March 14, 2014 – Federal Register Recent Federal Regulation Documents

Boundary Enlargement of the California Coastal National Monument
Document Number: X14-10314
Type: Proclamation
Date: 2014-03-14
Agency: Executive Office of the President
Reader Aids
Document Number: FR-2014-03-14-ReaderAids
Type: Reader Aids
Date: 2014-03-14
Continuation of the National Emergency With Respect to Iran
Document Number: 2014-05879
Type: Administrative Order
Date: 2014-03-14
Agency: Executive Office of the President
Trademarks, Trade Names, and Copyrights
Document Number: 2014-05804
Type: Rule
Date: 2014-03-14
Agency: Department of Homeland Security, U.S. Customs and Border Protection, Department of the Treasury
Proposed New Information Collection: OMB Control Number 1084-XXXX; Documenting, Managing and Preserving Department of the Interior Museum Collections Housed in Non-Federal Repositories
Document Number: 2014-05748
Type: Notice
Date: 2014-03-14
Agency: Department of the Interior, Office of the Secretary
In compliance with the Paperwork Reduction Act of 1995, the Office of Acquisition and Property Management, Office of the Secretary, Department of the Interior announces a proposed programmatic public information collection and seeks public comments on the provisions thereof.
Approval and Promulgation of Implementation Plans; West Virginia; Regional Haze Five-Year Progress Report State Implementation Plan
Document Number: 2014-05743
Type: Proposed Rule
Date: 2014-03-14
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is proposing approval of a revision to the West Virginia State Implementation Plan (SIP) submitted by the State of West Virginia (West Virginia) through the West Virginia Department of Environmental Protection (WVDEP). West Virginia's SIP revision addresses requirements of the Clean Air Act (CAA) and EPA's rules that require states to submit periodic reports describing progress towards reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the state's existing SIP addressing regional haze (regional haze SIP). EPA is proposing approval of West Virginia's SIP revision on the basis that it addresses the progress report and adequacy determination requirements for the first implementation period for regional haze.
Notice of Decision To Issue Clean Air Act PSD Permit for the Pio Pico Energy Center
Document Number: 2014-05740
Type: Notice
Date: 2014-03-14
Agency: Environmental Protection Agency
This notice announces that EPA Region 9 issued a final permit decision for a Clean Air Act Prevention of Significant Deterioration (PSD) permit to Pio Pico Energy Center, LLC (PPLLC) for the construction of the Pio Pico Energy Center (PPEC).
Notice of Issuance of Final Air Permits for Statoil Gulf Services, LLC, Florida Power & Light-Port Everglades Next Generation Clean Energy Center, and Tampa Electric Company.
Document Number: 2014-05737
Type: Notice
Date: 2014-03-14
Agency: Environmental Protection Agency
This notice is to announce that on October 28, 2013, the EPA issued final Outer Continental Shelf (OCS) air quality permit numbered OCS-EPA-R4012 for Statoil Gulf Services, LLC (Statoil); and on November 25, 2013 and December 18, 2013, the EPA issued final Prevention of Significant Deterioration (PSD) air quality permits numbered PSD-EPA- R4010 and PSD-EPA-R4014 for the Florida Power & Light (FPL)Port Everglades Next Generation Clean Energy Center (PEEC) and Tampa Electric Company (TECO), respectively.
Request for Comments of a Previously Approved Information Collection
Document Number: 2014-05734
Type: Notice
Date: 2014-03-14
Agency: Maritime Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on January 6, 2014 (Federal Register 701, Vol. 79, No. 3).
