July 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing a public workshop regarding the approach of the Center for Drug Evaluation and Research (CDER) to addressing drug shortages. This public workshop is intended to provide information for, and to gain additional insight from, professional societies, patient advocates, industry, consumer groups, health care professionals, researchers, and other interested persons about the causes and impact of drug shortages, and possible strategies for preventing or mitigating drug shortages. The input from this public workshop will help in developing topics for further discussion with industry and professional societies, and other stakeholders and may help the Agency to better address drug shortage issues. Date and Time: The public workshop will be held on September 26, 2011, from 8:30 a.m. to 4:30 p.m. Location: The public workshop will be held at 10903 New Hampshire Ave., Bldg. 31, rm. 1503 B and C (Great Room), Silver Spring, MD 20993. Information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https:// www.fda.gov/AdvisoryCommittees/default.htm; under the heading ``Resources for You,'' click on ``White Oak Conference Center Parking and Transportation Information for FDA Advisory Committee Meetings.'' Please note that visitors to the White Oak Campus must enter through Building 1. (https://www.fda.gov/AboutFDA/WorkingatFDA/ BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.ht m). Contact Persons: Christine Moser or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6202, Silver Spring, MD 20993-0002, 301- 796-1300 or 301-796-1600. Registration: To register electronically, e-mail registration information (including name, title, firm name, address, telephone, and fax number) to dsworkshop@fda.hhs.gov by September 19, 2011. Persons without access to the Internet can call Christine Moser at 301-796-1300 or Lori Benner at 301-796-1300 to register. Registration is free for the public workshop. Seating will be available on a first-come, first- served basis. Persons needing a sign language interpreter or other special accommodations should notify Christine Moser or Lori Benner (see Contact) at least 7 days in advance.

The Department of Labor (DOL) is submitting the Occupational Safety and Health Administration (OSHA) sponsored information collection request (ICR) titled, ``Design of Excavation Cave-in Protection Systems,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35).

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on June 27, 2011, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of AU Optronics Corporation of Taiwan and AU Optronics Corporation America of Milpitas, California. A letter supplementing the complaint was filed on July 12, 2011. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain flat panel display devices and products containing the same by reason of infringement of certain claims of U.S. Patent No. 6,281,955 (``the `955 patent''); U.S. Patent No. 7,697,093 (``the `093 patent''); U.S. Patent No. 7,286,192 (``the `192 patent''); U.S. Patent No. 6,818,967 (``the `967 patent''); U.S. Patent No. 7,199,854 (``the `854 patent''); and U.S. Patent No. 7,663,729 (``the `729 patent''). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue an exclusion order and cease and desist orders.

EPA is making an interim final determination to defer imposition of sanctions based on a proposed determination, published elsewhere in this Federal Register, that the State of California has submitted a rule that satisfies the requirements of Clean Air Act (CAA) Section 185 fee program.

The U.S. Office of Personnel Management is proposing to revise its regulations on agencies' use of appropriated funds to provide child care subsidies for lower-income civilian employees, to make the regulations clearer and more concise. It also would make certain technical corrections, and substantive changes including in the definition of ``child'' for purposes of the subpart. The proposed regulations also clarify the scope of regulations concerning alcohol and drug abuse counseling programs for employees and expand the regulations to extend coverage to domestic partners of Federal employees.

The U.S. Office of Personnel Management (OPM) is issuing proposed regulations to clarify that an employee's same-sex domestic partner qualifies, and should be treated as, a family member for purposes of eligibility for noncompetitive appointment based on overseas employment, as provided in section 315.608 of title 5, Code of Federal Regulations. These regulations implement, in part, a June 2, 2010, Presidential Memorandum by providing same-sex domestic partners with the same employment opportunities that opposite-sex spouses of Federal employees receive under 5 CFR 315.608.

This action modifies Class E airspace at Alturas Municipal Airport, Alturas, CA. Controlled airspace is necessary to accommodate aircraft using Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Alturas Municipal Airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport.

This action modifies Class E airspace at Wokal Field/Glasgow International Airport, Glasgow, MT. Controlled airspace is necessary to accommodate aircraft using Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at the airport. This improves the safety and management of Instrument Flight Rules (IFR) operations at the airport. This action also updates the airport name.

