October 2007 – Federal Register Recent Federal Regulation Documents
Results 251 - 300 of 2,746
Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility'' dated October 2007. The draft guidance document provides assistance to blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices. In the Federal Register of March 9, 2005 (70 FR 11679), FDA withdrew the guidance document entitled ``Draft Guideline for the Validation of Blood Establishment Computer Systems,'' issued on September 28, 1993, and is issuing this guidance to reflect our current considerations on this topic.
HUD Acquisition Regulation (HUDAR) Debarment and Suspension Procedures
This rule amends HUD's Acquisition Regulation (HUDAR) to codify the suspension and debarment procedures applicable to HUD's procurement contracts. Such an amendment affirms that the suspension and debarment procedures in 24 CFR part 24 apply to both procurement and nonprocurement contracts. The contracting community is familiar with the suspension and debarment procedures in part 24, and this rule is limited to amending the HUDAR regulations to reflect the applicability of these requirements to procurement contracts. This final rule follows a July 17, 2007, proposed rule. HUD received no public comments on the proposed rule. This final rule adopts the proposed rule without change.
Guidance for Industry: Considerations for Plasmid Deoxyribonucleic Acid Vaccines for Infectious Disease Indications; Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Considerations for Plasmid DNA Vaccines for Infectious Disease Indications'' dated November 2007. The guidance document is intended to assist manufacturers and sponsors in the development of deoxyribonucleic acid (DNA) vaccines to prevent infectious diseases. The guidance supersedes the guidance document entitled ``Points to Consider on Plasmid DNA Vaccines for Preventive Infectious Disease Indications'' dated December 1996. In addition, the guidance announced in this notice finalizes the draft guidance of the same title dated February 2005.
Submission to Office of Management and Budget-Information Collection, OMB Control Number 1004-0179
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) has submitted a request for an extension of an approved information collection to the Office of Management and Budget (OMB) for approval.
Submission to Office of Management and Budget-Information Collection, OMB Control Number 1004-0042
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) has submitted a request for an extension and revision of an approved information collection to the Office of Management and Budget (OMB) for approval.
Advisory Committee on Historical Diplomatic Documentation; Notice of Meeting
The Advisory Committee on Historical Diplomatic Documentation will meet in the Department of State, 2201 ``C'' Street, NW., Washington, DC, December 3-4, 2007, in Conference Room 1498. Prior notification and a valid government-issued photo ID (such as driver's license, passport, U.S. government or military ID) are required for entrance into the building. Members of the public planning to attend must notify Steven Galpern, Office of the Historian (202-663-1130) no later than November 29, 2007 to provide date of birth, valid government-issued photo identification number and type (such as driver's license number/state, passport number/country, or U.S. government ID number/agency or military ID number/branch), and relevant telephone numbers. If you cannot provide one of the enumerated forms of ID, please consult with Steven Galpern for acceptable alternative forms of picture identification. The Committee will meet in open session from 1:30 p.m. through 3 p.m. on Monday, December 3, 2007, in the Department of State, 2201 ``C'' Street, NW., Washington, DC, in Conference Room 1498, to discuss declassification and transfer of Department of State records to the National Archives and Records Administration and the status of the Foreign Relations series. The remainder of the Committee's sessions from 3:15 p.m. until 4:30 p.m. on Monday, December 3, 2007, and 8 a.m. until 12 p.m. on Tuesday, December 4, 2007, will be closed in accordance with Section 10(d) of the Federal Advisory Committee Act (Pub. L. 92-463). The agenda calls for discussions of agency declassification decisions concerning the Foreign Relations series and other declassification issues. These are matters not subject to public disclosure under 5 U.S.C. 552b(c)(1) and the public interest requires that such activities be withheld from disclosure. Questions concerning the meeting should be directed to Marc J. Susser, Executive Secretary, Advisory Committee on Historical Diplomatic Documentation, Department of State, Office of the Historian, Washington, DC 20520, telephone (202) 663-1123, (e-mail history@state.gov).
Notice of Proposed Withdrawal and Opportunity for Public Meeting; Nevada
The Secretary of the Interior proposes to withdraw approximately 58.65 acres of public land from location and entry under the United States mining laws for a period of 20 years to protect Porter Spring, in Pershing County, Nevada. This notice segregates the land from location and entry under the United States mining laws for up to 2 years while various studies and analyses are made to support a final decision on the withdrawal application.
