December 19, 2005 – Federal Register Recent Federal Regulation Documents

Reader Aids
Document Number: FR-2005-12-19-ReaderAids
Type: Reader Aids
Date: 2005-12-19
Mr. Lawrence T. Christian, et al.; Denial of Petition for Rulemaking
Document Number: E5-7518
Type: Proposed Rule
Date: 2005-12-19
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The Nuclear Regulatory Commission (NRC) is denying a petition for rulemaking submitted by Mr. Lawrence T. Christian and 3,000 co- signers on September 4, 2002. The petition was docketed by the NRC on September 23, 2002, and has been assigned Docket No. PRM-50-79. The petition requests that the NRC amend its regulations regarding offsite state and local government emergency plans for nuclear power plants to ensure that all daycare centers and nursery schools in the vicinity of nuclear power facilities are properly protected in the event of a radiological emergency.
Implementation of Sector Houston-Galveston
Document Number: E5-7509
Type: Notice
Date: 2005-12-19
Agency: Coast Guard, Department of Homeland Security
The Coast Guard announces the stand-up of Sector Houston- Galveston. Sector Houston-Galveston is an internal reorganization to combine Group Galveston, Base Galveston, Vessel Traffic Service Houston-Galveston, Marine Safety Office Houston-Galveston including Marine Safety Unit Galveston and Marine Safety Office Port Arthur including Marine Safety Unit Lake Charles into one command. The Coast Guard has established a continuity of operations order whereby all previous practices and procedures will remain in effect until superseded by an authorized Coast Guard official and/or document.
Natural Working Group on Small Passenger Vessel Access
Document Number: E5-7508
Type: Notice
Date: 2005-12-19
Agency: Coast Guard, Department of Homeland Security
On November 14, 2005, the United States Coast Guard (USCG) and the Passenger Vessel Association (PVA) signed a charter establishing a Natural Working Group (NWG). The purpose of this NWG is to determine the acceptability and usefulness of a proposed risk matrix that was developed, by the Volpe Center, to assist small passenger vessel designers in meeting the requirements of the Americans with Disabilities Act (ADA) without compromising vessel safety. The USCG is seeking comments on this initiative and the draft risk matrix to assist the NWG in meeting its objective.
The Individuals With Disabilities Education Act Paperwork Waiver Demonstration Program
Document Number: E5-7507
Type: Notice
Date: 2005-12-19
Agency: Department of Education
The Assistant Secretary for Special Education and Rehabilitative Services proposes requirements and selection criteria for a competition in which the Department will select up to 15 States to participate in a pilot program, the Paperwork Waiver Demonstration Program (Paperwork Waiver Program). State proposals approved under this program would create opportunities for participating States to reduce paperwork burdens and other administrative duties in order to increase time for instruction and other activities to improve educational and functional results for children with disabilities. The proposed requirements and selection criteria focus on an identified national need to reduce the paperwork burden associated with the requirements of Part B of the Individuals with Disabilities Education Act, as amended, while preserving students' civil rights and promoting academic achievement. The requirements and selection criteria proposed in this notice will be used for a single, one-time-only competition under this program.
The Individuals With Disabilities Education Act Multi-Year Individualized Education Program Demonstration Program
Document Number: E5-7506
Type: Notice
Date: 2005-12-19
Agency: Department of Education
The Assistant Secretary for Special Education and Rehabilitative Services proposes requirements and selection criteria for a competition in which the Department will select up to 15 States to participate in a pilot program, the Multi-Year Individualized Education Program (IEP) Demonstration Program (Multi-Year IEP Program). State proposals approved under this program would create opportunities for participating local educational agencies (LEAs) to improve long- term planning for children with disabilities through the development and use of comprehensive multi-year IEPs. Additionally, the proposed requirements and selection criteria focus on an identified national need to reduce the paperwork burden associated with IEPs while preserving students' civil rights and promoting academic achievement. The requirements and selection criteria proposed in this notice will be used for a single, one-time-only competition under this program.
