September 2005 – Federal Register Recent Federal Regulation Documents

Results 151 - 200 of 2,766
Federal Acquisition Regulation; Small Entity Compliance Guide
Document Number: 05-19479
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
This document is issued under the joint authority of the Secretary of Defense, the Administrator of General Services and the Administrator for the National Aeronautics and Space Administration. This Small Entity Compliance Guide has been prepared in accordance with Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. It consists of a summary of rules appearing in Federal Acquisition Circular (FAC) 2005-06 which amend the FAR. An asterisk (*) next to a rule indicates that a regulatory flexibility analysis has been prepared. Interested parties may obtain further information regarding these rules by referring to FAC 2005-06 which precedes this document. These documents are also available via the Internet at http:/ /www.acqnet.gov/far.
Federal Acquisition Regulation; Training and Education Cost Principle
Document Number: 05-19478
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed on a final rule amending the Federal Acquisition Regulation (FAR) by revising the ``training and education costs'' contract cost principle. The amendment streamlines the cost principle and increases clarity by eliminating restrictive and confusing language, and by restructuring the rule to list only specifically unallowable costs. The final rule eliminates several specific limitations on the allowability of costs associated with the various categories of education, eliminates the disparate treatment of full-time and part-time undergraduate education costs, and limits allowable costs to training and education related to the field in which the employee is working or may reasonably be expected to work. The rule makes job-related training and education costs generally allowable, except for six public policy exceptions that are retained from the current cost principle. Except for the six expressly unallowable cost exceptions, the reasonableness of specific contractor training and education costs is assessed by reference to the FAR section entitled ``Determining reasonableness.''
Federal Acquisition Regulation; Reimbursement of Relocation Costs on a Lump-Sum Basis
Document Number: 05-19477
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed on a final rule amending the Federal Acquisition Regulation (FAR) by revising the relocation cost principle to permit contractors the option of being reimbursed on a lump-sum basis for three types of employee relocation costs: costs of finding a new home; costs of travel to the new location; and costs of temporary lodging. These three types of costs are in addition to the miscellaneous relocation costs for which lump- sum reimbursements are already permitted.
Federal Acquisition Regulation; Accounting for Unallowable Costs
Document Number: 05-19476
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed on a final rule amending the Federal Acquisition Regulation (FAR) by revising language regarding accounting for unallowable costs. The final rule adds language which provides specific criteria on the use of statistical sampling as a method to identify unallowable costs, including the applicability of penalties for failure to exclude certain projected unallowable costs. The final rule also revises the language regarding advance agreements by adding statistical sampling methods as an example for which advance agreements between the contracting officers and contractors may be appropriate.
Federal Acquisition Regulation; Expiration of the Price Evaluation Adjustment
Document Number: 05-19475
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed on an interim rule amending the Federal Acquisition Regulation (FAR) to cancel for civilian agencies (except National Aeronautics and Space Administration (NASA) and Coast Guard) the Small Disadvantaged Business (SDB) price evaluation adjustment which was originally authorized under the Federal Acquisition Streamlining Act of 1994 (Public Law 103-355, Sec. 7102). Civilian agencies (except NASA and Coast Guard) are not authorized to apply the price evaluation adjustment to their acquisitions.
Federal Acquisition Regulation; Powers of Attorney for Bid Bonds
Document Number: 05-19474
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed on a final rule amending the Federal Acquisition Regulation (FAR) to establish that a copy of an original power of attorney, including a photocopy or facsimile copy, when submitted in support of a bid bond, is sufficient evidence of the authority to bind the surety. The authenticity and enforceability of the power of attorney at the time of the bid opening will be treated as a matter of responsibility.
Federal Acquisition Regulation; Addition of Landscaping and Pest Control Services to the Small Business Competitiveness Demonstration Program
Document Number: 05-19473
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed to finalize, without change, the interim rule published in the Federal Register at 70 FR 11740, March 9, 2005. This rule implements Section 821 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005. Section 821 added landscaping and pest control services to the Small Business Competitiveness Demonstration Program.
