July 2013 – Federal Register Recent Federal Regulation Documents

Results 651 - 700 of 2,788
Draft Guidance for Industry on Pre-Launch Activities Importation Requests; Availability
Document Number: 2013-17768
Type: Notice
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Pre-Launch Activities Importation Requests (PLAIR).'' This draft guidance describes FDA's policy regarding requests for the importation of unapproved finished dosage form drug products by applicants preparing products for market launch based on anticipated approval of a pending new drug application (NDA) or an abbreviated new drug application (ANDA). This draft guidance also applies to biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research. This draft guidance further describes the procedures for making these requests and the criteria that FDA will consider in granting such requests.
Endangered and Threatened Wildlife and Plants; Recovery Permit Application
Document Number: 2013-17766
Type: Notice
Date: 2013-07-24
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following application for a recovery permit to conduct activities with the purpose of enhancing the survival of an endangered species. The Endangered Species Act of 1973, as amended (Act), prohibits certain activities with endangered species unless a Federal permit allows such activity. The Act also requires that we invite public comment before issuing such permits.
Airworthiness Directives; Dassault Aviation Airplanes
Document Number: 2013-17765
Type: Proposed Rule
Date: 2013-07-24
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for all DASSAULT AVIATION Model FAN JET FALCON; Model MYSTERE-FALCON 200 airplanes; and Model MYSTERE-FALCON 20-C5, 20-D5, 20-E5, and 20-F5 airplanes. This proposed AD was prompted by reports of defective fire extinguisher bottle cartridges. This proposed AD would require checking manufacturing references of pyrotechnical cartridges for batch number and date, repetitive checking of cartridges for electrical continuity, and replacing defective pyrotechnical cartridges if necessary. We are proposing this AD to detect and correct defective fire bottle cartridges, which could affect the capability to extinguish a fire in an engine, auxiliary power unit, or rear compartment, which could result in damage to the airplane and injury to the occupants.
Airworthiness Directives; BAE Systems (Operations) Limited Airplanes
Document Number: 2013-17764
Type: Proposed Rule
Date: 2013-07-24
Agency: Federal Aviation Administration, Department of Transportation
We propose to supersede an existing airworthiness directive (AD) that applies to all BAE Systems (Operations) Limited Model BAe 146 series airplanes and Model Avro 146-RJ series airplanes. The existing AD currently requires revising the maintenance program by incorporating certain airworthiness limitations that require new life limits on certain main landing gear (MLG) components. Since we issued that AD, we have determined that reduced safe life limits on certain nose landing gear (NLG) fittings are necessary. Analysis of these fittings showed the presence of forging indications in the flash line, which might reduce the life limits of these fittings.
Notice of Public Meeting; Wyoming Resource Advisory Council
Document Number: 2013-17763
Type: Notice
Date: 2013-07-24
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Federal Land Policy and Management Act of 1976 and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Wyoming Resource Advisory Council (RAC) will meet as indicated below.
Comment Request for Information Collection for Veterans Retraining Assistance Program Participant (VRAP) Outreach Reporting, Extension Without Changes
Document Number: 2013-17762
Type: Notice
Date: 2013-07-24
Agency: Employment and Training Administration, Department of Labor
The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act (PRA) of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, ETA is soliciting comments concerning the collection of data about ``Veterans Retraining Assistance Program Participant Outreach Reporting'' which is a request for an extension without changes to the data collection from State Workforce Agencies (SWA), collected on a quarterly basis. We will use this information collection to ensure that VRAP participants are offered employment services after they complete the program as required in the VOW to Hire Heroes Act of 2011.
167th Meeting of the Advisory Council on Employee Welfare and Pension Benefit Plans; Notice of Meeting
Document Number: 2013-17761
Type: Notice
Date: 2013-07-24
Agency: Employee Benefits Security Administration, Department of Labor
Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to a Pier Replacement Project
Document Number: 2013-17760
Type: Notice
Date: 2013-07-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In accordance with the regulations implementing the Marine Mammal Protection Act (MMPA) as amended, notification is hereby given that we have issued an incidental harassment authorization (IHA) to the U.S. Navy (Navy) to incidentally harass, by Level B harassment only, four species of marine mammals during construction activities associated with a pier replacement project in San Diego Bay, California.