Notification of a Partially Closed Consultation of the Science Advisory Board's Homeland Security Advisory Committee (HSAC)
Document Number: E5-7505
Type: Notice
Date: 2005-12-19
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) announces a partially closed consultation of the HSAC.
Petitions for Modification
Document Number: E5-7504
Type: Notice
Date: 2005-12-19
Agency: Department of Labor, Mine Safety and Health Administration
Mortgagee Review Board; Administrative Actions
Document Number: E5-7503
Type: Notice
Date: 2005-12-19
Agency: Department of Housing and Urban Development
In compliance with section 202(c) of the National Housing Act, this notice advises of the cause and description of administrative actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees.
Notice of Proposed Information Collection: Comment Request; Deed-in-Lieu of Foreclosure (Corporate Mortgagors or Mortgagors Owning More than One Property)
Document Number: E5-7502
Type: Notice
Date: 2005-12-19
Agency: Department of Housing and Urban Development
The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Used Oil Management Standards Recordkeeping and Reporting Requirements (Renewal), EPA ICR Number 1286.07, OMB Control Number 2050-0124
Document Number: E5-7498
Type: Notice
Date: 2005-12-19
Agency: Environmental Protection Agency
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. This ICR is scheduled to expire on December 31, 2005. Under OMB regulations, the Agency may continue to conduct or sponsor the collection of information while this submission is pending at OMB. This ICR describes the nature of the information collection and its estimated burden and cost.
Office of Environmental Management; Record of Decision for the Idaho High-Level Waste and Facilities Disposition Final Environmental Impact Statement
Document Number: E5-7497
Type: Notice
Date: 2005-12-19
Agency: Department of Energy
DOE is making decisions pursuant to the Idaho High-Level Waste and Facilities Disposition Final Environmental Impact Statement (Final EIS) (DOE/EIS-287), issued in October 2002. The Final EIS presents the analysis of a proposed action containing two sets of alternatives: (1) Waste processing alternatives for treating, storing and disposing of liquid mixed (radioactive and hazardous) transuranic (TRU) waste/sodium-bearing waste (SBW) \1\ and newly-generated liquid radioactive waste (NGLW) stored in below-grade tanks and solid high- level radioactive waste (HLW) calcine stored in bin sets at the Idaho Nuclear Technology and Engineering Center (INTEC) on the Idaho National Laboratory (INL) Site, previously named the Idaho National Engineering and Environmental Laboratory (INEEL); and
Proposed Information Collection Request Submitted for Public Comment and Recommendations; ATAA Activities Report
Document Number: E5-7496
Type: Notice
Date: 2005-12-19
Agency: Employment and Training Administration, Department of Labor
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.
Notice of Public Meeting; Central Montana Resource Advisory Council
Document Number: E5-7495
Type: Notice
Date: 2005-12-19
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
In accordance with the Federal Land Policy and Management Act and the Federal Advisory Committee Act of 1972, the U.S. Department of the Interior, Bureau of Land Management (BLM) Central Montana Resource Advisory Council (RAC) will meet as indicated below.
Qualification of Drivers; Exemption Applications; Diabetes
Document Number: E5-7494
Type: Notice
Date: 2005-12-19
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces receipt of applications from six individuals for exemptions from the prohibition against persons with insulin- treated diabetes mellitus (ITDM) operating commercial motor vehicles (CMVs) in interstate commerce. If granted, the exemptions would enable these individuals with ITDM to operate as drivers of commercial motor vehicles in interstate commerce.
