May 27, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 50 of 131
Bioequivalence Recommendations for Risperidone; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on risperidone injection entitled ``Draft Guidance on Risperidone.'' The recommendations provide specific guidance on the design of studies to support abbreviated new drug applications (ANDAs) for risperidone injection. This draft guidance is the second revision of a previously issued draft guidance on the same subject.
Federal Need Analysis Methodology for the 2016-17 Award Year-Federal Pell Grant, Federal Perkins Loan, Federal Work-Study, Federal Supplemental Educational Opportunity Grant, William D. Ford Federal Direct Loan, Iraq and Afghanistan Service Grant and TEACH Grant Programs
The Secretary announces the annual updates to the tables used in the statutory Federal Need Analysis Methodology that determines a student's expected family contribution (EFC) for award year 2016-17 for these student financial aid programs. The intent of this notice is to alert the financial aid community and the broader public to these required annual updates used in the determination of student aid eligibility.
Access to Confidential Business Information by Eastern Research Group
EPA has authorized its contractor, Eastern Research Group (ERG) of Lexington, MA, to access information which has been submitted to EPA under all sections of the Toxic Substances Control Act (TSCA). Some of the information may be claimed or determined to be Confidential Business Information (CBI).
Revisions to Denied Boarding Compensation, Domestic Baggage Liability Limits, and Civil Penalty Amounts
In accordance with existing regulations, this final rule raises the maximum denied boarding compensation (DBC) amounts that have been in effect since August 2011, raising the maximum DBC amounts from the current figures of $650/$1,300 to $675/$1,350. Also, in accordance with existing regulations, this final rule raises the minimum liability limit air carriers may impose for mishandled baggage in domestic air transportation, adjusting the minimum limit of liability from the current amount of $3,400 to $3,500. To account for inflation, this rule also raises the maximum civil penalties that can be assessed as a result of DOT aviation enforcement actions for violations of certain economic provisions of Title 49 of the U.S. Code from $2,500 to $2,750.
Polyvinyl Alcohol From Japan, the Republic of Korea and the People's Republic of China: Continuation of Antidumping Duty Orders on Japan and the People's Republic of China, Revocation of the Antidumping Order on the Republic of Korea
As a result of the determinations by the Department of Commerce (the Department) and the International Trade Commission (ITC) in their five year (sunset) reviews that revocation of the antidumping duty (AD) orders on polyvinyl alcohol (PVA) from Japan and the People's Republic of China (PRC) would likely lead to a continuation or recurrence of dumping and material injury to an industry in the United States, the Department is publishing a notice of continuation of the AD orders on PVA from Japan and the PRC. In addition, as a result of the ITC's determination that revocation of the AD order on PVA from the Republic of Korea (Korea) is not likely to lead to continuation or recurrence of material injury to an industry in the United States, the Department is revoking the AD order on PVA from Korea.
Utility Scale Wind Towers From the Socialist Republic of Vietnam: Notice of Court Decision Not in Harmony With the Final Determination of Less Than Fair Value Investigation and Notice of Amended Final Determination of Investigation
On May 11, 2015, the United States Court of International Trade (CIT or Court) issued final judgment in CS Wind Vietnam Co., Ltd. and CS Wind Corporation v. United States, Consol. Court No. 13-00102, affirming the Department of Commerce's (the Department) final results of redetermination pursuant to remand. Consistent with the decision of the United States Court of Appeals for the Federal Circuit (CAFC) in Timken Co. v. United States, 893 F.2d 337 (Fed. Cir. 1990) (Timken), as clarified by Diamond Sawblades Mfrs. Coalition v. United States, 626 F.3d 1374 (Fed. Cir. 2010) (Diamond Sawblades), the Department is notifying the public that the final judgment in this case is not in harmony with the Department's final determination in the less than fair value investigation on utility scale wind towers from the Socialist Republic of Vietnam, and is amending the final determination with respect to the CS Wind Group.\1\
Circular Welded Carbon Quality Steel Pipe From the People's Republic of China: Notice of Court Decision Not in Harmony With the Implemented Final Determination Under Section 129 of the Uruguay Round Agreements Act
On May 7, 2015, the United States Court of International Trade (CIT or Court) issued final judgment in Wheatland Tube Company v. United States, Consol. Court No. 12-00298, affirming the Department of Commerce's (the Department) redetermination pursuant to court remand. Consistent with section 516A of the Tariff Act of 1930, as amended (the Act), the Department is notifying the public that the final judgment in this case is not in harmony with the Department's implemented final determination in a proceeding conducted under section 129 of the Uruguay Round Agreements Act (section 129) related to the Department's final affirmative countervailing duty determination on circular welded carbon quality steel pipe (CWP) from the People's Republic of China (China).
