August 14, 2014 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2014-08-14-ReaderAids
Type: Reader Aids
Date: 2014-08-14
Proposed Flood Hazard Determinations
Document Number: C1-2014-16051
Type: Notice
Date: 2014-08-14
Agency: Federal Emergency Management Agency, Department of Homeland Security
Sunshine Act Notice
Document Number: 2014-19430
Type: Notice
Date: 2014-08-14
Agency: Defense Nuclear Facilities Safety Board, Agencies and Commissions
Pursuant to the provisions of the ``Government in the Sunshine Act'' (5 U.S.C. 552b), and as authorized by 42 U.S.C. 2286b, notice is hereby given of the Defense Nuclear Facilities Safety Board's (Board) public meeting and hearing described below. The Board invites any interested persons or groups to present any comments, technical information, or data concerning safety issues related to the matters to be considered.
Sunshine Act Meeting
Document Number: 2014-19379
Type: Notice
Date: 2014-08-14
Agency: Federal Retirement Thrift Investment Board, Agencies and Commissions
Defense Programs Advisory Committee
Document Number: 2014-19370
Type: Notice
Date: 2014-08-14
Agency: Department of Energy, National Nuclear Security Administration
This notice announces a closed meeting of the Defense Programs Advisory Committee (DPAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) (the Act) requires that public notice of these meetings be announced in the Federal Register. Due to national security considerations, under section 10(d) of the Act and 5 U.S.C. 552b(c), the meeting will be closed to the public and matters to be discussed are exempt from public disclosure under Executive Order 13526 and the Atomic Energy Act of 1954, 42 U.S.C. 2161 and 2162, as amended.
Sunshine Act Meeting
Document Number: 2014-19351
Type: Notice
Date: 2014-08-14
Agency: Merit Systems Protection Board, Agencies and Commissions
Notice is hereby given of the scheduling of a Sunshine Act Meeting on the proposed 2015-2018 research agenda of the Merit System Protection Board's Office of Policy and Evaluation.
Environmental Management Site-Specific Advisory Board, Paducah
Document Number: 2014-19307
Type: Notice
Date: 2014-08-14
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Paducah. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.
Oranges and Grapefruit Grown in Lower Rio Grande Valley in Texas; Decreased Assessment Rate
Document Number: 2014-19306
Type: Rule
Date: 2014-08-14
Agency: Agricultural Marketing Service, Department of Agriculture
This rule decreases the assessment rate established for the Texas Valley Citrus Committee (Committee) for the 2014-15 and subsequent fiscal periods from $0.16 to $0.11 per 7/10-bushel carton or equivalent of oranges and grapefruit handled. The Committee locally administers the marketing order, which regulates the handling of oranges and grapefruit grown in the Lower Rio Grande Valley in Texas. Assessments upon orange and grapefruit handlers are used by the Committee to fund reasonable and necessary expenses of the program. The fiscal period begins August 1 and ends July 31. The assessment rate will remain in effect indefinitely unless modified, suspended, or terminated.
Environmental Management Site-Specific Advisory Board, Nevada
Document Number: 2014-19305
Type: Notice
Date: 2014-08-14
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of this meeting be announced in the Federal Register.
Physical Characterization of Grid-Connected Commercial and Residential Buildings End-Use Equipment and Appliances
Document Number: 2014-19297
Type: Notice
Date: 2014-08-14
Agency: Department of Energy, Office of Energy Efficiency and Renewable Energy
The U.S. Department of Energy (DOE) is announcing the availability of a Framework Document for the physical characterization of grid-connected building's end-use equipment and appliances. DOE welcomes written comments and relevant data from interested parties on any subject within the scope of this framework. A copy of the Framework Document is available at: http://www.regulations.gov/ #!documentDetail;D=EERE-2014-BT-NOA-0016-0022.
Wind and Water Power Technologies Office; Request for Information
Document Number: 2014-19295
Type: Notice
Date: 2014-08-14
Agency: Department of Energy, Office of Energy Efficiency and Renewable Energy
The U.S. Department of Energy (DOE) invites public comment on its Request for Information (RFI) to help inform DOE's research and development activities related to Distributed Generation from Wind Energy Systems.
