April 29, 2009 – Federal Register Recent Federal Regulation Documents
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Office of Postsecondary Education; Title IV, Part I, Section 499 of the Higher Education Act of 1965, as Amended-Competitive Loan Auction Pilot Program
Through this notice, the Secretary of Education (the Secretary) announces the cancellation of the auction (Auction) that was scheduled to occur on April 15, 2009 under the Competitive Loan Auction Pilot Program (Auction Program) for the rights to originate PLUS loans to parent borrowers under the FFEL Program.
Submission for OMB Review; Comment Request
The National Endowment for the Humanities (NEH) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval as required by the provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-1344 U.S.C. Chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling Susan G. Daisey, Director, Office of Grant Management, the National Endowment for the Humanities (202-606-8494) or may be requested by e-mail to sdaisey@neh.gov. Comments should be sent to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for the National Endowment for the Humanities, Office of Management and Budget, Room 10235, Washington, DC 20503 (202-395-7316), within 30 days from the date of this publication in the Federal Register.
Prospective Grant of Exclusive License: Treating and Preventing Inflammatory Bowel Disease (IBD) Involving Interleukin-13 (IL-13) and Natural Killer T (NKT) Cells
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in PCT Patent Application No. PCT/US02/18790, filed June 14, 2002, which published as WO 2004/001655 on December 31, 2003, now expired, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-PCT-01];U.S. Patent Application No. 10/517,898, filed December 13, 2004, which was published as US-2006- 0024306 A1 on February 2, 2006, entitled ``A Method of Treating Inflammatory Bowel Disease (IBD)'' [HHS Ref. No. E-131-2002/0-US-02]; European Patent Application No. 02742057.9, filed June 14, 2002, which published as 1552462 on July 13, 2005, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-EP-08]; Australian Patent Application No. 2002315115, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-AU- 05]; Japanese Patent Application No. 2004515561, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-JP-04]; New Zealand Patent Application No. 537726, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-NZ-06]; Hong Kong Patent Application No. 05112119.6, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E- 131-2002/0-HK-09]; South African Patent Application No. 2005/00375, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-ZA- 07]; Canadian Patent Application No. 2489540, filed June 14, 2002, entitled ``Method of Treating and Preventing Colitis Involving IL-13 and NK-T Cells'' [HHS Ref. No. E-131-2002/0-CA-03]; U.S. Provisional Patent Application No. 60/671,624, filed April 15, 2005, now abandoned, entitled ``Treatment and prevention of IBD using Mutant and Chimeric IL-13 Molecules'' [HHS Ref. No. E-003-2005/0-US-01]; PCT Patent Application No. PCT/US06/014393, filed April 14, 2006, now expired, entitled ``Methods of Treating and Preventing Inflammatory Bowel Disease Involving IL-13 and NKT Cells,'' which published as WO 2006/ 113614 on October 20, 2006 [HHS Ref. No. E-003-2005/0-PCT-02]; European Patent Application No. 06750435.7, filed November 12, 2007, entitled ``Methods of Treating and Preventing Inflammatory Bowel Disease Involving IL-13 and NKT Cells,'' which published as 1877074 on January 16, 2008, [HHS Ref. No. E-003-2005/0-EP-04]; and U.S. Patent Application No. 11/918,711, filed April 14, 2006, entitled ``Treatment and Prevention of Inflammatory Bowel Disease (IBD) Using Mutant and Chimeric IL-13 Molecules'' [HHS Ref. No. E-003-2005/0-US-03] to Innate Immune, Inc. which has an office in Stanford, California, U.S.A. The patent rights in these inventions have been assigned to the United States of America and Brigham and Women's Hospital.
Request for Comment on Minimum Requirements for Criteria in Grant Applications Under the National All Schedules Prescription Electronic Reporting Act of 2005 (NASPER)
This notice is to request comments from interested parties regarding criteria for grants issued under NASPER (42 U.S.C. 280g-3). NASPER establishes a formula grant program for States to establish or improve State controlled substance monitoring systems (``prescription monitoring programs,'' or ``PMPs''). Under NASPER, the Secretary will award grants to qualifying States, defined in the legislation as the 50 States and the District of Columbia (42 U.S.C. 280g-3(i)(8)). This notice is required under NASPER and comments received in response to this notice will be evaluated and as appropriate, included in public announcements for grants under this law.