Sunshine Act Meetings
Document Number: 2014-05732
Type: Notice
Date: 2014-03-14
Agency: Federal Election Commission, Agencies and Commissions
Sunshine Act Cancellation Notice; OPIC's March 12, 2014 Annual Public Hearing
Document Number: 2014-05731
Type: Notice
Date: 2014-03-14
Agency: Overseas Private Investment Corporation, Agencies and Commissions
Marine Transportation System National Advisory Council
Document Number: 2014-05730
Type: Notice
Date: 2014-03-14
Agency: Maritime Administration, Department of Transportation
The Maritime Administration announces that the Marine Transportation System National Advisory Council (MTSNAC) meeting, originally scheduled for February 13, 2014 and cancelled due to inclement weather, has now been rescheduled for April 1, 2014. The meeting will be held to discuss potential recommendations to the Secretary on the integration of marine highways into the national transportation system, options to provide a steady and reliable funding mechanism for port infrastructure development, methods to mitigate the impact of cargo diverted as a result of natural disasters, and surface transportation reauthorization issues. A public comment period will commence at 2:30 p.m. on April 1, 2014. To provide time for as many people to speak as possible, speaking time for each individual will be limited to three minutes. Members of the public who would like to speak are asked to contact Richard J. Lolich by March 25, 2014. Commenters will be placed on the agenda in the order in which notifications are received. If time allows, additional comments will be permitted. Copies of oral comments must be submitted in writing at the meeting. Additional written comments are welcome and must be filed by April 4, 2014.
Sunshine Act Cancellation Notice-OPIC March 12, 2014 Public Hearing
Document Number: 2014-05728
Type: Notice
Date: 2014-03-14
Agency: Overseas Private Investment Corporation, Agencies and Commissions
Final Modification of the National Pollutant Discharge Elimination System (NPDES) General Permit (GP) for Small Suction Dredges in Idaho, IDG370000
Document Number: 2014-05724
Type: Notice
Date: 2014-03-14
Agency: Environmental Protection Agency
When the 2013 General Permit (GP) was issued, the language of the GP contained a discrepancy with the total maximum daily load (TMDL) that was issued for Mores Creek. The Environmental Protection Agency (EPA) proposed to modify the permit on December 18, 2013, and provided a 45 day comment period. EPA prepared a Response to Comments and modified the GP so it now includes the tributaries of Mores, Elk or Grimes creeks in the loading allocations of the TMDL and a list of these tributaries in Appendix F.
Request for Comments of a Previously Approved Information Collection
Document Number: 2014-05723
Type: Notice
Date: 2014-03-14
Agency: Maritime Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on November 29, 2013 (Federal Register 71705, Vol. 78, No. 230).
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel BLUE HERON; Invitation for Public Comments
Document Number: 2014-05720
Type: Notice
Date: 2014-03-14
Agency: Maritime Administration, Department of Transportation
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.
Meeting of the Judicial Conference Committee on Rules of Practice and Procedure
Document Number: 2014-05715
Type: Notice
Date: 2014-03-14
Agency: Judicial Conference of the United States, Agencies and Commissions
The Advisory Committee on Rules of Bankruptcy Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation.
Meeting of the Judicial Conference Committee on Rules of Practice and Procedure
Document Number: 2014-05714
Type: Notice
Date: 2014-03-14
Agency: Judicial Conference of the United States, Agencies and Commissions
The Advisory Committee on Rules of Appellate Procedure will hold a two-day meeting. The meeting will be open to public observation but not participation.
List of Units of the National Park System Exempt From the Provisions of the National Parks Air Tour Management Act
Document Number: 2014-05712
Type: Notice
Date: 2014-03-14
Agency: Federal Aviation Administration, Department of Transportation, Department of the Interior, National Park Service
The National Parks Air Tour Management Act (NPATMA) requires the Federal Aviation Administration (FAA) and National Park Service (NPS) to develop an air tour management plan for units of the national park system where an operator has requested authority to provide commercial air tours. The FAA Modernization and Reform Act of 2012 amended various provisions of NPATMA. One provision exempted national park units with 50 or fewer annual flights from the provisions of NPATMA and requires FAA and NPS to jointly publish a list of exempt parks. By Federal Register notice (See 77 FR 75254, December 19, 2012), FAA and NPS published an initial list of exempt parks in 2012. This notice provides the annual updated list of parks that are exempt from the provisions of the NPATMA.