Final Priority; Rehabilitation Services Administration-Assistive Technology Alternative Financing Program
Document Number: 2014-19289
Type: Rule
Date: 2014-08-14
Agency: Department of Education
The Assistant Secretary for Special Education and Rehabilitative Services announces a priority under the Assistive Technology Alternative Financing Program administered by the Rehabilitation Services Administration (RSA). The Assistant Secretary may use this priority for competitions in fiscal year (FY) 2014 and later years. This priority is designed to ensure that the Department funds high-quality assistive technology (AT) alternative financing programs (AFPs) that meet rigorous standards in order to enable individuals with disabilities to access and acquire assistive technology devices and services necessary to achieve education, community living, and employment goals.
Applications for New Awards; National Institute on Disability and Rehabilitation Research-Disability and Rehabilitation Research Projects and Centers Program-Advanced Rehabilitation Research and Training Program-Advanced Rehabilitation Research Policy Fellowship; Correction
Document Number: 2014-19287
Type: Notice
Date: 2014-08-14
Agency: Department of Education
On July 21, 2014, we published in the Federal Register (79 FR 42403) a notice inviting applications for new awards for fiscal year (FY) 2014 for the Advanced Rehabilitation Research and Training (ARRT) ProgramAdvanced Rehabilitation Research Policy Fellowship. This notice corrects the applicant eligibility information.
Final Priorities; Rehabilitation Services Administration-Capacity Building Program for Traditionally Underserved Populations-Vocational Rehabilitation Training Institute for the Preparation of Personnel in American Indian Vocational Rehabilitation Services Projects
Document Number: 2014-19285
Type: Rule
Date: 2014-08-14
Agency: Department of Education
The Assistant Secretary for Special Education and Rehabilitative Services announces two priorities under the Capacity Building Program for Traditionally Underserved Populations administered by the Rehabilitation Services Administration (RSA). The Assistant Secretary may use one or more of these priorities for competitions in fiscal year (FY) 2014 and later years. Priority 1 establishes a new vocational rehabilitation (VR) training institute for the preparation of personnel in American Indian Vocational Rehabilitation Services (AIVRS) projects (the Institute). Priority 2 requires a partnership between a four-year institution of higher education (IHE) and a two- year community college or tribal college. This partnership is designed to successfully implement the VR training Institute established in Priority 1. In addition, the partnership agreement required under Priority 2 provides a brief description of how the partnership will be managed, the partners' roles and responsibilities and a strategy for sustaining the partnership after the Federal investment ends.
Privacy Act of 1974; System of Records
Document Number: 2014-19283
Type: Notice
Date: 2014-08-14
Agency: Department of Veterans Affairs
As required by the Privacy Act of 1974, 5 U.S.C. 552a(e), notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records currently entitled ``Patient Medical Record-VA'' (24VA10P2) as set forth in the Federal Register 77 FR 65938. VA is amending the system by revising the Routine Uses of Records Maintained in the System, Storage, and Safeguard. VA is republishing the system notice in its entirety.
Florida Power & Light Company; Turkey Point Nuclear Generating Units 3 and 4
Document Number: 2014-19282
Type: Notice
Date: 2014-08-14
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) approved a request by Florida Power & Light Company (the licensee) for amendments to Renewed Facility Operating License Nos. DPR-31 and DPR-41, issued to the licensee for operation of Turkey Point Nuclear Generating Units 3 and 4 (Turkey Point), located in Miami-Dade County, Florida. The amendments revise the ultimate heat sink (UHS) water temperature limit in the Turkey Point Technical Specifications (TSs) from 100 to 104 degrees Fahrenheit ([deg]F) and revise surveillance requirements for monitoring the UHS temperature and component cooling water (CCW) heat exchangers. The amendments also made editorial changes to the TSs. The Staff finds that the application for the license amendments complies with the requirements of the Atomic Energy Act of 1954, as amended, and the NRC's regulations.