Notice of Availability for the Renewal of an Expired Section 10(a)(1)(B) Permit for Incidental Take of the Golden-Cheeked Warbler in Travis County, TX (Lake)
Document Number: E5-7492
Type: Notice
Date: 2005-12-19
Agency: Fish and Wildlife Service, Department of the Interior
On February 26, 1999, the U.S. Fish and Wildlife Service (Service) issued a section 10(a)(1)(B) permit, pursuant to Section 10(a) of the Endangered Species Act (Act), for incidental take of the golden-cheeked warbler (GCW) (Dendroica chrysoparia) to Mark and Brenda Hogan. This permit was subsequently transferred to Ralph Lake, Jr. on January 12, 2001. The permit (TE-005497) was for a period of five years and expired on February 26, 2004. The requested permit renewal by Ralph Lake will extend the permit expiration by five years from the date the permit is reissued.
Draft Environmental Assessment/Habitat Conservation Plan and Receipt of Applications for Incidental Take Permits for the Douglas County Board of Commissioners, the Town of Castle Rock and the Town of Parker for the Douglas County Habitat Conservation Plan, in Douglas County, CO
Document Number: E5-7491
Type: Notice
Date: 2005-12-19
Agency: Fish and Wildlife Service, Department of the Interior
The Board of Commissioners of the County of Douglas, the Town of Castle Rock and the Town of Parker (Applicants) have each separately applied for an incidental take permit pursuant to section 10(a)(1)(B) of the Endangered Species Act (ESA) of 1973, as amended. The requested permits would authorize the incidental take of the federally threatened Preble's meadow jumping mouse, (Zapus hudsonius preblei) (Prebles), through the potential loss and modification of its habitat associated with the otherwise legal construction, use, maintenance, and repair of new and existing public facilities and with habitat improvements, along the mainstem and tributaries to the South Platte River, Plum Creek, and Cherry Creek, in Douglas County, Colorado. The duration of the permit would be 10 years from the date of issuance. We also announce the availability of a document combining the Service's Environmental Assessment (EA) and the Douglas County Habitat Conservation Plan (DCHCP) for public review and comment. The Service requests comments from the public on the permit applications and the EA. The permit applications include the proposed DCHCP and associated draft Implementing Agreement. The DCHCP describes the proposed action and the measures that the Applicants will undertake to minimize and mitigate to the maximum extent practicable the take of Prebles. All comments on the EA and permit applications will become part of the administrative record and will be available to the public. We provide this notice pursuant to section 10(a) of the ESA and National Environmental Policy Act regulations (40 CFR 1506.6).
Notice of Public Meeting, Dakotas Resource Advisory Council Meeting
Document Number: E5-7490
Type: Notice
Date: 2005-12-19
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM), Dakotas Resource Advisory Council will meet as indicated below.
Notice of Availability of an Environmental Assessment/Habitat Conservation Plan and Receipt of Application for Construction and Operation of a Residential and Commercial Development on the 307.85-acre Shadow Canyon Property, Williamson County, TX
Document Number: E5-7489
Type: Notice
Date: 2005-12-19
Agency: Fish and Wildlife Service, Department of the Interior
San Gabriel Harvard Limited Partnership (Applicant) has applied to the U.S. Fish and Wildlife Service (Service) for an incidental take permit pursuant to section 10(a) of the Endangered Species Act (Act). The requested permit, which is for a period of 30 years, would authorize incidental take of the endangered golden-cheeked warbler (Dendroica chrysoparia), Bone Cave harvestman (Texella reyesi), and Coffin Cave mold beetle (Batrisodes texanus). The proposed take would occur as a result of the construction and operation of a residential development on 307.85 acres (124.6 hectares) of the Shadow Canyon property, Williamson County, Texas.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: E5-7488
Type: Notice
Date: 2005-12-19
Agency: Department of Health and Human Services, Health Resources and Services Administration
Manufacturer of Controlled Substances; Notice of Application
Document Number: E5-7487
Type: Notice
Date: 2005-12-19
Agency: Drug Enforcement Administration, Department of Justice
Privacy Act of 1974; Report of a Modified or Altered System of Records
Document Number: E5-7486
Type: Notice
Date: 2005-12-19
Agency: Department of Health and Human Services, Centers for Medicare & Medicaid Services