Caribbean Fishery Management Council; Public Meetings
Document Number: 2013-17759
Type: Notice
Date: 2013-07-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Caribbean Fishery Management Council (Council) and its Administrative Committee will hold meetings.
Application for Final Commitment for a Long-Term Loan or Financial Guarantee in Excess of $100 Million: AP088035XX
Document Number: 2013-17758
Type: Notice
Date: 2013-07-24
Agency: Export-Import Bank, Agencies and Commissions
This Notice is to inform the public, in accordance with Section 3(c)(10) of the Charter of the Export-Import Bank of the United States (``Ex-Im Bank''), that Ex-Im Bank has received an application for final commitment for a long-term loan or financial guarantee in excess of $100 million (as calculated in accordance with Section 3(c)(10) of the Charter). Comments received within the comment period specified below will be presented to the Ex-Im Bank Board of Directors prior to final action on this transaction. Reference: AP088035XX. Purpose and Use: Brief description of the purpose of the transaction: To support the export of U.S.-manufactured commercial aircraft to Norway. Brief non-proprietary description of the anticipated use of the items being exported: To be used for medium-haul and long-haul air service between Norway/Sweden and destinations in Asia, United States and other countries. To the extent that Ex-Im Bank is reasonably aware, the item(s) being exported may be used to produce exports or provide services in competition with the exportation of goods or provision of services by a United States industry. Parties: Principal Supplier: The Boeing Company. Obligor: Norwegian Air Shuttle ASA. Guarantor(s): N/A. Description of Items Being Exported: The items being exported are Boeing 787 aircraft. Information on Decision: Information on the final decision for this transaction will be available in the ``Summary Minutes of Meetings of Board of Directors'' on https://exim.gov/newsandevents/boardmeetings/ board/. Confidential Information: Please note that this notice does not include confidential or proprietary business information; information which, if disclosed, would violate the Trade Secrets Act; or information which would jeopardize jobs in the United States by supplying information that competitors could use to compete with companies in the United States.
New Animal Drugs; Change of Sponsor; Fentanyl; Iron Injection
Document Number: 2013-17754
Type: Rule
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two approved new animal drug applications (NADAs) from Alstoe, Ltd., Animal Health, to Sogeval S.A., and a change of sponsor for an NADA from Nexcyon Pharmaceuticals, Inc. to Elanco Animal Health, A Division of Eli Lilly & Co.
Draft Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers With Outdoor Access); Availability
Document Number: 2013-17750
Type: Proposed Rule
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Questions and Answers Regarding the Final Rule, Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation (Layers with Outdoor Access)'' (the draft guidance). The document provides guidance to egg producers on certain provisions contained in FDA's final rule entitled, ``Prevention of Salmonella Enteritidis in Shell Eggs During Production, Storage, and Transportation'' concerning the management of production systems that provide laying hens with access to the outdoors. Laying hens are provided outdoor access in some production systems, including certified organic production systems governed by the U.S. Department of Agriculture's National Organic Program regulations.
Inquiry Routing and Information System; Correction
Document Number: 2013-17749
Type: Notice
Date: 2013-07-24
Agency: Department of Veterans Affairs
The Department of Veterans Affairs (VA) published an information collection notice in a Federal Register on July 15, 2013 (78 FR 42157), that contained errors. In the SUMMARY section of the notice, VA announced that the Veterans Health Administration (VHA) had submitted the collection of information titled ``Inquiry Routing and Information System (IRIS) to the Office of Management and Budget (OMB) for review and comment. It should have stated that the Office of Information and Technology (OIT) had submitted the collection of information to OMB. Also, at the AGENCY heading, VHA was named the sponsoring program office when the sponsoring program office is OIT. Lastly, we have corrected the office title of the FOR FURTHER INFORMATION CONTACT person. Those errors are corrected by this notice.
