September 17, 2009 – Federal Register Recent Federal Regulation Documents

Notice of Class Deviation Approval
Document Number: E9-22385
Type: Notice
Date: 2009-09-17
Agency: Department of Energy
This notice announces the approval of a Class Deviation to the regulations at 10 CFR part 600. The Department is publicizing notice of the Class Deviation approval to satisfy the requirements of 10 CFR 600.4(d). The effect of this action is that the Department may require the submission of monthly performance reports on projects selected under the Clean Coal Power InitiativeRound 3 Funding Opportunity Announcement.
New Animal Drugs; Fomepizole
Document Number: E9-22384
Type: Rule
Date: 2009-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA provides for the veterinary prescription use of fomepizole injectable solution as an antidote for ethylene glycol (antifreeze) poisoning in dogs.
Reasonable Charges for Inpatient MS-DRGs and SNF Medical Services for 2010; Fiscal Year Update
Document Number: E9-22382
Type: Notice
Date: 2009-09-17
Agency: Department of Veterans Affairs
Section 17.101 of Title 38 of the Code of Federal Regulations sets forth the Department of Veterans Affairs (VA) medical regulations concerning ``Reasonable Charges'' for medical care or services provided or furnished by VA to a veteran:
In the Matter of Certain Probe Card Assemblies, Components Thereof and Certain Tested DRAM and NAND Flash Memory Devices and Products Containing Same; Notice of Commission Determination To Review a Final Initial Determination in Part and Set a Schedule for Filing Written Submissions on the Issues Under Review and on Remedy, the Public Interest, and Bonding
Document Number: E9-22381
Type: Notice
Date: 2009-09-17
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined to review in part the final initial determination (``ID'') issued by the presiding administrative law judge (``ALJ'') on June 29, 2009, in the above-captioned investigation.
Draft Guidance for Industry on Microbiological Data for Systemic Antibacterial Drug Products-Development, Analysis, and Presentation; Availability
Document Number: E9-22380
Type: Notice
Date: 2009-09-17
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 ``Microbiological Data for Systemic Antibacterial Drug Products Development, Analysis, and Presentation.'' The draft guidance informs industry of FDA's current thinking regarding the types of microbiological studies, assessments, and clinical trials needed to support an investigational new drug application (IND) and a new drug application (NDA) for a systemic antibacterial drug product. Recommendations in this guidance cover microbiological considerations in the three major areas of conducting general nonclinical studies; conducting animal and human studies and clinical trials; and establishing and updating in vitro susceptibility test methods, quality control (QC) parameters, and interpretive criteria. This guidance also recommends the content and format for presentation of microbiological data for antibacterial drug products in the Microbiology subsection of labeling.
Buck Island, Green Cay, and Sandy Point National Wildlife Refuges, U.S. VI
Document Number: E9-22379
Type: Notice
Date: 2009-09-17
Agency: Fish and Wildlife Service, Department of the Interior
We, the Fish and Wildlife Service (Service), announce the availability of a draft comprehensive conservation plan and environmental assessment (Draft CCP/EA) for Buck Island, Green Cay, and Sandy Point National Wildlife Refuges for public review and comment. In this Draft CCP/EA, we describe the alternative we propose to use to manage these three refuges for the 15 years following approval of the final CCP.
Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Extension of Deadlines to Request Participation in Pilot Program and to Submit Applications; and Notice of Increase in the Number of Original Applications in Pilot Program
Document Number: E9-22378
Type: Notice
Date: 2009-09-17
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an extension of the deadline for submitting requests to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls (CMC)) information for biotechnology products in an Expanded Change Protocol consistent with the principles of quality-by-design and risk management in pharmaceutical manufacturing. Because the deadline for requests to participate in the pilot is being extended, FDA is also extending the application submission deadlines. FDA is also announcing an increase in the number of original applications being accepted into the pilot program.
Endangered and Threatened Species Permit Applications
Document Number: E9-22377
Type: Notice
Date: 2009-09-17
Agency: Fish and Wildlife Service, Department of the Interior
The following applicants have applied for scientific research permits to conduct certain activities with endangered species under the Endangered Species Act of 1973, as amended (Act). The Act requires that we invite public comment on these permit applications.
Submission for OMB Review; Comment Request
Document Number: E9-22376
Type: Notice
Date: 2009-09-17
Agency: Department of Commerce, Patent and Trademark Office
Endangered and Threatened Wildlife and Plants; Permit Applications
Document Number: E9-22375
Type: Notice
Date: 2009-09-17
Agency: Fish and Wildlife Service, Department of the Interior
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (Act) prohibits activities with endangered and threatened species unless a Federal permit allows such activity. The Act requires that we invite public comment before issuing these permits.