Prospective Grant of Exclusive License: Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3′-UTR of Dengue Types 1,2,3, and 4
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a an exclusive license to practice the following invention as embodied in the following patent applications: (1) E-120-2001/0, Whitehead et al., ``Development of Mutations Useful for Attenuating Dengue Viruses and Chimeric Dengue Viruses'', Brazilian Patent Application PI0209943.8, filed May 22, 2002, (2) E-089-2002/0,1, Whitehead et al., ``Dengue Tetravalent Vaccine Containing a Common 30 Nucleotide Deletion in the 3'-UTR of Dengue Types 1,2,3, and 4, or Antigenic Chimeric Dengue Viruses 1,2,3, and 4'', Brazilian Patent Application PI0309631-9, filed April 25, 2003, and (3) E-139-2006/0, Whitehead et al., ``Development of Dengue Vaccine Components'', Brazilian Patent Application TBA, filed August 15, 2007 to Fundacao Butantan, having a place of business in Sao Paulo, Brazil. The patent rights in this invention have been assigned to the United States of America.
Establishment of the Lake Chelan Viticultural Area (2007R-103P)
This Treasury decision establishes the 24,040-acre ``Lake Chelan'' American viticultural area in Chelan County, Washington. It lies within the larger Columbia Valley viticultural area in north- central Washington. We designate viticultural areas to allow vintners to better describe the origin of their wines and to allow consumers to better identify wines they may purchase.
Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania: Transportation Conformity Requirement
EPA is taking direct final action to approve revisions to the Pennsylvania State Implementation Plan (SIP) submitted by the Commonwealth of Pennsylvania. The revisions establish State transportation conformity requirements. EPA is approving these revisions in accordance with the requirements of the Clean Air Act.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), notice is hereby given of a meeting of SACATM on June 25-26, 2009, at the Hilton Arlington Hotel, 950 North Stafford Street, Arlington, VA 22203. The meeting is open to the public with attendance limited only by the space available. SACATM advises the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), and the Director of the NIEHS and NTP regarding statutorily mandated duties of ICCVAM and activities of NICEATM.
Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Transportation Conformity Requirements
EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the Commonwealth of Pennsylvania for Transportation Conformity Requirements. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments
Privacy Act of 1974, as Amended; Proposed Alteration to Existing System of Records, New Routine Use, and General Housekeeping Changes
We are issuing public notice of our intent to alter, add a new routine use, and make minor housekeeping changes to an existing system of records in accordance with the Privacy Act (5 U.S.C. 552a(e)(4) and (e)(11)). The affected system of records is the Working File of the Appeals Council (60-0004), hereinafter referred to as the AC Working File. The proposed alterations will result in the following changes:
Office of the National Coordinator for Health Information Technology
This notice announces the establishment of the HIT Policy Committee. The American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 13101, directs the establishment of the HIT Policy Committee. The HIT Policy Committee (also referred to as the ``Committee'') is charged with recommending to the National Coordinator a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed. The HIT Policy Committee is also charged with recommending to the National Coordinator an order of priority for the development, harmonization, and recognition of such standards, specifications, and certification criteria.
Office of the National Coordinator for Health Information Technology
This notice announces the establishment of the HIT Standards Committee. The American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5), section 13101, directs the establishment of the HIT Standards Committee. The HIT Standards Committee (also referred to as the ``Committee'') is charged with making recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the HIT Policy Committee.
Outer Continental Shelf Air Regulations Consistency Update for Alaska
On March 3, 2009, EPA proposed the rulemaking ``Outer Continental Shelf Air Regulations Consistency Update for Alaska''. The original comment period closed on April 2, 2009. In this notice, we are announcing a 14-day reopening of the public comment period for the proposal.