Proposed Information Collection (Wrist Conditions Disability Benefits Questionnaire) Activity: Withdrawal
Document Number: 2013-17748
Type: Notice
Date: 2013-07-24
Agency: Department of Veterans Affairs
The Department of Veterans Affairs (VA) published a notice in a Federal Register on June 17, 2013 (78 FR 36307), inviting the public to comment on a proposed information collection titled ``Wrist Conditions Disability Benefits Questionnaire, VA Form 21-0960M-16.'' On June 18, 2013 (78 FR 36643), VA inadvertently published an identical notice for the same information collection. This document corrects that error by withdrawing the FR notice that published on June 18, 2013 (FR Doc 2013-14412).
Guidance for Industry on Providing Submissions in Electronic Format-Postmarket Non-Expedited Individual Case Safety Reports; Technical Questions and Answers; Availability
Document Number: 2013-17747
Type: Notice
Date: 2013-07-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance to industry entitled ``Providing Submissions in Electronic FormatPostmarket Non-Expedited ICSRs; Technical Questions and Answers.'' The guidance provides firms with information on the appropriate electronic file format to use when electronically submitting to FDA postmarket non-expedited individual case safety reports (ICSRs) on adverse drug experiences.\1\ The guidance explains that firms that had previously submitted non-expedited ICSRs in an electronic format that is not supported by FDA should contact the Center for Drug Evaluation and Research (CDER) or Center for Biologics and Evaluation and Research (CBER) and resubmit their non-expedited ICSRs in a compatible electronic format.
Combined Notice of Filings #2
Document Number: 2013-17743
Type: Notice
Date: 2013-07-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2013-17742
Type: Notice
Date: 2013-07-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Salt River Pima-Maricopa Indian Community-Amendment to Alcoholic Beverage Control Ordinance
Document Number: 2013-17741
Type: Notice
Date: 2013-07-24
Agency: Department of the Interior, Bureau of Indian Affairs
This notice publishes the amendment to the Salt River Pima- Maricopa Indian Community Alcoholic Beverage Control Ordinance, Chapter 14, Salt River Pima-Maricopa Indian Community Code of Ordinances to provide consistency with newly amended Arizona State Liquor Law and to enact certain technical amendments. The amended Salt River Pima- Maricopa Indian Alcohol Beverage Control Ordinance, Chapter 14 of the Salt River Pima-Maricopa Indian Community Code of Ordinances was last published in the Federal Register on July 13, 2010 (Vol. 75, No 133, FR 39960-39967). Sections 14-5(c)(4), 14-9(g), 14-18(o) and (t) of the Salt River Pima-Maricopa Indian Community Code of Ordinances shall be repealed and replaced in their entirety, and a new Section 14-12 has been added.
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-17740
Type: Notice
Date: 2013-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-17739
Type: Notice
Date: 2013-07-24
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2013-17738
Type: Notice
Date: 2013-07-24
Agency: Agency for Toxic Substances and Disease Registry, Department of Health and Human Services
Marine Mammals; Notice of Availability of a Draft Environmental Impact Statement To Amend the Atlantic Large Whale Take Reduction Plan
Document Number: 2013-17737
Type: Notice
Date: 2013-07-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS proposes to amend the regulations implementing the Atlantic Large Whale Take Reduction Plan (Plan). The proposed rule revises the management measures for reducing the incidental mortality and serious injury to the North Atlantic right whale (Eubalaena glacialis), humpback whale (Megaptera novaeangliae), and fin whale (Balaenoptera physalus) in commercial trap/pot and gillnet fisheries to meet the goals of the Marine Mammal Protection Act (MMPA) and the Endangered Species Act (ESA). A Draft Environmental Impact Statement (DEIS) was prepared in accordance with the National Environmental Policy Act (NEPA), to analyze impacts to the environment of the management alternatives under consideration. NMFS will hold 16 public hearings along the East coast in August and September for the purpose of answering questions and receiving public testimony on the DEIS.