Fisheries of the Exclusive Economic Zone Off Alaska; Prohibited Species Bycatch Management
NMFS amends regulations governing salmon bycatch in the Bering Sea and Aleutian Islands management area (BSAI). This action is necessary to enhance the effectiveness of salmon bycatch measures by exempting pollock vessels from Chinook and Chum Salmon Savings Area closures if they participate in an intercooperative agreement (ICA) to reduce salmon bycatch, and exempting vessels participating in non- pollock trawl fisheries from Chum Salmon Savings Area closures because these fisheries intercept minimal amounts of salmon. This action is intended to promote the goals and objectives of the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP).
Notice of Request for Renewal of a Previously Approved Collection
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 has been forwarded to the Office of Management and Budget (OMB) for renewal and comment. The ICR describes the nature of the information collection and its expected cost and burden. The Federal Register Notice, with a 60-day comment period soliciting comments on the following collection of information, was published on August 8, 2007 {FR Vol 72, No. 152, page 44606{time} . No comments were received.
Notice of Request for Renewal of a Previously Approved Collection
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 has been forwarded to the Office of Management and Budget (OMB) for renewal and comment. The ICR describes the nature of the information collection and its expected cost and burden. The Federal Register Notice, with a 60-day comment period soliciting comments on the following collection of information, was published on August 8, 2007 {FR Vol 72, No. 152, page 44605{time} . No comments were received.
Ohio: Final Authorization of State Hazardous Waste Management Program Revision
EPA is granting Ohio Final authorization of the changes to its hazardous waste program under the Resource Conservation and Recovery Act (RCRA). The agency published a proposed rule on June 6, 2007 at 72 FR 31237 and provided for public comment. The public comment period ended on July 6, 2007. We received no comments. No further opportunity for comment will be provided. EPA has determined that these changes satisfy all requirements needed to qualify for Final authorization, and is proposing to authorize the State's changes through this proposed final action.
Board of Scientific Counselors, Human Health Risk Assessment Subcommittee Meeting-November 14-16, 2007
Pursuant to the Federal Advisory Committee Act, Public Law 92- 463, the Environmental Protection Agency, Office of Research and Development (ORD), gives notice of a meeting of the Board of Scientific Counselors (BOSC) Human Health Risk Assessment Subcommittee.
Agency Information Collection Activities: Notice of Request for Renewal of a Previously Approved Information Collection
The FHWA invites public comments about our intention to request the Office of Management and Budget's (OMB) approval for renewal of a previously approved information collection that is summarized below under SUPPLEMENTARY INFORMATION. We are required to publish this notice in the Federal Register by the Paperwork Reduction Act of 1995.
Special Conditions: Boeing Model 777 Series Airplanes; Seats With Non-Traditional, Large, Non-Metallic Panels
This action proposes special conditions for Boeing Model 777 series airplanes. These airplanes will have a novel or unusual design feature(s) associated with seats that include non-traditional, large, non-metallic panels that would affect survivability during a post-crash fire event. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Texas Disaster # TX-00267
This is a notice of an Administrative declaration of a disaster for the State of Texas dated 10/22/2007. Incident: Hurricane Humberto. Incident Period: 09/12/2007 through 09/13/2007.
Approval and Promulgation of Implementation Plans Kentucky: Approval of Revisions to the State Implementation Plan
EPA is proposing to approve a request submitted on May 25, 2007, by the Commonwealth of Kentucky (Kentucky), through the Kentucky Division for Air Quality (KDAQ), to remove the ``Potentially hazardous matter or toxic substances'' rule from the EPA-approved Kentucky State Implementation Plan (SIP). KDAQ requested that EPA remove this rule from the Kentucky SIP, because the rule is not related to the attainment and maintenance of the National Ambient Air Quality Standards (NAAQS). EPA is proposing to approve this request and correct the Kentucky SIP by removing this rule from the SIP pursuant to section 110(k)(6) of the Clean Air Act (CAA).
