February 21, 2014 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2014-02-21-ReaderAids
Type: Reader Aids
Date: 2014-02-21
Imogo Mobile Technologies Corp.; Order of Suspension of Trading
Document Number: 2014-03822
Type: Notice
Date: 2014-02-21
Agency: Securities and Exchange Commission, Agencies and Commissions
Meeting; Government in the Sunshine Act
Document Number: 2014-03804
Type: Notice
Date: 2014-02-21
Agency: International Trade Commission, Agencies and Commissions
Sunshine Act Meeting; Open Commission Meeting; Thursday, February 20, 2014
Document Number: 2014-03753
Type: Notice
Date: 2014-02-21
Agency: Federal Communications Commission, Agencies and Commissions
The Commission will consider a Memorandum Opinion and Order concerning an Application for Review filed by Jet Fuel Broadcasting seeking review of a decision by the Media Bureau. 3..................... MEDIA................ TITLE: Jet Fuel Broadcasting Application for a New AM Broadcast Station at Lolo, MT and RAMS III Application for a New AM Broadcast Station at Springville, Utah. SUMMARY: The Commission will consider a Memorandum Opinion and Order concerning an Application for Review filed by Jet Fuel Broadcasting seeking review of a decision by the Media Bureau.
Endangered and Threatened Wildlife; 90-Day Finding on a Petition To List Multiple Species and Subpopulations of Marine Mammals as Threatened or Endangered Under the Endangered Species Act
Document Number: 2014-03735
Type: Notice
Date: 2014-02-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
We (NMFS) announce a 90-day finding on a petition to list two species and three distinct population segments of marine mammals as threatened or endangered under the Endangered Species Act (ESA). We find that the petition does not present substantial scientific or commercial information indicating that the petitioned action may be warranted for the Gal[aacute]pagos fur seal (Arctocephalus galapagoensis). We also find that the petition presents substantial information indicating that the petitioned action may be warranted for Hector's dolphin (Cephalorhynchus hectori), the Baltic Sea subpopulation of harbor porpoise (Phocoena phocoena), the eastern Taiwan Strait subpopulation of the Indo-Pacific humpback dolphin (Sousa chinensis), and the Fiordland subpopulation of bottlenose dolphin (Tursiops truncatus). We will conduct status reviews for this species and three subpopulations to determine if the petitioned actions are warranted. To ensure that these status reviews are comprehensive, we are soliciting scientific and commercial information pertaining to these marine mammals from any interested party.
Saflufenacil; Pesticide Tolerances
Document Number: 2014-03734
Type: Rule
Date: 2014-02-21
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of saflufenacil in or on multiple commodities which are identified and discussed later in this document. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Alkyl Alcohol Alkoxylate Phosphate and Sulfate Derivatives; Exemption From the Requirement of a Tolerance
Document Number: 2014-03733
Type: Rule
Date: 2014-02-21
Agency: Environmental Protection Agency
This regulation amends two exemptions from the requirement of a tolerance for residues of [alpha]-alkyl (minimum C6 linear, branched, saturated and/or unsaturated)-[omega]- hydroxypolyoxyethylene polymer with or without polyoxypropylene, mixture of di- and monohydrogen phosphate esters and the corresponding ammonium, calcium, magnesium, monoethanolamine, potassium, sodium, and zinc salts of the phosphate esters; minimum oxyethylene content is 2 moles; minimum oxypropylene content is 0 moles, herein referred to as alkyl alcohol alkoxylate phosphate derivatives (AAAPD) and [alpha]- Alkyl(C6-C15)-[omega]- hydroxypoly(oxyethylene)sulfate, and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts, poly(oxyethylene) content averages 2-4 moles, herein referred to alkyl alcohol alkoxylate sulfate derivatives (AAASD) when used as inert ingredients (surfactants) applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910 and applied to animals under 40 CFR 180.930; not to exceed 30% of pesticide formulations. Joint Inerts Task Force Cluster Support Team 2 (JITF CST 2) c/o Huntsman Corp. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an amendment to an existing requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of alkyl alcohol alkoxylate phosphate and sulfate derivatives.
Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
Document Number: 2014-03728
Type: Proposed Rule
Date: 2014-02-21
Agency: Environmental Protection Agency
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Environmental Impact Statements; Notice of Availability
Document Number: 2014-03726
Type: Notice
Date: 2014-02-21
Agency: Environmental Protection Agency
Statement of Organization, Functions, and Delegations of Authority; Office of the General Counsel
Document Number: 2014-03725
Type: Notice
Date: 2014-02-21
Agency: Department of Health and Human Services
This document announces the Office of the Secretary (OS)'s Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services, Office of the General Counsel (OGC), is being amended to reflect title changes in several of its components.
Western Pacific Fishery Management Council; Public Meetings
Document Number: 2014-03723
Type: Notice
Date: 2014-02-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Western Pacific Fishery Management Council (Council) will hold meetings of its 115th Scientific and Statistical Committee (SSC) and its 159th Council meeting to take actions on fishery management issues in the Western Pacific Region. The Council will also convene meetings of the Marianas Plan Team (PT), Guam Regional Ecosystem Advisory Committee (REAC), the Commonwealth of the Northern Marianas (CNMI) REAC, the Mariana Archipelago Advisory Panel (AP) and the Council's Program Planning Standing Committee and Executive and Budget Standing Committee.
Final Environmental Impact Statement for Proposed Strategies To Benefit Native Species by Reducing the Abundance of Lake Trout in Flathead Lake, Montana
Document Number: 2014-03722
Type: Notice
Date: 2014-02-21
Agency: Department of the Interior, Bureau of Indian Affairs
This notice advises the public that the Bureau of Indian Affairs (BIA) as lead agency, with the Confederated Salish and Kootenai Tribes (CSKT) as a cooperating agency, intends to file a final environmental impact statement (FEIS) with the Environmental Protection Agency (EPA) for the CSKT proposed management action on Flathead Lake, Montana to benefit native trout by reducing the abundance of lake trout. The notice also announces that the FEIS is now available for public review.
Revision of Agency Information Collection for Reporting Systems for Public Law 102-477 Demonstration Project
Document Number: 2014-03721
Type: Notice
Date: 2014-02-21
Agency: Department of the Interior, Bureau of Indian Affairs
The Bureau of Indian Affairs (BIA) published a notice in the Federal Register of February 14, 2014, announcing the revision of agency information collection for Reporting Systems for Public Law 102- 477 Demonstration Project authorized by OMB Control Number 1076-0135 and providing information for the tribal consultation meeting. This notice corrects the date and time for the tribal consultation meeting. In compliance with the Paperwork Reduction Act of 1995, the Assistant SecretaryIndian Affairs is seeking comments on the revision of the collection of information for the Reporting System for Public Law 102-477 Demonstration Project authorized by OMB Control Number 1076-0135. This information collection expires January 31, 2017. See the SUPPLEMENTARY INFORMATION section of this notice for details on the tribal consultation session.
Contract Support Costs
Document Number: 2014-03720
Type: Notice
Date: 2014-02-21
Agency: Department of the Interior, Bureau of Indian Affairs
The Assistant SecretaryIndian Affairs, in conjunction with the Acting Director, Indian Health Service (IHS), will conduct a consultation session with Indian tribes to work together to identify long-term solutions concerning contract support costs (CSC) as it relates to the Fiscal Year (FY) 2014 Consolidated Appropriations Act.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; 2014 Commercial Accountability Measure and Closure for Coastal Migratory Pelagic Resources of the Gulf of Mexico and South Atlantic
Document Number: 2014-03718
Type: Rule
Date: 2014-02-21
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS implements an accountability measure (AM) to close the hook-and-line component of the commercial sector for king mackerel in the southern Florida west coast subzone. This closure is necessary to protect the Gulf of Mexico (Gulf) king mackerel resource.