Department of the Air Force, Kirtland Air Force Base, New Mexico
Document Number: 2014-19280
Type: Notice
Date: 2014-08-14
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is considering an amendment to License No. 42-23539-01AF (Docket No. 030-28641) which authorizes the unrestricted release of Radioactive Waste Site RW-06 at Kirtland Air Force Base. The NRC has reviewed the Department of the Air Force's final status survey report and conducted an independent confirmatory survey of the site. The NRC concludes that the site meets the radiological criteria established in regulations for unrestricted use. The NRC plans to approve the final status survey report and issue an amendment to the license which allows Site RW-06 to be released for unrestricted use.
Certain Circular Welded Carbon Steel Pipes and Tubes From Taiwan: Notice of Final Results of Antidumping Duty Administrative Review; 2012-2013
Document Number: 2014-19277
Type: Notice
Date: 2014-08-14
Agency: Department of Commerce, International Trade Administration
On June 18, 2014, the Department of Commerce (the Department) published the preliminary results of the administrative review of the antidumping duty order on certain circular welded carbon steel pipes and tubes from Taiwan.\1\ The review covers Shin Yang Steel Co., Ltd. (Shin Yang). The period of review (POR) is May 1, 2012, through April 30, 2013. We invited interested parties to comment on our Preliminary Results. No parties commented, and our final results remain unchanged from our Preliminary Results. The final results are listed in the section entitled ``Final Results of Review'' below.
National Environmental Education Advisory Council Meetings
Document Number: 2014-19273
Type: Notice
Date: 2014-08-14
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA or Agency) Office of External Affairs and Environmental Education (OEAEE) is issuing this notice to cancel the August 8, 2014 NEEAC Teleconference and reschedule it for August 21, 2014 from 3:00 p.m.-4:00 p.m. Eastern Time. Notice of the August 8, 2014 meeting was previously published on July 1, 2014: FR Doc 2014-15397 Filed 6-30-2014. The purpose of these teleconference(s), is to discuss specific topics of relevance for consideration by the council in order to provide advice and insights to the Agency on environmental education.
Determination That DRIXORAL (Dexbrompheniramine Maleate; Pseudoephedrine Sulfate) Tablet and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Document Number: 2014-19272
Type: Notice
Date: 2014-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Culturally Significant Objects Imported for Exhibition Determinations: “Faces of Impressionism: Portraits From the Musée d'Orsay”
Document Number: 2014-19271
Type: Notice
Date: 2014-08-14
Agency: Department of State
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the objects to be included in the exhibition ``Faces of Impressionism: Portraits from the Mus[eacute]e d'Orsay,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to loan agreements with the foreign owners or custodians. I also determine that the exhibition or display of the exhibit objects at the Kimbell Art Museum, Fort Worth, Texas, from on or about October 19, 2014, until on or about January 25, 2015, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Direct Deletion of the Monroe Auto Equipment (Paragould Pit) Superfund Site
Document Number: 2014-19270
Type: Rule
Date: 2014-08-14
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) Region 6 is publishing a direct final Notice of Deletion of the Monroe Auto (Paragould Pit) Superfund Site located in Paragould, Greene County, Arkansas, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). This direct final deletion is being published by EPA with the concurrence of the State of Arkansas, through the Arkansas Department of Environmental Quality (ADEQ), because EPA has determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude future actions under Superfund.
National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Monroe Auto Equipment (Paragould Pit) Superfund Site
Document Number: 2014-19269
Type: Proposed Rule
Date: 2014-08-14
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) Region 6 is issuing a Notice of Intent to Delete the Monroe Auto Equipment (Paragould Pit) Superfund Site (Site) located in Paragould, Greene County, Arkansas, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Arkansas, through the Arkansas Department of Environmental Quality have determined that all appropriate response actions under CERCLA have been completed. However, this deletion does not preclude future actions under Superfund.