Proposed Revision to Site Characteristics and Site Parameters
The U.S. Nuclear Regulatory Commission (NRC) is soliciting public comment on NUREG-0800, ``Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,'' Section 2.0, ``Site Characteristics and Site Parameters.'' The NRC seeks comments on the proposed revised section of the SRP concerning site characteristics and site parameters.
Fire Probabilistic Risk Assessment Courses
The U.S. Nuclear Regulatory Commission (NRC), Office of Nuclear Regulatory Research (RES), in cooperation with the Electric Power Research Institute (EPRI), will hold joint courses on fire probabilistic risk assessment (PRA). Since 2002, RES and EPRI, under a Memorandum of Understanding (MOU) on Cooperative Nuclear Safety Research, have been developing state-of-the-art methods for conduct of fire PRA. In September 2005, this work produced the ``EPRI/NRC-RES Fire PRA Methodology for Nuclear Power Facilities,'' NUREG/CR-6850 (EPRI 1011989).
Notice of Establishment of Housing Price Index
The Federal Housing Finance Agency (FHFA) is establishing and shall maintain a method for assessing the national average single- family house price for use in adjusting the conforming loan limits of Fannie Mae and Freddie Mac (the ``Enterprises''). For these purposes, FHFA has considered a number of different measures, including the House Price Index maintained by the Office of Federal Housing Enterprise Oversight (OFHEO) of the Department of Housing and Urban Development before the effective date of the Federal Housing Finance Regulatory Reform Act of 2008.\1\ FHFA also considered house price indexes of the Bureau of the Census of the Department of Commerce as well as other privately-produced indexes.\2\
Advisory Council on Alzheimer's Research, Care, and Services
The National Alzheimer's Project Act, Public Law 111-375 (42 U.S.C. 11225), requires that the Secretary of Health and Human Services (HHS) establish the Advisory Council on Alzheimer's Research, Care, and Services. The Advisory Council is governed by provisions of Public Law 92-463 (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees. The Secretary of HHS established the Advisory Council to provide advice and consultation to the Secretary on how to prevent or reduce the burden of Alzheimer's disease and related dementias on people with the disease and their caregivers. The Secretary signed the charter establishing the Advisory Council on May 23, 2011. HHS is soliciting nominations for seven (7) new non-Federal members of the Advisory Council, one for each category of membership, to replace the seven members whose terms will end September 30th, 2015. Nominations should include the nominee's contact information (current mailing address, email address, and telephone number) and current curriculum vitae or resume.
Evaluation of State Coastal Management Programs
The NOAA Office for Coastal Management announces its intent to evaluate the performance of the New York and Florida Coastal Management Programs. The Coastal Zone Management Program (CMP) evaluations will be conducted pursuant to section 312 of the Coastal Zone Management Act of 1972, as amended (CZMA) and regulations at 15 CFR part 923, subpart L. The CZMA requires continuing review of the performance of states with respect to CMP implementation. Evaluation of a CMP requires findings concerning the extent to which a state has met the national objectives, adhered to its CMP document approved by the Secretary of Commerce, and adhered to the terms of financial assistance awards funded under the CZMA. The evaluations will include a public meeting, consideration of written public comments and consultations with interested Federal, state, and local agencies and members of the public. When the evaluation is completed, the Office for Coastal Management will place a notice in the Federal Register announcing the availability of the Final Evaluation Findings. Notice is hereby given of the date, local time, and location of the public meeting. Date and Time: The New York CMP public meeting will be held on Wednesday, July 8, 2015 at 4:00 p.m. local time in room #505 on the 5th floor of 1 Commerce Plaza at 99 Washington Avenue, Albany, NY. The Florida CMP public meeting will be held on Wednesday, July 15, 2015, at 4:00 p.m. local time in Conference Rooms A and B, Marjory Stoneman Douglas Building, Florida Department of Environmental Protection, 3900 Commonwealth Blvd., Tallahassee, Florida 32399-3000.