On May 23, 2011, Delta Air Lines, Inc. (Delta) and US Airways, Inc. (US Airways) (together, the Joint Applicants or the carriers) submitted a joint request for the Department of Transportation (the Department) to waive a prohibition on purchasing operating authorizations (slots) at LaGuardia Airport (LGA). The carriers requested the waiver to allow them to consummate a transaction in which US Airways would transfer to Delta 132 slot pairs (265 slots) at LGA. In exchange, Delta would transfer to US Airways 42 slot pairs (84 slots) at Ronald Reagan Washington National Airport (DCA), convey route authority to operate certain flights to Sao Paulo, Brazil, and make a cash payment to US Airways. The Department (the Office of the Secretary and the Federal Aviation Administration, or FAA) has evaluated the proposed transaction and tentatively determined that it affords significant benefits to the public. At the same time, we recognize that the transaction will result in an increase in market concentration that could negatively impact consumers. As a result, we have tentatively determined that the divestiture of a number of slots by the carriers is necessary for us to allow the transaction to proceed. We have tentatively concluded that the divestiture of 32 slots at LGA and 16 slots at DCA will reduce adverse impacts on consumers at DCA and LGA to a degree sufficient for us to conclude that the requested waiver is in the public interest. This Notice prescribes rules and procedures for the divestiture of those slots by the carriers to new entrant and limited incumbent carriers.

Notice is hereby given that the Advisory Council on Historic Preservation (ACHP) will meet Thursday, August 11, 2011. The meeting will be held in the Plymouth Room of the Mayflower Park Hotel, 405 Olive Way, Seattle, WA 98101. The ACHP was established by the National Historic Preservation Act of 1966 (16 U.S.C. 470 et seq.) to advise the President and Congress on national historic preservation policy and to comment upon Federal, federally assisted, and federally licensed undertakings having an effect upon properties listed in or eligible for inclusion in the National Register of Historic Places. The ACHP's members are the Architect of the Capitol; the Secretaries of the Interior, Agriculture, Defense, Housing and Urban Development, Commerce, Education, Veterans Affairs, and Transportation; the Administrator of the General Services Administration; the Chairman of the National Trust for Historic Preservation; the President of the National Conference of State Historic Preservation Officers; a Governor; a Mayor; a Native American; and eight non-Federal members appointed by the President.

In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR Part 107, Subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the ``Nature of Application'' portion of the table below as follows: 1Motor vehicle, 2Rail freight, 3Cargo vessel, 4Cargo aircraft only, 5Passenger-carrying aircraft.

We are advising the public of our decision to authorize the importation into the continental United States of fresh persimmon fruit from the Republic of South Africa. Based on the findings of a pest risk analysis, which we made available to the public for review and comment through a previous notice, we believe that the application of one or more designated phytosanitary measures will be sufficient to mitigate the risks of introducing or disseminating plant pests or noxious weeds via the importation of fresh persimmon fruit from South Africa.

This notice amends the notice of a major disaster declaration for the State of Vermont (FEMA-1995-DR), dated June 15, 2011 and related determinations.

An open meeting of the Taxpayer Advocacy Panel Joint Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

An open meeting of the Taxpayer Advocacy Panel Volunteer Income Tax Assistance Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

An open meeting of the Taxpayer Advocacy Panel Notice Improvement Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.

In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. chapter 35), the OCC, the Board, the FDIC, and the OTS (the ``agencies'') may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. On June 17, 2011, OMB approved the agencies' emergency clearance requests to implement assessment-related reporting revisions to the Consolidated Reports of Condition and Income (Call Report) for banks, the Thrift Financial Report (TFR) for savings associations, the Report of Assets and Liabilities of U.S. Branches and Agencies of Foreign Banks (FFIEC 002), and the Report of Assets and Liabilities of a Non-U.S. Branch that is Managed or Controlled by a U.S. Branch or Agency of a Foreign (Non-U.S.) Bank (FFIEC 002S), all of which currently are approved collections of information, effective as of the June 30, 2011, report date. Because the assessment-related reporting revisions will need to remain in effect beyond the limited approval period associated with an emergency clearance request, the agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), are requesting public comment on a proposal to extend, with revision, the collections of information identified above. At the end of the comment period, the comments and recommendations received will be analyzed to determine the extent to which the FFIEC and the agencies should modify the proposed revisions prior to giving final approval. The agencies will then submit the revisions to OMB for review and approval.

An open meeting of the Taxpayer Advocacy Panel Taxpayer Assistance Center Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

NMFS closes the northern area Angling category fishery for large medium and giant (``trophy'') Atlantic bluefin tuna (BFT) for the remainder of 2011. This action is being taken to prevent overharvest of the 2011 Angling category northern area subquota for large medium and giant BFT.

The Bureau of Land Management (BLM) will file the plat of survey of the lands described below in the BLM Montana State Office, Billings, Montana, on August 26, 2011.