Drawbridge Operation Regulations; Kennebec River, Bath and Woolwich, ME
The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Carlton Bridge across the Kennebec River at mile 14.0, between Bath and Woolwich, Maine. Under this temporary deviation the Carlton Bridge may remain in the closed position to facilitate bridge painting operations from 6:30 a.m. to 6:30 p.m. on November 5, 6, 12, 13, 19, 20, 26, 27, and December 3, 4, 10, 11, 17, and 18, 2007. Vessels that can pass under the draw without a bridge opening may do so at all times. This deviation is necessary to facilitate bridge painting.
Special Conditions: Boeing Model 787 Series Airplanes; Seats With Non-Traditional, Large, Non-Metallic Panels
This action proposes special conditions for Boeing Model 787 series airplanes. These airplanes will have a novel or unusual design feature(s) associated with seats that include non-traditional, large, non-metallic panels that would affect survivability during a post-crash fire event. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Drawbridge Operation Regulation; Rigolets Pass, Mile 6.2, Between Orleans and St. Tammany Parishes, LA
The Commander, Eighth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the U.S. 90 Swing Bridge across Rigolets Pass, mile 6.2, between Orleans and St. Tammany Parishes, Louisiana. This deviation will allow the draw of the U.S. 90 Swing Bridge to remain in the closed to navigation position until January 15, 2007.
Special Conditions: Boeing Model 767 Series Airplanes; Seats With Non-Traditional, Large, Non-Metallic Panels
This action proposes special conditions for Boeing Model 767 series airplanes. These airplanes will have a novel or unusual design feature(s) associated with seats that include non-traditional, large, non-metallic panels that would affect survivability during a post-crash fire event. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Drawbridge Operation Regulations; Sacramento River, Rio Vista, CA
The Commander, Eleventh Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Rio Vista Drawbridge across the Sacramento River, mile 12.8, at Rio Vista, CA. The deviation is necessary to allow the bridge owner, the California Department of Transportation (Caltrans), to conduct required maintenance of the drawspan. This deviation allows for a 4-hour notice for openings during nighttime.
Drawbridge Operation Regulations; Gowanus Canal, Brooklyn, NY
The Coast Guard has temporarily changed the drawbridge operating regulations governing the operation of the Hamilton Avenue Bridge, mile 1.2, across the Gowanus Canal at Brooklyn, New York. This final rule allows the bridge owner to require a four-hour notice for bridge openings from November 5, 2007 to January 15, 2009. This rule is necessary to facilitate rehabilitation construction at the bridge.
Special Conditions: Boeing Model 747 Series Airplanes; Seats With Non-Traditional, Large, Non-Metallic Panels
This action proposes special conditions for Boeing Model 747 series airplanes. These airplanes will have a novel or unusual design feature(s) associated with seats that include non-traditional, large, non-metallic panels that would affect survivability during a post-crash fire event. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
National Institute for Occupational Safety and Health; Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Ames Laboratory, Ames, Iowa, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 12, 2007, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at Combustion Engineering, Windsor, CT, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Combustion Engineering, Windsor, Connecticut, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Combustion Engineering. Location: Windsor, Connecticut. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1965 through December 31, 1972.
National Institute for Occupational Safety and Health; Decision To Evaluate a Petition To Designate a Class of Employees at Area IV of the Santa Susana Field Laboratory, Santa Susana, CA, To Be Included in the Special Exposure Cohort
The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at Area IV of the Santa Susana Field Laboratory, Santa Susana, California, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Area IV of the Santa Susana Field Laboratory. Location: Santa Susana, California. Job Titles and/or Job Duties: All workers. Period of Employment: January 1, 1955 through December 31, 1965.
Drawbridge Operating Regulations; Gulf Intracoastal Waterway, Morgan City to Port Allen Alternate Route, Lower Grand River, Bayou Sorrel, LA
The Commander, Eighth Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the State Route 75 (SR 75) pontoon span bridge across the Lower Grand River at mile 38.4, Gulf Intracoastal Waterway, Morgan City to Port Allen Alternate Route at Bayou Sorrel, Iberville Parish, Louisiana. This deviation provides for the bridge to remain closed to navigation for 24 consecutive hours to conduct scheduled maintenance to the drawbridge.
Issuance of Permits
The following permits were issued.
