August 20, 2014 – Federal Register Recent Federal Regulation Documents

The Defense Acquisition Regulations System has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

The Defense Acquisition Regulations System has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. chapter 35).

The Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) intends to provide a Single Source Cooperative Agreement Award to the National Academy of Science to establish a rapid and agile process for convening subject matter experts to address adverse health effects of public health emergencies and disasters when they occur. The goal of the process will be to prioritize scientific research needs in the immediate aftermath of a disaster that culminates in a summary report of the strategic science research questions most relevant to promote better response, recovery or enhanced resilience in the affect community. Research results would also inform response to the next disaster event. Subject matter expertise would vary, depending on the nature of the emergency/disaster. This could include experts with background in public health, epidemiology, environmental health, emergency management, first response, emergency medicine, infectious diseases, nursing, emergency management, bioethics, medical countermeasures, state and local government, operations research national civic organizations, and risk communication. The process convened by the Institute of Medicine (IOM) would also provide a connection to the local communities affected by the disaster, and include important stakeholders, such as non-government funders or other organizations. This cooperative Agreement will support ASPR's Government Performance and Results Act goals that ``HHS will work with its Federal, state, local, tribal, and international partners to build community resilience and strengthen health and emergency response systems. Robust systems are essential to a secure and resilient. Nation with required capabilities to prevent, protect against, mitigate, respond to, and recover from the threats and hazards that pose the greatest risk. This includes strengthening the Federal medical and public health response capability''. Scientific research involved with preparedness and response is a key component of this endeavor.

NASA, with the concurrence of the Office of Government Ethics (OGE), has adopted as final, without change, an interim rule amending the Supplement Standards of Ethical Conduct for Employees of the National Aeronautics and Space Administration.

Per the Mineral Leasing Act of 1920, Bakken Hunter LLC, Baytex Energy USA Ltd. and Williston Hunter Inc. timely filed a petition for reinstatement of competitive oil and gas lease NDM 94466, Divide County, North Dakota. The lessees paid the required rentals accruing from the date of termination. No leases were issued that affect these lands.

The Bureau of Land Management (BLM) is proposing to sell a 1.06-acre parcel of public land in Teton County, Wyoming, to TSR Limited under the provisions of Section 203 of the Federal Land Policy and Management Act of October 21, 1976 (FLPMA), as amended, for not less than the appraised fair market value of $75,000. This parcel is in an inaccessible location that is difficult and uneconomical for the BLM to manage as it is surrounded by private lands, most of which belongs to TSR Limited, and is not suitable for management by another Federal agency.

We propose to supersede Airworthiness Directive (AD) 81-09-09, which applies to certain Meggitt (Troy), Inc. (previously known as Stewart Warner South Wind Corporation and as Stewart Warner South Wind Division) Model Series 8240 (Models 8240-A, 8240-C, 8240E, and 8248), 8253 (Models 8253-A, 8253-B, and 8253-C), 8259 (Models 8259-A, 8259-C, 8259-DL, 8259HL2, 8259HR2, 8259JR2, 8259L, and 8259M), and 8472 (Models 8472C and 8472D) combustion heaters. AD 81-09-09 currently requires repetitive inspections of the combustion heater; repetitive general inspections of the combustion heater installation; and, for combustion heaters having 1,000 hours or more time-in-service (TIS), overhaul of the combustion heater. Since we issued AD 81-09-09, there was an airplane accident, and we received reports of the heater malfunction. This proposed AD would retain most actions from AD 81-09-09, add a calendar time to the repetitive inspections, and add more detailed actions for the general inspection. We are proposing this AD to correct the unsafe condition on these products.

We (the U.S. Geological Survey) will ask the Office of Management and Budget (OMB) to approve the information collection (IC) described below. As required by the Paperwork Reduction Act (PRA) of 1995, and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this IC. This collection is scheduled to expire on October 31, 2014.

Notice is hereby given that the U.S. International Trade Commission has determined to review in part the final initial determination (``final ID'') issued by the presiding administrative law judge (``ALJ'') on June 13, 2014, finding no violation of section 337 of the Tariff Act of 1930 as amended, 19 U.S.C. 1337 (``section 337''), in this investigation. On review, the Commission has determined to reverse certain findings, to take no position on others, and to terminate the investigation with a finding of no violation.

The Food and Drug Administration (FDA) has determined that LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 milligrams (mg)/vial and 7.5 mg/vial; and LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for leuprolide acetate for depot suspension, injectable 3.75 mg/vial and 7.5 mg/vial; and injectable 7.5 mg/vial and 7.5 mg/vial, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for leuprolide acetate for depot suspension, future applicants are advised that they may not be able to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/ vial and 7.5 mg/vial, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 3.75 mg/vial and 7.5 mg/vial; or LUPRON DEPOT-PED (leuprolide acetate for depot suspension), Injectable 7.5 mg/vial and 7.5 mg/vial, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and the same therapeutic effect.

In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense (Personnel and Readiness) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information 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 proposed information collection; (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.

Virginia has scheduled a special general election on November 4, 2014, to fill the U.S. House of Representatives seat being vacated by Representative Eric I. Cantor. Committees required to file reports in connection with the Special General Election shall file a 12-day Pre-General Report and a Post- General Report.

The Indian Health Service published a document in the Federal Register on July 29, 2014, for the FY 2014 Office of Tribal Self- Governance Program, Planning Cooperative Agreement Announcement. The notice contained an incorrect date.

The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for current vacancies and for those that will or may occur through December 2014. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and therefore, encourages nominations of appropriately qualified candidates from these groups.