Risk Management Agency; 2014 Farm Bill Implementation Listening Session
Document Number: 2014-05710
Type: Notice
Date: 2014-03-14
Agency: Department of Agriculture, Farm Service Agency
In preparing to implement the Agricultural Act of 2014 (commonly referred to as the 2014 Farm Bill), we are hosting a listening session for initial public input about the new programs and changes to existing programs for which the Farm Service Agency (FSA) and the Risk Management Agency (RMA) have been delegated the authority to implement. The 2014 Farm Bill is intended to maintain a strong farm safety-net, restore funding for a number of critical programs including disaster assistance that has lapsed, conserve our natural resources, and prepare the nation for the next generation of farming and agriculture. The listening session will provide an opportunity for stakeholders to voice their priorities, concerns, or requests. Examples of new programs FSA will implement include the Agriculture Risk Coverage (ARC), Price Loss Coverage (PLC), and Dairy Margin Protection Programs (MPP-Dairy). RMA will be implementing the new Supplemental Coverage Option (SCO), Stacked Income Protection Plan (STAX) for producers of upland cotton, conservation compliance requirements, and several new program revisions leading to enhanced crop insurance coverage. Instructions regarding registering for and attending the listening session are in the SUPPLEMENTARY INFORMATION section of this notice.
Next Meeting of the North American Numbering Council
Document Number: 2014-05708
Type: Notice
Date: 2014-03-14
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Commission released a public notice announcing the meeting and agenda of the North American Numbering Council (NANC). The intended effect of this action is to make the public aware of the NANC's next meeting and agenda.
Marine Mammals; File No. 18182
Document Number: 2014-05705
Type: Notice
Date: 2014-03-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
Notice is hereby given that Marilyn Mazzoil, Harbor Branch Oceanographic Institute at Florida Atlantic University, 5600 US 1 North, Fort Pierce, Florida 34946 has been issued a permit to take bottlenose dolphins (Tursiops truncatus) for purposes of scientific research.
Atlantic Highly Migratory Species; Meeting of the Atlantic Highly Migratory Species Advisory Panel
Document Number: 2014-05704
Type: Notice
Date: 2014-03-14
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS will hold a 2-day Atlantic Highly Migratory Species (HMS) Advisory Panel (AP) meeting in April 2014. The intent of the meeting is to consider options for the conservation and management of Atlantic HMS. The meeting is open to the public.
Information Collection Being Reviewed by the Federal Communications Commission
Document Number: 2014-05703
Type: Notice
Date: 2014-03-14
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Information Collection Being Reviewed by the Federal Communications Commission
Document Number: 2014-05702
Type: Notice
Date: 2014-03-14
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid Office of Management and Budget (OMB) control number.
Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority
Document Number: 2014-05701
Type: Notice
Date: 2014-03-14
Agency: Federal Communications Commission, Agencies and Commissions
As part of its continuing effort to reduce paperwork burden and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s). Comments are requested concerning: whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information burden for small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid OMB control number.
Draft Guidance for Industry on Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products; Availability
Document Number: 2014-05700
Type: Notice
Date: 2014-03-14
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 ``Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products.'' This guidance clarifies the FDA requirements and regulations pertaining to allowable excess volume in injectable vials and reinforces the importance of appropriate packaging sizes for injectable drug \1\ and biological products.
Submission for OMB Review; 30-Day Comment Request; Cardiovascular Health and Needs Assessment in Washington, DC-Development of a Community-Based Behavioral Weight Loss Intervention
Document Number: 2014-05698
Type: Notice
Date: 2014-03-14
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on January 2, 2014, Volume 79, Issue Number 1, pages 41-42 and allowed 60-days for public comment. Public comments were received during the 60-day period. The purpose of this notice is to allow an additional 30 days for public comment. The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, 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. Direct Comments to OMB: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974, Attention: NIH Desk Officer. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30-days of the date of this publication.
Regulation of Fuel and Fuel Additives: Reformulated Gasoline Requirements for the Atlanta Covered Area
Document Number: 2014-05697
Type: Rule
Date: 2014-03-14
Agency: Environmental Protection Agency
In this final rule, the Environmental Protection Agency (EPA) has determined that the Atlanta metro area is not a federal reformulated gasoline (RFG) covered area and, therefore, that there is no requirement to use RFG in the Atlanta area. Atlanta is the only RFG covered area formerly classified as a severe ozone nonattainment area under the 1-hour ozone National Ambient Air Quality Standard that was redesignated to attainment for that standard before its revocation, and at a time when it was designated as nonattainment for the 8-hour ozone standard with a classification less than severe. EPA has determined that the statute is ambiguous as to whether RFG is required in this situation. EPA believes that the comprehensive planning conducted by the State through the SIP process, the array of regulatory tools at the State's disposal, and the current limited emissions benefits of RFG in Atlanta as compared to the current state fuel (as explained elsewhere in the document) indicate that it would be appropriate to interpret the relevant statutory language to not require RFG use in Atlanta.