Proposed Information Collection; Comment Request; Licensing of Private Remote-Sensing Space Systems
Document Number: 2013-17736
Type: Notice
Date: 2013-07-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Revision to Transmission Vegetation Management Reliability Standard; Notice of Compliance Filing
Document Number: 2013-17732
Type: Notice
Date: 2013-07-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Chesapeake Energy Marketing, Inc. v. Midcontinent Express Pipeline LLC; Notice of Complaint
Document Number: 2013-17731
Type: Notice
Date: 2013-07-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Protection System Maintenance Reliability Standard
Document Number: 2013-17730
Type: Proposed Rule
Date: 2013-07-24
Agency: Federal Energy Regulatory Commission, Department of Energy, Deparment of Energy
Pursuant to section 215 of the Federal Power Act, the Commission proposes to approve a revised Reliability Standard, PRC-005- 2Protection System Maintenance, to supersede four existing Reliability Standards, PRC-005-1.1b (Transmission and Generation Protection System Maintenance and Testing), PRC-008-0 (Underfrequency Load Shedding Equipment Maintenance), PRC-011-0 (Undervoltage Load Shedding Equipment Maintenance) and PRC-017-0 (Special Protection System Maintenance and Testing). In addition, the Commission seeks clarification and comment on three aspects of the proposed Reliability Standard and proposes to modify one violation severity level.
Revisions to Page 700 of FERC Form No. 6
Document Number: 2013-17729
Type: Rule
Date: 2013-07-24
Agency: Department of Energy, Federal Energy Regulatory Commission
The Federal Energy Regulatory Commission (Commission) is modifying Page 700 of FERC Form No. 6 (Form 6) to facilitate the calculation of an oil pipeline's actual return on equity for preliminary screening purposes. The Commission will expand the information provided regarding Rate Base (line 5), Rate of Return (line 6), Return on Rate Base (line 7), and Income Tax Allowance (line 8).
Stingray Pipeline Company, L.L.C.; Notice of Request Under Blanket Authorization
Document Number: 2013-17728
Type: Notice
Date: 2013-07-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Effective Date of Revised Company Registration Requirements
Document Number: 2013-17727
Type: Notice
Date: 2013-07-24
Agency: Department of Energy, Federal Energy Regulatory Commission
This document establishes the effective date of the Revised Company Registration Requirements. The Commission issued a Notice in the Federal Register, 78 FR 10,614 (February 14, 2013), requesting public comments by April 15, 2013.
Duke Energy Kentucky, Inc.; Notice of Petition for Rate Approval
Document Number: 2013-17726
Type: Notice
Date: 2013-07-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Submission for OMB Review; Comment Request
Document Number: 2013-17723
Type: Notice
Date: 2013-07-24
Agency: Securities and Exchange Commission, Agencies and Commissions
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Applications for Assistance Section 8002 Impact Aid Program
Document Number: 2013-17721
Type: Notice
Date: 2013-07-24
Agency: Department of Education
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501 et seq.), ED is proposing an extension of an existing information collection.
Sickle Cell Disease Treatment Demonstration Program
Document Number: 2013-17720
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, Health Resources and Services Administration
HRSA currently has nine programs that are funded through competitive grant awards under the Sickle Cell Disease Treatment Demonstration Program. Three of these awards will end on August 31, 2013, prior to the end of the other six awards. HRSA intends to implement a non-competitive extension of the project period for the three grants that will end in 2013. This will allow improved data gathering from each of the grantees in the program, which will be used in a report for Congress that is mandated by the legislation authorizing the grant. In addition, the program will benefit from cost savings realized from having the program completed in a consolidated funding cycle.