Culturally Significant Object Imported for Exhibition Determinations: “Pablo Picasso's “Woman””
Document Number: 2014-19268
Type: Notice
Date: 2014-08-14
Agency: Department of State
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, and Delegation of Authority No. 236-3 of August 28, 2000 (and, as appropriate, Delegation of Authority No. 257 of April 15, 2003), I hereby determine that the object to be included in the exhibition ``Pablo Picasso's ``Woman'','' imported from abroad for temporary exhibition within the United States, are of cultural significance. The object is imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit object at the J. Paul Getty Museum, Los Angeles, California, from on or about January 1, 2015, until on or about March 31, 2015, and at possible additional exhibitions or venues yet to be determined, is in the national interest. I have ordered that Public Notice of these Determinations be published in the Federal Register.
Guidance for Industry on Immunogenicity Assessment for Therapeutic Protein Products; Availability
Document Number: 2014-19267
Type: Notice
Date: 2014-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a guidance for industry entitled ``Immunogenicity Assessment for Therapeutic Protein Products.'' Therapeutic protein products may elicit immune responses, which may lead to serious or life-threatening adverse events for the patient or loss of efficacy of the product. This guidance is intended to assist manufacturers and clinical investigators in developing a risk-based approach in both the nonclinical and clinical phases of product development that will allow them to evaluate and reduce the likelihood that the immunogenicity of the product will cause harm to patients. This guidance finalizes the draft guidance issued in February 2013.
Proposed Settlement Agreement
Document Number: 2014-19266
Type: Notice
Date: 2014-08-14
Agency: Environmental Protection Agency
In accordance with section 113(g) of the Clean Air Act, as amended (``Act''), notice is hereby given of a proposed settlement agreement to address lawsuits filed by WildEarth Guardians and National Parks Conservation Association (``NCPA'') (collectively ``Petitioners'') in the United States Court of Appeals for the Tenth Circuit: WildEarth Guardians v. EPA, No. 13-9520 (10th Cir.) and National Parks Conservation Association v. EPA, No. 13-9525 (10th Cir.). On February 25, 2013, WildEarth Guardians filed a petition for review challenging EPA's approval of the Colorado regional haze SIP. Specifically, WildEarth Guardians challenged EPA's approval of certain BART and reasonable progress determinations for Units 1, 2, and 3 of the Craig Generating Station; Units 1 and 2 of the Comanche Power Station; Boilers 4 and 5 of the Colorado Energy Nations Company, LLLP facility at the Coors Brewery in Golden, Colorado; and the time by which the Colorado regional haze SIP required emission limits to be met at the these facilities. On March 1, 2013, NPCA filed a petition for review challenging EPA's approval of the NOX emission limits for Craig Units 1, 2, and 3. The proposed settlement agreement seeks to resolve all of Petitioners' claims regarding the Craig Generating Station and establishes deadlines for the State of Colorado to submit a SIP revision to EPA and for EPA to take action on that SIP revision.
Revised Draft Guidance for Industry on Clinical Pharmacology Labeling for Human Prescription Drug and Biological Products-Considerations, Content, and Format; Availability
Document Number: 2014-19264
Type: Notice
Date: 2014-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry entitled ``Clinical Pharmacology Labeling for Human Prescription Drug and Biological ProductsConsiderations, Content, and Format.'' This draft guidance is one of a series of guidance documents intended to assist applicants in complying with FDA regulations on the content and format of labeling for human prescription drug and biological products. The guidance describes the recommended information to include in the Clinical Pharmacology section of labeling that pertains to the safe and effective use of human prescription drug and biological products. This revised draft guidance replaces the 2009 draft guidance for industry entitled ``Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological ProductsContent and Format.''
Draft Guidance for Industry on Best Practices in Developing Proprietary Names for Drugs; Reopening of the Comment Period
Document Number: 2014-19261
Type: Notice
Date: 2014-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is reopening the comment period for the draft guidance entitled ``Best Practices in Developing Proprietary Names for Drugs,'' which published in the Federal Register of May 29, 2014 (79 FR 30852). FDA is reopening the comment period in response to several requests for additional time and to allow interested persons more time to submit comments.
