November 16, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act permanently debarring Scott S. Reuben, M.D. from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Dr. Reuben was convicted of a felony under Federal law for conduct relating to the regulation of a drug product under the Federal Food, Drug, and Cosmetic Act. Dr. Reuben was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. Dr. Reuben failed to respond. Dr. Reuben's failure to respond constitutes a waiver of his right to a hearing concerning this action.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information, in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments on the proposed extension of the Labor Market Information (LMI) Cooperative Agreement application package. A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the ADDRESSES section of this notice.

Section 2715 of the National Defense Authorization Act for Fiscal Year 2010, Public Law 111-84, amended the Defense Base Closure and Realignment Act of 1990 to change the authority of the Department of Defense to convey property to a local redevelopment authority (LRA) for purposes of job generation on a military installation closed or realigned under a base closure law. Such a conveyance is known as an Economic Development Conveyance (EDC). Economic Development Conveyances were created by amendments to the Base Closure and Realignment law in 1993, creating a new tool for communities experiencing negative economic effects caused by the elimination of a significant number of jobs in the community. Congress recognized that the existing authority under the Federal Property and Administrative Services Act of 1949 (as amended and otherwise known as the Real Property Act) was not structured to deal with the unique challenges of assisting base closure communities with economic recovery and job creation, many with decaying or obsolete infrastructure and other redevelopment challenges. Under this revised authority, the Department is no longer required to seek fair market value for an EDC. An EDC may be for consideration at or below the estimated fair market value, including without consideration. The amendment expands the flexibility of the Department regarding the form of consideration it may accept, including the authority to accept consideration in the form of revenue sharing or so-called ``back-end'' funding. Back-end funding is consideration consisting of a share of the revenues that the LRA receives from third- party buyers or lessees from sales and leases of the conveyed property, consideration in kind (including goods and services), real property and improvements, or such other consideration as the Secretary considers appropriate. The amendment also provides that the Department's determination of the consideration may account for the economic conditions of the local affected community and the estimated costs to redevelop the property. This final rule amends the existing regulation on reutilization of installations closed under the base closure process to conform to the amendment to the Defense Base Closure and Realignment Act of 1990 and makes other improvements that encourage expedited property transfers for job creation that allow for the Department to recover a share of the revenues obtained.

In compliance with Section 3506 (c) (2) (A) of the Paperwork Reduction Act of 1995, the Defense Security Service (DSS) announces the proposed extension of a public information collection and seeks public comments on the provision thereof. Comments are invited on: (a) Whether the proposed collection is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the information to be collected; and (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

The Federal Transit Administration invites public comment about our intention to request the Office of Management and Budget (OMB) to extend the approval of the following information collection: 49 U.S.C. Section 5330Rail Fixed Guideway Systems, State Safety Oversight. The information collected is used to monitor the safety of the rail transit agencies. The Federal Register notice with a 60-day comment period soliciting comments was published on August 29, 2011 (Citation 76 FR 53713). No comments were received from that notice.

The Federal Transit Administration invites public comment about our intention to request the Office of Management and Budget's (OMB) approval to renew the following information collection: 49 U.S.C. Section 5320Paul S. Sarbanes Transit in Parks Program. The information collected is to monitor projects and satisfy Congressional requests. The Federal Register notice with a 60-day comment period soliciting comments was published on August 29, 2011 (Citation 76 FR 53714). No comments were received from that notice.

The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Section 4 of the Church Arson Prevention Act of 1996 authorizes the Secretary to guarantee loans made to certain nonprofit organizations whose properties have been damaged by an act or acts of arson or terrorism.

This Treasury decision expands the Russian River Valley viticultural area in Sonoma County, California, by 14,044 acres, and the Northern Sonoma viticultural area in Sonoma County, California, by 44,244 acres. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.

