May 3, 2012 – Federal Register Recent Federal Regulation Documents

On April 27, 2012 (77 FR 25150), the National Defense University Board of Visitors gave notice of a date correction to an open meeting that was to be held on May 2, 2012, from 10:00 a.m. to 5:00 p.m. Subsequent to the publication of that notice, Department of Defense learned that the May 2 meeting would be cancelled. This notice announcing the cancellation is publishing in the Federal Register after the May 2 open meeting was to have been held.

The Export-Import Bank of the United States (Ex-Im Bank), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995. Ex-Im Bank is requesting an emergency approval of Ex-Im Bank form EIB 99-14 Export Import Bank Trade Reference form. Export-Import (Ex- Im) Bank is requesting an emergency approval of form EIB 99-14, Trade Reference Form. This form provides essential credit information used by Ex-Im Bank credit officers when analyzing requests for export credit insurance/financing support, both short-term (360 days & less) & medium-term (longer than 360 days), for the export of their US goods and services. Additionally, this form is an integral part of the short- term Multi-Buyer export credit insurance policy for those policyholders granted foreign buyer discretionary credit limit authority (DCL). Multi-Buyer policy holders given DCL authority may use this form as the sole source or one piece among several sources of credit information for their internal foreign buyer credit decision in which, in turn, commits Ex-Im's guarantee. Lack of an emergency approval of this form would greatly restrict our ability to support many of the export sales made by U.S. businesses. Ex-Im Bank and its Multi-Buyer policyholders use the Trade Reference Form approximately 6,500 times annually. Thus the Trade Reference Form is critical to Ex-Im Bank and in particular to over 2,300 Multi-Buyer policyholders during their foreign buyer credit review process. This would adversely impact Ex-Im Bank's ability to finance small business exporters and its overall mission to support U.S. exports and maintain U.S. jobs. Accordingly, Ex-Im Bank requests emergency approval of EIB 99-14 in order to continue operation of this important export program. The form can be viewed at www.exim.gov/pub/pending/eib99-14.pdf.

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 (the PRA).

The Defense Intelligence Agency proposes to delete a system of records notice in its existing inventory of records systems subject to the Privacy Act of 1974, (5 U.S.C. 552a), as amended.

The Defense Intelligence Agency is proposing to alter a system to its existing inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The National Security Agency/Central Security Service proposes to add a new system of records in its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Joint Institute for Food Safety and Applied Nutrition (JIFSAN). FDA believes that University of Maryland, College Park (UMCP)-JIFSAN is a sound investment to protect and promote public health. FDA faces an increasing number of critical and complex food safety and public health issues associated with the products that FDA regulates. These complex issues can be addressed most efficiently by expanding the scientific base through the development of collaborative partnerships. FDA believes that partnering with UMCP-JIFSAN will enhance FDA's ability to address safety and other public health issues related to foods, cosmetics, and animal health and continue to stimulate the integration of applied research, education, and outreach programs.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge.'' The purpose of the public workshop is to initiate constructive dialogue and information-sharing among regulators, researchers, the pharmaceutical industry, health care organizations, health care providers, and others from the general public about survey methodologies and instruments that can be used to evaluate patients' and health care providers' knowledge about the risks of drugs marketed with an approved Risk Evaluation and Mitigation Strategy (REMS). The input from this workshop will be used to develop guidance for industry describing the best practices for conducting an assessment of a REMS goal regarding patient and/or health care provider knowledge about a drug's risk(s). To assist in the workshop discussion and the ultimate development of the guidance, FDA is making available an issue paper that discusses our experience with knowledge assessments for REMS and contains specific questions we hope to receive input on. FDA is also opening a public docket to receive written comments. Date and Time: The public workshop will be held on June 7, 2012, from 8 a.m. to 5 p.m. Location: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-0002. Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation / ucm241740.htm. Participants are encouraged to arrive early to ensure time for parking and security screening before the workshop. Contact Person: Colleen O'Malley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4305, Silver Spring, MD 20993-0002, 301-796-1786, FAX: 301-796- 9832, email: colleen.omalley@fda.hhs.gov. Registration and Requests for Oral Presentations: There is no fee to attend the workshop, and attendees who do not wish to make a formal presentation do not need to register. Seating will be on a first-come, first-served basis. Individuals who wish to make a presentation at the public workshop must register and provide an abstract of your presentation by 5 p.m. on May 21, 2012. Submit electronic registration requests to make a presentation to KnowledgeAssessmentWorkshop@fda.hhs.gov. Submit written registration requests to make a presentation to Colleen O'Malley (see Contact Person). Please provide your name, title, business affiliation (if applicable), address, telephone, FAX number, and email address. Identify the Panel number(s) for the question(s) you will discuss in your presentation (see section IV of this document). FDA will do its best to accommodate requests to speak. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations and request time for a joint presentation. FDA will determine the amount of time allotted to each presenter and the approximate time that each oral presentation is scheduled to begin. Persons registered to make a formal presentation should check in before the workshop. Time will be allowed during the scheduled agenda for attendees to ask questions of the panelists. In addition, we strongly encourage electronic or written comments to the docket. FDA has developed an issue paper entitled ``Risk Evaluation and Mitigation Strategy Assessments: Social Science Methodologies to Assess Goals Related to Knowledge'' that discusses our experience with knowledge assessments for REMS. The issue paper also contains a number of specific questions that we hope to receive input on. The issue paper can be found on the Internet at https://www.fda.gov/Drugs/NewsEvents/ ucm292337.htm. Background information on the public workshop, registration information, the agenda, and other relevant information will be posted on the Internet at https://www.fda.gov/Drugs/NewsEvents/ucm132703.htm as it becomes available. If you need special accommodations due to a disability, please contact Colleen O'Malley (see Contact Person) at least 7 days before the workshop. Comments: FDA is opening a docket to allow for public comments to be submitted to the Agency on the issues and questions presented in the issue paper or at the workshop. Regardless of attendance at the public workshop, interested persons may submit to the Division of Dockets Management either electronic or written comments by July 7, 2012, to receive consideration. Submit electronic comments to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