Discontinuation of the Qualitative (30 mL) Campylobacter Analysis for Young Chickens
Document Number: 2014-03716
Type: Notice
Date: 2014-02-21
Agency: Department of Agriculture, Food Safety and Inspection Service
The Food Safety and Inspection Service (FSIS) is discontinuing the use of its 30-mL qualitative analysis for Campylobacter for young chickens. The Agency suspended this analysis on June 3, 2013. FSIS evaluated the available Campylobacter data, and its analysis suggested that the performance standard based on an analysis of the 1-mL sample volume is sufficiently sensitive to identify establishments whose process control is substandard. This is the only change that FSIS has made to its Campylobacter sampling program.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee-April 30, 2014
Document Number: 2014-03711
Type: Notice
Date: 2014-02-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces that a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) (``Committee'') will be held on Wednesday, April 30, 2014. The Committee generally provides advice and recommendations concerning the adequacy of scientific evidence needed to determine whether certain medical items and services can be covered under the Medicare statute. This meeting will focus on the use of low dose computed tomography (LDCT) screening for lung cancer in adult smokers. This meeting is open to the public in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers; Extension of Comment Period
Document Number: 2014-03710
Type: Proposed Rule
Date: 2014-02-21
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This document extends the comment period for the Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers proposed rule, which was published in the December 27, 2013 Federal Register (78 FR 79082 through 79200). The comment period for the proposed rule, which would have ended on February 25, 2014, is extended to March 31, 2014.
Reorganization of Foreign-Trade Zone 185 Under Alternative Site Framework; Culpeper County, VA
Document Number: 2014-03709
Type: Notice
Date: 2014-02-21
Agency: Department of Commerce, Foreign-Trade Zones Board
Lightweight Thermal Paper From the People's Republic of China: Final Results of Expedited First Sunset Review of the Antidumping Duty Order
Document Number: 2014-03708
Type: Notice
Date: 2014-02-21
Agency: Department of Commerce, International Trade Administration
On October 1, 2013, the Department of Commerce (the Department) initiated the first five-year (sunset) review of the antidumping duty order on lightweight thermal paper from the People's Republic of China (PRC) pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act).\1\ As a result of this sunset review, the Department finds that revocation of the antidumping duty order on lightweight thermal paper from the PRC would likely lead to continuation or recurrence of dumping at the levels indicated in the ``Final Results of Review'' section of this notice.
Notice of Membership of SES Performance Review Board
Document Number: 2014-03707
Type: Notice
Date: 2014-02-21
Agency: Broadcasting Board of Governors, Agencies and Commissions
Title 5 United States Code, Section 4314, requires that notice of the appointment of an individual to serve as a member of a performance review board (PRB) shall be published in the Federal Register. The following individuals have been appointed to serve as members of the PRB for the Broadcasting Board of Governors: Carol Chan, Director of the Office of U.S. Foreign Disaster Assistance, U.S. Agency for International Development; Gil H. Harden, Assistant Inspector General for Audit, U.S. Department of Agriculture; and Steven Rickrode, Deputy Assistant Inspector General for Audit, U.S. Department of Agriculture.
Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB
Document Number: 2014-03706
Type: Notice
Date: 2014-02-21
Agency: Federal Reserve System, Agencies and Commissions
Notice is hereby given of the final approval of proposed information collections by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
The Tobacco Products Scientific Advisory Committee; Notice of Meeting
Document Number: 2014-03705
Type: Notice
Date: 2014-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
Endocrinologic and Metabolic Drugs Advisory Committee; Notice of Meeting
Document Number: 2014-03704
Type: Notice
Date: 2014-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
Blood Products Advisory Committee; Notice of Meeting
Document Number: 2014-03703
Type: Notice
Date: 2014-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Application for Continuation of Death Benefit for Student
Document Number: 2014-03701
Type: Notice
Date: 2014-02-21
Agency: Department of Labor, Office of the Secretary
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, ``Application for Continuation of Death Benefit for Student,'' to the Office of Management and Budget (OMB) for review and approval for continued use, without change, in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq.
Certain Windshield Wiper Devices and Components Thereof; Notice of Commission Determination Not To Review an Initial Determination Granting Complainants' Motion To Amend the Complaint and Notice of Investigation
Document Number: 2014-03700
Type: Notice
Date: 2014-02-21
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 27) granting the motion of complainants Federal-Mogul Corporation of Southfield, Michigan and Federal-Mogul S.A. of Aubange, Belgium (collectively ``Federal-Mogul'') to amend the complaint to correct respondent Trico Corporation's corporate name and to identify additional accused products.
Spent Fuel Transportation Risk Assessment
Document Number: 2014-03698
Type: Notice
Date: 2014-02-21
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing NUREG- 2125, ``Spent Fuel Transportation Risk Assessment.'' This NUREG provides an update of the estimated impacts from transporting spent nuclear fuel (SNF) by highway or railway in NRC certified casks under both routine and accident conditions.