Notice of Intent (for NEPA EIS); Environmental Impact Statement: Erie County, NY
The FHWA is issuing this notice to advise the public that an environmental impact statement will be prepared for proposed highway project: NYS Route 198 (Scajaquada Expressway) Corridor, PIN 5470.22, I-190 to NYS Route 33, City of Buffalo, Erie County, New York.
Notice of Final Federal Agency Actions on Proposed Highway in North Carolina
This notice announces actions taken by the FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139 (I)(1). The actions relate to a proposed highway project, Wilmington Bypass, from U.S. 17 to U.S. 421 in New Hanover and Brunswick Counties, Wilmington, North Carolina. Those actions grant licenses, permits, and approvals for the project.
Notice of Intent To Grant a Partially Exclusive Patent License; United States-Vietnam Foundation
The Department of the Navy hereby gives notice of its intent to grant to United States-Vietnam Foundation, a revocable, nonassignable, partially exclusive license to practice worldwide the Government owned inventions described in the invention disclosed and claimed in International Application Number PCT/US2005/019963, with the International Filing Date of June 6, 2005, which was published on December 14, 2006 with the International Publication Number WO 2006/ 132635 A1, for ``Hand-Held Fluorescence Polarimeter''; and the national stage patent applications to be filed in Vietnam, Thailand, Cambodia, Laos, Indonesia, the Philippines and Myanmar in the fields of screening and diagnosis of: (1) Infectious diseases; (2) viral-induced cancer, such as Human Paplloma Virus/AIDs; and (3) toxins.
Proposed Data Collection Available for Public Comment and Recommendations
In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which provides opportunity for public comment on new or revised data collections, the Railroad Retirement Board will publish periodic summaries of proposed data collections. Comments are invited on: (a) Whether the proposed information collection is necessary for the proper performance of the functions of the agency, including whether the information has practical utility; (b) the accuracy of the RRB's estimate of the burden of the collection of the information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden related to the collection of information on respondents, including the use of automated collection techniques or other forms of information technology. Title and Purpose of information collection: Representative Payee Parental Custody Monitoring: OMB 3220-0176. Under Section 12(a) of the Railroad Retirement Act (RRA), the Railroad Retirement Board (RRB) is authorized to select, make payments to, and to conduct transactions with, a beneficiary's relative or some other person willing to act on behalf of the beneficiary as a representative payee. The RRB is responsible for determining if direct payment to the beneficiary or payment to a representative payee would best serve the beneficiary's interest. Inherent in the RRB's authorization to select a representative payee is the responsibility to monitor the payee to assure that the beneficiary's interests are protected. The RRB utilizes Form G-99d, Parental Custody Report, to obtain information needed to verify that a parent-for-child representative payee still has custody of the child. One response is required from each respondent. The RRB proposes no changes to Form G-99d. The estimated annual respondent burden is as follows:
Notice of Intent To Grant a Partially Exclusive Patent License; Oasis Diagnostics Corp
The Department of the Navy hereby gives notice of its intent to grant to Oasis Diagnostics Corp., a revocable, nonassignable, partially exclusive license to practice worldwide the Government owned inventions described in U.S. Patent 6,927,068 entitled ``A Rapid and Non-Invasive Method to Evaluate Immunization Status of a Patient'' issued 9 August 2005 and related foreign filings (PCT/US 2003/002239, EP/1490665, and AU/2003301840) in the fields of detection of antibodies in present in oral fluids from the group saliva, oral rinse expectorant, oral mucosal transudate, gingival crevicular fluid, and phlegmuntil.
Notice of Intent To Grant a Partially Exclusive Patent License; Oasis Diagnostics Corp
The Department of the Navy hereby gives notice of its intent to grant to Oasis Diagnostics Corp., a revocable, nonassignable, partially exclusive license to practice worldwide the Government owned inventions described in U.S. Patent No. 6,841,159 issued on January 11, 2005, for ``Rapid Lateral Flow Assay for Determining Exposure to Mycobacterium Tuberculosis and other mycobacteria''; and related foreign filings (PCT/US 03/02311, EP/1478395, and AU/2003210662 filed) in the fields of detection of antibodies in present in oral fluids from the group saliva, oral rinse expectorant, oral mucosal transudate, gingival crevicular fluid, and phlegmuntil.
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