Combined Notice of Filings #1
Document Number: 2014-19259
Type: Notice
Date: 2014-08-14
Agency: Department of Energy, Federal Energy Regulatory Commission
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2014-19258
Type: Notice
Date: 2014-08-14
Agency: Federal Reserve System, Agencies and Commissions
Clinical Development of Drugs for the Prevention of Infections Caused by Staphylococcus aureus in the Health Care Setting; Public Workshop
Document Number: 2014-19257
Type: Notice
Date: 2014-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing a public workshop regarding the clinical development of drugs for the prevention of serious infections caused by Staphylococcus aureus in the health care setting. This public workshop is intended to provide information for and gain perspective from health care providers, patients and patient advocacy organizations, academia, and industry on various aspects of clinical development of drugs to prevent Staphylococcus aureus infections including the design of clinical trials. The input from this public workshop will help in developing topics for further discussion. Date and Time: The public workshop will be held on September 5, 2014, from 8:30 a.m. to 5 p.m. Location: The public workshop will be held at the DoubleTree by Hilton Hotel Washington DC, 8727 Colesville Rd., Silver Spring, MD 20910. The hotel's phone number is 301-589-5200. Contact Persons: Carole Miller or Lori Benner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6217, Silver Spring, MD 20993-0002, 301- 796-1300. Registration: Registration is free for the public workshop. Interested parties are encouraged to register early. Seating is limited and will be available on a first-come, first-served basis. To register electronically, email registration information (including name, title, firm name, address, telephone, and fax number) to FDASTAPHWORKSHOP@fda.hhs.gov. Onsite registration the day of the workshop will be available, but advanced registration is preferred. Persons without access to the Internet can call 301-796-1300 to register. If you need a sign language interpreter or other special accommodations, please notify Carole Miller or Lori Benner (see Contact Persons) at least 7 days in advance.
Direct Investment Surveys: BE-13, Survey of New Foreign Direct Investment in the United States
Document Number: 2014-19256
Type: Rule
Date: 2014-08-14
Agency: Department of Commerce, Bureau of Economic Analysis
This final rule amends regulations of the Department of Commerce's Bureau of Economic Analysis (BEA) to reinstate the reporting requirements for the BE-13, Survey of New Foreign Direct Investment in the United States, which was discontinued in 2009. This survey will better measure Commerce Department efforts through the ``Build It Here, Sell It Everywhere'' initiative to expand foreign business investment in the United States and ensure complete coverage of BEA's other foreign direct investment statistics. This survey collects information on the acquisition or establishment of U.S. business enterprises by foreign investors, which was collected on the previous BE-13 survey, and information on expansions by existing U.S. affiliates of foreign companies, which was not previously collected. This mandatory survey will be conducted under the authority of the International Investment and Trade in Services Survey Act (the Act). Unlike other BEA surveys conducted pursuant to the Act, a response would be required from persons subject to the reporting requirements of the BE-13, Survey of New Foreign Direct Investment in the United States, whether or not they are contacted by BEA, in order to insure that respondents subject to the requirements for foreign direct investments in the U.S. are identified.
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
Document Number: 2014-19255
Type: Notice
Date: 2014-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is correcting a final rule entitled ``Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements'' that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with incorrect information regarding the availability of the International Conference on Harmonization's (ICH) data elements for postmarketing safety reports. The document also published with an incorrect statement regarding the impact of the final rule on small entities. This document corrects those errors.
Pacific Fishery Management Council; Public Meeting
Document Number: 2014-19254
Type: Notice
Date: 2014-08-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Pacific Fishery Management Council's (Pacific Council) Salmon Advisory Subpanel (SAS) and ad hoc Lower Columbia River Natural Coho Workgroup (LRC Workgroup) will hold a public work session. The meeting is open to the public, but is not intended as a public hearing. Public comments will be taken as time allows.
