June 2011 – Federal Register Recent Federal Regulation Documents

This is Supplement No. 12 to the Treasury Department Circular 570; 2010 Revision, published July 1, 2010, at 75 FR 38192.

Before a Federal agency can collect certain information from the public, it must receive approval from the Office of Management and Budget (OMB). Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatement of previously approved collections. This document describes one collection of information for which NHTSA intends to seek OMB approval.

This notice announces a meeting of the Electricity Advisory Committee (EAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.

The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), will hold a public forum from July 11-13, 2011 on processes relating to community health needs assessment (CHNA) and implementation strategy/plan development and execution. HHS/CDC is developing best practices designed to support state and local health departments to meet public health accreditation standards, and by other entities who may wish to utilize them in their community health planning processes. This notice announces the public forum.

In accordance with the Emergency Economic Stabilization Act of 2008, Title VI, Secure Schools and Community Self-Determination Program (H.R. 1424), the Federal Land Policy and Management Act, and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM), Eugene District Resource Advisory Committee will meet as indicated below.

HHS gives notice of a determination concerning a petition to add a class of employees from the Bliss & Laughlin Steel Company located at 110 Hopkins Street, Buffalo, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

Notice is hereby given that the U.S. Nuclear Regulatory Commission (NRC) is issuing a final Supplemental Environmental Impact Statement (SEIS) to the Generic Environmental Impact Statement for In- Situ Leach Uranium Milling Facilities (GEIS), (NUREG-1910, Supplement 3) for the Lost Creek In-Situ Recovery Project in Sweetwater County, Wyoming. By letter dated October 30, 2007, Lost Creek ISR, LLC (LCI), a wholly-owned subsidiary of UR-Energy USA, Inc. submitted an application to the NRC for a new source and byproduct material license for the Lost Creek ISR Project, which LCI proposed to be located in the Great Divide Basin in Sweetwater County, Wyoming. LCI is proposing to recover uranium from the Lost Creek ISR Project site using the in-situ leach (also known as the in-situ recovery [ISR]) process. In this final SEIS, the NRC staff assessed the environmental impacts from the construction, operation, aquifer restoration, and decommissioning of the proposed Lost Creek ISR Project. In addition to the proposed action, the NRC staff assessed two alternatives in the final SEIS: An alternative that would result in dry yellowcake production at the proposed Lost Creek ISR Project and the No-Action Alternative. In addition, the NRC staff evaluated alternative wastewater disposal options to the proposed action of disposing of liquid effluent via Class I disposal wells. Under the No-Action alternative, NRC would deny LCI's request to construct, operate, conduct aquifer restoration, and decommission an ISR facility at Lost Creek. Alternatives that were considered, but were eliminated from detailed analysis, included conventional mining and milling or heap leach processing. However, given the substantial environmental impact from implementing these alternatives, they were not further considered. The NRC staff also evaluated alternate lixiviants. For reasons discussed in the SEIS, this alternative was also eliminated from detailed analysis. As discussed in Section 2.4 of the final SEIS, unless safety issues mandate otherwise, the NRC staff's recommendation to the Commission related to the environmental aspects of the proposed action is that the source and byproduct material license be issued as requested. This recommendation is based upon: (1) The license application, including the environmental and technical report submitted by LCI and the applicant's supplemental letters and responses to the NRC staff's requests for additional information; (2) consultation with Federal, State, Tribal, and local agencies; (3) the NRC staff's independent review; (4) the NRC staff's consideration of comments received on the draft SEIS; and (5) the assessments summarized in this SEIS. The final SEIS for the Lost Creek ISR Project may be accessed on the Internet at https://www.nrc.gov/reading-rm/doc-collections/nuregs/ staff/sr1910/s3/. Additionally, the NRC maintains an Agencywide Documents and Management System (ADAMS), which provides text and image files of the NRC's public documents. The SEIS may also be accessed online at NRC's Library at: https://www.nrc.gov/ reading-rm/adams.html. The final ``Environmental Impact Statement for the Lost Creek ISR Project in Sweetwater County, WyomingSupplement to the Generic Environmental Impact Statement for In-Situ Leach Uranium Milling Facilities'' is available electronically under ADAMS Accession Number ML11125A006. If you do not have access to ADAMS or if there is a problem accessing documents located in ADAMS, contact the NRC Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by e-mail pdr.resource@nrc.gov. Information and documents associated with the final SEIS are also available for inspection at the NRC's PDR, NRC's Headquarters Building, Room O1-F21, 11555 Rockville Pike (first floor), Rockville, Maryland 20852-2783. For those without access to the Internet, paper copies of any electronic documents may be obtained for a fee by contacting the NRC's PDR at 1-800-397-4209. The final SEIS and related documents may also be found at the following public libraries:

HHS gives notice of a determination concerning a petition to add a class of employees from the Chapman Valve Manufacturing Company (i.e., Building 23 and Dean Street facility) in Indian Orchard, Massachusetts, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

The Committee is proposing to add products and a service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes a product previously furnished by such agency. Comments Must Be Received On or Before: 7/25/2011.

HHS gives notice of a determination concerning a petition to add a class of employees from the Linde Ceramics Plant in Tonawanda, New York, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On June 3, 2011, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

Notice is hereby given that under the authority of the Federal Land Policy and Management Act of 1976 (FLPMA), as amended, the Bureau of Land Management (BLM) Winnemucca District, Black Rock Field Office, will implement and enforce temporary closures and temporary restrictions to protect public safety and resources on public lands within and adjacent to the Burning Man event on the Black Rock Desert playa.

The Food and Drug Administration (FDA) is issuing a final regulation to confirm, with one change, the interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed Consent.'' This final rule confirms the IFR's establishment of a new exception from the general requirements for informed consent to permit the use of investigational in vitro diagnostic devices to identify chemical, biological, radiological, or nuclear agents without informed consent in certain circumstances. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. This final rule adds a requirement that the investigator submit the required documentation to FDA, in addition to submitting it to the reviewing Institutional Review Board (IRB).

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7(R2): Dissolution Test General Chapter'' (Q4B Annex 7(R2)). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The Q4B Annex 7(R2) is a revision of the previously published ICH guidance, ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 7: Dissolution Test General Chapter'' (Q4B Annex 7). The revised guidance specifies additional dissolution apparatuses to which interchangeability applies in the three ICH regions, updates the considerations for implementation, and updates the references used for the Q4B evaluation. The guidance is intended to recognize the interchangeability between the local regional pharmacopoeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. The guidance is in the form of an annex to the core guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions'' (core ICH Q4B guidance).

The FAA is correcting an airworthiness directive (AD) that published in the Federal Register. That AD applies to the products listed above. The AD number in the preamble on the first page of the AD is incorrect. This document corrects that error. In all other respects, the original document remains the same.

In compliance with the National Environmental Policy Act (NEPA) of 1969, as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Oklahoma Field Office intends to prepare an amendment to the 1994 Oklahoma Resource Management Plan, as amended, and associated Environmental Assessment (EA) in response to four coal lease applications covering lands in Haskell and LeFlore Counties, Oklahoma. By this notice, the Oklahoma Field Office announces the beginning of the scoping process to solicit public comments and identify issues.

This document announces a modification of U.S. Customs and Border Protection's (CBP's) Post-Entry Amendment (PEA) Processing test, which allows the amendment of entry summaries prior to liquidation. The test is being modified to reflect that PEA procedures will no longer be accepted for entry summaries filed in the Automated Commercial Environment (ACE). In addition, this notice clarifies that for any PEA which results in Antidumping/Countervailing Duty (AD/CVD) cash deposits due (or bond, if allowed), such deposits or bond are due with the submission of the PEA. Lastly, this notice announces that the PEA test is extended for an additional three-year period.

The Commander, Fifth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Route 30/Abescon Boulevard Bridge across Beach Thorofare, NJICW mile 67.2, at Atlantic City, NJ. The deviation allows the bridge to remain in the closed position to vessels requiring an opening to accommodate heavy volumes of vehicular traffic due to the Fourth of July fireworks show.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Guidance for Industry on Pharmacogenomic Data Submissions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Coast Guard is establishing a temporary safety zone in the navigable waters of Richmond Inner Harbor, off of the Lucretia Edwards Park in Richmond, CA in support of the Independence Day Fireworks Celebration for the City of Richmond. This temporary safety zone is established to ensure the safety of participants and spectators from the dangers associated with the pyrotechnics. Unauthorized persons or vessels are prohibited from entering into, transiting through, or remaining in the safety zone without permission of the Captain of the Port or a designated representative.