National Women's Business Council; Addendum to Quarterly Public Meeting
Document Number: 2014-05696
Type: Notice
Date: 2014-03-14
Agency: Small Business Administration, Agencies and Commissions
The SBA is issuing this notice to announce the location, date, time, and agenda for its public meeting of the National Women's Business Council. The meeting will be open to the public.
LWD, Inc. Superfund Site; Calverty City, Marshall County, Kentucky; Notice of Settlement
Document Number: 2014-05695
Type: Notice
Date: 2014-03-14
Agency: Environmental Protection Agency
Under 122(h) of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), the United States Environmental Protection Agency (EPA) has entered into a settlement with the approximately fifty (50) parties concerning the LWD, Inc. Superfund Site located in Calvert City, Marshall County, Kentucky. The settlement addresses remaining costs from a fund- lead Removal Action taken by the EPA at the Site.
Combinatorial Approaches to Functional Materials Workshop
Document Number: 2014-05694
Type: Notice
Date: 2014-03-14
Agency: Department of Commerce, National Institute of Standards and Technology
In cooperation with the National Science Foundation (NSF) and the Office of Science and Technology Policy (OSTP), NIST announces the ``Combinatorial Approaches to Functional Materials Workshop'' on Monday, May 5, 2014 from 8 a.m. to 5 p.m. Pacific Time and Tuesday, May 6, 2014 from 8 a.m. to 12 p.m. Pacific Time in San Francisco, California hosted by the University of South Carolina and Applied Material Inc. The Workshop will bring together the community of combinatorial materials science practitioners from academia, industry, and government in efforts to advance the Materials Genome Initiative. The goal of this workshop is to identify challenges in the field, brainstorm ideas for breakthrough, and identify areas of cross- community collaboration.
Request for Comments of a Previously Approved Information Collection
Document Number: 2014-05692
Type: Notice
Date: 2014-03-14
Agency: Maritime Administration, Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on November 29, 2013 (Federal Register 71713, Vol. 78, No. 230).
Disclosures to Participate in State Prescription Drug Monitoring Programs
Document Number: 2014-05691
Type: Rule
Date: 2014-03-14
Agency: Department of Veterans Affairs
This document adopts as final, without change, an interim final rule published in the Federal Register that amended the Department of Veterans Affairs' (VA) regulations concerning the sharing of certain patient information in order to implement VA's authority to participate in State Prescription Drug Monitoring Programs (PDMP).
30-Day Notice of Proposed Information Collection: Online Application for Nonimmigrant Visa
Document Number: 2014-05689
Type: Notice
Date: 2014-03-14
Agency: Department of State
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Proposed Establishment of Class E Airspace; Bois Blanc Island, MI
Document Number: 2014-05688
Type: Proposed Rule
Date: 2014-03-14
Agency: Federal Aviation Administration, Department of Transportation
This action proposes to establish Class E airspace at Bois Blanc Island, MI. Controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Bois Blanc Island Airport. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel HAKUNA MATATA II; Invitation for Public Comments
Document Number: 2014-05687
Type: Notice
Date: 2014-03-14
Agency: Maritime Administration, Department of Transportation
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.
Notice of Intent To Prepare an Environmental Assessment for Proposed Wind Energy-Related Research Activities on the Atlantic Outer Continental Shelf Offshore Virginia and Notice of Public Scoping Meeting MMAA104000
Document Number: 2014-05683
Type: Notice
Date: 2014-03-14
Agency: Department of the Interior, Bureau of Ocean Energy Management
In compliance with the National Environmental Policy Act (NEPA) of 1969, as amended (42 U.S.C. 4231 et seq.), BOEM intends to prepare an Environmental Assessment (EA) to consider the reasonably foreseeable environmental consequences associated with the approval of wind energy-related research activities offshore Virginia as proposed by the Virginia Department of Mines, Minerals and Energy (DMME). BOEM is seeking public input regarding important environmental issues and the identification of reasonable alternatives that should be considered in the EA. In addition to the request for written comments, BOEM is holding a public scoping meeting to solicit comments on the scope of the EA. The meeting will be held from 5:00 p.m.-8:00 p.m. EDT on Thursday, April 3, 2014, at the Virginia Aquarium and Marine Science Center, 717 General Booth Boulevard, Virginia Beach, Virginia 23451.
