Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 016, 64718-64725 [E6-18604]

Download as PDF 64718 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices requirements are also not subject to review under the PRA because they are a public disclosure of information originally supplied by the Federal Government to the recipient for the purpose of disclosure to the public (5 CFR 1320.3(c)(2)): Sections 21 CFR 1020.10(c)(4), 1030.10(c)(6), 1040.10(g), 1040.30(c)(1), and 1050.10(d)(1). Dated: October 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–18559 Filed 11–2–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006N–0326] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by December 4, 2006. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 1472. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Medical Devices: Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (OMB Control Number 0910–0510)—Extension The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107–250) was signed into law on October 26, 2002. Section 201 of MDUFMA adds a new paragraph ‘‘g’’ to section 704 of the Federal, Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons or APs) to conduct inspections of eligible manufacturers of class II or class III devices. This is a voluntary program. FDA has a guidance document that provides information for those interested in participating in this program. The guidance is entitled ‘‘Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002; Accreditation Criteria.’’ In the Federal Register of August 24, 2006 (71 FR 50067), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. Respondents are expected to be businesses or other for profit organizations. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 Information Collection No. of Respondents Request for Accreditation Annual Frequency per Response 3 Total Annual Responses 1 Hours per Response 3 80 Total Hours 1There 240 240 are no capital costs or operating and maintenance costs associated with this collection of information. FDA based these estimates on conversations with industry, trade association representatives, and internal FDA estimates. Once an organization is accredited, it will not be required to reapply. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: October 30, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E6–18603 Filed 11–2–06; 8:45 am] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 016 BILLING CODE 4160–01–S AGENCY: Food and Drug Administration [Docket No. 2004N–0226] Food and Drug Administration, HHS. ACTION: mstockstill on PROD1PC68 with NOTICES Total Hours Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 016’’ (Recognition List Number: 016), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. DATES: Submit written or electronic comments concerning this document at any time. See section VII of this document for the effective date of the recognition of standards announced in this document. ADDRESSES: Submit written requests for single copies of ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 016’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological E:\FR\FM\03NON1.SGM 03NON1 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices Health (HFZ–220), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that office in processing your requests, or fax your request to 301–443–8818. Submit written comments concerning this document, or recommendations for additional standards for recognition, to the contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail: standards@cdrh.fda.gov. This document may also be accessed on FDA’s Web site at https://www.fda.gov/cdrh/ fedregin.html. See section VI of this document for electronic access to the searchable database for the current list of FDA recognized consensus standards, including Recognition List Number: 016 modifications and other standards related information. FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices and Radiological Health (HFZ–84), Food and Drug Administration, 12720 Twinbrook Pkwy., Rockville, MD 20857, 301–827– 0021. SUPPLEMENTARY INFORMATION: I. Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105–115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended section 514 allows FDA to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements. In a notice published in the Federal Register of February 25, 1998 (63 FR 64719 9561), FDA announced the availability of a guidance entitled ‘‘Recognition and Use of Consensus Standards.’’ The notice described how FDA would implement its standard recognition program and provided the initial list of recognized standards. FDA has modified its initial list of recognized standards in the following Federal Register notices: list of ‘‘FDA Recognized Consensus Standards.’’ Both versions are publicly accessible at the agency’s Web site. See section VI of this document for electronic access information. Interested persons should review the supplementary information sheet for the standard to understand fully the extent to which FDA recognizes the standard. TABLE 1. II. Modifications to the List of Recognized Standards, Recognition List Number: 016 Federal Register Cite October 16, 1998 (63 FR 55617) July 12, 1999 (64 FR 37546) November 15, 2000 (65 FR 69022) May 7, 2001 (66 FR 23032) January 14, 2002 (67 FR 1774) October 2, 2002 (67 FR 61893) April 28, 2003 (68 FR 22391) March 8, 2004 (69 FR 10712) June 18, 2004 (69 FR 34176) October 4, 2004 (69 FR 59240) May 27, 2005 (70 FR 30756) November 8, 2005 (70 FR 67713) March 31, 2006 (71 FR 16313) June 23, 2006 (71 FR 36121) These notices describe the addition, withdrawal, and revision of certain standards recognized by FDA. The agency maintains ‘‘hypertext markup language’’ (HTML) and ‘‘portable document format’’ (PDF) versions of the FDA is announcing the addition, withdrawal, correction, and revision of certain consensus standards the agency will recognize for use in satisfying premarket reviews and other requirements for devices. FDA will incorporate these modifications in the list of FDA Recognized Consensus Standards in the agency’s searchable database. FDA will use the term ‘‘Recognition List Number: 016’’ to identify these current modifications. In table 1 of this document, FDA describes the following modifications: (1) The withdrawal of standards and their replacement by others, (2) the correction of errors made by FDA in listing previously recognized standards, and (3) the changes to the supplementary information sheets of recognized standards that describe revisions to the applicability of the standards. In section III of this document, FDA lists modifications the agency is making that involve the initial addition of standards not previously recognized by FDA. TABLE 2. Old Item No. Standard Change Replacement Item No. A. Anesthesia 39 CGA V–5: 2005, Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) Withdrawn and replaced with newer version 68 53 ASTM F1464–93 (2005), Standard Specification for Oxygen Concentrators for Domiciliary Use Withdrawn and replaced with newer version 69 65 ISO 21647: 2005, Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Respiratory Gas Monitors Devices affected, Code of Federal Regulations citation, and relevant guidance mstockstill on PROD1PC68 with NOTICES B. Biocompatibility 107 ASTM F1877–05, Standard Practice for Characterization of Particles Withdrawn and replaced with newer version 108 ASTM F1905–98 (2003), Standard Practice for Selecting Tests for Determining the Propensity of Materials for Cause Immunotoxicity Title VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1 114 64720 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. C. Dental/Ear, Nose, and Throat (ENT) 49 ANSI/ADA Specification No. 17: 1983 (R1999), Denture Base Temporary Relining Resins Withdrawn and replaced with newer version 130 64 ISO 3107: 2004, Dental Zinc Oxide/Eugenol Cements and Zinc Oxide Non-Eugenol Cements Withdrawn and replaced with newer version 131 66 ISO 4049: 1988, Dentistry—Resin-Based Filling Materials Withdrawn. Refer to item no. 99 70 ISO 6874: 2005, Dental Resin-Based Pit and Fissure Sealants Withdrawn and replaced with newer version 132 71 ISO 6876: 2001, Dental Root Canal Sealing Materials Withdrawn and replaced with newer version 133 74 ISO 7494–1: 2004, Dentistry—Dental Units—Part 1: General Requirements and Test Methods Withdrawn and replaced with newer version 134 114 ANSI/ADA Specification No. 48: 1989, Visible Curing Units Title 116 ISO 10139–1: 2005, Dentistry—Soft Lining Materials for Removable Dentures—Part 1: Materials for Short-Term Use Withdrawn and replaced with newer version 135 D. General Hospital/General Plastic Surgery 83 ASTM D6319–00a (2005), Standard Specification for Nitrile Examination Gloves for Medical Application Withdrawn and replaced with newer version 167 87 ASTM D3577–06, Standard Specification for Rubber Surgical Gloves Withdrawn and replaced with newer version 168 106 ASTM D3772–01 (2005), Standard Specification for Natural Rubber Finger Cots Withdrawn and replaced with newer version 169 E. In Vitro Diagnostics CLSI/NCCLS GP10–A 1995, Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline Contact person 004 CLSI/NCCLS GP14–A 1996, Labeling of Home-Use In Vitro Testing Products; Approved Guideline Contact person 007 CLSI/NCCLS LA1–A2 1994, Assessing the Quality of Radioimmunoassay Systems—2d ed.; Approved Guideline Contact person 012 CLSI/NCCLS C12–A, Definitions of Quantities and Conventions Related to Blood pH and Gas Analysis; Approved Standard Contact person 013 CLSI/NCCLS C21–A, Performance Characteristics for Devices Measuring PO2 and PCO2 in Blood Samples; Approved Standard Contact person 015 CLSI/NCCLS C25–A, Fractional Oxyhemoglobin, Oxygen Content and Saturation, and Related Quantities in Blood: Terminology, Measurement, and Reporting; Approved Guideline Contact person 016 CLSI/NCCLS C27–A, Blood Gas Preanalytical Considerations: Specimen Collection, Calibration, and Controls; Approved Guideline Contact person 018 CLSI/NCCLS C30–A, Ancillary (Bedside) Blood Glucose Testing Contact person 038 mstockstill on PROD1PC68 with NOTICES 003 CLSI/NCCLS I/LA10–A, Choriogonadotropin Testing: Nomenclature, Reference Preparations, Assay Performance, and Clinical Application; Approved Guideline Contact person 039 CLSI/NCCLS I/LA17–A, Assessing the Quality of Systems for AlphaFetoprotein (AFP) Assays Used in Prenatal Screening and Diagnosis of Neural Tube Defects; Approved Guideline Contact person VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices 64721 TABLE 2.—Continued Old Item No. Standard Change Replacement Item No. 043 CLSI/NCCLS LA4–A3, Blood Collection on Filter Paper for Neonatal Screening Programs; Approved Standard—3d ed. Contact person 048 CLSI/NCCLS T/DM6–A, Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline Contact person 051 CLSI/NCCLS GP 27–A, Using Proficiency Testing (PT) to Improve the Clinical Laboratory; Approved Guideline Contact person 052 CLSI/NCCLS NRSCL 8–A, Terminology and Definitions for Use in National Committee for Clinical Laboratory Standards (NCCLS) Documents; Approved Standard Contact person 055 CLSI/NCCLS H18–A2, Procedures for the Handling and Processing of Blood Specimens; Approved Guideline Contact person 059 CLSI/NCCLS AUTO2–A, Laboratory Automation: Bar Codes for Specimen Container Identification; Approved Standard Contact person 40 ASTM F2063–05, Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants Withdrawn and replaced with newer version 48 ASTM F899–02, Standard Specification for Stainless Steel for Surgical Instruments Contact person 60 ISO 5832–5: 2005, Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy Withdrawn and replaced with newer version 123 65 ISO 5834–2: 2006, Implants for Surgery—Ultra-High-Molecular-Weight Polyethylene—Part 2: Moulded Forms Withdrawn and replaced with newer version 127 67 ISO 7153–1: 1991/Amd. 1: 1999, Surgical Instruments—Metallic Materials—Part 1: Stainless Steel Contact person 70 ASTM F2052–06e1, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment Withdrawn and replaced with newer version 124 72 ASTM F2213–06, Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment Withdrawn and replaced with newer version 128 85 ASTM F1854–01, Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants Contact person 86 ASTM F1926–03, Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Coatings Contact person 88 ASTM F2024–00, Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings Contact person 89 ASTM F1873–98, Standard Specification for High-Purity Dense Yttria Tetragonal Zirconium Oxide Polycrystal (Y-TZP) for Surgical Implant Applications Contact person 94 ASTM F601–03, Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants Contact person 99 ASTM F2004–05, Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis Withdrawn and replaced with newer version 103 ASTM F1801–97 (2004), Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials Contact person 106 ASTM F648–04, Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants Contact person 109 ASTM F561–05a, Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids Withdrawn and replaced with newer version mstockstill on PROD1PC68 with NOTICES F. Materials VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1 122 125 126 64722 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices TABLE 2.