Federal Acquisition Regulation; Increased Justification and Approval Threshold for DOD, NASA, and Coast Guard
Document Number: 05-19472
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed to convert the interim rule published in the Federal Register at 70 FR 11739, March 9, 2005, to a final rule with minor changes. The rule amended the Federal Acquisition Regulation (FAR) to increase the justification and approval thresholds for DoD, NASA, and the U.S. Coast Guard. The FAR revision implemented Section 815 of the Ronald W. Reagan National Defense Authorization Act for Fiscal Year 2005 which amended 10 U.S.C. 2304(f)(1)(B) by striking $50,000,000 both places it appears and inserting $75,000,000. In addition, corresponding language in the FAR is also changed to reflect these higher thresholds for DoD, NASA, and the Coast Guard.
Federal Acquisition Regulation; Implementation of the Anti-Lobbying Statute
Document Number: 05-19471
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Department of Defense (DoD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA) have agreed to convert the interim rule published in the Federal Register at 55 FR 3190, January 30, 1990, to a final rule with several minor changes. The interim rule amended the Federal Acquisition Regulation (FAR) to implement section 319 of the Department of the Interior and Related Agencies Appropriations Act, Public Law 101-121, which added a new section 1352 to title 31 U.S.C. entitled ``Limitation on use of appropriated funds to influence certain Federal contracting and financial transactions.'' Section 319 generally prohibits recipients of Federal contracts, grants, and loans from using appropriated funds for lobbying the executive or legislative branches of the Federal Government in connection with a specific contract, grant, or loan. Section 319 also requires that each person who requests or receives a Federal contract, grant, or cooperative agreement in excess of $100,000, or a loan, or Federal commitment to insure or guarantee a loan, in excess of $150,000 must disclose lobbying with other than appropriated funds.
Federal Acquisition Regulation; Title 40 of United States Code Reference Corrections
Document Number: 05-19470
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed on a final rule amending the Federal Acquisition Regulation (FAR) to reflect the most recent codification of Title 40 of the United States Code.
Federal Acquisition Regulation; Improvements in Contracting for Architect-Engineer Services
Document Number: 05-19469
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have adopted as final, without change, an interim rule amending the Federal Acquisition Regulation (FAR) to implement Section 1427(b) of the Services Acquisition Reform Act of 2003 (Title XIV of Public Law 108-136). This final rule emphasizes the requirement to place orders for architect- engineer services consistent with the FAR and reiterates that such orders shall not be placed under General Services Administration (GSA) multiple award schedule (MAS) contracts and Governmentwide task and delivery order contracts unless the contracts were awarded using the procedures as stated in the FAR.
Federal Acquisition Regulation; Information Technology Security
Document Number: 05-19468
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
The Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council (Councils) have agreed on an interim rule amending the Federal Acquisition Regulation (FAR) to implement the Information Technology (IT) Security provisions of the Federal Information Security Management Act of 2002 (FISMA) (Title III of the E-Government Act of 2002 (E-Gov Act)).
Federal Acquisition Circular 2005-06; Introduction
Document Number: 05-19467
Type: Rule
Date: 2005-09-30
Agency: General Services Administration, Agencies and Commissions, National Aeronautics and Space Administration, Department of Defense
This document summarizes the Federal Acquisition Regulation (FAR) rules agreed to by the Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council in this Federal Acquisition Circular (FAC) 2005-06. A companion document, the Small Entity Compliance Guide (SECG), follows this FAC. The FAC, including the SECG, is available via the Internet at https://www.acqnet.gov/far.
Defense Federal Acquisition Regulation Supplement; Central Contractor Registration
Document Number: 05-19464
Type: Rule
Date: 2005-09-30
Agency: Department of Defense
DoD has adopted as final, with changes, an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to remove policy on Central Contractor Registration (CCR) that duplicated policy found in the Federal Acquisition Regulation (FAR). The rule also addresses requirements for use of Commercial and Government Entity (CAGE) codes in DoD contracts.
Defense Federal Acquisition Regulation Supplement; Prohibition of Foreign Taxation on U.S. Assistance Programs
Document Number: 05-19463
Type: Rule
Date: 2005-09-30
Agency: Department of Defense
DoD has issued an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a statutory prohibition on foreign taxation under contracts funded by U.S. assistance programs. The rule addresses the responsibilities of the contractor and the contracting officer regarding the prohibition.
