September 20, 2010 – Federal Register Recent Federal Regulation Documents

Section 602 of Public Law 102-585, the ``Veterans Health Care Act of 1992'' enacted Section 340B of the Public Health Service Act (PHSA). Section 340B implements a drug pricing program by which manufacturers enter into an agreement to sell covered outpatient drugs to particular covered entities at a price not exceeding the amount determined under a statutory formula. Manufacturers are required by section 1927(a) of the Social Security Act to enter in agreements with the Secretary that comply with section 340B if they participate in the Medicaid Drug Rebate Program. Section 7102(a) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148) requires the Secretary of HHS to develop and issue regulations for the 340B Drug Pricing Program (340B Program) establishing standards for the imposition of sanctions in the form of civil monetary penalties for manufacturers that knowingly and intentionally overcharge a covered entity for a 340B drug. As HHS never has had civil monetary penalty authority that addresses manufacturing overcharging of the 340B Program, these regulations present a number of issues that have the potential to impact stakeholders. Accordingly, the Health Resources and Services Administration (HRSA) is issuing this advance notice of proposed rulemaking (ANPRM) to solicit public comment on multiple issues regarding the implementation of this requirement. These comments will be used to help draft a proposed rule that will be published in the Federal Register for public comments.

The Director, Information Collection Clearance Division, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13).

NMFS and the New England Fishery Management Council (Council) announce that they are seeking public comment on the reaffirmation of the current control date of March 30, 2006, in anticipation of developing a limited access program for the NE multispecies open access charter and party boat (charter/party) fishery. This component of the fishery includes vessels with open access charter/party permits, as well as limited access NE multispecies permits, while not on a NE multispecies day-at-sea (DAS) or fishing under the sector management program. The Council has not made a determination that limiting the number of participants in this fishery is necessary, but reaffirming the current control date keeps the stakeholders informed of possible future consideration of the issue and promotes awareness of potential eligibility criteria for future access so as to discourage speculative entry into the fishery, while the Council considers whether and how access to the charter/party fishery should be controlled. By this notification, NMFS reaffirms, on behalf of the Council, that March 30, 2006, may be used as a ``control date'' to establish eligibility criteria for determining levels of future access to the fishery.

NMFS announces its request for applications for the 2011 shark research fishery from commercial shark fishermen with a directed or incidental limited access permit. The shark research fishery allows for the collection of fishery-dependent data for future stock assessments while also allowing NMFS and commercial fishermen to conduct cooperative research to meet the shark research objectives for the Agency. The only commercial vessels authorized to land sandbar sharks are those participating in the shark research fishery. Shark research fishery permittees may also land non-sandbar large coastal sharks (LCS), small coastal sharks (SCS), and pelagic sharks. Commercial vessels not participating in the shark research fishery may only land only non-sandbar LCS, SCS, and pelagic sharks. Commercial shark fishermen who are interested in participating in the shark research fishery need to submit a completed Shark Research Fishery Permit Application in order to be considered.

NMFS issues this advance notice of proposed rulemaking (ANPR) to provide background information and request public comment on potential adjustments to the regulations governing the U.S. Atlantic shark fishery to address several specific issues currently affecting management of the shark fishery and to identify specific goals for management of fishery in the future. NMFS is requesting public comment regarding the potential implementation of changes to the quota and/or permit structure that are currently in place for the Atlantic shark fishery. NMFS is also requesting comments on the implementation of programs such as catch shares, limited access privilege programs (LAPPs), individual fishing quotas (IFQs), and/or sectors for the Atlantic shark fishery.

Based on affirmative final determinations by the Department of Commerce (the Department) and the International Trade Commission (the ITC), the Department is issuing antidumping duty orders on certain magnesia carbon bricks (MCB) from Mexico and the People's Republic of China (PRC). On September 8, 2010, the ITC notified the Department of its affirmative determinations of material injury to a U.S. industry. See Certain Magnesia Carbon Bricks from China and Mexico (Investigation Nos. 701-TA-468 and 731-TA-1166-1167 (Final), USITC Publication 4182, September 2010).

The Department of State invites the public, including NGOs, educational institutions, private sector enterprises and other interested persons, to submit written comments or suggestions regarding items for inclusion in a new Plan of Action for implementing the United States-Oman Memorandum of Understanding on Environmental Cooperation (MOU) signed on February 20, 2006. We encourage submitters to refer to: (1) The U.S.-Oman MOU, (2) the U.S.-Oman 2006-2008 Environmental Cooperation Work Program, (3) the Environment Chapter (17) of the U.S.- Oman Free Trade Agreement, and (4) the Environmental Review of the U.S.-Oman Free Trade Agreement. (Documents are available at: https://www.state.gov/g/oes/env/trade/ oman/index.htm).

