Human Services November 2019 – Federal Register Recent Federal Regulation Documents

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Outcome Measure Harmonization and Data Infrastructure for Patient Centered Outcomes Research in Depression.'' This proposed information collection was previously published in the Federal Register on August 22, 2019 and allowed 60 days for public comment. No substantive comments were received by AHRQ during these 60 days. The purpose of this notice is to allow an additional 30 days for public comment.

The original Federal Register Notice announcing the December 2019 Advisory Commission on Childhood Vaccines (ACCV) meeting indicated that this meeting would be held December 5-6, 2019. This meeting is not being conducted over two days, and instead will only take place only on December 5, 2019. The ACCV will hold a public meeting on December 5, 2019, at 10:00 a.m. Eastern Time via Adobe Connect and telephone conference. This will not be an in-person meeting. The public can join the meeting by: 1. (Audio Portion) Calling the conference phone number: 800-988- 0218 and providing the following information:

The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule) authorizes AHRQ, on behalf of the Secretary of HHS, to list as a patient safety organization (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 and Quality Improvement Act of 2005 (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 accepted a notification of proposed voluntary relinquishment from Symbria SAFE, PSO number P0146, of its status as a PSO, and has delisted the PSO accordingly.

This notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces clarifications for and correction to certain data collection fields, terminology, and definitions used for reporting of pregnancy success rates from assisted reproductive technology (ART) programs. This reporting is required by the Fertility Clinic Success Rate and Certification Act of 1992 (FCSRCA).

In accordance with the Federal Advisory Committee Act, this notice announces that the Secretary's Advisory Committee on Infant Mortality (ACIM or Committee) has scheduled a public meeting. Information about ACIM and the agenda for this meeting can be found on the ACIM website at https://www.hrsa.gov/advisory-committees/infant- mortality/.

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 Network of Sexually Transmitted Diseases Clinical Prevention Training Centers.'' The purpose of the collection is to support program management of the National Network of Sexually Transmitted Disease Clinical Prevention Training Center (NNPTC) and to evaluate the reach and impact of the NNPTC's training activities.

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 ``The National Notifiable Diseases Surveillance System (NNDSS).'' The NNDSS is the nation's public health surveillance system that monitors the occurrence and spread of diseases and conditions that are nationally notifiable or under standard surveillance.

The National Eye 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 Patents and Patent Applications listed in the Supplementary Information section of this notice to CellRay, LLC, (``CellRay'') located in New York, New York and its affiliates.

The Clinical Center and National Heart Lung and Blood Institute, each an institute of the National Institutes of Health, Department of Health and Human Services, are contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to TeamedOn International Inc., (``TeamedOn''), a Delaware corporation with offices in Gaithersburg, Maryland.

The Food and Drug Administration (FDA, Agency, or we) is proposing to amend its regulations to establish a program for the testing of food in certain circumstances by accredited laboratories, as required under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Establishing such a program will help FDA improve the safety of the U.S. food supply and protect U.S. consumers by helping ensure that certain food testing of importance to public health is conducted subject to appropriate oversight and in accordance with appropriate model standards, and produces reliable and valid test results.

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, Agency, or we) has determined that MEXITIL (mexiletine hydrochloride) capsules, 150 milligrams (mg), 200 mg, and 250 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 MEXITIL (mexiletine hydrochloride) capsules, 150 mg, 200 mg, and 250 mg, if all other legal and regulatory requirements are met.

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.

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 on Interventions for Dyspnea in Patients with Advanced Cancer, 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.