Pediatric Device Consortia Grant Program
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of the Office of Orphan Products Development (OOPD) Pediatric Device Consortia (PDC) Grant Program. The goal of the PDC Grant Program is to facilitate the development, production, and distribution of pediatric medical devices. The PDC will provide grants to nonprofit consortia which provide expert advising and support services to innovators of pediatric devices. These services should include business and regulatory consulting as well as device testing capabilities. This program is intended to further the development of multiple pediatric devices; thus, grants are not awarded to support the development of a single device project. Although administered by the OOPD, this grant program is intended to encompass devices that could be used in all pediatric conditions and diseases, not just rare diseases. The pediatric population (neonates, infants, children, and adolescents) includes patients who are 21 years of age or younger at the time of diagnosis or treatment.
Munder Series Trust, et al.;
Summary of Application: Applicants request an order that would permit them to enter into and materially amend sub-advisory agreements with Wholly-Owned Sub-Advisers (as defined below) and non-affiliated sub-advisers without shareholder approval and would grant relief from certain disclosure requirements. Applicants: Munder Series Trust (the ``Trust'') and Munder Capital Management (``MCM'').
Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940
Each applicant, a closed-end investment company, seeks an order declaring that it has ceased to be an investment company. Applicants have transferred their assets to a series of Pyxis Funds I, and on June 13, 2011, each applicant made a final distribution to its shareholders based on net asset value. Expenses of approximately $275,832 and $365,637, respectively, incurred in connection with the reorganizations were paid by each applicant. Filing Dates: The applications were filed on October 12, 2012, and amended on January 24, 2013. Applicant's Address: 300 Crescent Ct., Suite 700, Dallas, TX 75201.
Ochoco National Forest, Paulina Ranger District; Oregon; Wolf Creek Vegetation and Fuels Management Project EIS
The Ochoco National Forest is preparing an environmental impact statement (EIS) to analyze the effects of managing vegetation and fuels within the 24,506 acre Wolf project area, which is approximately 50 miles east of Prineville, Oregon. The project area includes National Forest system lands within the Lower Beavercreek watershed. The alternatives that will be analyzed include the proposed action, no action, and additional alternatives that will respond to issues generated through the scoping process. The Ochoco National Forest will give notice of the full environmental analysis and decision making process so interested and affected people may participate and contribute to the final decision.
Nantucket National Wildlife Refuge, Nantucket, MA; Final Comprehensive Conservation Plan and Finding of No Significant Impact
We, the U.S. Fish and Wildlife Service (Service), announce the availability of our final comprehensive conservation plan (CCP), finding of no significant impact (FONSI), and land protection plan (LPP) for Nantucket National Wildlife Refuge (NWR, refuge) in Nantucket, Massachusetts. Nantucket NWR is part of the Eastern Massachusetts NWR Complex, administered from Sudbury, Massachusetts. In this final CCP, we describe how we will manage the refuge for the next 15 years.
Environmental Impact Statement: Cook County, Illinois
The FHWA is issuing this revised notice of intent to advise the public that an environmental impact statement is being prepared for the proposed I-290 highway improvement project in Cook County, Illinois, and that the project limits in the Notice of Intent (NOI) published in the Federal Register on February 26, 2010 have been expanded.
Airworthiness Directives; Rolls-Royce plc Turbofan Engines
We propose to adopt a new airworthiness directive (AD) for all Rolls-Royce plc (RR) RB211-535E4-B-37 series turbofan engines. This proposed AD was prompted by recalculating the life of certain life limited parts operated to certain flight profiles. This proposed AD would require removal of affected parts using a drawdown plan. We are proposing this AD to prevent the failure of critical rotating parts, which could result in uncontained failure of the engine and damage to the airplane.
