May 2011 – Federal Register Recent Federal Regulation Documents

The Department of Education (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.

This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

The ``Veterans Health Care Act of 1992,'' enacted section 340B of the Public Health Service Act (PHSA) ``Limitation on Prices of Drugs Purchased by Covered Entities.'' Section 340B implemented a drug pricing program by which manufacturers who participate in Medicaid are required to sell covered outpatient drugs to particular covered entities listed in the statute and must agree to charge a price that will not exceed the amount determined under a statutory formula. The manufacturer's obligation to sell at no greater than the ceiling price extends only to covered outpatient drugs and does not apply to inpatient drugs. Covered entities are required to ensure that drugs purchased under 340B are used only for outpatients. The Patient Protection and Affordable Care Act expanded the types of covered entities eligible to participate in the 340B Drug Pricing Program (340B Program) under the PHSA to include certain free standing cancer hospitals, rural referral centers, sole community hospitals, critical access hospitals, and children's hospitals. Of these entities, children's hospitals were already eligible to participate in the 340B drug pricing program under the Deficit Reduction Act of 2005. The Health Care and Education Reconciliation Act (HCERA) (the Patient Protection and Affordable Care Act and HCERA collectively hereinafter will be referred to as the ``Affordable Care Act''), as amended by the Medicare and Medicaid Extenders Act of 2010, contained a provision that limits the types of drugs that free standing cancer hospitals, rural referral centers, sole community hospitals and critical access hospitals could obtain through the 340B Program. Under the changes made by the Affordable Care Act, orphan drugs, when used for the rare condition or disease for which that orphan drug was designated under the Federal Food, Drug, and Cosmetic Act (FFDCA), are excluded from the definition of covered outpatient drug for the specified newly-eligible covered entity types for purposes of the 340B Program. This regulatory action details how these exclusions will be implemented under the 340B Program.

This notice advises the public that the Bureau of Indian Affairs (BIA) as lead agency, with the Campo Band of Mission Indians (Tribe) as a cooperating agency, intends to gather information necessary for preparing an Environmental Impact Statement (EIS) for the proposed Campo Shu'luuk Wind Project, located on the Campo Indian Reservation in southeastern San Diego County, approximately 60 miles east of San Diego, California. Construction of the Shu'luuk Wind Project within the Campo Reservation is subject to BIA approval of a lease and sublease, which, as proposed, is a major Federal action under the National Environmental Policy Act of 1969 (NEPA), as amended. A brief description of the proposed action and areas of environmental concern are provided below in the SUPPLEMENTARY INFORMATION section. This notice also announces a public scoping meeting to identify potential issues, concerns and alternatives to be considered in the EIS. The scoping process will include notice to the public and Federal, State, local, and Tribal agencies of the proposed action.

This action adds services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes services from the Procurement List previously provided by such agencies.

The Bureau of Indian Affairs (BIA) published a document in the Federal Register of April 8, 2011, advising the public that the Bureau of Indian Affairs (BIA), as lead agency, in cooperation with the Pueblo of Jemez, intends to file a Draft Environmental Impact Statement (DEIS) with the U.S. Environmental Protection Agency (EPA) for the proposed approval of a 70.277 acre fee-to-trust transfer and casino project to be located within Do[ntilde]a Ana County, New Mexico. The document contained an error in the public comment deadline.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 25, 2011 (76 FR 22805). The document announced that FDA is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. The document published inadvertently used outdated contact information. This document corrects that error.

The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, ``Rehabilitation Plan and Award,'' Form OWCP-16, to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

In accordance with the requirement of Section 3506 (c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board (RRB) will publish periodic summaries of proposed data collections. Comments are invited on: (a) Whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the RRB's estimate of the burden of the collection of the information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden related to the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. 1. Title and purpose of information collection: Application for Reimbursement for Hospital Insurance Services in Canada; OMB 3220-0086. Under section 7(d) of the Railroad Retirement Act (RRA), the RRB administers the Medicare program for persons covered by the railroad retirement system. Payments are provided under section 7(d)(4) of the RRA for medical services furnished in Canada to the same extent as for those furnished in the United States. However, payments for the services furnished in Canada are made from the Railroad Retirement Account rather than from the Federal Hospital Insurance Trust Fund, with the payments limited to the amount by which insurance benefits under Medicare exceed the amount payable under Canadian Provincial plans. Form AA-104, Application for Canadian Hospital Benefits Under MedicarePart A, is provided by the RRB to a claimant seeking reimbursement for covered hospital services received in Canada. The form obtains information needed to determine the eligibility of the applicant and the amount of any reimbursement due. One response is requested of each respondent. Completion is required to obtain a benefit.

The Lawrence County Resource Advisory Committee will meet in Spearfish, South Dakota. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) and in compliance with the Federal Advisory Committee Act. The committee has received several formal project proposals and will be soliciting for additional projects. The purpose of the meeting is to review submitted projects and vote on project proposals to recommend for funding.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Missouri (FEMA- 1980-DR), dated 05/09/2011. Incident: Severe Storms, Tornadoes, and Flooding. Incident Period: 04/19/2011 and continuing. Effective Date: 05/09/2011. Physical Loan Application Deadline Date: 07/08/2011. Economic Injury (EIDL) Loan Application Deadline Date: 02/09/2012.

Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled In Re Certain Lighting Control Devices Including Dimmer Switches and Parts Thereof (IV), DN 2805; the Commission is soliciting comments on any public interest issues raised by the complaint.

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Arkansas (FEMA-1975-DR), dated 05/02/2011. Incident: Severe Storms, Tornadoes, and Associated Flooding. Incident Period: 04/23/2011 and continuing. Effective Date: 05/09/2011. Physical Loan Application Deadline Date: 07/01/2011. Economic Injury (EIDL) Loan Application Deadline Date: 02/02/2012.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Iowa (FEMA-1977- DR), dated 05/05/2011. Incident: Severe Storms, Tornadoes, and Straight-line Winds. Incident Period: 04/09/2011 through 04/10/2011. Effective Date: 05/05/2011. Physical Loan Application Deadline Date: 07/05/2011. Economic Injury (EIDL) Loan Application Deadline Date: 02/06/2012.