Defense Federal Acquisition Regulation Supplement; Quality Control of Aviation Critical Safety Items and Related Services
Document Number: 05-19462
Type: Rule
Date: 2005-09-30
Agency: Department of Defense
DoD has adopted as final, with changes, an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement Section 802 of the National Defense Authorization Act for Fiscal Year 2004. Section 802 requires DoD to establish a quality control policy for the procurement of aviation critical safety items and the modification, repair, and overhaul of those items.
Defense Federal Acquisition Regulation Supplement; Advisory and Assistance Services
Document Number: 05-19458
Type: Rule
Date: 2005-09-30
Agency: Department of Defense
DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to update text pertaining to the acquisition of advisory and assistance services. This rule is a result of a transformation initiative undertaken by DoD to dramatically change the purpose and content of the DFARS.
Defense Federal Acquisition Regulation Supplement; Defense Logistics Agency Waiver Authority
Document Number: 05-19457
Type: Rule
Date: 2005-09-30
Agency: Department of Defense
DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to authorize the Defense Logistics Agency Component Acquisition Executive to waive domestic source restrictions on the acquisition of ball and roller bearings, when adequate domestic supplies are not available to meet DoD requirements on a timely basis.
Defense Federal Acquisition Regulation Supplement; Extension of Partnership Agreement-8(a) Program
Document Number: 05-19456
Type: Rule
Date: 2005-09-30
Agency: Department of Defense
DoD has issued a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to reflect an extension in the expiration date of a partnership agreement between DoD and the Small Business Administration (SBA). The partnership agreement permits DoD to award contracts to 8(a) Program participants on behalf of SBA.
Publication of State Plans Pursuant to the Help America Vote Act
Document Number: 05-19440
Type: Notice
Date: 2005-09-30
Agency: Election Assistance Commission, Agencies and Commissions
Pursuant to sections 254(a)(11)(A) and 255(b) of the Help America Vote Act (HAVA), Public Law 107-252, the U.S. Election Assistance Commission (EAC) hereby causes to be published in the Federal Register material changes to the HAVA State plans previously submitted by Pennsylvania.
Grant Guideline
Document Number: 05-19439
Type: Notice
Date: 2005-09-30
Agency: State Justice Institute, Agencies and Commissions
This Guideline sets forth the administrative, programmatic, and financial requirements attendant to Fiscal Year 2006 State Justice Institute grants, cooperative agreements, and contracts.
Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Contractor Re-Certification of Program Compliance
Document Number: 05-19399
Type: Proposed Rule
Date: 2005-09-30
Agency: National Aeronautics and Space Administration, Agencies and Commissions
This proposed rule is to amend the NASA FAR Supplement (NFS) to include a requirement for NASA's Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) contractors to complete a re-certification of program compliance prior to final payment. This requirement is being established to facilitate the Government's ability to hold contractors accountable for compliance with Federal statute, regulation, and program requirements as outlined in the Office of Inspector General's Management Alert Memorandum dated April 28, 2004. As part of its continuing effort to reduce the paperwork and respondent burden, NASA invites the general public and other Federal agencies to comment on this proposed rule and/or continuing information collections, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).
Adoption of Updated EDGAR Filer Manual
Document Number: 05-19315
Type: Rule
Date: 2005-09-30
Agency: Securities and Exchange Commission, Agencies and Commissions
The Securities and Exchange Commission (the Commission) is adopting revisions to the Electronic Data Gathering, Analysis, and Retrieval System (EDGAR) Filer Manual to reflect changes made to improve, reorganize and restructure the EDGAR Filer Manual volumes to make it easier for filers and those wishing to apply for EDGAR access codes to locate the information that they need to apply for EDGAR access, maintain company information and submit a filing. With this reorganization, no changes have been made to the filing process. The revisions to the Filer Manual reflect changes within Volumes I, II and III, entitled ``EDGAR Filer Manual Volume I General Information,'' ``EDGAR Filer Manual Volume II EDGAR Filing,'' and ``EDGAR Filer Manual Volume III N-SAR Supplement'' respectively. The updated manual will be incorporated by reference into the Code of Federal Regulations.
Medicare Program; Health Care Infrastructure Improvement Program; Forgiveness of Indebtedness
Document Number: 05-19307
Type: Proposed Rule
Date: 2005-09-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This proposed rule would implement section 1016 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173) by establishing the loan forgiveness criteria for qualifying hospitals who receive loans under the Health Care Infrastructure Improvement Program.