Airworthiness Directives; Pratt & Whitney Canada Corp. Turboprop Engines
We propose to adopt a new airworthiness directive (AD) for certain Pratt & Whitney Canada Corp. (P&WC) PW118A, PW118B, PW119B, PW119C, PW123, PW123B, PW123C, PW123D, PW123E, PW123AF, PW124B, PW125B, PW126A, PW127, PW127E, PW127F, PW127G, and PW127M turboprop engines. This proposed AD was prompted by reports of fractures of the 1st stage power turbine (PT) blade. This proposed AD would require inspection of the 1st stage PT blades and the removal from service of those blades that fail the inspection or their replacement with blades eligible for installation. We are proposing this AD to prevent fracture of the 1st stage PT blade, possible engine fire, and damage to the airplane.
Customer Account Registration and Maintenance
The United States Patent and Trademark Office (USPTO), 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 this new information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Airworthiness Directives; Rolls-Royce plc Turbofan Engines
We propose to adopt a new airworthiness directive (AD) for all Rolls-Royce plc (RR) RB211-535E4-37, RB211-535E4-B-37, RB211-535E4-C- 37, and RB211-535E4-B-75 turbofan engines. This proposed AD was prompted by RR updating the low-cycle-fatigue life analysis for the low pressure turbine (LPT) stage 2 discs. This proposed AD would require removal of affected parts using a drawdown plan. We are proposing this AD to prevent LPT stage 2 disc failure, which could result in uncontained engine damage and damage to the airplane.
Airworthiness Directives; Rolls-Royce plc Turbofan Engines
We propose to adopt a new airworthiness directive (AD) for certain Rolls-Royce plc (RR) RB211-524B-02; -524B2-19; -524B3-02; - 524B4-02; -524C2-19; -524D4-19; -524D4-B-19; -524D4-39; -535C-37; - 535E4-37; -535E4-B-37, and -535E4-B-75 turbofan engines, and all RB211- 524G2-19; -524G3-19; -524H2-19; and -524H-36 turbofan engines. This proposed AD was prompted by the discovery of a cracked and distorted front combustion liner (FCL) metering panel, which was made from the wrong material. This proposed AD would require a one-time inspection of the FCL metering panel to determine if it was made from N75 material and replacing it with one made from C263 material if it was made from N75 material. We are proposing this AD to prevent hot gas burning through the engine casing, which could result in an under-cowl fire and damage to the airplane.
Endangered and Threatened Wildlife and Plants; Receipt of Application for Renewal of Incidental Take Permit; Availability of Proposed Low-Effect Habitat Conservation Plan; Eber Cove, LLC, Brevard County, FL
We, the Fish and Wildlife Service (Service), have received an application from Eber Cove, LLC (applicant), for a 5-year renewal of incidental take permit (ITP) TE151089-0 under the Endangered Species Act of 1973, as amended (Act). We request public comment on the permit application and accompanying proposed habitat conservation plan (HCP), as well as on our preliminary determination that the plan qualifies as low effect under the National Environmental Policy Act (NEPA). To make this determination, we used our environmental action statement and low- effect screening form, which are also available for review.
Food and Drug Administration/National Institutes of Health/National Science Foundation Public Workshop on Computer Methods for Medical Devices
The Food and Drug Administration (FDA) is announcing its fifth public workshop on Computer Methods for Medical Devices entitled ``FDA/ NIH/NSF Workshop on Computer Models and Validation for Medical Devices.'' The purpose of the workshop is to present, discuss, and receive input on an FDA library of models and data relevant to medical devices (day 1) and present, discuss, and receive input on a strategy to assess the credibility of computer models used to evaluate medical devices (day 2).
Notice of a Public Meeting of the Advisory Committee on Apprenticeship (ACA)
Pursuant to Section 10 of the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2 Sec. 10), notice is hereby given to announce a public meeting of the Advisory Committee on Apprenticeship (ACA) on June 5, 2013, and June 6, 2013. The ACA is a discretionary committee established by the Secretary of Labor, in accordance with FACA, as amended in 5 U.S.C. App. 2, and its implementing regulations (41CFR parts 101-6 and 102-3). All meetings of the ACA are open to the public.