Privacy Act of 1974; New System of Records
In accordance with the Privacy Act of 1974, as amended, the Overseas Private Investment Corporation (OPIC) is giving notice of a proposed new system of records. This system, the Salesforce Customer Relationship Management System (``Insight'') is utilized by OPIC as a Customer Relationship Management (CRM) tool. This system, which has gained broad acceptance across federal agencies, supports OPIC in executing its federal function in providing political risk insurance products, financing through direct loans and loan guarantees, and support for private equity funding to eligible investment projects in developing countries and emerging markets. This is executed through the system's ability to facilitate OPIC's insurance, finance, and funds processes. The system generates automated workflows and seamless integration with processes such as application intake. Additionally, the Salesforce customer relationship management system supports Office of Investment Policy clearances and Portfolio Services project monitoring. This system will provide a common platform upon which to conduct key business functions across the agency, thereby gaining efficiencies, enabling integration, collaboration, transparency and establishing a single, authoritative data source.
Privacy Act of 1974: Implementation
The Office of the Director of National Intelligence (ODNI) proposes to exempt two new systems of records from subsections (c)(3); (d)(1),(2),(3),(4); (e)(1) and (e)(4)(G),(H),(I); and (f) of the Privacy Act. With respect to the existing system of records named ODNI Information Technology Systems Activity and Access Records (ODNI-19), the ODNI proposes to invoke subsection (k)(2) as an additional rationale for exempting records from these provisions of the Privacy Act. The ODNI has previously established a rule, published on March 28, 2008, that will preserve the exempt status of records it receives when the reason for the exemption remains valid.
Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled Certain Electric Skin Care Devices, Brushes and Chargers Therefor, and Kits Containing Same, DN 3067; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant's filing under section 210.8(b) of the Commission's Rules of Practice and Procedure (19 CFR Sec. 210.8(b)).
Certain Loom Kits for Creating Linked Articles
Notice is hereby given that the U.S. International Trade Commission has determined to amend the notice of investigation to reflect a change in corporate form by the complainant, to terminate the investigation with respect to claims 2 and 3 of U.S. Patent No. 8,485,565 (``the '565 patent''), and to enter a general exclusion order barring entry of loom kits that infringe claim 4 of the '565 patent. The Commission's determination is final and the investigation is terminated in its entirety.
Privacy Act of 1974; System of Records
The Office of the Director of National Intelligence (ODNI) provides notice that it is establishing two (2) new Privacy Act systems of records, updating and amending four (4) existing Privacy Act systems of records, and rescinding two (2) Privacy Act systems of records. This action is necessary to meet the requirements of the Privacy Act to publish in the Federal Register notice of the existence and character of records maintained by the agency (5 U.S.C. 552a(e)(4)).
60-Day Notice of Proposed Information Collection: CDBG-DR Expenditure Deadline Extension Request Template (Pub. L. 113-2 Grantees Only)
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Submission to OMB for Review; General Services Administration Acquisition Regulation; Contract Financing Final Payment (GSA Form 1142 Release of Claims)
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement and the reinstatement of GSA Form 1142, Release of Claims, regarding final payment under construction and building services contract. GSA Form 1142 was inadvertently deleted as part of the rewrite of GSAR regulations on Contract Financing. GSA Contracting Officers have used this form to achieve uniformity and consistency in the release of claims process. A notice published in the Federal Register at 80 FR 10648 on February 27, 2015. No comments were received.
Notice of Request for Extension of Approval of an Information Collection; Customer/Stakeholder Satisfaction Surveys for the National Animal Health Monitoring System and the National Veterinary Services Laboratories
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 to conduct customer/stakeholder satisfaction surveys for the National Animal Health Monitoring System and the National Veterinary Services Laboratories.
Buy America Waiver Notification
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for the obligation of Federal-aid funds for 21 State projects involving the acquisition of vehicles and equipment on the condition that they be assembled in the U.S.
Marketing Order Regulating the Handling of Spearmint Oil Produced in the Far West; Revision of the Salable Quantity and Allotment Percentage for Class 3 (Native) Spearmint Oil for the 2014-2015 Marketing Year
The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim rule recommended by the Spearmint Oil Administrative Committee (Committee) that revised the quantity of Class 3 (Native) spearmint oil that handlers may purchase from, or handle on behalf of, producers during the 2014-2015 marketing year under the Far West spearmint oil marketing order. The Committee locally administers the order and is comprised of spearmint oil producers operating within the production area. The interim rule increased the Native spearmint oil salable quantity from 1,090,821 pounds to 1,280,561 pounds and the allotment percentage from 46 percent to 54 percent. This change is expected to help maintain orderly marketing conditions in the Far West spearmint oil market.
Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Delay of Compliance Date; Safety Reporting Portal of Electronic Submission of Postmarketing Safety Reports for Human Drugs and Nonvaccine Biological Products
The Food and Drug Administration (FDA or Agency) is delaying the compliance date for the final rule for the electronic submission of postmarketing safety reports for human drugs and biological products that published in the Federal Register of June 10, 2014. The rule amended FDA's postmarketing safety reporting regulations for human drugs 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. FDA is also announcing the availability of the Safety Reporting Portal (SRP), a Web-based electronic submission system, for the electronic submission of postmarketing individual case safety reports (ICSRs) of adverse events for human drug and nonvaccine biological products. The SRP is intended to facilitate the secure electronic submission of postmarketing ICSRs and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database. The SRP creates a simple and efficient mechanism for electronic reporting of ICSRs that does not require an internal database that is compatible with the International Conference on Harmonisation-based direct submission system. FDA is delaying the compliance date for the final rule because FDA understands that not all persons subject to mandatory postmarketing reporting requirements who wish to use the newly available Safety Reporting Portal (SRP) will have the opportunity to register for an account and test the submission process prior to June 10, 2015, the effective date of the final rule.
Irish Potatoes Grown in Colorado; Relaxation of the Handling Regulation for Area No. 3
The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim rule implementing a recommendation from the Colorado Potato Administrative Committee, Area No. 3 (Committee) that relaxed the minimum quantity exception for potatoes handled under the Colorado potato marketing order, Area No. 3 (order). The Committee locally administers the order and is comprised of producers and handlers of potatoes operating within the production area. This rule increases the quantity of potatoes that may be handled under the order without regard to the order's handling regulation requirements from 1,000 to 2,000 pounds. This action is expected to benefit producers and handlers.
Certifications Pursuant to Section 609 of Public Law 101-162
On April 27, 2015, the Department of State certified, pursuant to Section 609 of Public Law 101-162, that 14 nations have adopted programs to reduce the incidental capture of sea turtles in their shrimp fisheries comparable to the program in effect in the United States. The Department also certified that the fishing environments in 26 other countries and one economy do not pose a threat of the incidental taking of sea turtles protected under Section 609.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel RONIN; Invitation for Public Comments
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Marine Mammals; File No. 19108
Notice is hereby given that Daniel P. Costa, Ph.D., University of California at Santa Cruz, Long Marine Laboratory, 100 Shaffer Road, Santa Cruz, CA 95064, has applied in due form for a permit to conduct research on northern elephant seals (Mirounga angustirostris) throughout their range.
Medical Devices; Immunology and Microbiology Devices; Classification of Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers From Positive Blood Cultures
The Food and Drug Administration (FDA) is classifying multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the multiplex nucleic acid assay for identification of microorganisms and resistance markers from positive blood cultures. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
Proposed Agency Information Collection Activities; Comment Request
On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board- approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments 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 number.
Drawbridge Operation Regulations; James River, Isle of Wight and Newport News, VA
The Coast Guard has issued a temporary deviation from the operating schedule that governs the James River Draw Bridge across the James River, mile 5.0, between Isle of Wight and Newport News, VA. This deviation is necessary to facilitate electrical repairs to the south tower of the bridge. This deviation allows the bridge to remain in the closed-to-navigation position.
Safety Zones, Captain of the Port New Orleans Zone
The Coast Guard is establishing temporary safety zones for multiple locations and dates within the Captain of the Port New Orleans zone. These safety zones are necessary to protect persons and vessels from potential safety hazards associated with fireworks displays on or over Federal waterways. Entry into these zones is prohibited unless specifically authorized by the Captain of the Port (COTP) New Orleans or a designated representative.
Endangered Species; Marine Mammals; Receipt of Applications for Permit
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species, marine mammals, or both. With some exceptions, the Endangered Species Act (ESA) and Marine Mammal Protection Act (MMPA) prohibits activities with listed species unless Federal authorization is acquired that allows such activities.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.