The Commission will consider a Notice of Proposed Rulemaking inviting comment on whether to allow noncommercial educational broadcast stations to conduct on-air fundraising activities that interrupt regular programming for the benefit of third- party non-profit organizations.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

We, the U.S. Fish and Wildlife Service (Service), are reclassifying the wood bison (Bison bison athabascae) from endangered to threatened. This action is based on a review of the best available scientific and commercial data, which indicate that the primary threat that led to population decline, unregulated hunting, is no longer a threat and that recovery actions have led to a substantial increase in the number of herds that have a stable or increasing trend in population size. Critical habitat has not been designated because free- ranging wood bison only occur in Canada and we do not designate critical habitat in foreign countries.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during February 2012. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable.

The purpose of this notice is to announce that: 1 the EPA has received a complete application from the State of Tennessee requesting approval of its Underground Injection Control program; 2 the EPA has determined the application contains all the required elements; 3 the application is available for inspection and copying at the address appearing below; 4 public comments are requested; and (5) a public hearing will be held.

The Rural Utilities Service (RUS) announces the availability of $993,000 in grant funds to be competitively awarded for the Household Water Well System (HWWS) Grant Program for fiscal year 2012 (FY 2012). RUS will make grants to qualified private non-profit organizations to establish lending programs for homeowners to borrow up to $11,000 to construct or repair household water wells for an existing home. The HWWS Grant Program is authorized under 7 U.S.C. 1926e. Regulations are contained in 7 CFR 1776.

The Bureau of Consumer Financial Protection published an interim final rule on December 21, 2011 (76 FR 79486), republishing implementing regulations under the Interstate Land Sales Full Disclosure Act (ILSA). The interim final rule contained a typographical error, which this document corrects.

42 U.S.C. 299c establishes a National Advisory Council for Healthcare Research and Quality (the Council). The Council is to advise the Secretary of HHS (Secretary) and the Director of the Agency for Healthcare Research and Quality (AHRQ) on matters related to activities of the Agency to improve the quality, safety, efficiency, and effectiveness of health care for all Americans. Seven current members' terms will expire in November 2012. To fill these positions, we are seeking individuals who are distinguished: (1) In the conduct of research, demonstration projects, and evaluations with respect to health care; (2) in the fields of health care quality research or health care improvement; (3) in the practice of medicine; (4) in other health professions; (5) in representing the private health care sector (including health plans, providers, and purchasers) or administrators of health care delivery systems; (6) in the fields of health care economics, information systems, law, ethics, business, or public policy; and, (7) in representing the interests of patients and consumers of health care. 42 U.S.C. 299c(c)(2). Individuals are particularly sought with experience and success in activities specified in the summary above.

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). The actions relate to the extension and reconstruction of Broadway Road between 67th Avenue and 7th Street within the city of Phoenix, Maricopa County, Arizona. Those actions grant licenses, permits, and approvals for the project.

We are adopting a new airworthiness directive (AD) for certain Cessna Aircraft Company Model 560XL airplanes. This AD was prompted by reports of wheel inserts becoming loose and damaging brake assemblies on Model 560XL airplanes. This AD requires an inspection of the torque lug and surrounding components (wheel base, side rim, lock ring) for damage (such as corrosion, cracks, dents, bent areas, damaged or missing paint or primer, or wear on the metal), and of the bearing cup for corrosion, turned cup, or clearance that exceeds limits, and repair as applicable; measuring the torque lugs for width and replacing screws and inserts with new, improved screws and inserts; and re-identifying the wheel assemblies. We are issuing this AD to prevent brake failure, which could result in an airplane not being able to stop on the runway.

We are adopting a new airworthiness directive (AD) for all Saab AB, Saab Aerosystems Model SAAB 2000 airplanes. This AD was prompted by reports of hydraulic accumulator failure. This AD requires replacing certain hydraulic accumulators with stainless steel hydraulic accumulators, and structural modifications in the nose landing gear bay. We are issuing this AD to prevent failure of hydraulic accumulators, which may result in damage to the airplane and injury to occupants.

This action amends VOR Federal airway V-14 in the vicinity of St. Louis, MO. The FAA is taking this action to correct the V-14 description contained in Part 71 to ensure it matches the information contained in the FAA's aeronautical database, matches the depiction on the associated charts, and to ensure the safety and efficiency of the National Airspace System (NAS).