Proposed Submission of Information Collection for OMB Review; Comment Request; Annual Reporting (Form 5500 Series)
Document Number: 2014-03697
Type: Notice
Date: 2014-02-21
Agency: Pension Benefit Guaranty Corporation, Agencies and Commissions
The Pension Benefit Guaranty Corporation (PBGC) intends to request that the Office of Management and Budget (OMB) extend approval (with modifications), under the Paperwork Reduction Act of 1995, of its collection of information for Annual Reporting (OMB control number 1212-0057, expires April 30, 2014). This notice informs the public of PBGC's intent and solicits public comment on the collection of information.
Falcon and Amistad Projects' Rate Order No. WAPA-164
Document Number: 2014-03696
Type: Notice
Date: 2014-02-21
Agency: Department of Energy, Western Area Power Administration
This action is a proposal to extend the existing Falcon and Amistad Projects' Firm Power Rate Formula through June 7, 2019. The Falcon and Amistad Projects' Firm Power Rate Formula will expire on June 7, 2014.
Environmental Management Site-Specific Advisory Board, Portsmouth
Document Number: 2014-03695
Type: Notice
Date: 2014-02-21
Agency: Department of Energy
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Portsmouth. 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.
Decision and Order Granting a Waiver to Samsung From the Department of Energy Residential Refrigerator and Refrigerator-Freezer Test Procedures
Document Number: 2014-03694
Type: Notice
Date: 2014-02-21
Agency: Department of Energy, Office of Energy Efficiency and Renewable Energy
The U.S. Department of Energy (DOE) gives notice of its decision and order in Case No. RF-034 that grants to Samsung Electronics America, Inc. (Samsung) a waiver from the DOE electric refrigerator and refrigerator-freezer test procedures for specific basic models set forth in its petition for waiver. In its petition, Samsung provides an alternate test procedure that is identical to the test procedure DOE published in a final rule dated January 25, 2012 (77 FR 3559) that manufacturers will be required to use starting in 2014. Under today's decision and order, Samsung shall be required to test and rate these refrigerator-freezers using an alternate test procedure as adopted in that January 2012 final rule, which accounts for multiple defrost cycles when measuring energy consumption.
Resolution of a Systemically Important Financial Institution: The Single Point of Entry Strategy
Document Number: 2014-03692
Type: Notice
Date: 2014-02-21
Agency: Federal Deposit Insurance Corporation, Agencies and Commissions
On December 18, 2013, the FDIC published in the Federal Register for public comment the Resolution of Systemically Important Financial Institutions: The Single Point of Entry Strategy (the ``SPOE Strategy''). To allow the public more time to consider the SPOE Strategy and the issues and questions posed for comment, the FDIC has determined that an extension of the comment period for an additional 30-day period to March 20, 2014, is appropriate. This action will allow interested persons additional time to analyze the SPOE Strategy and prepare their comments.
Notice of Request for Extension of Approval of an Information Collection; Importation of Hass Avocados From Michoacan, Mexico
Document Number: 2014-03691
Type: Notice
Date: 2014-02-21
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request an extension of approval of an information collection associated with regulations for the importation of Hass avocados from Michoacan, Mexico.
Notice of Request for Revision to and Extension of Approval of an Information Collection; Plants for Planting Regulations
Document Number: 2014-03690
Type: Notice
Date: 2014-02-21
Agency: Department of Agriculture, Animal and Plant Health Inspection Service
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the plants for planting regulations.
Helicopter Air Ambulance, Commercial Helicopter, and Part 91 Helicopter Operations
Document Number: 2014-03689
Type: Rule
Date: 2014-02-21
Agency: Federal Aviation Administration, Department of Transportation
This final rule addresses helicopter air ambulance, commercial helicopter, and general aviation helicopter operations. To address an increase in fatal helicopter air ambulance accidents, the FAA is implementing new operational procedures and additional equipment requirements for helicopter air ambulance operations. This final rule also increases safety for commercial helicopter operations by revising requirements for equipment, pilot testing, and alternate airports. It increases weather minimums for all general aviation helicopter operations. Many of these requirements address National Transportation Safety Board safety recommendations, and are already found in FAA guidance. Today's changes are intended to provide certificate holders and pilots with additional tools and procedures that will aid in preventing accidents.
