June 2020 – Federal Register Recent Federal Regulation Documents

Notice of Intent to Prepare a Draft Supplemental Final Environmental Impact Statement (DSFEIS) for development of a new Federal Correctional Institution (FCI) and Federal Prison Camp (FPC) by the U.S. Department of Justice, Federal Bureau of Prisons. Under consideration for development are vacant areas of the property comprising the United States Penitentiary (USP) in Leavenworth, Kansas.

The Coast Guard will establish a safety zone for the Alpena 4th of July fireworks. Our regulation for safety zones within the Captain of the Port Sault Sainte Marie Zone identifies the regulated area for this safety zone. This action is necessary and intended to protect the safety of life and property on navigable waters prior to, during, and immediately after firework displays. During the enforcement periods listed below, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Sault Sainte Marie or a designated representative.

The Coast Guard will establish safety zones for the Mackinaw Area Visitors Bureau Friday Night fireworks. Our regulation for safety zones within the Captain of the Port Sault Sainte Marie Zone identifies the regulated area for this safety zone. This action is necessary and intended to protect the safety of life and property on navigable waters prior to, during, and immediately after firework displays. During the enforcement periods listed below, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Sault Sainte Marie or a designated representative.

On April 2, 2020, the U.S. Small Business Administration (SBA) posted on its website an interim final rule relating to the implementation of Sections 1102 and 1106 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act or the Act) (published in the Federal Register on April 15, 2020). Section 1102 of the Act temporarily adds a new product, titled the ``Paycheck Protection Program,'' to the U.S. Small Business Administration's (SBA's) 7(a) Loan Program. Subsequently, SBA issued a number of interim final rules implementing the Paycheck Protection Program. This interim final rule supplements the previously posted interim final rules by providing additional guidance on certain eligible payroll costs.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Development of Anti-Infective Drug Products for the Pediatric Population.'' The purpose of this guidance is to provide general recommendations on the development of anti-infective drug products for pediatric patients. The guidance addresses initiation of pediatric clinical studies, enrollment strategies, extrapolation of efficacy, and other considerations to help facilitate pediatric anti-infective drug product development.

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

The Department of Defense has submitted to OMB for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

In this document, the Federal Communications Commission (Commission) announces that the Office of Management and Budget (OMB) has approved, for a period of three years, an information collection associated with the rules for the Connect America Fund contained in the Commission's Rate-of-Return Order, FCC 18-176. This document is consistent with the Rate-of-Return Order, which stated that the Commission would publish a document in the Federal Register announcing the effective date of the new information collection requirements.

The Department of Defense is publishing the unclassified text of an arms sales notification.

The Department of Defense is publishing the unclassified text of an arms sales notification.

The Department of Defense is publishing the unclassified text of an arms sales notification.

The Department of Defense is publishing the unclassified text of an arms sales notification.

The Environmental Protection Agency (EPA), Office of Research and Development announces two separate public meetings of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects.

FMCSA announces its decision to exempt 11 individuals from the hearing requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) to operate a commercial motor vehicle (CMV) in interstate commerce. The exemptions enable these hard of hearing and deaf individuals to operate CMVs in interstate commerce.

In compliance with of the Paperwork Reduction Act of 1995, HRSA has 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 National Cancer Institute (NCI) through its National Clinical Trials Network (NCTN) is developing a successor precision medicine trial to `NCI-Molecular Analysis for Therapy Choice (NCI- MATCH)' entitled `NCI-ComboMATCH'. The principal of this intiative is to overcome drug resistance to single-agent therapy by developing genomically-directed targeted agent combinations. All combinations must be supported by robust, preclinical in vivo evidence. Due to the coronavirus pandemic the NCI is providing an extension of the previously published notice in the Federal Register on March 11, 2020 to allow candidate more time to submit LOIs. NCI-ComboMATCH trial leadership invites applications for Clinical Laboratory Improvements Program (CLIA) certified/accredited laboratories that test tumor specimens from patients utilizing Next-Generation Sequencing (NGS) assays to participate in the NCI-ComboMATCH trial. In order to support this trial, the designated laboratories participating in NCI-ComboMATCH will identify patients for the specific variants needed for trial eligibility. Laboratories will be required to contact any of the NCTN sites that have activated NCI-ComboMATCH if a specimen sent from one of these sites has a variant(s) that would potentially make the patient eligible for one of the treatment arms.

The Director, Defense Health Agency (DHA), has approved the creation of a demonstration to waive cost-sharing for up to three physical therapy (PT) visits for TRICARE beneficiaries with low back pain (LBP). The purpose of the demonstration is to encourage the uptake of PT services for the treatment and management of LBP and to incentivize beneficiaries towards higher-value care and away from lower-value care. This demonstration will operate in 10 states, test whether waiving cost-sharing increases the uptake of PT services among patients with LBP, and measure the impact of LBP on lower-value services such as imaging, opioids, and surgery.

The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITFs) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine or Oral Fluid (Mandatory Guidelines).

The Coast Guard is establishing a temporary safety zone for navigable waters within a 560-ft radius of a fireworks display. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Sault Sainte Marie.