August 1, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2009. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (PDUFA IV) (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2009 for application fees for an application requiring clinical data ($1,247,200), for an application not requiring clinical data or a supplement requiring clinical data ($623,600), for establishment fees ($425,600), and for product fees ($71,520). These fees are effective on October 1, 2008, and will remain in effect through September 30, 2009. For applications and supplements that are submitted on or after October 1, 2008, the new fee schedule must be used. Invoices for establishment and product fees for FY 2009 will be issued in August 2008, using the new fee schedule.

This document corrects several technical and typographical errors in the proposed rule that was issued on June 30, 2008 and appeared in the July 7, 2008 Federal Register (73 FR 38502). The proposed rule addressed Medicare Part B payment policy, including the physician fee schedule (PFS) that is applicable for calendar year (CY) 2009. The proposed rule also addressed refinements to relative value units (RVUs) and physician self-referral issues. Specifically, the errors pertain to the following provisions: Practice expense, telehealth services, competitive acquisition program (CAP), anti-markup provisions, and the Physician Quality Reporting Initiative.

To comply with the Paperwork Reduction Act of 1995 (PRA), we are inviting comments on a collection of information that we will submit to the Office of Management and Budget (OMB) for review and approval. We changed the title of this information collection request (ICR) to meet OMB requirements. The new title of this ICR is ``30 CFR Parts 202, 206, and 207, Indian Oil and Gas Valuation.''

EPA has entered into a Consent Agreement with Windstream Corporation (Windstream) to resolve violations of the Clean Water Act (CWA) and the Emergency Planning and Community Right-to-Know Act (EPCRA), and their implementing regulations. The Administrator is hereby providing public notice of this Consent Agreement and proposed Final Order, and providing an opportunity for interested persons to comment on this Consent Agreement, in accordance with CWA Section 311(b)(6)(C), 33 U.S.C. 1321(b)(6)(c).

EPA expressed environmental concerns about the long-term availability of the water supply, conservation and water use efficiency, and indirect and cumulative impacts, and recommended continued collaboration through a regional groundwater framework to ensure efficient long-term sustainable use of the deep carbonate-rock aquifer, and evaluation and commitment to specific climate change adaptation measures and back-up water supplies. Rating EC2.

The Environmental Protection Agency (``EPA'' or ``the Agency'') announces and requests comment on its Interim Approach to Applying the Audit Policy to New Owners (``Interim Approach''). (EPA's April 11, 2000 policy on ``Incentives for Self-Policing: Discovery, Disclosure, Correction and Prevention of Violations,'' is commonly referred to as the ``Audit Policy'' (65 FR 19618).) This Interim Approach offers a detailed description of how EPA will apply its Audit Policy to new owners of regulated facilities. Under the Interim Approach, EPA will offer certain incentives specifically tailored to new owners that want to make a ``clean start'' at their newly acquired facilities by addressing environmental noncompliance that began prior to acquisition. This Interim Approach is designed to motivate new owners to audit newly acquired facilities and use the Audit Policy to disclose, correct, and prevent the recurrence of violations. It is also designed to encourage self-disclosures of violations that will, once corrected, yield significant pollutant reductions and benefits to the environment. The incentives tailored for new owners include penalty mitigation beyond what is provided in the Audit Policy, as well as the modification of certain Audit Policy conditions. Through applying a clear, transparent, and easily administered Interim Approach to resolving disclosures from new owners, the Agency seeks to use the Audit Policy to leverage its ability to make effective use of scarce government resources. If procedural and transaction costs can be minimized for regulators and self-disclosing new owners, EPA anticipates that the opportunity to work with new owners as they make clean starts at their new facilities can help secure higher quality environmental improvements more quickly and effectively than might otherwise occur. On May 14, 2007, EPA published a Federal Register Notice entitled ``Enhancing Environmental Outcomes From Audit Policy Disclosures Through Tailored Incentives for New Owners'' (72 FR 27116) (``First Notice'') seeking public comment on whether and to what extent the Agency should consider offering tailored incentives to encourage new owners of regulated entities to discover, disclose, correct, and prevent the recurrence of environmental violations pursuant to the Audit Policy. The Agency received public comment supportive of the idea of offering tailored incentives to new owners, and decided to develop an approach to applying the Audit Policy to new owners. The Agency believes the most efficient way to effectively test this strategy, and learn from practical experience, is to implement it on an interim basis. Accordingly, the Agency has decided to begin applying the Interim Approach, effective upon publication of this Notice. EPA is concurrently seeking public comment on the Interim Approach for a period of 90 days. EPA will be reviewing public comment as it is received and will continue its dialogue with stakeholders on whether refinements to the Interim Approach are needed. In addition, the Agency will place into the public docket copies of agreements resolving violations disclosed by new owners under the Interim Approach. In any event, EPA intends to assess the effectiveness of the Interim Approach on a continual basis. Based on public comment and after the Agency has gained sufficient experience in implementing the Interim Approach, EPA will decide to finalize, revise or discontinue these tailored incentives for new owners.

In accordance with section 751(c) of the Tariff Act of 1930, as amended (``the Act''), the Department of Commerce (``the Department'') is automatically initiating a five-year review (``Sunset Review'') of the antidumping and countervailing duty orders listed below. The International Trade Commission (``the Commission'') is publishing concurrently with this notice its notice of Institution of Five-year Review which covers the same orders.

In this document, the Consumer and Governmental Affairs Bureau (Bureau) reminds public mobile service providers and digital wireless handset manufacturers of their obligation to designate an agent for service of informal complaints received by the Commission, as well as notices, inquiries, and orders, relating to hearing aid compatibility.

This notice amends the notice of a major disaster declaration for the State of Missouri (FEMA-1773-DR), dated June 25, 2008, and related determinations.

This notice amends the notice of a major disaster declaration for the State of Wisconsin (FEMA-1768-DR), dated June 14, 2008, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of Nebraska (FEMA-1779-DR), dated July 18, 2008, and related determinations.

This is a notice of the Presidential declaration of a major disaster for the State of Texas (FEMA-1780-DR), dated July 24, 2008, and related determinations.

This action adds to the Procurement List products and a service to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

This notice amends the notice of a major disaster declaration for the State of Wisconsin (FEMA-1768-DR), dated June 14, 2008, and related determinations.

In response to an industry member request, the Alcohol and Tobacco Tax and Trade Bureau extends the comment period for Notice No. 83, Proposed Revision of Distilled Spirits Plant Regulations, a notice of proposed rulemaking published in the Federal Register on May 8, 2008, for an additional 90 days.

The OST invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for renewal of a previously approved information collection that is summarized below under SUPPLEMENTARY INFORMATION. We published a Federal Register Notice with a 60-day public comment period on this information collection on May 22, 2008. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.