In accordance with section 102(a)(4)(C) of the Department of Housing and Urban Development Reform Act of 1989, this announcement notifies the public of funding decisions made by the Department for funding under the Notice of Funding Availability (NOFA) for the Fair Housing Initiatives Program (FHIP) Enforcement Testing Technical Assistance for Fiscal Year (FY) 2010. This announcement contains the names and addresses of those award recipients selected for funding based on the rating and ranking of all applications and the amount of the awards.

Title VIII of the Civil Rights Act of 1968, as amended (Fair Housing Act or Act), prohibits discrimination in the sale, rental, or financing of dwellings and in other housing-related activities on the basis of race, color, religion, sex, disability, familial status, or national origin.\1\ HUD, to which Congress gave the authority and responsibility for administering the Fair Housing Act and the power to make rules implementing the Act, has long interpreted the Act to prohibit housing practices with a discriminatory effect, even where there has been no intent to discriminate.

In this document, the Commission, via the Consumer and Governmental Affairs Bureau (CGB), terminates, as dormant, certain docketed Commission proceedings. Termination of these inactive proceedings furthers the Commission's organizational goals of increasing the efficiency of its decision-making, modernizing the agency's processes in the digital age, and enhancing the openness and transparency of Commission proceedings for practitioners and the public.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``State Petitions for Exemption for Preemption'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Consumer Product Safety Commission (``Commission'' or ``CPSC'' or ``we'') has received a petition requesting an exception from the 100 ppm lead content limit under section 101(b) of the Consumer Product Safety Improvement Act of 2008 (``CPSIA''), as amended by Public Law 112-28. We invite written comments concerning the petition.

On August 25, 2011, (76 FR 53086) PHMSA published in the Federal Register an Advance Notice of Proposed Rulemaking (ANPRM) titled: ``Safety of Gas Transmission Pipelines'' seeking comments on the need for changes to the regulations covering gas transmission pipelines. PHMSA has received requests to extend the comment period in order to have more time to evaluate the ANPRM. PHMSA is extending the comment period from December 2, 2011, to January 20, 2012.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of Thursday, October 20, 2011 (76 FR 65199). The document announced the availability of a draft guidance entitled ``E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation GuideData Elements and Message Specification'' (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled ``ICSRs: Appendix to the Implementation GuideBackwards and Forwards Compatibility'' (the draft BFC appendix). The document was published with an incorrect date in the DATES section. This document corrects that error.

The Food and Drug Administration (FDA) is extending to April 25, 2012, the comment period for the notice on its report of scientific and medical literature and information concerning the use of non- standardized allergenic extracts in the diagnosis and treatment of allergic disease that appeared in the Federal Register of September 26, 2011 (76 FR 59407). In the notice, FDA requested comments from public and private stakeholders on the report it provided in a data file entitled ``Center for Biologics Evaluation and Research Report of Scientific and Medical Literature and Information on Non-Standardized Allergenic Extracts in the Diagnosis and Treatment of Allergic Disease.'' The Agency is taking this action in response to input it received from the Allergenic Products Advisory Committee (APAC) at a meeting held on October 25, 2011, to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Infant Formula Recall Regulations'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

EPA is finalizing approval of revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) portion of the California State Implementation Plan (SIP). These revisions were proposed in the Federal Register on September 12, 2011 and concern volatile organic compound (VOC) emissions from steam enhanced crude oil production and aerospace coating operations. We are approving local rules that regulate these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act).

The U.S. Nuclear Regulatory Commission (NRC or the Commission) has made available its initial Plan for retrospective analysis of its existing regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed. This action is part of the NRC's voluntary implementation of Executive Order (EO) 13579, ``Regulation and Independent Regulatory Agencies,'' issued by the President on July 11, 2011. The purpose of the NRC's review is to make its regulatory program more effective and less burdensome in achieving its regulatory objectives. The NRC is not instituting a public comment period for the initial Plan at this time but anticipates issuing a revised version for public comment in Calendar Year (CY) 2012 to reflect, as appropriate, any Commission decisions related to the Fukushima Task Force Report.

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 (44 U.S.C. 3501 et seq.), before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes an Information Collection Request (ICR) for which NHTSA intends to seek OMB approval.