National Cancer Institute; Notice of Meeting
Document Number: 2013-17718
Type: Notice
Date: 2013-07-24
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Inventory Completion: Washington State Parks and Recreation Commission, Olympia, WA
Document Number: 2013-17717
Type: Notice
Date: 2013-07-24
Agency: Department of the Interior, National Park Service
The Washington State Parks and Recreation Commission has completed an inventory of human remains in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Washington State Parks and Recreation Commission. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: State Historical Society of Wisconsin, Madison, WI
Document Number: 2013-17716
Type: Notice
Date: 2013-07-24
Agency: Department of the Interior, National Park Service
The State Historical Society of Wisconsin has completed an inventory of human remains and associated funerary objects, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is no cultural affiliation between the human remains and associated funerary objects and any present-day Indian tribes or Native Hawaiian organizations. Representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the State Historical Society of Wisconsin. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the Indian tribes or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Thomas Burke Memorial Washington State Museum, University of Washington, Seattle, WA
Document Number: 2013-17714
Type: Notice
Date: 2013-07-24
Agency: Department of the Interior, National Park Service
The Thomas Burke Memorial Washington State Museum, University of Washington (Burke Museum), has completed an inventory of human remains and associated funerary objects in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and associated funerary objects and present-day Indian tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains and associated funerary objects should submit a written request to the Burke Museum. If no additional requestors come forward, transfer of control of the human remains and associated funerary objects to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Inventory Completion: Washington State Parks and Recreation Commission, Olympia, WA
Document Number: 2013-17713
Type: Notice
Date: 2013-07-24
Agency: Department of the Interior, National Park Service
The Washington State Parks and Recreation Commission has completed an inventory of human remains, in consultation with the appropriate Indian tribes or Native Hawaiian organizations, and has determined that there is a cultural affiliation between the human remains and present-day Indian tribes or Native Hawaiian organizations. Lineal descendants or representatives of any Indian tribe or Native Hawaiian organization not identified in this notice that wish to request transfer of control of these human remains should submit a written request to the Washington State Parks and Recreation Commission. If no additional requestors come forward, transfer of control of the human remains to the lineal descendants, Indian tribes, or Native Hawaiian organizations stated in this notice may proceed.
Notice of Organization Name and Address Change
Document Number: 2013-17712
Type: Rule
Date: 2013-07-24
Agency: Postal Service, Agencies and Commissions
The Postal Service is revising the rules concerning authorization to manufacture and distribute postage evidencing systems to reflect that the Office of Postage Technology Management is now known as Payment Technology and has a new mailing address.
Burned Area Emergency Response, Forest Service
Document Number: 2013-17710
Type: Notice
Date: 2013-07-24
Agency: Department of Agriculture, Forest Service
The Forest Service is correcting a notice of interim directive that appeared in the Federal Register of June 6, 2013, (78 FR 34031). This correction adds the Web site that was inadvertently omitted from the interim directive which is necessary to allow the public more detailed information and time to review the Burned Area Emergency Response revisions. This correction lists the Web site for the interim directive and the current Forest Service Manual in the Supplementary Information section of this notice and extends the comment period by 30 days.
Proposed Information Collection (Conduct the Point-of-Care Research Questionnaire); Activities Under OMB Review
Document Number: 2013-17709
Type: Notice
Date: 2013-07-24
Agency: Department of Veterans Affairs
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521), this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Forest Resource Coordinating Committee
Document Number: 2013-17706
Type: Notice
Date: 2013-07-24
Agency: Department of Agriculture, Office of the Secretary
The Department of Agriculture re-established the Forest Resource Coordinating Committee (Committee) pursuant to Section 8005 of the Food, Conservation, and Energy Act of 2008 (Act) (Pub. L. 110-246), and the Federal Advisory Committee Act (FACA), (5 U.S.C. App. 2). The Act passed into law as an amendment to the Cooperative Forestry Assistance Act of 1978 on June 18, 2008. The Committee has been re- established to continue coordinating non-industrial private forestry activities within the U.S. Department of Agriculture (USDA) and the private sector. The Secretary of Agriculture (Secretary) has determined that the work of the Committee is in the public's interest and relevant to the duties of the USDA. Therefore, the Secretary is seeking nominations to fill a vacancy and three expiring positions, with terms of 3 years, in the Conservation Organization, Forest Industry, Nonindustrial Private Forest Landowner, and Conservation District categories. The nominees must be associated with such organizations and be willing to represent that sector as it relates to non-industrial private forestry. The public is invited to submit nominations for membership on the Committee, either as a self-nomination or a nomination of any qualified and interested person.
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