Government-Owned Inventions; Availability for Licensing
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.
Agency Information Collection Activities; Proposed Collection; Comment Request; Agreement for Shipment of Devices for Sterilization
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements relating to shipment of nonsterile devices that are to be sterilized elsewhere or are shipped to other establishments for further processing, labeling, or repacking.
Agency Information Collection Activities; Proposed Collection; Comment Request; Export of Medical Devices; Foreign Letters of Approval
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements for firms that intend to export certain unapproved medical devices.
New Competitive Product
The Commission is noticing a recent Postal Service filing concerning an addition to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Safety Zones; Annual Events Requiring Safety Zones in the Captain of the Port Lake Michigan Zone
The Coast Guard is amending its regulations requiring safety zones in the Captain of the Port Lake Michigan zone. This rule will amend the rules that restrict vessels from portions of water areas during events that pose a hazard to public safety. The safety zones amended or established by this rule are necessary to protect spectators, participants, and vessels from the hazards associated with various maritime events.
Transportation Worker Identification Credential (TWIC)-Reader Requirements
The Coast Guard announces a public meeting to take place on May 2, 2013, in Seattle, Washington to receive comments on a notice of proposed rulemaking published in the Federal Register on March 22, 2013, under the title ``Transportation Worker Identification Credential (TWIC)Reader Requirements.'' The Coast Guard encourages members of the public to attend this meeting and provide oral comments on the notice of proposed rulemaking on TWIC reader requirements.
Safety Zones; Swim Events in the Captain of the Port New York Zone; Hudson River, East River, Upper New York Bay, Lower New York Bay; New York, NY
The Coast Guard proposes to establish five temporary safety zones for swim events within the Captain of the Port (COTP) New York Zone. These proposed zones will be established on the navigable waters of the Hudson River, East River, Upper New York Bay, and Lower New York Bay. These temporary safety zones are necessary to protect the maritime public and event participants from the hazards associated with these events. Persons and vessels are prohibited from entering into, transiting through, mooring, or anchoring within the safety zones unless authorized by the COTP New York or the designated representative.
Drawbridge Operation Regulations; Pelican Island Causeway, Galveston, Channel, TX
The Coast Guard is temporarily changing the operating schedule that governs the Pelican Island Causeway bridge across Galveston Channel mile 4.5 (GIWW mile 356.1), at Galveston, Texas. The temporary change to the regulations will allow the bridge to remain closed to navigation while major repairs are conducted to the mechanical portions of the bascule span. Failure to complete the repairs in a timely manner may render the bridge completely inoperable for the passage of vessel traffic.
Prospective Grant of A Start-Up Commercialization Exclusive License: The Development of Fenoterol Analogues for the Treatment of Brain and Hepatocellular Cancers
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant to Nova Therapeutics LLC of a start-up exclusive commercialization license to practice the inventions embodied in the following US Provisional Patent Application (and all domestic and foreign counterparts claiming priority to it): Serial No. 61/651,961, filed May 25, 2012, entitled, ``Methods of Regulating Cannabinoid Receptor Activity-related Disorders and Diseases'' [HHS Ref. E-139-2012/0-US-01]. The patent rights in this invention have been assigned to the Government of the United States of America. The prospective start-up exclusive commercialization license territory may be worldwide, and the field of use may be limited to:
Towing Safety Advisory Committee; Vacancies
The United States Coast Guard (the Coast Guard) is requesting applications from qualified candidates seeking consideration for appointment as public members to the Towing Safety Advisory Committee (TSAC). TSAC advises the Coast Guard on matters relating to shallow- draft inland and coastal waterway navigation and towing safety.