Medicare Program; Health Care Infrastructure Improvement Program; Selection Criteria of Loan Program for Qualifying Hospitals Engaged in Cancer-Related Health Care
Document Number: 05-19306
Type: Rule
Date: 2005-09-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This interim final rule with comment period sets forth the criteria for implementing a loan program for qualifying hospitals engaged in research in the causes, prevention, and treatment of cancer as specified in section 1016 of the Medicare Prescription Drug, Improvement and Modernization Act of 2003 (MMA) (Pub. L. 108-173). Specifically, this rule establishes a loan application process by which qualifying hospitals including specified entities may apply for a loan for the capital costs of health care infrastructure improvement projects.
Federal Property Suitable as Facilities To Assist the Homeless
Document Number: 05-19298
Type: Notice
Date: 2005-09-30
Agency: Department of Housing and Urban Development
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for possible use to assist the homeless.
Minimum Wages for Federal and Federally Assisted Construction; General Wage Determination Decisions
Document Number: 05-19248
Type: Notice
Date: 2005-09-30
Agency: Employment Standards Administration, Department of Labor, Wage and Hour Division
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 05-19245
Type: Notice
Date: 2005-09-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Agency Information Collection Activities: Submission for OMB Review; Comment Request
Document Number: 05-19244
Type: Notice
Date: 2005-09-30
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Reader Aids
Document Number: FR-2005-09-29-ReaderAids
Type: Reader Aids
Date: 2005-09-29
Proposed Information Collection Activity: Proposed Collection; Comment Request
Document Number: E5-5320
Type: Notice
Date: 2005-09-29
Agency: Department of Veterans Affairs
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments for information needed to determine the holder's election to convey and transfer foreclosed property to VA.
Agency Information Collection Activities Under OMB Review
Document Number: E5-5319
Type: Notice
Date: 2005-09-29
Agency: Department of Veterans Affairs
In compliance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3521) this notice announces that the Veterans Benefits Administration (VBA), Department of Veterans Affairs, has submitted the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden; it includes the actual data collection instrument.
Advisory Committee on Reactor Safeguards; Procedures for Meetings
Document Number: E5-5317
Type: Notice
Date: 2005-09-29
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Sunshine Act Meeting
Document Number: 05-19638
Type: Notice
Date: 2005-09-29
Agency: Federal Election Commission, Agencies and Commissions
Drawbridge Operation Regulations; Saugus River, MA
Document Number: 05-19583
Type: Proposed Rule
Date: 2005-09-29
Agency: Coast Guard, Department of Homeland Security
The Coast Guard proposes to temporarily change the drawbridge operating regulations governing the operation of the General Edwards SR1A Bridge, at mile 1.7, across the Saugus River between Lynn and Revere, Massachusetts. This change to the drawbridge operation regulations would allow the bridge to remain in the closed position from November 1, 2005 through April 30, 2006. This action is necessary to facilitate structural maintenance at the bridge.
Shasta County Resource Advisory Committee
Document Number: 05-19553
Type: Notice
Date: 2005-09-29
Agency: Department of Agriculture, Forest Service
The Shasta County Resource Advisory Committee (RAC) will hold meetings at the USDA Service Center in Redding, California, on October 5, November 2, and December 7, 2005. The purpose of these meetings is to discuss proposed projects under Title II of the Secure Rural Schools and Community Self-Determination Act of 2000.
Royalty Payment and Royalty and Production Reporting Requirements Relief for Federal Oil and Gas Lessees Affected by Hurricane Katrina or Hurricane Rita
Document Number: 05-19533
Type: Rule
Date: 2005-09-29
Agency: Department of the Interior, Minerals Management Service
The Minerals Management Service (MMS) is publishing a final rule to provide immediate temporary relief to reporters in the aftermath of Hurricanes Katrina and Rita. The final rule provides an extension to pay royalties owed on Federal oil and gas leases and report corresponding royalty and production reports. On August 29, 2005, Hurricane Katrina struck the Gulf of Mexico coast of the United States. Subsequently, in late September 2005, Hurricane Rita struck the Gulf Coast. Both hurricanes caused extensive damage to areas in which a number of Federal oil and gas lessees, particularly lessees of offshore leases, have their offices and principal operations. This final rule extends the due date for monthly royalty payments and reports and monthly operations reports for Federal oil and gas lessees, royalty payors, and operators whose operations have been disrupted by one or both of the hurricanes to the extent that the lessee, payor, or operator is prevented from submitting accurate payments or accurate reports. Extending the due date for royalty payments means that late payment interest will not accrue for the period between the original due date and the new due date established by this rule.