De Novo Classification Process (Evaluation of Automatic Class III Designation); Draft Guidance for Industry and Food and Drug Administration Staff; Availability
Document Number: 2014-19253
Type: Notice
Date: 2014-08-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``De Novo Classification Process (Evaluation of Automatic Class III Designation).'' The purpose of this document is to provide FDA's proposals for guidance to FDA staff and industry on the process for the submission and review of petitions submitted under the Evaluation of Automatic Class III Designation section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), also known as the de novo classification process. FDA is issuing this draft guidance to provide proposed updated recommendations for efficient interaction with FDA, including what information to submit when seeking a path to market for a novel device via the de novo process. This draft guidance has been revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation Act (FDASIA), which became law on July 9, 2012, amended the FD&C Act to provide for the submission of de novos without a preceding premarket notification (510(k)) submission. This draft guidance is not final nor is it in effect at this time.
Publication of Revised Guidance on Entities Owned by Persons Whose Property and Interests in Property Are Blocked
Document Number: 2014-19252
Type: Notice
Date: 2014-08-14
Agency: Department of the Treasury, Office of Foreign Assets Control
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing Revised Guidance on Entities Owned by Persons Whose Property and Interests in Property are Blocked.
Designation of 3 Individuals Pursuant to Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism”
Document Number: 2014-19251
Type: Notice
Date: 2014-08-14
Agency: Department of the Treasury, Office of Foreign Assets Control
The Treasury Department's Office of Foreign Assets Control (``OFAC'') is publishing the names of 3 individuals whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, ``Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.''
Qualification of Drivers; Exemption Applications; Diabetes Mellitus
Document Number: 2014-19250
Type: Notice
Date: 2014-08-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces receipt of applications from 46 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would allow these individuals with ITDM to operate CMVs in interstate commerce.
Airworthiness Directives; Dassault Aviation Airplanes
Document Number: 2014-19249
Type: Proposed Rule
Date: 2014-08-14
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain Dassault Aviation Model FALCON 2000 and FALCON 2000EX airplanes. This proposed AD was prompted by a design review, which revealed that the forward servicing compartment (FSC) is configured with tie-down points. This proposed AD would require inspecting the FSC for installed tie-down points, and removing those tie-down points. We are proposing this AD to detect and correct installed tie-down points, which could lead to inadvertent use of the FSC as a cargo compartment, which could result in damage to the structure of the airplane or potential risk of fire.
Airworthiness Directives; The Boeing Company Airplanes
Document Number: 2014-19248
Type: Proposed Rule
Date: 2014-08-14
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 767-200, -300, and -400ER series airplanes. This proposed AD was prompted by a report of the engine indication and crew alerting system (EICAS) display system malfunctioning during flight. This proposed AD would require an inspection for plastic couplings, corrective actions if necessary, and installation of new spray shrouds. We are proposing this AD to prevent an uncontrolled water leak from a defective potable water system coupling, which could cause the main equipment center (MEC) line replaceable units (LRUs) to become wet, resulting in an electrical short and potential loss of several functions essential for safe flight.
Qualification of Drivers; Exemption Applications; Diabetes Mellitus
Document Number: 2014-19247
Type: Notice
Date: 2014-08-14
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces receipt of applications from 56 individuals for exemption from the prohibition against persons with insulin-treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions will allow these individuals with ITDM to operate CMVs in interstate commerce.
Notice of Intent To Grant Exclusive License
Document Number: 2014-19246
Type: Notice
Date: 2014-08-14
Agency: Agricultural Research Service, Department of Agriculture
Notice is hereby given that the U.S. Department of Agriculture, Agricultural Research Service, intends to grant to Washington State Crop Improvement Association of Pullman, Washington, an exclusive license to the chickpea variety named ``Royal.''
Proposed Data Collections Submitted for Public Comment and Recommendations
Document Number: 2014-19245
Type: Notice
Date: 2014-08-14
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Airworthiness Directives; Bombardier, Inc. Airplanes
Document Number: 2014-19244
Type: Proposed Rule
Date: 2014-08-14
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This proposed AD was prompted by issuance of revised certification maintenance requirements (CMR) for the horizontal stabilizer trim actuator (HSTA). This proposed AD would require revising the maintenance or inspection program. We are proposing this AD to detect and correct premature wear and cracking of the HSTAs, which could result in reduced structural integrity and reduced control of the airplane due to the failure of system components.