January 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for ``single-entity'' and ``co-packaged'' combination products.

This document contains corrections to the final regulation that was published Friday, December 21, 2012 (74 FR 75509-75521). The regulation pertains to the insurance of Florida Citrus Fruit.

The Department of Homeland Security is giving concurrent notice of a newly established system of records pursuant to the Privacy Act of 1974 for the ``Department of Homeland Security/U.S. Customs and Border Protection; DHS/CBP-004-Intellectual Property Rights e- Recordation and Search Systems (IPRRSS), System of Records'' and this proposed rulemaking. In this proposed rulemaking, the Department proposes to exempt portions of the system of records from one or more provisions of the Privacy Act because of criminal, civil, and administrative enforcement requirements.

This notice lists the newspapers that Ranger Districts, Forests, and the Regional Office of the Alaska Region will use to publish legal notice of all decisions subject to appeal under 36 CFR Part 215 and to publish legal notices for public comment on actions subject to the notice and comment provisions of 36 CFR Part 215, as updated on June 4, 2003. The intended effect of this action is to inform interested members of the public which newspapers will be used to publish legal notice of actions subject to public comment and decisions subject to appeal under 36 CFR Part 215, thereby allowing them to receive constructive notice of a decision or proposed action, to provide clear evidence of timely notice, and to achieve consistency in administering the appeals process.

EPA is taking final action to approve a request submitted on May 2, 2011, from the State of Alabama, through the Alabama Department of Environmental Management (ADEM), Air Division, to redesignate the Birmingham fine particulate matter (PM2.5) nonattainment area (hereafter referred to as the ``Birmingham Area'' or ``Area'') to attainment for the 1997 Annual PM2.5 national ambient air quality standards (NAAQS). The Birmingham 1997 Annual PM2.5 nonattainment area is comprised of Jefferson and Shelby Counties in their entireties and a portion of Walker County. EPA's approval of the redesignation request is based on the determination that the State of Alabama has met the criteria for redesignation to attainment set forth in the Clean Air Act (CAA or Act), including the determination that the Birmingham Area has attained the 1997 Annual PM2.5 NAAQS. Additionally, EPA is approving a revision to the Alabama state implementation plan (SIP) to include the 1997 Annual PM2.5 maintenance plan for the Birmingham Area that contains the new 2024 motor vehicle emission budgets (MVEBs) for nitrogen oxides (NOX) and PM2.5. This action also approves the 2009 emissions inventory submitted with the maintenance plan.

The National Indian Gaming Commission (NIGC or Commission) proposes to revise its appeals rules to include, amongst the appealable actions, the Chair's decisions to approve or object to a tribal gaming regulatory authority's adoption of alternate standards from those required by the Commission's minimum internal control standards and/or technical standards.

This document updates a non-mandatory appendix in OSHA's Occupational Exposure to Hazardous Chemicals in Laboratories Standard. The non-mandatory appendix is being updated to include the contents of the latest National Academy of Sciences publication entitled, ``Prudent Practices in the Laboratory: Handling and Management of Chemical Hazards,'' 2011 edition. All revisions being made are minor and non- substantive.

EPA is approving the submittal from the State of New Mexico pursuant to the Clean Air Act (CAA or Act) that addresses the infrastructure elements specified in the CAA necessary to implement, maintain, and enforce the 2006 fine particulate matter (PM2.5) national ambient air quality standards (NAAQS or standard). The submittal addresses the infrastructure elements specified in the CAA necessary to implement, maintain and enforce the 2006 PM2.5 NAAQS. We find that the current New Mexico State Implementation Plan (SIP) contains the infrastructure elements for the 2006 PM2.5 NAAQS.

EPA is taking direct final action to approve a revision to the West Virginia State Implementation Plan (SIP). The SIP revision consists of a legislative rule adopted by West Virginia to amend its prior general conformity rule for the purpose of incorporating revisions to Federal general conformity requirements established under rules promulgated by EPA in July of 2006 and in April of 2010. EPA is approving West Virginia's SIP revision to amend its general conformity SIP to comply with recent changes in Federal general conformity requirements. This rulemaking action is in accordance with the requirements of the Clean Air Act (CAA).

This proposed rule would implement provisions of the Patient Protection and Affordable Care Act of 2010 and the Health Care and Education Reconciliation Act of 2010 (collectively referred to as the Affordable Care Act), and the Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA). This proposed rule reflects new statutory eligibility provisions; proposes changes to provide states more flexibility to coordinate Medicaid and the Children's Health Insurance Program (CHIP) eligibility notices, appeals, and other related administrative procedures with similar procedures used by other health coverage programs authorized under the Affordable Care Act; modernizes and streamlines existing rules, eliminates obsolete rules, and updates provisions to reflect Medicaid eligibility pathways; revises the rules relating to the substitution of coverage to improve the coordination of CHIP coverage with other coverage; implements other CHIPRA eligibility-related provisions, including eligibility for newborns whose mothers were eligible for and receiving Medicaid or CHIP coverage at the time of birth; amends certain provisions included in the ``State Flexibility for Medicaid Benefit Packages'' final rule published on April 30, 2010; and implements specific provisions including eligibility appeals, notices, and verification of eligibility for qualifying coverage in an eligible employer-sponsored plan for Affordable Insurance Exchanges. This rule also proposes to update and simplify the complex Medicaid premiums and cost sharing requirements, to promote the most effective use of services, and to assist states in identifying cost sharing flexibilities.