In accordance with the requirements of the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, titled ``Non-Medicare Beneficiary Workers' Compensation (WC) Set-aside File (WCSAF),'' System No. 09-70-0537, last published at 67 FR 36892 (May 28, 2002). We propose to expand the scope of this system to include non-Medicare beneficiaries whose applications for a WC Arrangement have not been approved (denied) as submitted. The disclosure provisions contained in published routine use number 2 and 3 are deemed to be duplicative of each other and as such require corrective action. This modified routine use will now be number 2 and will authorize disclosure to ``another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent.'' We are modifying the language in the remaining routine uses to provide clarity to CMS's intention to disclose individual-specific information contained in this system. The routine uses will then be prioritized and reordered according to their usage. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of the non-Medicare beneficiary WCSAF is to maintain a file of individuals who were injured while employed; are not currently Medicare beneficiaries; whose WC Settlement included a WC Medicare Set-aside Arrangement that is intended to pay for future medical expenses in place of future Medicare benefits; and was approved or not approved (denied) by CMS as submitted. The information retrieved from this system will be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) another Federal and/or state agency, agency of a state government, an agency established by state law, or its fiscal agent to contribute to the accuracy of CMS' proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) an individual or organization for research, evaluation or epidemiological projects related to the prevention of disease or disability, the restoration or maintenance of health, or for understanding and improving payment projects; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in health benefits programs funded in whole or in part by Federal funds. We have provided background information about the modified system in the Supplementary Information section, below. Although the Privacy Act requires only that the ``routine use'' portion of the system be published for comment, CMS invites comments on all portions of this notice. See Effective Date section for comment period.
Public Land Order No. 7650; Revocation of Public Land Order No. 852; Utah
Document Number: E5-7485
Type: Notice
Date: 2005-12-19
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
This order revokes a Public Land Order in its entirety, which withdrew approximately 8,927 acres for automobile racing and testing grounds. The lands are located within another overlapping withdrawal, so Public Land Order No. 852 is no longer needed.
Notice of Proposed Withdrawal and Transfer of Jurisdiction, Colorado; Correction
Document Number: E5-7484
Type: Notice
Date: 2005-12-19
Agency: Department of the Interior, Bureau of Land Management, Land Management Bureau
This action corrects errors in the notice published as FR doc 05-21568 in the Federal Register, 70 FR 62138 (October 28, 2005). On page 62138, second column, delete last paragraph of the notice and replace with the following paragraph: ``Notice is hereby given that an opportunity for a public meeting is afforded in connection with the proposed withdrawal and transfer of jurisdiction. All interested persons who desire a public meeting for the purpose of being heard on the proposed withdrawal and transfer of jurisdiction must submit a written request to the BLM Colorado State Director, within 90 days from the date of publication of this correction. If the authorized officer determines that a public meeting will be held, a notice of the time and place will be published in the Federal Register at least 30 days before the scheduled date of the meeting.''
Submission for OMB Review; Comment Request
Document Number: E5-7483
Type: Notice
Date: 2005-12-19
Agency: Department of Agriculture
Agency Information Collection Activities: Submission to OMB for Revision to a Currently Approved Collection; Comment Request
Document Number: E5-7480
Type: Notice
Date: 2005-12-19
Agency: National Credit Union Administration, Agencies and Commissions
The NCUA is submitting the following information collection to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). This information collection is published to obtain comments from the public.
2005-2006 Allocations of the Tariff-Rate Quotas for Raw Cane Sugar
Document Number: E5-7479
Type: Notice
Date: 2005-12-19
Agency: Office of the Trade Representative, Trade Representative, Office of United States, Executive Office of the President
The Office of the United States Trade Representative (USTR) is providing notice of additional country-by-country allocations of the in-quota quantity of the tariff-rate quota for imported raw cane sugar beginning on October 1, 2005 and ending on September 30, 2006.
