Department of Health and Human Services January 18, 2023 – Federal Register Recent Federal Regulation Documents

This Notice advises the public that the Indian Health Service (IHS) proposes to expand the geographic boundaries of the Purchased/ Referred Care Delivery Area (PRCDA) for the Hoh Tribe in the State of Washington to include the county of Clallam in the State of Washington. The current PRCDA for the Hoh Tribe includes the Washington county of Jefferson. Hoh Tribe members residing outside of the PRCDA are eligible for direct care services, however, they are not eligible for Purchased/ Referred Care (PRC) services. The sole purpose of this expansion would be to authorize additional Hoh Tribe members and beneficiaries to receive PRC services.

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. 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 or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

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 Requirements for Negative Pre- Departure COVID-19 Test Result or Documentation of Recovery from COVID- 19 for all Airline or Other Aircraft Passengers Traveling to the United States from the People's Republic of China (PRC). This data collection is created to protect the U.S. population from potential importation, transmission, and spread of new COVID-19 variants into the United States from the PRC.

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies to take this opportunity to comment on a proposed information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a new proposed information collection project titled Pre-Shift Lighting Interventions to Improve Miner Safety and Well-Being. The purpose of this information collection is to examine the effect of human centric lighting (HCL) interventions on circadian disruption (CD) and well-being in underground mineworkers.

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 ``Supporting and Evaluating the Dissemination and Implementation of PCOR to Improve Non-Surgical Treatment of Urinary Incontinence Among Women in Primary Care.'' This proposed information collection was previously published in the Federal Register on October 28, 2022 and allowed 60 days for public comment. AHRQ received no substantive comments. The purpose of this notice is to allow an additional 30 days for public comment.

The Food and Drug Administration (FDA, Agency, or we) has determined that OFIRMEV (acetaminophen) injection, 1,000 milligrams (mg)/100 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for acetaminophen injection, 1,000 mg/100 mL (10 mg/mL), if all other legal and regulatory requirements are met.

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. OMB may act on HRSA's ICR only after the 30-day comment period for this notice has closed.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases.'' This guidance is intended to assist sponsors in identifying the optimal dosage(s) for human prescription drugs or biological products for the treatment of oncologic diseases during clinical development prior to submitting an application for approval for a new indication and usage. This guidance does not address selection of the starting dosage for first-in-human trials nor does it address dosage optimization for radiopharmaceuticals, cellular and gene therapy products, microbiota, or cancer vaccines.