September 9, 2015 – Federal Register Recent Federal Regulation Documents

Following consultation with the General Services Administration, notice is hereby given that the Secretary of the Interior (Secretary) is renewing the charter for the Glen Canyon Dam Adaptive Management Work Group. The purpose of the Adaptive Management Work Group is to provide advice and recommendations to the Secretary concerning the operation of Glen Canyon Dam and the exercise of other authorities pursuant to applicable Federal law.

In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Western Montana Resource Advisory Council (RAC) will meet as indicated below.

The Maritime Administration (MARAD) invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The collection involves documenting shipments made during the life of certain EXIM Bank financed projects. The information to be collected is necessary for MARAD to fulfill its legislative requirement to monitor the percentage of ocean freight revenues/tonnage. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995, Public Law 104-13.

We are advising the public of our decision to authorize the importation of fresh cranberries from Chile into the continental United States. Based on the findings of a pest risk assessment, which we made available for the public to review and comment through a previous notice, we have concluded 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 cranberries from Chile.

The Department of State is giving notice that certain portions of the Family Advocacy Case Records, STATE -75, system of records are proposed to be exempt from one or more provisions of the Privacy Act of 1974.

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) 3206-0172, Application for Death Benefits under the Federal Employees Retirement System and Documentation and Elections in Support of Application for Death Benefits When Deceased Was an Employee at the Time of Death. 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. This information collection was previously published in the Federal Register on December 8, 2014 at Volume 79 FR 72711 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 U.S. Department of Health and Human Services (HHS) intends to hold a prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more successful rapid point-of-care diagnostics that may be used by health care providers to identify bacterial infections. The National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) are sponsoring the prize competition and will convene a public consultation to seek comments regarding the technical criteria and performance characteristics of the diagnostic(s) for which the prize(s) will be offered.

The Center for Medicare and Medicaid Innovation (CMMI)/ Seamless Care Models Group will issue a single-source, cooperative agreement award to three (3) grantees to test a data aggregation model that combines data from insurance companies and Medicare in support of an innovative payment and service delivery initiative.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Nonclinical Evaluation of Endocrine-Related Drug Toxicity.'' The purpose of this guidance is to clarify when additional studies are warranted after the standard toxicology tests have been conducted and there is a signal for potential adverse endocrine-related toxicity. This guidance finalizes the draft guidance entitled ``Endocrine Disruption Potential of Drugs: Nonclinical Evaluation'' issued on September 20, 2013.

In accordance with 10 U.S.C. 9355, the U.S. Air Force Academy (USAFA) Board of Visitors (BoV) will hold a meeting at the Falcon Club, U.S. Air Force Academy, Colorado Springs, CO, on September 25, 2015. On Friday, the meeting will begin at 9:00 a.m. The meeting is scheduled to close to the public at 2:00 p.m. The purpose of this meeting is to review morale and discipline, social climate, curriculum, instruction, infrastructure, fiscal affairs, academic methods, and other matters relating to the Academy. Specific topics for this meeting include a Superintendent's Update; USAFA Academics Update; Outreach Subcommittee brief. In accordance with 5 U.S.C. 552b, as amended, and 41 CFR 102-3.155, one session of this meeting shall be closed to the public because it involves matters covered by subsection (c)(6) of 5 U.S.C. 552b. Public attendance at the open portions of this USAFA BoV meeting shall be accommodated on a first-come, first-served basis up to the reasonable and safe capacity of the meeting room. In addition, any member of the public wishing to provide input to the USAFA BoV should submit a written statement in accordance with 41 CFR 102-3.140(c) and section 10(a)(3) of the Federal Advisory Committee Act and the procedures described in this paragraph. Written statements must address the following details: The issue, discussion, and a recommended course of action. Supporting documentation may also be included as needed to establish the appropriate historical context and provide any necessary background information. Written statements can be submitted to the Designated Federal Officer (DFO) at the Air Force address detailed below at any time. However, if a written statement is not received at least 10 calendar days before the first day of the meeting which is the subject of this notice, then it may not be provided to or considered by the BoV until its next open meeting. The DFO will review all timely submissions with the BoV Chairman and ensure they are provided to members of the BoV before the meeting that is the subject of this notice. If after review of timely submitted written comments and the BoV Chairman and DFO deem appropriate, they may choose to invite the submitter of the written comments to orally present the issue during an open portion of the BoV meeting that is the subject of this notice. Members of the BoV may also petition the Chairman to allow specific personnel to make oral presentations before the BoV. In accordance with 41 CFR 102-3.140(d), any oral presentations before the BoV shall be in accordance with agency guidelines provided pursuant to a written invitation and this paragraph. Direct questioning of BoV members or meeting participants by the public is not permitted except with the approval of the DFO and Chairman. For the benefit of the public, rosters that list the names of BoV members and any releasable materials presented during the open portions of this BoV meeting shall be made available upon request. Contact Information: For additional information or to attend this BoV meeting, contact Lt Col Jeffrey Rosa, Accessions and Training Division, AF/A1PT, 1040 Air Force Pentagon, Washington, DC 20330, (703) 695-6711, Jeffrey.T.Rosa.mil@mail.mil.