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E9-22374
Type: Notice
Date: 2009-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Agency Forms Undergoing Paperwork Reduction Act Review
Document Number: E9-22373
Type: Notice
Date: 2009-09-17
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
Early Warning Reporting Regulations
Document Number: E9-22365
Type: Rule
Date: 2009-09-17
Agency: National Highway Traffic Safety Administration, Department of Transportation
This rule amends certain provisions of the early warning reporting (EWR) rule published pursuant to the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act and adds requirements for information identifying products involved in a recall under 49 CFR part 573 Defect and Noncompliance Responsibility and Reports. This rule modifies the threshold for submitting quarterly EWR reports for light vehicle, bus, medium-heavy vehicle (excluding emergency vehicles), motorcycle and trailer manufacturers. It further requires manufacturers submitting EWR reports to submit product names that are consistent from reporting quarter to quarter and amends the definition of ``other safety campaign.'' It also amends part 573 Defect and Noncompliance Responsibility and Reports to add requirements that tire manufacturers provide a range of tire identification numbers of recalled tires and manufacturers provide the country of origin of a component involved in a recall.
NASA Advisory Council; Science Committee; Astrophysics Subcommittee; Meeting
Document Number: E9-22364
Type: Notice
Date: 2009-09-17
Agency: National Aeronautics and Space Administration, Agencies and Commissions
The National Aeronautics and Space Administration (NASA) announces a meeting of the Astrophysics Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The Meeting will be held for the purpose of soliciting from the scientific community and other persons scientific and technical information relevant to program planning.
New York Disaster Number NY-00079
Document Number: E9-22362
Type: Notice
Date: 2009-09-17
Agency: Small Business Administration, Agencies and Commissions
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of New York (FEMA-1857-DR), dated 09/01/2009 .
Privacy Act of 1974; Altering a System of Records
Document Number: E9-22361
Type: Notice
Date: 2009-09-17
Agency: Farm Credit Administration, Agencies and Commissions
Pursuant to the provisions of the Privacy Act of 1974, as amended (5 U.S.C. 552a), notice is hereby given that the Farm Credit Administration (FCA) is publishing an amended system notice, which indicates that the agency is now maintaining information on employees' health savings accounts.
Safety Zone, Chicago Harbor, Navy Pier Southeast, Chicago, IL
Document Number: E9-22359
Type: Rule
Date: 2009-09-17
Agency: Coast Guard, Department of Homeland Security
The Coast Guard will enforce the Navy Pier Southeast Safety Zone in Chicago Harbor from September 2, 2009, through September 26, 2009. This action is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after fireworks events. This rule will establish restrictions upon and control movement of vessels in the specified area immediately prior to, during, and immediately after the fireworks events. During the enforcement period, no person or vessel may enter the safety zone without permission of the Captain of the Port Lake Michigan.
Lower Mississippi River Waterway Safety Advisory Committee
Document Number: E9-22358
Type: Notice
Date: 2009-09-17
Agency: Coast Guard, Department of Homeland Security
The Lower Mississippi River Waterway Safety Advisory Committee will meet in New Orleans to discuss various issues relating to navigational safety on the Lower Mississippi River and related waterways. This meeting will be open to the public.
Certificate of Alternative Compliance for the Offshore Supply Vessel TYLER STEPHEN
Document Number: E9-22357
Type: Notice
Date: 2009-09-17
Agency: Coast Guard, Department of Homeland Security
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the offshore supply vessel Tyler Stephen as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
Certificate of Alternative Compliance for the Offshore Supply Vessel ELLA G
Document Number: E9-22356
Type: Notice
Date: 2009-09-17
Agency: Coast Guard, Department of Homeland Security
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the offshore supply vessel ELLA G as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
Large Passenger Vessel Crew Requirements
Document Number: E9-22355
Type: Rule
Date: 2009-09-17
Agency: Coast Guard, Department of Homeland Security
This rule finalizes, with minor non-substantive changes, the amendments to Coast Guard regulations on merchant mariner documentation which were published as an interim rule with request for comments on April 24, 2007. These amendments implement section 3509 of the John Warner National Defense Authorization Act for Fiscal Year 2007 (Warner Act), which allows for the issuance of merchant mariner's documents (MMDs), (which have since been consolidated by the Coast Guard into merchant mariner credentials (MMCs)), to certain non-resident aliens for service in the steward's departments of U.S. flag large passenger vessels endorsed for coastwise trade. Prior to publication of the interim rule, the regulations prohibited the Coast Guard from issuing MMDs, which are required for service on large passenger vessels, to non-resident aliens. Specifically, this rule finalizes the amendments to Coast Guard regulations allowing the Coast Guard to issue MMCs to qualified non-resident aliens who are authorized to be employed in the United States, the amendments setting the requirements these aliens must meet in order to qualify for MMCs, and the requirements for the large passenger vessels that may choose to hire these aliens. This rule only applies to large passenger vessels, as defined under the Warner Act.
Information Reporting for Discharges of Indebtedness
Document Number: E9-22354
Type: Rule
Date: 2009-09-17
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
This document contains final regulations relating to information returns for cancellation of indebtedness by certain entities under section 6050P of the Internal Revenue Code. The final regulations will avoid premature information reporting from certain businesses and will reduce the number of information returns required to be filed. The final regulations will impact certain businesses required to file information returns under the existing regulations.