Submission for OMB Review: Comment Request
Document Number: E5-7478
Type: Notice
Date: 2005-12-19
Agency: Office of the Secretary, Department of Labor
Submission for OMB Review: Comment Request
Document Number: E5-7477
Type: Notice
Date: 2005-12-19
Agency: Office of the Secretary, Department of Labor
Manufacturers' Shipments, Inventories, and Orders (M3) Survey
Document Number: E5-7476
Type: Notice
Date: 2005-12-19
Agency: Census Bureau, Department of Commerce
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Submission for OMB Review; Comment Request
Document Number: E5-7475
Type: Notice
Date: 2005-12-19
Agency: Department of Commerce
Proposed Information Collection; Comment Request; Economic Surveys for U.S. Commercial Fisheries
Document Number: E5-7474
Type: Notice
Date: 2005-12-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Service Regulations Committee Meeting
Document Number: E5-7473
Type: Notice
Date: 2005-12-19
Agency: Fish and Wildlife Service, Department of the Interior
The Fish and Wildlife Service (hereinafter Service) will conduct an open meeting on February 1, 2006, to identify and discuss preliminary issues concerning the 2006-07 migratory bird hunting regulations.
Receipt of Applications for Permit
Document Number: E5-7472
Type: Notice
Date: 2005-12-19
Agency: Fish and Wildlife Service, Department of the Interior
The public is invited to comment on the following applications to conduct certain activities with endangered species and/or marine mammals.
Receipt of Applications for Permit
Document Number: E5-7471
Type: Notice
Date: 2005-12-19
Agency: Fish and Wildlife Service, Department of the Interior
The public is invited to comment on the following applications to conduct certain activities with endangered species and marine mammals.
Findings of Scientific Misconduct
Document Number: E5-7470
Type: Notice
Date: 2005-12-19
Agency: Office of the Secretary, Department of Health and Human Services
Notice is hereby given that on November 23, 2005, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the scientific misconduct findings of the U.S. Public Health Service (PHS) in the following case: Jessica Lee Grol, University of Pittsburgh: Based on the report of an investigation conducted by the University of Pittsburgh (UP) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, HHS found on October 17, 2005, that Ms. Grol, former Research Project Coordinator, Department of Neurological Surgery, UP, engaged in scientific misconduct by fabricating study research records for 15 subjects, including the patient interview data, the forms tracking data, and the medical record extraction data in a study on the management of cerebral aneurysms. The research was supported by National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), career development award K23 NS02159. In a final decision dated November 23, 2005, the HHS Debarring Official, on behalf of the Secretary of HHS, issued the final debarment notice based on the PHS findings of scientific misconduct finding. The following actions have been implemented for a period of three (3) years, beginning on November 23, 2005: (1) Ms. Grol has been debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility for or involvement in nonprocurement programs of the United States Government as defined in the debarment regulations at 45 CFR part 76; and (2) Ms. Grol is prohibited from serving in any advisory capacity to PHS, including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant.
Proposed Information Collection; Comment Request; Highly Migratory Species Tournament Reporting
Document Number: E5-7469
Type: Notice
Date: 2005-12-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection; Comment Request; Pacific Billfish Angler Survey
Document Number: E5-7468
Type: Notice
Date: 2005-12-19
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Proposed Information Collection; Comment Request; Online Performance Database, the Online Phoenix Database, and the Online Opportunity Database
Document Number: E5-7467
Type: Notice
Date: 2005-12-19
Agency: Department of Commerce, Minority Business Development Agency
The Department of Commerce, 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 proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request
Document Number: E5-7466
Type: Notice
Date: 2005-12-19
Agency: Department of Commerce
Availability of Funds and Collection of Checks
Document Number: E5-7462
Type: Rule
Date: 2005-12-19
Agency: Federal Reserve System, Agencies and Commissions
The Board of Governors is amending appendix A of Regulation CC to delete the reference to the New Orleans branch office of the Federal Reserve Bank of Atlanta and reassign the Federal Reserve routing symbols currently listed under that office to the head office of the Federal Reserve Bank of Atlanta, and to correct typographical errors in the routing symbols listed under the Helena branch office of the Federal Reserve Bank of Minneapolis. The Board also is providing notice that the previously announced transfer of the Nashville branch office's check-processing operations to the Atlanta head office will be delayed until 2007. Finally, the Board is providing advance notice concerning future appendix A changes affecting the Federal Reserve Bank of New York and the Federal Reserve Bank of Philadelphia.
