2016 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.

This regulation establishes time-limited tolerances for residues of tolfenpyrad in or on vegetable, fruiting, group 8-10. This action is in response to EPA's granting of an emergency exemption under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on agricultural commodities in the group ``vegetable, fruiting, group 8- 10.'' This regulation establishes a maximum permissible level for residues of tolfenpyrad in or on these commodities. The time-limited tolerances expire on December 31, 2019.

The U.S. Nuclear Regulatory Commission (NRC) is requesting public comments on proposed revisions to its Enforcement Policy (the Policy). The NRC is proposing to revise Section 4.1, ``Considerations in Determining Enforcement Actions Involving Individuals,'' of the Policy to indicate that the NRC typically will not consider Fitness- for-Duty (FFD) Drug and Alcohol (D&A) related violations for enforcement unless the licensee's FFD program has apparent deficiencies.

The Food Safety and Inspection Service (FSIS) is announcing the availability of an updated version of the Agency's compliance guideline on documentation needed to support animal-raising claims on product labels that must be submitted for Agency approval before they can be used on product labels. The updated guideline reflects FSIS's current position and procedures for reviewing animal-raising claims and includes explanations of animal-raising claims that FSIS may approve and the types of supporting documentation that the Agency requires to be submitted to support these claims.

The Surface Transportation Board (Board) is proposing changes to its rules pertaining to Offers of Financial Assistance to improve the process and protect it against abuse.

The U.S. Small Business Administration (SBA) announces that it is holding a public webinar regarding its Early Stage Small Business Investment Companies proposed rule, which was published on September 19, 2016. The webinar will describe the changes proposed in the rulemaking and answer questions regarding the proposed rule.

The Environmental Protection Agency (EPA) is proposing to approve portions of two revisions to the Georgia State Implementation Plan submitted by the Georgia Department of Environmental Protection on July 25, 2014, and November 1, 2015. These revisions modify the definition of ``volatile organic compounds'' (VOC). Specifically, these revisions add two compounds to the list of those excluded from the VOC definition on the basis that these compounds make a negligible contribution to tropospheric ozone formation. This action is being taken pursuant to the Clean Air Act.

We, the U.S. Fish and Wildlife Service (Service), determine endangered species status under the Endangered Species Act of 1973 (Act), as amended, for the Miami tiger beetle (Cicindelidia floridana), a beetle species from Miami-Dade County, Florida. The effect of this regulation will be to add this species to the Federal List of Endangered and Threatened Wildlife and extend the Act's protections to this species.

HUD is issuing this document to supplement its responses to certain insurance industry comments to HUD's proposed rule implementing the Fair Housing Act's (``Act'') discriminatory effects standard. These commenters requested, inter alia, total or partial exemptions or safe harbors from liability under the Act's discriminatory effects standard. After careful reconsideration of the insurance industry comments in accordance with the court's decision in Property Casualty Insurers Association of America (PCIAA) v. Donovan, HUD has determined that categorical exemptions or safe harbors for insurance practices are unworkable and inconsistent with the broad fair housing objectives and obligations embodied in the Act. HUD continues to believe that the commenters' concerns regarding application of the discriminatory effects standard to insurance practices can and should be addressed on a case-by-case basis.

We, the U.S. Fish and Wildlife Service (Service), designate critical habitat for the Kentucky arrow darter (Etheostoma spilotum) under the Endangered Species Act (Act). In total, approximately 398 stream kilometers (skm) (248 stream miles (smi)) fall within the boundaries of the critical habitat designation.

This document contains final and temporary regulations concerning how liabilities are allocated for purposes of section 707 of the Internal Revenue Code (Code) and when certain obligations are recognized for purposes of determining whether a liability is a recourse partnership liability under section 752. These regulations affect partnerships and their partners. The text of these temporary regulations serves as part of the text of proposed regulations (REG- 122855-15) published in the Proposed Rules section in this issue of the Federal Register.

The Stop Trading on Congressional Knowledge Act (STOCK Act) was enacted on April 4, 2012. The Act imposed additional financial disclosure requirements on individuals required to file public financial disclosure statements pursuant to the Ethics in Government Act. Pursuant to section 402(b) of the Ethics in Government Act, the U.S. Office of Government Ethics (OGE) is revising the regulations governing financial disclosure to incorporate the new reporting requirements imposed by the STOCK Act. As a part of the revision, OGE also is modernizing language, making changes to the confidential filing requirements, adding and updating examples, and conforming the language of the regulation more closely to that of the Ethics in Government Act. In addition, OGE is proposing an updated definition of ``widely diversified'' for Excepted Investment Fund purposes that brings the definition in line with the definition of ``diversified'' found in the exemptions to the conflicts of interest law governing personal financial interests.

