November 5, 2013 – Federal Register Recent Federal Regulation Documents

The United States Department of Commerce, International Trade Administration is amending the Notice published at 78 FR 42505, July 16, 2013, regarding the U.S. Healthcare Education Mission to New Delhi, Hyderabad, and Ahmedabad, India to revise the date of the application deadline from November 1, 2013 to the new deadline of November 22, 2013.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for Infection with Treponema pallidum (Syphilis),'' dated October 2013. The draft guidance document provides establishments that make donor eligibility determinations for donors of HCT/Ps (HCT/P Establishments), with updated recommendations concerning donor testing for evidence of Treponema pallidum (T. pallidum) infection, the etiologic agent of syphilis. HCT/P Establishments must, as required under Federal regulations, test a donor specimen for evidence of T. pallidum infection using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, unless an exception to this requirement applies. The draft guidance clarifies that FDA does not consider diagnostic tests or pre-amendment devices (which have not been licensed, approved, or cleared) to be adequate for use in donor testing for T. pallidum infection under the criteria specified in Federal regulations. The recommendations in this guidance, when finalized, will supersede those recommendations for testing HCT/P donors for evidence of T. pallidum infection contained in the document entitled ``Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated August 2007.

The Federal Emergency Management Agency (FEMA) will submit the information collection abstracted below to the Office of Management and Budget for review and clearance in accordance with the requirements of the Paperwork Reduction Act of 1995. The submission will describe the nature of the information collection, the categories of respondents, the estimated burden (i.e., the time, effort and resources used by respondents to respond) and cost, and the actual data collection instruments FEMA will use.

Pursuant to the Federal Advisory Committee Act of 1972 (5 U. S. C., Appendix, as amended), the Sunshine in the Government Act of 1976 (U. S. C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3. 140 through 160), the Department of the Army announces the following committee meeting: Name of Committee: Advisory Committee on Arlington National Cemetery. Date of Meeting: Tuesday, November 19, 2013. Time of Meeting: 9:30 a.m.-3:30 p.m. Place of Meeting: Women in Military Service for America Memorial, Conference Room, Arlington National Cemetery, Arlington, VA. Proposed Agenda: Review and discuss the Section 60 Mementos Pilot Program, highlights of upcoming events for the 50th Commemoration of the interment of John F. Kennedy and 150th anniversary of Arlington National Cemetery, and the status of expansion projects. Public's Accessibility to the Meeting: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public. Seating is on a first-come basis.

The Charter for the Internal Revenue Service Advisory Council (IRSAC), has been renewed for a two-year period beginning October 29, 2013.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing notice of proposed rulemaking and temporary regulation, REG- 135898-04 (TD 9154), Extension of Time to Elect Method for Determining Allowable Loss; REG-152524-02 (TD 9057), Guidance Under Section 1502, Amendment of Waiver of Loss Carryovers from Separate Return Limitation Years; REG-123305-02, REG-102740-02 (TD 9187), Loss Limitation Rules.

The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13(44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning an existing final regulation, IA-33-92 (TD 8507), Information Reporting for Reimbursements of Interest on Qualified Mortgages (Sec. 1.6050H- 2).

The Copyright Royalty Judges are publishing final regulations setting the rates and terms for the making of an ephemeral recording of a sound recording by a business establishment service for the period January 1, 2014, through December 31, 2018.

This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.

On April 19, 2013, the Ohio Environmental Protection Agency (Ohio EPA), submitted a request to EPA to make a determination under the Clean Air Act (CAA) that the Bellefontaine nonattainment area has attained the 2008 lead (Pb) national ambient air quality standards (NAAQS or standard). In this action, EPA is determining that the Bellefontaine nonattainment area (hereafter also referred to as the ``Bellefontaine area'' or ``area'') has attained the 2008 Pb NAAQS. This determination of attainment is based upon complete, quality- assured and certified ambient air monitoring data for the 2010-2012 design period showing that the area has monitored attainment of the 2008 Pb NAAQS. Additionally, as a result of this determination, EPA is suspending the requirements for the area to submit an attainment demonstration, together with reasonably available control measures (RACM), a reasonable further progress (RFP) plan, and contingency measures for failure to meet RFP and attainment deadlines for as long as the area continues to attain the 2008 Pb NAAQS.

Under Clean Air Act (CAA) Section 112(l), EPA may approve State or local rules or programs to be implemented and enforced in place of certain otherwise applicable Federal rules, emissions standards, or requirements. On September 13, 2012, the State of North Dakota, Department of Agriculture (NDDA), requested partial delegation of the CAA section 112(r)(7) Risk Management Program (RM Program) for agricultural anhydrous ammonia facilities. The September 13, 2012 request was supplemented by the NDAA on February 26, 2013, and April 11, 2013. EPA has preliminarily determined that NDDA's request meets CAA requirements for partial delegation, and EPA is proposing to approve the request.

This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(l)(1). These actions relate to a proposed highway project, State Route 1011, Section 470, Pond Eddy Bridge (also known locally as the All Veterans Memorial Bridge), in Pike County in the State of Pennsylvania. These actions grant licenses, permits, and approvals for the project.

The Securities Investor Protection Corporation (``SIPC'') filed a proposed rule change with the Securities and Exchange Commission (``Commission''). The proposed rule change amends SIPC Rule 400, entitled ``Rules Relating to Satisfaction of Customer Claims for Standardized Options,'' which relates to the satisfaction of customer claims for standardized options under the Securities Investor Protection Act of 1970 (``SIPA''). The Commission is publishing the proposed rule change for public comment. Because SIPC rules have the force and effect as if promulgated by the Commission, those rules are published in Title 17 of the Code of Federal Regulations.

On September 26, 2012, the Bureau of Consumer Financial Protection (Bureau) issued a safe harbor list of countries that qualify for an exception in subpart B of Regulation E, which implements the Electronic Fund Transfer Act, and published this list on its Web site. The Bureau is now publishing the current list, which is unchanged from the prior release, in the Federal Register. The Bureau recognizes that the list may change, and it intends to revise the list periodically.

The Securities and Exchange Commission is proposing for comment new Regulation Crowdfunding under the Securities Act of 1933 and the Securities Exchange Act of 1934 to implement the requirements of Title III of the Jumpstart Our Business Startups Act. Regulation Crowdfunding would prescribe rules governing the offer and sale of securities under new Section 4(a)(6) of the Securities Act of 1933. The proposal also would provide a framework for the regulation of registered funding portals and brokers that issuers are required to use as intermediaries in the offer and sale of securities in reliance on Section 4(a)(6). In addition, the proposal would exempt securities sold pursuant to Section 4(a)(6) from the registration requirements of Section 12(g) of the Securities Exchange Act of 1934.

We are adopting a new airworthiness directive (AD) for certain Bell Model 206B and 206L helicopters. This AD requires installing a placard beneath the engine power dual tachometer and revising the operating limitations section of the rotorcraft flight manual (RFM). This AD was prompted by several incidents of third stage engine turbine wheel failures, which were caused by excessive vibrations at certain engine speeds during steady-state operations. These actions are intended to alert pilots to avoid certain engine speeds during steady- state operations, prevent failure of the third stage engine turbine, engine power loss, and subsequent loss of control of the helicopter.