Agreements in Force as of December 31, 2004 Between the American Institute in Taiwan and the Taipei Economic and Cultural Representative Office in the United States
Document Number: E5-7435
Type: Notice
Date: 2005-12-19
Agency: National Archives and Records Administration, Agencies and Commissions, Office of the Federal Register, Federal Register Office
The American Institute in Taiwan has concluded a number of agreements with the Taipei Economic and Cultural Representative Office in the United States (formerly the Coordination Council for North American Affairs) in order to maintain cultural, commercial and other unofficial relations between the American people and the people of Taiwan. The Director of the Federal Register is publishing the list of these agreements on behalf of the American Institute in Taiwan in the public interest.
Improving Agency Disclosure of Information
Document Number: 05-24255
Type: Executive Order
Date: 2005-12-19
Agency: Executive Office of the President, Presidential Documents
Sunshine Act Meeting; Farm Credit Administration Board; Regular Meeting
Document Number: 05-24236
Type: Notice
Date: 2005-12-19
Agency: Farm Credit Administration, Agencies and Commissions
Notice is hereby given, pursuant to the Government in the Sunshine Act (5 U.S.C. 552b(e)(3)), that the January 12, 2006 regular meeting of the Farm Credit Administration Board (Board) has been rescheduled. The regular meeting of the Board will be held Friday, January 6, 2006 starting at 9 a.m. An agenda for this meeting will be published at a later date.
Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review
Document Number: 05-24224
Type: Rule
Date: 2005-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) proposed to amend the biologics regulations and proposed to classify the bacterial vaccines and toxoids on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the U.S. District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004 (69 FR 78281). The purpose of this final rule and final order is to amend the biologics regulations, issue a final order in response to the report and recommendations of the Panel; and, respond to comments on the previously published proposed rule and proposed order submitted to the Division of Dockets Management. This final rule and final order does not address Anthrax Vaccine Adsorbed (AVA). The final order concerning AVA is published elsewhere in this issue of the Federal Register. FDA is classifying these products as Category I (safe, effective, and not misbranded), Category II (unsafe, ineffective, or misbranded), or Category IIIB (off the market pending completion of studies permitting a determination of effectiveness).
Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Anthrax Vaccine Adsorbed; Final Order
Document Number: 05-24223
Type: Notice
Date: 2005-12-19
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) proposed, among other things, to classify Anthrax Vaccine Adsorbed (AVA) on the basis of findings and recommendations of the Panel on Review of Bacterial Vaccines and Toxoids (the Panel) on December 13, 1985. The Panel reviewed the safety, efficacy, and labeling of bacterial vaccines and toxoids with standards of potency, bacterial antitoxins, and immune globulins. After the initial final rule and final order was vacated by the United States District Court for the District of Columbia on October 27, 2004, FDA published a new proposed rule and proposed order on December 29, 2004. The purpose of this final order is to categorize AVA according to the evidence of its safety and effectiveness, thereby determining if it may remain licensed and on the market; issue a final response to recommendations made in the Panel's report, and; respond to comments on the previously published proposed order. The final rule and final order concerning bacterial vaccines and toxoids other than AVA is published elsewhere in this issue of the Federal Register.
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