Pursuant to section 994(a), (o), and (p) of title 28, United States Code, the United States Sentencing Commission is considering promulgating certain amendments to the sentencing guidelines, policy statements, and commentary. This notice sets forth the proposed amendments and, for each proposed amendment, a synopsis of the issues addressed by that amendment. This notice also sets forth a number of issues for comment, some of which are set forth together with the proposed amendments; some of which are set forth independent of any proposed amendment; and one of which (regarding retroactive application of proposed amendments) is set forth in the SUPPLEMENTARY INFORMATION portion of this notice. The proposed amendments and issues for comment in this notice are as follows: (1) A proposed amendment to Sec. 2B1.1 (Theft, Property Destruction, and Fraud) regarding offenses involving pre-retail medical products to implement the directive in the SAFE DOSES Act, Public Law 112-186 (October 5, 2012), and a related issue for comment; (2) an issue for comment on the directive in section 3 of the Foreign and Economic Espionage Penalty Enhancement Act of 2012, Public Law 112 , relating to offenses involving stolen trade secrets or economic espionage; (3) proposed changes to the guidelines applicable to offenses involving counterfeit or adulterated drugs or counterfeit military parts, including (A) a proposed amendment on offenses involving counterfeit military goods and services, including options to amend Sec. 2B5.3 (Criminal Infringement of Copyright or Trademark) or Appendix A (Statutory Index) with respect to such offenses to address the statutory changes to 18 U.S.C. 2320 made by section 818 of the National Defense Authorization Act for Fiscal Year 2012, Public Law 112-81 (December 31, 2011); (B) a proposed amendment on offenses involving counterfeit drugs, including options to amend Sec. 2B5.3 or Appendix A with respect to such offenses to address the statutory changes to 18 U.S.C. 2320, and to implement the directive to the Commission, in section 717 of the Food and Drug Administration Safety and Innovation Act, Public Law 112-144 (July 9, 2012); and (C) a proposed amendment on offenses involving adulterated drugs, including options to amend Sec. 2N2.1 (Violations of Statutes and Regulations Dealing With Any Food, Drug, Biological Product, Device, Cosmetic, Agricultural Product, or Consumer Product) or Appendix A with respect to such offenses to address the statutory changes to 21 U.S.C. 333 in section 716 of such Act; and related issues for comment; (4) a proposed amendment to Sec. 2T1.1 (Tax Evasion; Willful Failure to File Return, Supply Information, or Pay Tax; Fraudulent or False Returns, Statements, or Other Documents) to respond to a circuit conflict over whether a sentencing court, in calculating the tax loss in a tax case, may subtract the unclaimed deductions that the defendant legitimately could have claimed if he or she had filed an accurate tax return, and related issues for comment; (5) a proposed amendment and issues for comment in response to two circuit conflicts relating to the circumstances under which the defendant is eligible for a third level of reduction under subsection (b) of Sec. 3E1.1 (Acceptance of Responsibility), including (A) a proposed amendment to Sec. 3E1.1 to respond to a circuit conflict over whether the court has discretion to deny the third level of reduction when the government has filed the motion described in subsection (b), which would recognize that the court does have such discretion; and (B) an issue for comment on a circuit conflict over whether the government has discretion to withhold making a motion under subsection (b) when there is no evidence that the government was required to prepare for trial; (6) a proposed amendment to Sec. 5G1.3 (Imposition of a Sentence on a Defendant Subject to an Undischarged Term of Imprisonment) to respond to Setser v. United States, U.S. (March 28, 2012), which held that a federal court in imposing sentence generally has discretion to order that the sentence run consecutive to (or concurrently with) an anticipated, but not yet imposed, term of imprisonment; and (7) a proposed amendment and related issue for comment in response to miscellaneous issues arising from legislation recently enacted and to address technical and stylistic issues in the guidelines, including (A) proposed changes to Appendix A (Statutory Index) to address certain criminal provisions in the Federal Aviation Administration Modernization and Reform Act of 2012, Public Law 112-95 (February 14, 2012); the Child Protection Act of 2012, Public Law 112-206 (December 7, 2012); the Federal Restricted Buildings and Grounds Improvement Act of 2011, Public Law 112-98 (March 8, 2012); and the Ultralight Aircraft Smuggling Prevention Act of 2012, Public Law 112-93 (February 10, 2012); (B) a proposed change to Appendix A (Statutory Index) to address offenses under 18 U.S.C. 554; (C) proposed changes to guidelines in Chapter Two, Part J (Offenses Involving the Administration of Justice) to address an application issue involving the interaction of those guidelines with adjustments in Chapter Three, Part C (Obstruction and Related Adjustments); and (D) technical and stylistic changes.

