December 5, 2005 – Federal Register Recent Federal Regulation Documents

This Notice amends and updates the list of devices that conform to the Model Specifications for Screening Devices to Measure Alcohol in Bodily Fluids.

As a result of the determinations by the Department of Commerce (``Department'') and the International Trade Commission (``Commission'') that revocation of this antidumping duty order would be likely to lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to section 751(c) of the Tariff Act of 1930, as amended (``the Act''), the Department hereby orders the continuation of the antidumping duty order on sparklers from the People's Republic of China (``China''). The Department is publishing notice of the continuation of this antidumping duty order.

Section 4314(c)(4) of Title 5, U.S.C.; requires each agency to publish notification of the appointment of individuals who may serve as members of that Agency's Performance Review Board (PRB). The following individuals have been designated to serve on the FY 05 Performance Review Board for the U.S. Small Business Administration: 1. Raul Cisneros, Associate Administrator for Communications and Public Liaison; 2. Thomas A. Dumaresq, Chief Financial Officer; 3. Delorice P. Ford, Assistant Administrator for the Office of Hearings and Appeals; 4. Karen Hontz, Associate Administrator for Government Contracting; 5. Cheryl A. Mills, Associate Deputy Administrator for Entrepreneurial Development; 6. Janet A. Tasker, Deputy Associate Deputy Administrator for Capital Access; and 7. C. Edward Rowe, III, Associate Administrator for Congressional and Legislative Affairs.

This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina ( FEMA-1608-DR), dated October 7, 2005. Incident: Hurricane Ophelia. Incident Period: September 11, 2005 through September 17, 2005. Effective Date: October 7, 2005. Physical Loan Application Deadline Date: December 6, 2005.

This is a notice of an Administrative declaration of a disaster for the State of Tennessee dated November 29, 2005. Incident: Severe Storms and Tornadoes. Incident Period: November 15, 2005. Effective Date: November 29, 2005. Physical Loan Application Deadline Date: January 30, 2006. Economic Injury (EIDL) Loan Application Deadline Date: August 28, 2006.

This is a notice of the Presidential declaration of a major disaster for the State of North Dakota (FEMA-1616-DR), dated November 21, 2005, and related determinations.

This notice amends the notice of a major disaster for the State of Mississippi (FEMA-1604-DR), dated August 29, 2005, and related determinations.

This notice amends the notice of a major disaster declaration for the State of Louisiana (FEMA-1607-DR), dated September 24, 2005, and related determinations.

This notice amends the notice of a major disaster for the State of Louisiana (FEMA-1603-DR), dated August 29, 2005, and related determinations.

In accordance with the Paperwork Reduction Act of 1995, this notice announces the Small Business Administration's intentions to request approval on a new and/or currently approved information collection.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled, ``Fluoro-Deoxy Glucose (FDG) Positron Emission Tomography (PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, Testicular and Other Cancers (PET 6), HHS/CMS/OCSQ, System No. 09-70-0549.'' National Coverage Determinations (NCD) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under Title XVIII of the Social Security Act (the Act) Sec. 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained in Part A or Part B, and must not be otherwise excluded from coverage. In our review of the other cancer indications, we found sufficient evidence to determine that PET scans are no longer experimental. However, the evidence was insufficient to reach a conclusion that FDG PET is reasonable and necessary in all instances. A sufficient inference of benefit, however, can be drawn to support limited coverage if certain safeguards for patients are provided. This inference is based on both the physiological basis for FDG PET usefulness in cancer, as well as, evidence of a positive benefit of FDG PET for patients with several other cancers for which there is evidence of sufficient quality to warrant coverage. The purpose of this system is to collect and maintain information on Medicare beneficiaries receiving FDG PET scans for indications for when there is not sufficient evidence to reach a firm conclusion that the scan is reasonable and necessary unless they are enrolled in an approved study. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) to an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a Congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system of records title, ``Implantable Cardioverter-Defibrillator (ICD) System, System No. 09- 70-0548.'' National coverage determinations (NCDs) are determinations by the Secretary with respect to whether or not a particular item or service is covered nationally under title XVIII of the Social Security Act (the Act) Sec. 1869(f)(1)(B). In order to be covered by Medicare, an item or service must fall within one or more benefit categories contained within Part A or Part B, and must not be otherwise excluded from coverage. Moreover, with limited exceptions, the expenses incurred for items or services must be ``reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member,'' Sec. 1862(a)(1)(A). CMS has determined that the evidence is adequate to conclude that an implantable cardioverter-defibrillator (ICD) is reasonable and necessary in several patient groups where certain criteria for these patients have been met. The reasonable and necessary determination requires that patients meet the ICD implantation criteria set forth in the decision memorandum and are consistent with the trials discussed. Collection of these data elements allows that determination to be made. The purpose of this system is to provide reimbursement for ICDs and assist in the collection of data on patients receiving an ICD for primary prevention to a data collection process to assure patient safety and protection and to determine that the ICD is reasonable and necessary. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor or consultant; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) to an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support constituent requests made to a congressional representative; (5) support litigation involving the agency; and (6) combat fraud and abuse in certain health benefits programs. We have provided background information about the modified system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

The Leader, Information Management Case Services Team, Regulatory Information Management Services, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

As required by the Paperwork Reduction Act (44 U.S.C. Chapter 35), the Consumer Product Safety Commission requests comments on a proposed extension of approval for a period of three years from the date of approval of a collection of information associated with the procurement of goods and services. Forms used by the Commission for procurement of goods and services request persons who quote, propose, or bid on contracts to provide information needed to evaluate quotes, proposals, and bids in accordance with applicable laws and regulations. The Commission will consider all comments received in response to this notice before requesting extension of approval of this collection of information from the Office of Management and Budget (OMB).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission requests comments on a proposed extension of approval, for a period of three years from the date of approval by the Office of Management and Budget (OMB), of information collection requirements for manufacturers and importers of carpets and rugs. The collection of information is in regulations implementing the Standard for the Surface Flammability of Carpets and Rugs (16 CFR part 1630) and the Standard for the Surface Flammability of Small Carpets and Rugs (16 CFR part 1631). These regulations establish requirements for testing and recordkeeping for manufacturers and importers who furnish guaranties for products subject to the carpet flammability standards. The Commission will consider all comments received in response to this notice before requesting an extension of approval of this collection of information from the OMB.