Land Acquisitions; Kaw Nation of Oklahoma
Document Number: 2014-05682
Type: Notice
Date: 2014-03-14
Agency: Department of the Interior, Bureau of Indian Affairs
The Assistant SecretaryIndian Affairs made a final agency determination to acquire 21.54 acres more or less of land in trust for the Kaw Nation of Oklahoma for gaming and other purposes on March 10, 2014.
Steel Threaded Rod From Thailand: Final Determination of Sales at Less Than Fair Value and Affirmative Final Determination of Critical Circumstances
Document Number: 2014-05681
Type: Notice
Date: 2014-03-14
Agency: Department of Commerce, International Trade Administration
On December 31, 2013, the Department of Commerce (the ``Department'') published the preliminarily determination of the antidumping investigation of steel threaded rod from Thailand. The period of investigation (``POI'') is April 1, 2012, through March 31, 2013. We gave interested parties an opportunity to comment on the preliminary determination, but we received no comments. The final weighted-average dumping margins of sales at less than fair value (``LTFV'') are listed below in the ``Final Determination'' section of this notice.
Requested Administrative Waiver of the Coastwise Trade Laws: Vessel DUCHESS OF LONGWOOD; Invitation for Public Comments
Document Number: 2014-05679
Type: Notice
Date: 2014-03-14
Agency: Maritime Administration, Department of Transportation
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.
Prospective Grant of an Exclusive Evaluation License Agreement: Pre-Clinical Evaluation and Commercial Development of Anti-Tyrosine Kinase-Like Orphan Receptor 1 Antibody-Drug Conjugates for the Treatment of Human Cancers
Document Number: 2014-05678
Type: Notice
Date: 2014-03-14
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application 61/ 172,099 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0- US-01], PCT Application No. PCT/US2010/032208 entitled ``Anti-human ROR1 Antibodies'' [HHS Ref. E-097-2009/0-PCT-02], U.S. Patent Application 61/418,550 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'' [HHS Ref. No. E-039-2011/0-US-01], and PCT Application No. PCT/US2011/062670 entitled, ``Chimeric Rabbit/Human ROR1 Antibodies'', and all related continuing and foreign patents/patent applications for the technology family, to Ardeagen Corporation. The patent rights in these inventions have been assigned to the Government of the United States of America. The prospective start-up exclusive evaluation option license territory may be worldwide and the field of use may be limited to pre- clinical evaluation and commercial development of an antibody-drug conjugate comprising an anti-tyrosine protein kinase transmembrane receptor (ROR1) antibody for the treatment of human ROR1 expressing cancers, wherein the antibody moiety comprises the anti-ROR1 antibodies designated as 2A2, 2D11, R11, R12, or R31. For avoidance of doubt, this Agreement explicitly excludes the development of an immunotoxin comprising 2A2 and Pseudomonas exotoxin A targeted immunotoxins for the treatment of human ROR1 expressing cancers. Upon expiration or termination of the start-up exclusive evaluation option license, Ardeagen Corporation will have the right to execute a start-up exclusive patent commercialization license which will supersede and replace the start-up exclusive evaluation option license with no broader territory than granted in the start-up exclusive evaluation option license and the field of use will be commensurate with the commercial development plan at the time of conversion.
National Institute of Neurological Disorders and Stroke; Notice of Closed Meeting
Document Number: 2014-05677
Type: Notice
Date: 2014-03-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2014-05676
Type: Notice
Date: 2014-03-14
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Environmental Health Sciences; Notice of Closed Meeting
Document Number: 2014-05675
Type: Notice
Date: 2014-03-14
Agency: Department of Health and Human Services
Environmental Impact Statements; Notice Of Availability
Document Number: 2014-05674
Type: Notice
Date: 2014-03-14
Agency: Environmental Protection Agency
National Institute on Alcohol Abuse and Alcoholism; Notice of Meeting
Document Number: 2014-05673
Type: Notice
Date: 2014-03-14
Agency: Department of Health and Human Services, National Institutes of Health