Notice is hereby given that the State of New York is revising its approved Public Water System Supervision Program to adopt EPA's National Primary Drinking Water Regulations for one major rule and one correction. The EPA has determined that these revisions are no less stringent than the corresponding Federal regulations. Therefore, the EPA intends to approve these program revisions. All interested parties may request a public hearing.

This final rule amends the roof truss testing procedures in the Federal Manufactured Home Construction and Safety Standards by adopting certain recommendations made by the Manufactured Home Consensus Committee (MHCC), as modified by HUD. Pursuant to the National Manufactured Housing Construction and Safety Standards Act of 1974, HUD published a recommendation submitted by MHCC to revise the existing roof truss testing procedures in 2003. In response to public comments, HUD returned the proposal to MHCC for further evaluation. After further consideration, MHCC submitted to HUD an amended version of its original proposal on roof truss testing. HUD was in agreement with the majority of MHCC's revised recommendations on roof truss testing which were published as a proposed rule on June 16, 2010. Many of MHCC's recommendations are included in this final rule. HUD identifies MHCC's proposals that were not accepted, or that were modified in light of public comments received or upon further evaluation, and provides its reasons for not accepting or for modifying these proposed revisions.

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. Collection of this information will result in a better determination of reporting how Primary Inspection Agencies and manufacturers request certification labels, track payment, track production, refund monies, and report missing or damaged labels to the Department or its monitoring contractor.

The proposed information collection requirement described below will be 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.

The proposed information collection requirement described below will be 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.

EPA is revising the regulations on the labeling of pesticide products and devices intended solely for export. Specifically, EPA is restructuring the current regulations to clarify which provisions apply under various circumstances. EPA is also increasing specificity in the regulations by requiring that people who transfer unregistered pesticide products between registered establishments operated by the same producer within the United States must also comply with the requirements of this part if those products are intended solely for export at the time of such transfer. EPA believes that this requirement is necessary to ensure appropriate handling of such products as they move in commerce before they actually leave the United States.

Pursuant to the provisions of the Federal Advisory Committee Act (FACA), the Advisory Committee on the Secretary of State's Strategic Dialogue with Civil Society will convene in Washington, DC on March 12, 2013. The Committee provides advice on the formulation of U.S. policies, proposals, and strategies for engagement with, and protection of, civil society worldwide. The objective of this meeting is to review the progress of the Committee's five subcommittees.

The Gulf of Mexico Fishery Management Council (Council) will convene a public meeting.

The Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on a revised information collection request (ICR) 3206-0042, Notice of Change in Student's Status. As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The information collection was previously published in the Federal Register on August 15, 2012 at Volume 77 FR 49028 allowing for a 60-day public comment period. No comments were received for this information collection. The purpose of this notice is to allow an additional 30 days for public comments. The Office of Management and Budget is particularly interested in comments that: 1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility; 2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; 3. Enhance the quality, utility, and clarity of the information to be collected; and 4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.

In response to requests from the United States Steel Corporation (``U.S. Steel'' or ``Petitioner''), a domestic producer and Petitioner in the underlying investigation of this case, and Wuxi Seamless Oil Pipe Co., Ltd. (``WSP''), a producer of subject merchandise from the People's Republic of China (``PRC''), the Department of Commerce (the ``Department'') initiated an administrative review of the antidumping duty order on oil country tubular goods (``OCTG'') from the PRC. The period of review is May 1, 2011 through April 30, 2012. Based on the timely withdrawal of the request for review submitted by both U.S. Steel and WSP, we are now rescinding this administrative review.

The U.S. Army Corps of Engineers (USACE), Chicago District has posted on https://glmris.anl.gov/documents/interim/anscontrol/screening/ index.cfm aquatic nuisance species (ANS) Controls that can be used to prevent the transfer of algae, crustaceans, fish and plants via aquatic pathways. USACE is announcing a comment period to allow for the submission of information on available ANS Controls for these organism types. In a December 8, 2010 notice of intent, Federal Register Notice (75 FR 76447), USACE announced it will prepare a feasibility report and an Environmental Impact Statement (EIS) for GLMRIS. GLMRIS is a feasibility study of the range of options and technologies that could be applied to prevent ANS transfer between the Great Lakes and Mississippi River basins through aquatic pathways. USACE is conducting GLMRIS in consultation with other federal agencies, Native American tribes, state agencies, local governments and non-governmental organizations. For additional information regarding GLMRIS, please refer to the project Web site https://glmris.anl.gov. This notice announces a comment period during which USACE is asking the public to submit (i) information on ANS Controls that may be effective at preventing the transfer of fish, algae, crustaceans and plants in the CAWS but are missing from the USACE's lists of ANS Controls, or (ii) comments regarding the identified ANS Controls.