FMCSA announces its decision to exempt twenty-one individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions will enable these individuals to operate CMVs in interstate commerce.

In response to a petition for rulemaking from the Truck Manufacturers Association (TMA), the Federal Motor Carrier Safety Administration (FMCSA) amends its regulations to eliminate turbochargers from the list of equipment considered to be noise dissipative devices. As written, the regulation may allow vehicle operators to remove mufflers and still meet the Federal inspection requirements if commercial motor vehicle (CMV) engines are equipped with turbochargers. This was not the intent of that rule. Therefore, the Agency amends the rule to restore its original intent.

Summary of Application: Applicant, American Capital, Ltd. requests an order approving a proposal to grant certain stock options to directors who are not also employees or officers of the applicant (the ``Non-employee Directors'') under its 2009 Stock Option Plan (the ``Plan'').

In accordance with Section 122(I) of the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (``CERCLA''), 42 U.S.C. 9622(I), notice is hereby given of a proposed administrative settlement for recovery of past response costs concerning the Gilberts/Kedzie Site in the Village of Gilberts, Illinois with the following settling parties: Glen J. Kedzie, Big Timber Landscape Company, Inc., and GTCS Corp. (the settling parties). The settlement requires the settling parties to pay $3,000.00 to the Hazardous Substance Superfund and additional payments when the Site is sold. The settlement includes a covenant not to sue the settling parties pursuant to Section 107(a) of CERCLA, 42 U.S.C. 9607(a). For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the U.S. EPA Record Center, Room 714 U.S. EPA, 77 West Jackson Boulevard, Chicago, Illinois.

The State of Rhode Island has applied to EPA for final authorization of certain changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). EPA determined that these changes satisfy all requirements needed to qualify for final authorization and recently authorized all but one of the State's changes through an immediate final rule. However, EPA also stated in that rule that it would address the authorization of the state's requirements regarding EPA's Zinc Fertilizer Rule in a separate final rule (following the proposed rule) as it anticipated possible adverse comments that would oppose the Federal authorization of Rhode Island for this particular rule. There was, in fact, an adverse comment filed objecting to EPA authorizing Rhode Island for the Zinc Fertilizer Rule. Today's action responds to that comment but does not agree with it and, thus, finalizes the Agency's decision to authorize Rhode Island for EPA's Zinc Fertilizer Rule. In addition, the comment also objected to EPA authorizing Rhode Island for the Burden Reduction Initiative. Accordingly, EPA is partially withdrawing the immediate final rule insofar as it authorized Rhode Island for the Burden Reduction Initiative. However, EPA is now responding to the comment and again not agreeing with it and, thus, today's action also authorizes Rhode Island for the Burden Reduction Initiative. No objections were filed to EPA regarding authorizing the other revisions submitted by Rhode Island. Accordingly, the immediate final rule is not being withdrawn as to these other revisions, which will continue to be authorized pursuant to the immediate final rule.

The EPA is announcing a public hearing to be held for the proposed ``Rule to Implement the 1997 8-Hour Ozone National Ambient Air Quality Standard: New Source Review Anti-Backsliding Provisions for Former 1-Hour Ozone Standard'' which published in the Federal Register on August 24, 2010. The hearing will be held on Tuesday, October 12, 2010, in Washington, DC.

The United States Patent and Trademark Office (USPTO) is considering pro-business strategies for incentivizing the development and widespread distribution of technologies that address humanitarian needs. One proposal being considered is a fast-track ex parte reexamination voucher pilot program to create incentives for technologies and licensing behavior that address humanitarian needs. Because patents under reexamination are often the most commercially significant patents, a fast-track reexamination proceeding would allow patent owners to more readily and less expensively affirm the validity of their patents. Therefore, the opportunity to utilize a voucher for a fast-track reexamination proceeding could provide a valuable incentive for entities to pursue humanitarian technologies or licensing. The USPTO is requesting comments from the public regarding this proposal as well as other incentive proposals set forth in this notice.

Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), GSA will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement regarding the agency's Supplier Greenhouse Gas (GHG) Emissions Inventory pilot. Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Supplier GHG Emissions Inventory pilot, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

This action proposes to establish Class E Airspace at Crewe, VA, to accommodate the additional airspace needed for the Standard Instrument Approach Procedures (SIAPs) developed for Crewe Municipal Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport.