August 2005 – Federal Register Recent Federal Regulation Documents

Results 551 - 600 of 2,956
Fitness for Duty Programs
Document Number: 05-15576
Type: Proposed Rule
Date: 2005-08-26
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations for Fitness for Duty (FFD) programs to update the rule and enhance consistency with advances in other relevant Federal rules and guidelines, including the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines), and other Federal drug and alcohol testing programs that impose similar requirements on NRC licensees. The proposed amendments would require nuclear power plant licensees to strengthen the effectiveness of their FFD programs in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue; and ensure consistency with the NRC's access authorization requirements for nuclear power plants. The proposed rule would ensure that individuals who are subject to these regulations are trustworthy and reliable, as demonstrated by avoiding substance abuse; are not under the influence of drugs or alcohol while performing their duties; and are not mentally or physically impaired from any other cause, that would in any way adversely affect their ability to perform their duties safely and competently. This proposed rule would also grant, in part, a petition for rulemaking (PRM-26-1) submitted by Virginia Electric and Power Company (now Dominion Virginia Power) on December 30, 1993, by relaxing several required FFD program audit frequencies, and would partially grant a petition for rulemaking (PRM-26-2) submitted by Barry Quigley on December 28, 1999.
Reader Aids
Document Number: FR-2005-08-25-ReaderAids
Type: Reader Aids
Date: 2005-08-25
Third-Party Disclosure in IRS Regulations; Proposed Collection; Comment Request for Regulation Project
Document Number: E5-4654
Type: Notice
Date: 2005-08-25
Agency: Internal Revenue Service, Department of Treasury, Department of the Treasury
The Department of the Treasury, 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)). Currently, the IRS is soliciting comments concerning existing regulations, Third-Party Disclosure Requirements in IRS Regulations.
Filings Under the Public Utility Holding Company Act of 1935, as Amended (“Act”)
Document Number: E5-4649
Type: Notice
Date: 2005-08-25
Agency: Securities and Exchange Commission, Agencies and Commissions
Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
Document Number: E5-4648
Type: Notice
Date: 2005-08-25
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The NRC has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a current valid OMB control number. 1. Type of submission, new, revision, or extension: Extension. 2. The title of the information collection: 10 CFR Part 33 Specific Domestic Licenses of Broad Scope for Byproduct Material. 3. The form number if applicable: Not applicable. 4. How often the collection is required: There is a one-time submittal of information to receive a license. Once a specific license has been issued, there is a 10-year resubmittal of the information for renewal of the license. 5. Who will be required or asked to report: All applicants requesting a license of broad scope for byproduct material and all current licensees requesting renewal of a broad scope license. 6. An estimate of the number of responses: All of the information collections in Part 33 are captured under OMB clearance number 3150- 0120 for NRC Form 313. 7. The estimated number of annual respondents: See item 6, above. 8. An estimate of the number of hours needed annually to complete the requirement or request: See item 6 above. 9. An indication of whether Section 3507(d), Public Law 104-13 applies: Not applicable. 10. Abstract: 10 CFR Part 33 contains mandatory requirements for the issuance of a broad scope license authorizing the use of byproduct material. The subparts cover specific requirements for obtaining a license of broad scope. These requirements include equipment, facilities, personnel, and procedures adequate to protect health and minimize danger to life or property. A copy of the final supporting statement may be viewed free of charge at the NRC Public Document Room, One White Flint North, 11555 Rockville Pike, Room O-1 F23, Rockville, MD 20852. OMB clearance requests are available at the NRC worldwide web site: http:// www.nrc.gov/public-involve/doc-comment/omb/index.html. The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments and questions should be directed to the OMB reviewer listed below by September 26, 2005. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. John Asalone, Office of Information and Regulatory Affairs (3150- 0016), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be e-mailed to JohnA.Asalone@omb.eop.gov or submitted by telephone at (202) 395-4650. The NRC Clearance Officer is Brenda Jo Shelton, 301-415-7233.
Draft Regulatory Guide: Issuance, Availability
Document Number: E5-4647
Type: Notice
Date: 2005-08-25
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Southwest Power Pool, Inc.; Notice of Filing
Document Number: E5-4644
Type: Notice
Date: 2005-08-25
Agency: Department of Energy, Federal Energy Regulatory Commission
Vesta Trading LP; Vesta Capital Partners, LP; Notice of Issuance of Order
Document Number: E5-4643
Type: Notice
Date: 2005-08-25
Agency: Department of Energy, Federal Energy Regulatory Commission
Ocean Peaking Power, L.L.C. v. Jersey Central Power and Light Company; Notice of Complaint
Document Number: E5-4642
Type: Notice
Date: 2005-08-25
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Application for Amendment of License and Soliciting Comments, Motions To Intervene, and Protests
Document Number: E5-4641
Type: Notice
Date: 2005-08-25
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Application Accepting for Filing and Soliciting Motions To Intervene, Protests and Comments
Document Number: E5-4640
Type: Notice
Date: 2005-08-25
Agency: Department of Energy, Federal Energy Regulatory Commission
Natural Gas Pipeline Company of America; Notice of Emergency Petition for Waivers
Document Number: E5-4639
Type: Notice
Date: 2005-08-25
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Proposed Information Collection: Comment Request; Application for Housing Assistance Payments; Special Claims Processing
Document Number: E5-4636
Type: Notice
Date: 2005-08-25
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.
Notice of Proposed Information Collection: Comment Request; Contractor's Requisition Project Mortgages
Document Number: E5-4635
Type: Notice
Date: 2005-08-25
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.
Proposed Information Collection Activity: Proposed Collection; Comment Request
Document Number: E5-4634
Type: Notice
Date: 2005-08-25
Agency: Department of Veterans Affairs
The Veterans Health Administration (VHA) 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 revision of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the need to obtain written consent to disclose medical treatment information to individuals or third parties.
In the Matter of Global Development and Environmental Resources, Inc., Order of Suspension of Trading
Document Number: 05-17001
Type: Notice
Date: 2005-08-25
Agency: Securities and Exchange Commission, Agencies and Commissions
Pistachios Grown in California; Establishment of Additional Inspection Requirements
Document Number: 05-16981
Type: Proposed Rule
Date: 2005-08-25
Agency: Agricultural Marketing Service, Department of Agriculture
This rule invites comments on the establishment of additional inspection requirements authorized under the California pistachio marketing order (order). The order regulates the handling of pistachios grown in California and is administered locally by the Administrative Committee for Pistachios (Committee). This rule would modify sampling procedures for dark-stained pistachios which are intended to be dyed or color-coated. It would also establish reinspection requirements for lots of pistachios, which are materially changed after meeting initial aflatoxin, quality, and size requirements. This action is expected to assure the quality of pistachios, improve the marketability of pistachios, and provide handlers more marketing flexibility. The benefits of this action are expected to offset the increased inspection costs.
Notice of Public Information Collection Requirements Submitted to OMB for Review
Document Number: 05-16947
Type: Notice
Date: 2005-08-25
Agency: Trade and Development Agency, Agencies and Commissions
USTDA invites general public and other Federal agencies to take this opportunity to comment on the following proposed information collection, as required by the Paperwork Reduction Act of 1995. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Indian Gaming
Document Number: 05-16943
Type: Notice
Date: 2005-08-25
Agency: Department of the Interior, Bureau of Indian Affairs, Indian Affairs Bureau
This notice publishes approval of the TribalState Compact between the State of New Mexico and the Pueblo of Pojoaque.
Information Collection Renewal Sent to the Office of Management and Budget (OMB) for Approval Under the Paperwork Reduction Act; OMB Control No. 1018-0100; Information Collection in Support of Grant Programs Authorized by the North American Wetlands Conservation Act (NAWCA)
Document Number: 05-16942
Type: Notice
Date: 2005-08-25
Agency: Fish and Wildlife Service, Department of the Interior
We (Fish and Wildlife Service, Service) have sent a request to OMB to renew the collection of information described below. We use the information collected to conduct our NAWCA grant programs in the manner prescribed by that Act, the Migratory Bird Conservation Commission, and the North American Wetlands Conservation Council. We also use the information to comply with Federal reporting requirements for grants awarded under the program.
Notice of Intent to Conduct Public Scoping Meetings and to Prepare an Environmental Impact Statement Related to the Makah Tribe's Continuation of Treaty Right Hunting of Gray Whales
Document Number: 05-16940
Type: Notice
Date: 2005-08-25
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
We intend to conduct public scoping meetings to gather information to prepare an Environmental Impact Statement (EIS) pursuant to the National Environmental Policy Act (NEPA), related to the Makah Tribe's request that NMFS waive the take moratorium of the Marine Mammal Protection Act (MMPA) to allow for treaty right hunting of eastern North Pacific gray whales in usual and accustomed grounds off the coast of Washington State. This notice briefly describes the background of the Makah's request for waiver; gives dates, times, and locations of public scoping meetings; identifies a set of preliminary alternatives to serve as a starting point for discussions; and terminates the prior notice of intent to prepare an EIS on a similar action.
List of Fisheries for 2005
Document Number: 05-16939
Type: Proposed Rule
Date: 2005-08-25
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
On December 2, 2004, the proposed List of Fisheries (LOF) for 2005 under the Marine Mammal Protection Act (MMPA) was published in the Federal Register. NMFS subsequently prepared a draft Environmental Assessment (EA) on the process for classifying U.S. commercial fisheries on the LOF. NMFS is reopening the comment period on the proposed 2005 LOF for an additional 60 days to allow the public to concurrently review and comment on both the draft EA and proposed 2005 LOF.
Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Navy Operations of Surveillance Towed Array Sensor System Low Frequency Active Sonar
Document Number: 05-16938
Type: Notice
Date: 2005-08-25
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
In accordance with the Marine Mammal Protection Act (MMPA), as amended, and implementing regulations, notification is hereby given that NMFS has issued two 1-year Letters of Authorization (LOAs) to take marine mammals by harassment incidental to the U.S. Navy's operation of Surveillance Towed Array Sensor System Low Frequency Active (SURTASS LFA) sonar operations to the Chief of Naval Operations, Department of the Navy, 2000 Navy Pentagon, Washington, D.C., and persons operating under his authority.
Culturally Significant Objects Imported for Exhibition Determinations: “Assorted Egyptian Treasures for Public Exhibition”
Document Number: 05-16937
Type: Notice
Date: 2005-08-25
Agency: Department of State
On June 2, 2005, notice was published on page 32392 of the Federal Register (volume 70, number 105) of determinations made by the Department of State pertaining to the exhibitions ``Mummy: the inside story'' and ``Treasures of Ancient Art from the British Museum.'' The referenced notice is corrected as to additional objects to be included in the the exhibition ``Mummy: the inside story.'' Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681, et seq.; 22 U.S.C. 6501 note, et seq.), Delegation of Authority No. 234 of October 1, 1999, Delegation of Authority No. 236 of October 19, 1999, as amended, and Delegation of Authority No. 257 of April 15, 2003 [68 FR 19875], I hereby determine that the additional objects to be included in the exhibition ``Mummy: the inside story'', imported from abroad for temporary exhibition within the United States, are of cultural significance. The additional objects are imported pursuant to loan agreements with the foreign owners. I also determine that the exhibition or display of the additional exhibit objects at the Houston Museum of Natural Science, Houston, TX, from on or about September 30, 2005, until on or about February 12, 2006 (with one object remaining for longer-term exhibit), at the Gulf Coast Exploreum, Mobile, AL, from on or about March 8, 2006, until on or about August 4, 2006, and at possible additional venues yet to be determined, is in the national interest. Public Notice of these Determinations is ordered to be published in the Federal Register.
Agency Information Collection Activities; Proposed Collection; Comment Request; Reporting Requirements Under EPA's Voluntary Aluminum Industrial Partnership (VAIP), EPA ICR Number 1867.03, OMB Control Number 2060-0411
Document Number: 05-16935
Type: Notice
Date: 2005-08-25
Agency: Environmental Protection Agency
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a continuing Information Collection Request (ICR) to the Office of Management and Budget (OMB). This is a request to renew an existing approved collection. This ICR is scheduled to expire on 12/30/05. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.
Agency Information Collection Activities: Proposed Collection; Comment Request; Assessment of Indoor Air Quality Outreach Products and Services, EPA ICR Number 2190.01; Correction
Document Number: 05-16934
Type: Notice
Date: 2005-08-25
Agency: Environmental Protection Agency
The Environmental Protection Agency published a notice in the Federal Register of July 16, 2005, concerning a request for comments on an information collection request regarding the assessment of indoor air quality outreach products and services. The document contained an incorrect date.
Approval and Promulgation of Air Quality Implementation Plans; Knox County, Tennessee; Revised Format for Materials Being Incorporated by Reference
Document Number: 05-16931
Type: Rule
Date: 2005-08-25
Agency: Environmental Protection Agency
EPA is revising the format of part 52 of title 40 of the Code of Federal Regulations (40 CFR part 52) for materials submitted by Knox County that are incorporated by reference (IBR) into the Tennessee State Implementation Plan (SIP). The regulations affected by this format change have all been previously submitted by the local agency and approved by EPA. This format revision will affect the ``Identification of Plan'' sections of 40 CFR part 52, by adding a table for the Knox County portion of the Tennessee SIP. This revision will also affect the format of the SIP materials that will be available for public inspection at the Office of Federal Register (OFR), the Air and Radiation Docket and Information Center, and the Regional Office.
Notice of a Public Meeting on Designated Uses and Use Attainability Analyses
Document Number: 05-16928
Type: Notice
Date: 2005-08-25
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is holding a public meeting to discuss designated uses and use attainability analyses. The meeting is co-sponsored with the Water Environment Federation (WEF). The primary goals of the meeting are to help educate the public on current water quality standards regulations, guidance and practices related to designated uses and use attainability analyses, and to provide a forum for the public to join in discussions, ask questions, and provide feedback.
Establishment of Class E Airspace; Marana Regional Airport, AZ
Document Number: 05-16926
Type: Rule
Date: 2005-08-25
Agency: Federal Aviation Administration, Department of Transportation
This action establishes a Class E airspace area at Marana Regional Airport, AZ. The establishment of an Area Navigation (RNAV) Global Positioning System (GPS) Instrument Approach Procedures (IAP) RNAV (GPS) Runway (RWY) 3, 12, 21 and 30 IAP and a Nondirectional Radio Beacon (NDB) IAP to RWY 12 at Marana Regional Airport, Tucson, AZ has made this action necessary. Additional controlled airspace extending upward from 700 feet or more above the surface of the earth is needed to contain aircraft executing these RNAV (GPS) and NDB approach procedures. The intended effect of this action is to provide adequate controlled airspace for Instrument Flight Rules operations at Marana Regional Airport, Tucson, AZ.
Modification to Class E Airspace; Ruidoso, NM
Document Number: 05-16925
Type: Rule
Date: 2005-08-25
Agency: Federal Aviation Administration, Department of Transportation
This action modifies the Class E airspace area at Santa Elena, TX to provide adequate controlled airspace for the Instrument Landing System (ILS) standard instrument approach procedure (SIAP) at the Sierra Blanca Regional Airport (SRR).
Establishment to Class E Airspace; Santa Teresa, NM
Document Number: 05-16924
Type: Rule
Date: 2005-08-25
Agency: Federal Aviation Administration, Department of Transportation
This action establishes the Class E airspace area at Dona Ana County, Santa Teresa, NM (K5T6) to provide adequate controlled airspace for the area navigation (RNAV) global positioning system (GPS) standard instrument approach procedure (SIAP).
Drawbridge Operation Regulation; Mississippi River, Rock Island, IL
Document Number: 05-16923
Type: Rule
Date: 2005-08-25
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is temporarily changing the regulation governing the Rock Island Railroad & Highway Drawbridge, across the Upper Mississippi River at Mile 482.9, at Rock Island, Illinois. The drawbridge need not open for river traffic and may remain in the closed-to-navigation position from 8 a.m. to 11 a.m. on September 25, 2005. This rule allows the drawbridge be maintained in the closed-to- navigation position to allow the annually scheduled running of a foot race as part of a local community event.
Petitions for Exemption; Dispositions of Petitions Issued
Document Number: 05-16922
Type: Notice
Date: 2005-08-25
Agency: Federal Aviation Administration, Department of Transportation
Pursuant to FAA's rulemaking provisions governing the application, processing, and disposition of petitions for exemption, part 11 of Title 14, Code of Federal Regulations (14 CFR), this notice contains the disposition of certain petitions previously received. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition.
Audit and Financial Management Advisory (AFMAC) Committee Meeting
Document Number: 05-16921
Type: Notice
Date: 2005-08-25
Agency: Small Business Administration, Agencies and Commissions
Small Business Size Standards: Waiver of the Nonmanufacturer Rule
Document Number: 05-16920
Type: Notice
Date: 2005-08-25
Agency: Small Business Administration, Agencies and Commissions
The U. S. Small Business Administration (SBA) is considering granting a waiver of the Nonmanufacturer Rule for Commercial Cooking Equipment. The basis for waivers is that no small business manufacturers are supplying these classes of products to the Federal government. The effect of a waiver would be to allow otherwise qualified regular dealers to supply the products of any domestic manufacturer on a Federal contract set aside for small businesses, service disabled veteran-owned small businesses or SBA's 8(a) Business Development Program. The purpose of this notice is to solicit comments and potential source information from interested parties.