The General Services Administration (GSA) is amending the General Services Administration Acquisition Regulation (GSAR) to make editorial changes. This case updates acquisition-related thresholds to align with the Federal Acquisition Regulation (FAR).

The Coast Guard is establishing a temporary special local regulation controlling movement of vessels for certain waters of the Ouachita River. This rule is necessary to provide for the safety of life on navigable waters during a paddle boat race on October 15, 2016. This regulation requires commercial vessels to notify the Captain of the Port Memphis before entering the event area and require all vessels transiting the area to maintain a minimum speed for safe navigation.

This final rule responds to public comments and updates DoD's Defense Industrial Base (DIB) Cybersecurity (CS) Activities. This rule implements mandatory cyber incident reporting requirements for DoD contractors and subcontractors who have agreements with DoD. In addition, the rule modifies eligibility criteria to permit greater participation in the voluntary DIB CS information sharing program.

This document revises the list of vehicles not originally manufactured to conform to the Federal Motor Vehicle Safety Standards (FMVSS) that NHTSA has decided to be eligible for importation. This list is published in an appendix to the agency's regulations that prescribe procedures for import eligibility decisions. The list has been revised to add all vehicles that NHTSA has decided to be eligible for importation since October 1, 2015, and to remove all previously listed vehicles that are now more than 25 years old and need no longer comply with all applicable FMVSS to be lawfully imported. NHTSA is required by statute to publish this list annually in the Federal Register.

We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 727 airplanes. This proposed AD was prompted by analysis of the cam support assemblies of the main cargo door that indicated the repetitive high frequency eddy current (HFEC) inspections required by the existing maintenance program are not adequate to detect cracks before two adjacent cam support assemblies of the main cargo door could fail. This proposed AD would require repetitive ultrasonic inspections for cracking of the cam support assemblies of the main cargo door and replacement if necessary. We are proposing this AD to detect and correct cracking of the cam support assemblies of the main cargo door. Such cracking could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ''copper reduction tablet test''). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

The Environmental Protection Agency (EPA) is proposing to approve revisions to the Sacramento Metropolitan Air Quality Management District (SMAQMD) and the San Diego County Air Pollution Control District (SDCAPCD) portions of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from architectural coatings. We are proposing to approve local rules and a rule rescission to regulate these emission sources under the Clean Air Act (CAA or the Act).

We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding for the western glacier stonefly (Zapada glacier). After a review of the best available scientific and commercial information, we find that listing the western glacier stonefly is warranted. We are also announcing the proposed listing rule for the candidate species meltwater lednian stonefly (Lednia tumana). Therefore, we are proposing to list both the meltwater lednian stonefly and the western glacier stonefly, two insect species from Glacier National Park and northwestern Montana, as threatened species under the Endangered Species Act (Act). If we finalize this rule as proposed, it would extend the Act's protections to these species. The effect of this regulation will be to add these species to the Federal List of Endangered and Threatened Wildlife. The Service seeks data and comments from the public on this proposed listing rule.

We, the U.S. Fish and Wildlife Service, add 1 national wildlife refuge (NWR or refuge) to the list of areas open for hunting, increase the hunting activities available at 12 other NWRs, open 1 refuge to fishing for the first time, and add pertinent refuge-specific regulations for other NWRs that pertain to migratory game bird hunting, upland game hunting, big game hunting, and sport fishing for the 2016- 2017 season.

FMCSA amends its regulations by making technical corrections throughout. The Agency is making minor changes to correct errors and omissions, ensure conformity with Office of the Federal Register style guidelines, update cross references, and improve clarity and consistency of certain regulatory provisions. Further, this set of amendments removes all remaining instances of the term ``common carrier'' and ``contract carrier'' as required by the ICC Termination Act (ICCTA) and the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU). This rule does not make any substantive changes to the affected regulations, except to remove obsolete provisions.

This notice announces the sixth meeting of the Advisory Committee on Accessible Air Transportation (ACCESS Advisory Committee).

The Coast Guard is establishing a temporary safety zone for the University of Pittsburgh Fireworks show, Pittsburgh, PA. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created from a barge-based fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Pittsburgh.