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: 2014-03688
Type: Notice
Date: 2014-02-21
Agency: Federal Reserve System, Agencies and Commissions
Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company
Document Number: 2014-03687
Type: Notice
Date: 2014-02-21
Agency: Federal Reserve System, Agencies and Commissions
Notice of Availability of the Record of Decision for the Final Supplemental Environmental Impact Statement and the Proposed Resource Management Plan Amendment for the Silver State Solar South Project, Clark County, NV
Document Number: 2014-03685
Type: Notice
Date: 2014-02-21
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD) for the Silver State Solar South Project and Proposed Las Vegas Field Office Resource Management Plan (RMP) amendment. The Principal Deputy Assistant Secretary for Land and Minerals Management signed the ROD on February 14, 2014, which constitutes the final decision of the Department.
Notice of Availability of the Draft Environmental Impact Statement and Land-Use Plan Amendments for the Energy Gateway South Transmission Project in Wyoming, Colorado, and Utah
Document Number: 2014-03683
Type: Notice
Date: 2014-02-21
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM) announces the availability of the Draft Environmental Impact Statement (EIS) and Land-Use Plan Amendments for the Energy Gateway South Transmission Project (Project).
Notice of Availability of the Draft Supplemental Environmental Impact Statement for the Alpine Satellite Development Plan for the Proposed Greater Mooses Tooth Unit Development Project, Alaska
Document Number: 2014-03682
Type: Notice
Date: 2014-02-21
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM), Arctic Field Office, Fairbanks, Alaska, issues the Draft Supplemental Environmental Impact Statement (EIS) for public comment and announces upcoming public meetings and subsistence hearings to receive comments on the Draft Supplemental EIS and the proposed project's potential to impact subsistence resources and activities. Pursuant to the National Environmental Policy Act of 1969, as amended, the Supplemental EIS is being prepared to supplement the Alpine Satellite Development Plan (ASDP) Final EIS, dated September 2004, regarding the establishment of satellite oil production pads and associated infrastructure within the Alpine field.
Procurement List, Proposed Deletions
Document Number: 2014-03681
Type: Notice
Date: 2014-02-21
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
The Committee is proposing to delete products from the Procurement List that was previously furnished by a nonprofit agency employing persons who are blind or have other severe disabilities. Comments must be received on or before: 3/24/2014.
Procurement List; Additions and Deletions
Document Number: 2014-03680
Type: Notice
Date: 2014-02-21
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
This action adds products to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and a service from the Procurement List previously furnished by such agencies.
Training Program for Regulatory Project Managers; Information Available to Industry
Document Number: 2014-03679
Type: Notice
Date: 2014-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Notice of Availability of the Record of Decision for the Stateline Solar Farm Project and California Desert Conservation Area Plan Amendment, San Bernardino County, California
Document Number: 2014-03678
Type: Notice
Date: 2014-02-21
Agency: Department of the Interior, Bureau of Land Management
The Bureau of Land Management (BLM) announces the availability of the Record of Decision (ROD)/Approved Amendment to the California Desert Conservation Area Plan (CDCA Plan) for the Stateline Solar Farm Project (SSFP). The Principal Deputy Assistant Secretary, Land and Minerals Management, approved the ROD on February 14, 2014, which constitutes the final decision of the Department.
International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability
Document Number: 2014-03677
Type: Notice
Date: 2014-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation GuideData Elements and Message Specification'' (the E2B(R3) implementation guidance) and an appendix to the guidance entitled ``ICSRs: Appendix to the Implementation GuideBackwards and Forwards Compatibility'' (the BFC appendix). The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and the E2B(R3) implementation guidance.
Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request
Document Number: 2014-03676
Type: Notice
Date: 2014-02-21
Agency: Department of Health and Human Services, Health Resources and Services Administration
In compliance with Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Health Resources and Services Administration (HRSA) has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Information Collection Activity; Comment Request
Document Number: 2014-03675
Type: Notice
Date: 2014-02-21
Agency: Department of Agriculture, Rural Utilities Service
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35, as amended), the Rural Utilities Service (RUS), invites comments on this information collection for which the Agency intends to request approval from the Office of Management and Budget (OMB).
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