Small Business Size Standards: Waiver of the Nonmanufacturer Rule
Document Number: 05-16919
Type: Notice
Date: 2005-08-25
Agency: Small Business Administration, Agencies and Commissions
The U.S. Small Business Administration (SBA) is considering granting a waiver of the Nonmanufacturer Rule for Household Refrigerator Equipment. The basis for waivers is that no small business manufacturers are supplying these classes of products to the Federal Government. The effect of a waiver would be to allow otherwise qualified regular dealers to supply the products of any domestic manufacturer on a Federal contract set aside for small businesses, service disabled veteran-owned small businesses or SBA's 8(a) Business Development Program. The purpose of this notice is to solicit comments and potential source information from interested parties.
Small Business Size Standards: Waiver of the Nonmanufacturer Rule
Document Number: 05-16918
Type: Notice
Date: 2005-08-25
Agency: Small Business Administration, Agencies and Commissions
The U.S. Small Business Administration (SBA) is considering granting a waiver of the Nonmanufacturer Rule for Household Cooking Equipment. The basis for waivers is that no small business manufacturers are supplying these classes of products to the Federal Government. The effect of a waiver would be to allow otherwise qualified regular dealers to supply the products of any domestic manufacturer on a Federal contract set aside for small businesses, service disabled veteran-owned small businesses or SBA's 8(a) Business Development Program. The purpose of this notice is to solicit comments and potential source information from interested parties.
Small Business Size Standards: Waiver of the Nonmanufacturer Rule
Document Number: 05-16917
Type: Notice
Date: 2005-08-25
Agency: Small Business Administration, Agencies and Commissions
The U.S. Small Business Administration (SBA) is considering granting a waiver of the Nonmanufacturer Rule for Household Laundry Equipment, including Laundry Equipment (washers and dryers) and Household Type Manufacturing. The basis for waivers is that no small business manufacturers are supplying these classes of products to the Federal government. The effect of a waiver would be to allow otherwise qualified regular dealers to supply the products of any domestic manufacturer on a Federal contract set aside for small businesses, service disabled veteran-owned small businesses or SBA's 8(a) Business Development Program. The purpose of this notice is to solicit comments and potential source information from interested parties.
Small Business Size Standards: Waiver of the Nonmanufacturer Rule
Document Number: 05-16916
Type: Notice
Date: 2005-08-25
Agency: Small Business Administration, Agencies and Commissions
The U.S. Small Business Administration (SBA) is considering granting a waiver of the Nonmanufacturer Rule for Commercial Laundry Equipment, including Commercial Laundry Manufacturing, Dry Cleaning Equipment Manufacturing, and Pressing Machine Manufacturing. The basis for waivers is that no small business manufacturers are supplying these classes of products to the Federal government. The effect of a waiver would be to allow otherwise qualified regular dealers to supply the products of any domestic manufacturer on a Federal contract set aside for small businesses, service disabled veteran-owned small businesses or SBA's 8(a) Business Development Program. The purpose of this notice is to solicit comments and potential source information from interested parties.
Agency Information Collection Activities; Proposed Collection; Comment Request; Financial Disclosure by Clinical Investigators
Document Number: 05-16915
Type: Notice
Date: 2005-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information requiring the sponsor of any drug, biologic, or device marketing application to certify to the absence of clinical investigators and/or disclose those financial interests as required, when covered clinical studies are submitted to FDA in support of product marketing.
Medical Devices; Immunology and Microbiology Devices; Classification of Ribonucleic Acid Preanalytical Systems
Document Number: 05-16914
Type: Rule
Date: 2005-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is classifying ribonucleic acid (RNA) preanalytical systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization, and Purification Systems for RT-PCR Used in Molecular Diagnostic Testing).'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for the device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Ribonucleic Acid Preanalytical Systems (Ribonucleic Acid Collection, Stabilization and Purification Systems for Real Time Polymerase Chain Reaction Used in Molecular Diagnostic Testing); Availability
Document Number: 05-16913
Type: Notice
Date: 2005-08-25
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: RNA Preanalytical Systems (RNA Collection, Stabilization and Purification Systems for RT-PCR used in Molecular Diagnostic Testing).'' This guidance document describes a means by which Ribonucleic Acid (RNA) preanalytical systems may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify RNA preanalytical systems into class II (special controls). This guidance document is immediately in effect as the special control for RNA preanalytical systems but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).