Literature Review Approach “Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid”; Request for Information and Comments
The National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS) in conjunction with the NIH Office of Dietary Supplements (ODS) is planning a workshop to identify research needs based on consideration of the state of the science related to the safe use of high intakes of folic acid. The NTP and the ODS invite comments on an approach document, ``Identifying Research Needs for Assessing Safe Use of High Intakes of Folic Acid,'' for review of the pertinent literature. The document is available on the NTP Folic Acid Request for Information (RFI) Web site (https:// ntp.niehs.nih.gov/go/38143). Information gathered through this request will be used in prioritizing topics for the state of the science workshop.
Society of Clinical Research Associates-Food and Drug Administration: Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice
The Food and Drug Administration (FDA) is announcing an educational conference co-sponsored with the Society of Clinical Research Associates (SOCRA). The conference on FDA's clinical trial requirements is designed to aid the clinical research professional's understanding of the mission, responsibilities, and authority of FDA and to facilitate interaction with FDA representatives. The program will focus on the relationships among FDA and clinical trial staff, investigators, and institutional review boards (IRBs). Individual FDA representatives will discuss the informed consent process and informed consent documents, and regulations relating to drugs, devices, and biologics, as well as inspections of clinical investigators, IRBs, and research sponsors.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food Additive Petitions and Investigational Food Additive Exemptions
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.
Notice of Availability of Corrected Record of Decision for the Final Environmental Impact Statement for the South Gillette Area Maysdorf II Coal Lease by Application, WY
In accordance with the National Environmental Policy Act of 1969, the Bureau of Land Management (BLM) announces the availability of a Correction to the Record of Decision (ROD) for the Maysdorf II Coal Lease-by-Application (LBA) included in the South Gillette Area Coal Lease Applications Final Environmental Impact Statement (EIS).
Agency Information Collection Activities OMB Responses
This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et. seq.). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Spill Prevention, Control and Countermeasure (SPCC) Plans (Renewal)
The Environmental Protection Agency has submitted an information collection request (ICR), ``Spill Prevention, Control and Countermeasures (SPCC) Plans (Renewal)'' (EPA ICR No. 0328.16, OMB Control No. 2050-0021) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). This is a proposed extension of the ICR, which is currently approved through June 30, 2013. Public comments were previously requested via the Federal Register (77 FR 74659) on December 17, 2012 during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; NESHAP for Plastic Parts and Products Surface Coating (Renewal)
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR which is abstracted below describes the nature of the collection and the estimated burden and cost.
Proposed Establishment of the Big Valley District-Lake County and Kelsey Bench-Lake County Viticultural Areas, and Modification of the Red Hills Lake County Viticultural Area
The Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to establish the 11,000-acre Big Valley District-Lake County viticultural area and the 9,100-acre Kelsey Bench-Lake County viticultural area, both in Lake County, California. Additionally, TTB proposes to modify the boundary of the established 31,250-acre Red Hills Lake County viticultural area in order to align its border with that of the proposed Kelsey Bench-Lake County viticultural area. The proposed modification would increase the size of the Red Hills Lake County viticultural area by approximately 7 acres. The proposed viticultural areas and the established viticultural area that are the subject of this proposed rule lie entirely within the existing Clear Lake viticultural area, which, in turn, is within the larger, multicounty North Coast viticultural area. TTB designates viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase. TTB invites comments on these proposed additions and modification to its regulations.
Environmental Impact Statement for Modernization and Repair of Piers 2 and 3, Military Ocean Terminal Concord, CA
The Department of the Army announces its intent to conduct public scoping under the National Environmental Policy Act to gather information to prepare an Environmental Impact Statement (EIS) related to the critically-needed modernization and repairs of Piers 2 and 3, Military Ocean Terminal Concord (MOTCO) due to structural decay caused by severe deterioration, wide-spread marine borer damage, and fungal decay. Piers 2 and 3 are used to transport military supplies in the Pacific region. There may be significant impacts to threatened and endangered species. The following other resource areas may be impacted: water quality, noise, terrestrial and marine species, and traffic. For example, the proposed action will replace a large number of piles; this work will likely result in water quality issues and an increase in noise. The Department of the Army will use the analysis in the EIS to determine whether and how to implement the proposed action.