Oil and Gas and Sulphur Operations in the Outer Continental Shelf-Plans and Information
Document Number: 05-19532
Type: Rule
Date: 2005-09-29
Agency: Department of the Interior, Minerals Management Service
MMS is delaying until January 1, 2006, the effective date of a rule that regulates plans and information that lessees and operators must submit in connection with oil and gas exploration, development and production on the Outer Continental Shelf (OCS). This delay is necessary because of damage in the New Orleans area caused by Hurricane Katrina and subsequent flooding. This temporary delay will provide relief to the government and the oil and gas industry as they recover from this disaster.
Veterans' Disability Benefits Commission Notice of Meeting
Document Number: 05-19522
Type: Notice
Date: 2005-09-29
Agency: Department of Veterans Affairs
Broadband Power Line Systems
Document Number: 05-19515
Type: Rule
Date: 2005-09-29
Agency: Federal Communications Commission, Agencies and Commissions
The Commission adopted new requirements and measurement guidelines for a new type of carrier current system that provides access to broadband services using electric utility companies over power lines. Certain rules contained new information collection requirements and were published in the Federal Register on January 7, 2005. This document announces the effective date of these published rules.
Data Collection Available for Public Comments and Recommendations
Document Number: 05-19513
Type: Notice
Date: 2005-09-29
Agency: Small Business Administration, Agencies and Commissions
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Small Business Administration's intention to request approval on a new and/or currently approved information collection.
The Very Small Business Program
Document Number: 05-19512
Type: Rule
Date: 2005-09-29
Agency: Small Business Administration, Agencies and Commissions
The U.S. Small Business Administration (SBA or Agency) is amending its regulations to remove provisions relating to the Very Small Business Program (VSB). The Agency no longer has statutory authority to provide assistance under this program; therefore, the regulations are unnecessary. Without any authority to carry out the program, removal of the applicable regulations is a ministerial act that does not require a comment period.
Food Labeling; Nutrient Content Claims, Definition of Sodium Levels for the Term “Healthy”
Document Number: 05-19511
Type: Rule
Date: 2005-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is amending its regulations concerning the maximum sodium levels permitted for foods that bear the implied nutrient content claim ``healthy.'' The agency is retaining the currently effective, less restrictive, ``first-tier'' sodium level requirements for all food categories, including individual foods (480 milligrams (mg)) and meals and main dishes (600 mg), and is dropping the ``second-tier'' (more restrictive) sodium level requirements for all food categories. Based on the comments received about technological barriers to reducing sodium in processed foods and poor sales of products that meet the second-tier sodium level, the agency has determined that requiring the more restrictive sodium levels would likely inhibit the development of new ``healthy'' food products and risk substantially eliminating existing ``healthy'' products from the marketplace. After reviewing the comments and evaluating the data from various sources, FDA has become convinced that retaining the higher first-tier sodium level requirements for all food products bearing the term ``healthy'' will encourage the manufacture of a greater number of products that are consistent with dietary guidelines for a variety of nutrients. The agency has also revised the regulatory text of the ``healthy'' regulation to clarify the scope and meaning of the regulation and to reformat the nutrient content requirements for ``healthy'' into a more readable set of tables, consistent with the Presidential Memorandum instructing that regulations be written in plain language.
Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data
Document Number: 05-19510
Type: Notice
Date: 2005-09-29
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is adding noncompression heart stabilizers to the list of critical reprocessed single-use devices (SUDs) whose exemption from premarket notification requirements has been terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), are necessary in a premarket notification (510(k)). The agency is also adding laparoscopic and endoscopic electrosurgical accessories to the list of reprocessed SUDs currently subject to premarket notification requirements that will now require submission of supplemental validation data. FDA is requiring submission of these data to ensure that reprocessed single-use noncompression heart stabilizers and laparoscopic and endoscopic electrosurgical accessories are substantially equivalent to predicate devices, in accordance with MDUFMA.
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