The Securities and Exchange Commission Equity Market Structure Advisory Committee is providing notice that it will hold a public meeting on Thursday, September 24, 2015, in Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F Street NE., Washington, DC. The meeting will begin at 10:00 a.m. (EDT) and will be open to the public, except for a period of approximately 60 minutes when the Committee will meet in an administrative work session during lunch. The public portions of the meeting will be webcast on the Commission's Web site at www.sec.gov. Persons needing special accommodations to take part because of a disability should notify the contact person listed below. The public is invited to submit written statements to the Committee. The meeting will focus on Rule 610 of SEC Regulation NMS and the regulatory structure of trading venues.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled ``Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis); Guidance for Industry.'' The guidance document provides establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (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 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 guidance announced in this notice finalizes the draft guidance of the same title, dated October 2013. The recommendations in the guidance announced in this notice supersedes 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 Food and Drug Administration (FDA) has determined that GLUCAGON (glucagon hydrochloride) for injection, equivalent to (EQ) 1 milligram (mg) base/vial and EQ 10 mg base/vial, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for glucagon hydrochloride for injection, EQ 1 mg base/vial and EQ 10 mg base/vial, if all other legal and regulatory requirements are met.

This document announces that U.S. Customs and Border Protection (CBP) plans to conduct the Automated Commercial Environment (ACE) Export Manifest for Rail Cargo Test, a National Customs Automation Program (NCAP) test concerning ACE export manifest capability. The ACE Export Manifest for Rail Cargo Test is a voluntary test in which participants agree to submit export manifest data electronically at least 2 hours prior to loading of the cargo onto the rail car in preparation for departure from the United States or, for empty rail cars, upon assembly of the train. CBP regulations do not require carriers to submit a manifest for export rail shipments. This notice provides a description of the test, sets forth eligibility requirements for participation, and invites public comment on any aspect of the test.

Albert Sparks, Kenneth C. Knowles, Joan Kathleen Knowles, and the David L. Sullivan Living Trust (Knowles) have applied for the United States to issue a recordable disclaimer of interest in lands which were patented by the State of California with a reservation to the United States for future use.

Notice is hereby given that an appealable decision will be issued by the Bureau of Land Management (BLM), approving conveyance of the surface estate in the lands described below to Eklutna, Inc., pursuant to the Alaska Native Claims Settlement Act.

An application has been filed with the Bureau of Land Management (BLM) by Charles J. Muncy, Jr., for a Recordable Disclaimer of Interest from the United States pursuant to Section 315 of the Federal Land Policy and Management Act of 1976, as amended (FLPMA), and the regulations in 43 CFR subpart 1864 for the surface estate of land lying between certain deeded lands and the adjusted left bank of the Rio Grande in Socorro County, New Mexico. This notice is intended to inform the public of the pending application and provide a public comment period for the Disclaimer of Interest.