Privacy Act of 1974, as Amended; Proposed Alteration to Existing System of Records, New Routine Use, and General Housekeeping Changes
We are issuing public notice of our intent to alter, add a new routine use, and make minor housekeeping changes to an existing system of records in accordance with the Privacy Act (5 U.S.C. 552a(e)(4)) and (e)(11). The affected system of records is the Administrative Law Judge (ALJ) Working File on Claimant Cases (60-0005), hereinafter referred to as the ALJ Working File. The proposed alterations will result in the following changes:
Good Neighbor Environmental Board
Pursuant to the Federal Advisory Committee Act, Public Law 92- 463, notice is hereby given that the Good Neighbor Environmental Board (GNEB) will hold a public teleconference on May 15, 2009, from 1 p.m. to 3 p.m. Eastern Standard Time. The meeting is open to the public. For further information regarding the teleconference and background materials, please contact Mark Joyce at the number listed below.
Notice of Solicitation of Applications: Section 514, 515, and 516 Multi-Family Housing Revitalization Demonstration Program (MPR) for Fiscal Year 2009
USDA Rural Development (Agency) which administers the programs of the Rural Housing Service (RHS) announces the timeframe to submit applications to participate in a demonstration program to preserve and revitalize existing rural rental housing projects financed by Rural Development under Section 515, Section 514, and Section 516 of the Housing Act of 1949, as amended. A subsequent Notice of Funding Availability (NOFA) will be published with specific funding information for fiscal year 2009 at a later date. The intended effect is to restructure selected existing Section 515 multi-family housing loans and Section 514 and 516 off-farm labor housing loans and grants expressly for the purpose of ensuring that sufficient resources are available to preserve the rental project for the purpose of providing safe and affordable housing for very low-, low-, or moderate-income residents. Expectations are that properties participating in this program will be revitalized and the affordable use will be extended without displacing tenants because of increased rents. No additional Agency rental assistance units will be made available under this program.
Notice of Funding Availability: Rural Development Voucher Program
This notice informs the public that the U.S. Department of Agriculture (USDA) has established a demonstration Rural Development Voucher Program, as authorized under Section 542 of the Housing Act of 1949, as amended, (without regard to Section 542(b)), which is being administered by USDA. This notice informs the public that funding is now available for the Rural Development voucher program. The notice also sets forth the general policies and procedures for use of these vouchers. Rural Development Vouchers are only available to tenants of Rural Development-financed multifamily properties where the owner pays off the loan, either through prepayment or a foreclosure action prior to the loan's maturity date.
Listing Endangered and Threatened Species: Initiation of Status Review for the Oregon Coast Evolutionarily Significant Unit of Coho Salmon
We, NMFS, initiate a status review under the Endangered Species Act (ESA) for the Oregon Coast coho salmon (Oncorhynchus kisutch) evolutionarily significant unit (ESU). To ensure that the status review is complete and based upon the best available scientific and commercial information, we solicit information regarding the population structure, status and trends, and limiting factors and threats of this coho salmon ESU.
Fisheries of the Exclusive Economic Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska
NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the second seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species fishery in the GOA has been reached.
Additions and Revisions to the List of Approved End-Users and Respective Eligible Items for the People's Republic of China (PRC) Under Authorization Validated End-User (VEU)
In this final rule, the Bureau of Industry and Security (BIS) amends the Export Administration Regulations (EAR) to add a name to the list of end-users for the People's Republic of China (PRC) approved to receive exports, reexports and transfers of certain items under Authorization Validated End-User (VEU). This rule also amends the EAR to add and revise eligible items and destinations for existing VEU authorizations. Specifically, this rule amends the EAR to authorize one additional VEU and identify its respective eligible items for export and reexport to the PRC. This rule also amends the authorizations of two pre-existing VEUs in the PRC. Finally, this rule makes a modification to the listed name of an existing VEU in the PRC. In a final rule published in the Federal Register on June 19, 2007, BIS revised and clarified U.S. export control policy for the PRC, establishing Authorization VEU and identifying the PRC as the initial eligible destination. In a final rule published in the Federal Register on October 19, 2007, BIS published the names of the first five validated end-users in the PRC that were approved to receive certain specified items under Authorization VEU.
Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permits
The Assistant Regional Administrator for Sustainable Fisheries, Northeast Region, NMFS (Assistant Regional Administrator), has made a preliminary determination that the subject exempted fishing permit (EFP) application submitted by Coonamessett Farm, which would exempt Atlantic sea scallop (scallop) vessels participating in a modified scallop dredge twine top (twine top) study from minimum twine top mesh sizes, Closed Area I Access Area (CAI) and Closed Area II Access Area (CAII) scallop vessel trip restrictions, and fish possession restrictions, should be issued for public comment. Although the Assistant Regional Administrator has not made a preliminary determination that the activities authorized under the EFP would be consistent with the goals and objectives of the Atlantic Sea Scallop Fishery Management Plan (FMP), NMFS seeks public comment on the exemptions the EFP is requesting. Further review and consultation may be necessary before a final determination is made.
Certain Hot-Rolled Carbon Steel Flat Products from Thailand: Extension of Time Limit for Final Results of Changed Circumstances Review
The U.S. Department of Commerce (``the Department'') is extending the time limit for the final results of the changed circumstances review of the antidumping duty order on certain hot- rolled carbon steel flat products (``hot-rolled steel'') from Thailand. The period of review is July 1, 2006, through June 30, 2007. This extension is made pursuant to 19 CFR 351.216(e) and 19 CFR 351.302(b).
Magnuson-Stevens Act Provisions; General Provisions for Domestic Fisheries; Application for Exempted Fishing Permits
The Assistant Regional Administrator for Sustainable Fisheries, Northeast Region, NMFS (Assistant Regional Administrator), has made a preliminary determination that an Exempted Fishing Permit (EFP) application submitted by the University of Rhode Island/Rhode Island Sea Grant (URI/RISG) contains all of the required information and warrants further consideration. The Assistant Regional Administrator has made a preliminary determination that the activities authorized under this EFP would be consistent with the goals and objectives of the Atlantic Mackerel, Squid and Butterfish Fishery Management Plans (FMP). However, further review and consultation may be necessary before a final determination is made to issue an EFP. Therefore, NMFS announces that the Assistant Regional Administrator proposes to recommend that an EFP be issued that would allow two commercial fishing vessels to conduct fishing operations that are otherwise restricted by the regulations governing the fisheries of the Northeastern United States.
Agency Information Collection Activities: Proposed Collection; Comment Request
The Federal Emergency Management Agency, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a proposed new information collection. In accordance with the Paperwork Reduction Act of 1995, this Notice seeks comments concerning the National Emergency Family Registry and Locator System (NEFRLS) established in accordance with Title VI of the Department of Homeland Security Appropriations Act of 2007 to help facilitate the reunification of families displaced due to a major disaster or emergency
Marine Mammal Stock Assessment Reports
As required by the Marine Mammal Protection Act (MMPA), NMFS has incorporated public comments into revisions of marine mammal stock assessment reports (SARs). These reports for 2008 are now final and available to the public.
Implementation of the Findings of the WTO Dispute Settlement Panel and Appellate Body in United States - Final Anti-Dumping Measures on Stainless Steel from Mexico: Notice of Determination Under Section 129 of the Uruguay Round Agreements Act
On March 31, 2009, the Department of Commerce (the Department) issued a determination regarding the dumping margin calculation in the less-than-fair-value investigation of stainless steel sheet and strip in coils (stainless steel) from Mexico challenged by Mexico before the World Trade Organization (WTO). On April 23, 2009, the U.S. Trade Representative (USTR) instructed the Department to implement in whole this determination under section 129 of the Uruguay Round Agreements Act (URAA). The Department is now implementing this determination.
Fisheries of the Northeastern United States; Summer Flounder Fishery; Quota Transfers
NMFS announces that the State of North Carolina is transferring a portion of its 2009 commercial summer flounder quota to the Commonwealth of Virginia. In addition, the Commonwealth of Virginia is transferring a portion of its 2009 commercial summer flounder quota to the State of New Jersey. By this action, NMFS adjusts the quotas and announces the revised commercial quota for each state involved.
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