Submission for OMB Review; Comment Request
Document Number: E9-22353
Type: Notice
Date: 2009-09-17
Agency: Department of Commerce
Multifamily Mortgage Insurance Premiums (MIPs) and Credit Subsidy Obligations for Fiscal Year (FY) 2010
Document Number: E9-22342
Type: Notice
Date: 2009-09-17
Agency: Department of Housing and Urban Development
This notice announces the mortgage insurance premiums (MIPs) for Federal Housing Administration (FHA) multifamily mortgage insurance programs, health care facilities; and hospital insurance programs that have commitments to be issued or reissued in Fiscal Year (FY) 2010. The FY2010 MIPs are the same as in FY2009. In addition to announcing MIPs for FY2010, this notice also announces:
Airworthiness Directives; Thielert Aircraft Engines GmbH (TAE) Model TAE 125-01 Reciprocating Engines
Document Number: E9-22314
Type: Proposed Rule
Date: 2009-09-17
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Airworthiness Directives; Thielert Aircraft Engines GmbH (TAE) Model TAE 125-01 Reciprocating Engines
Document Number: E9-22313
Type: Proposed Rule
Date: 2009-09-17
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Draft Program Comment for the National Telecommunications and Information Administration and the U.S. Department of Agriculture's Rural Utilities Service Regarding the Effects of Communication Facilities Construction or Modification Subject To Review by the Federal Communications Commission
Document Number: E9-22273
Type: Notice
Date: 2009-09-17
Agency: Historic Preservation, Advisory Council, Agencies and Commissions
The Advisory Council on Historic Preservation (ACHP) is considering issuing a Program Comment for the National Telecommunications and Information Administration and the U.S. Department of Agriculture's Rural Utilities Service that would relieve them of the need to conduct a separate Section 106 review regarding the effects of communication facilities construction or modification that will be subject to such review by the Federal Communications Commission. The ACHP seeks public input on the proposed Program Comment.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Contract Health Services Report
Document Number: E9-22271
Type: Notice
Date: 2009-09-17
Agency: Department of Health and Human Services, Indian Health Service
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires a 60-day advance opportunity for public comment on the proposed information collection project, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.
Notice of Proposed Information Collection for 1029-0094
Document Number: E9-22270
Type: Notice
Date: 2009-09-17
Agency: Department of the Interior, Office of Surface Mining Reclamation and Enforcement, Surface Mining Reclamation and Enforcement Office
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing that the information collection request for 30 CFR part 700General, has been forwarded to the Office of Management and Budget (OMB) for review and approval. The information collection request describes the nature of the information collection and its expected burden and cost.
Proposed Collection; Comment Request for Unmodified Qualified Trust Model Certificates and Model Trust Documents
Document Number: E9-22266
Type: Notice
Date: 2009-09-17
Agency: Office of Government Ethics, Government Ethics Office, Agencies and Commissions
The Office of Government Ethics is publishing this first round notice and seeking comment on the twelve executive branch OGE model certificates and model documents for qualified trusts. OGE intends to submit these forms for extension of approval for three years by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. OGE is proposing no changes to these forms at this time. As in the past, OGE will notify filers of an update to the privacy information contained in the existing forms, and will post a notification thereof on its Web site.
General Services Acquisition Regulation; GSAR Case 2008-G505; Rewrite of GSAR Part 514, Sealed Bidding
Document Number: E9-22209
Type: Rule
Date: 2009-09-17
Agency: General Services Administration, Agencies and Commissions
The General Services Administration (GSA) is amending the GSA Acquisition Regulation (GSAR) by revising the sections of GSAR Part 514 that provide requirements for sealed bidding. This rule is a result of the GSA Manual (GSAM) Rewrite initiative undertaken by GSA to revise the GSAM to maintain consistency with the Federal Acquisition Regulation (FAR), and to implement streamlined and innovative acquisition procedures that contractors, bidders, and GSA contracting personnel can utilize when entering into and administering contractual relationships. The GSAM incorporates the GSAR as well as internal agency acquisition policy.
Amendment to Restricted Areas R-5103A, R-5103B, and R-5103C; McGregor, NM
Document Number: E9-21263
Type: Rule
Date: 2009-09-17
Agency: Federal Aviation Administration, Department of Transportation
This action amends the airspace description of Restricted Areas R-5103A, R-5103B, and R-5103C; McGregor, NM. In a final rule published in the Federal Register on November 3, 1994, (59 FR 55030), an error was made in the airspace description to the time of designation for Restricted Areas R-5103A, R-5103B, R-5103C and R-5103D (R-5130D was subsequently revoked on January 20, 2005 (69 FR 72113)). Specifically, the time of designation stated ``0700-2000 local time, Monday-Friday, other times by NOTAM'' instead of ``0700-2000 local time Monday-Friday; other times by NOTAM''. This action corrects that error.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.