—Continued Old Item No. Standard Change 111 ASTM F1160–05, Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings Contact person 112 ASTM F1044–05, Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings Contact person 113 ASTM F1147–05, Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings Contact person 117 ASTM F86–04, Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants Replacement Item No. Contact person G. Obstetrics-Gynecology (OB-GYN)/Gastroenterology 28 ANSI/AAMI RD16: 1996/A1: 2002/(R)2005, Hemodialyzers Reaffirmation 29 ANSI/AAMI RD17: 1994/A1: 2002/(R)2005, Hemodialyzer Blood Tubing Reaffirmation 31 ANSI/AAMI ID54: 1996/(R)2005, Enteral Feeding Set Adapters and Connectors Reaffirmation H. Ophthalmic 20 ISO 11979–1: 1999, Ophthalmic Implants—Intraocular Lenses—Part 1: Vocabulary Contact person 22 ISO 11979–3: 1999, Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical Properties and Test Methods Contact person 32 ISO 11990: 2003, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Determination of Laser Resistance of Tracheal Tube Shafts Withdrawn and transferred to Radiology I. Orthopedic/Physical Medicine 85 ISO 14630: 2005, Non-Active Surgical Implants—General Requirements Withdrawn and replaced with newer version 194 141 ASTM F1612–95 (2005), Standard Practice for Cyclic Fatigue Testing of Metallic Stemmed Hip Arthroplasty Femoral Components With Torsion Withdrawn and replaced with newer version 195 142 ASTM F1672–95 (2005), Standard Specification for Resurfacing Patellar Prosthesis Withdrawn and replaced with newer version 196 150 ASTM F983–86 (2005), Standard Practice for Permanent Marking of Orthopaedic Implant Components Withdrawn and replaced with newer version 197 162 ASTM F564–02 (2006), Standard Specification and Test Methods for Metallic Bone Staples Withdrawn and replaced with newer version 201 174 ASTM F382–99 (2003) e1, Standard Specification and Test Method for Metallic Bone Plates Withdrawn and replaced with newer version 198 176 ASTM F565–04, Standard Practice for Care and Handling of Orthopedic Implants and Instruments Withdrawn and replaced with newer version 199 193 ASTM F2083–06, Standard Specification for Total Knee Prosthesis Withdrawn and replaced with newer version 200 32 (Opthalmic) ISO 11990: 2003, Optics and Optical Instruments—Lasers and Laser-Related Equipment—Determination of Laser Resistance of Tracheal Tube Shafts Transferred from Ophthalmic, type of standard, and contact person 144 92 IEC 61674 (1997–10), Medical Electrical Cquipment—Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in XRay Diagnostic Imaging Withdrawn and replaced 145 mstockstill on PROD1PC68 with NOTICES J. Radiology VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1 64723 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices TABLE 2.—Continued Old Item No. Standard Replacement Item No. Change 93 IEC 61674 (2002), Amendment 1, Medical Electrical Equipment— Dosimeters With Ionization Chambers and/or Semi-Conductor Detectors as Used in X-Ray Diagnostic Imaging Withdrawn and replaced 145 118 IEC 60601–2–17 (2005), Medical Electrical Equipment—Part 2–17: Particular Requirements for the Safety of Automatically-Controlled Brachytherapy Afterloading Equipment Withdrawn and replaced with newer version 146 135 IEC 60601–2–5 (2005), Medical Electrical Equipment—Part 2–5: Particular Requirements for the Safety of Ultrasonic Physiotherapy Equipment ed. 2.0 Withdrawn and replaced with newer version 147 8 IEC 60336 (2005), Medical Electrical Equipment—X-Ray Tube Assemblies for Medical Diagnosis—Characteristics of Focal Spots Withdrawn and replaced with newer version 149 74 ANSI/AAMI ST 60: 1996, Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements Withdrawn 103 ISO 11607–2000, Packaging for Terminally Sterilized Medical Devices Withdrawn K. Sterility III. Listing of New Entries modifications to the list of recognized standards under Recognition List Number: 016, follows: The listing of new entries and consensus standards, added as TABLE 3. Item No. Title of Standard Reference No. and Date A. Dental/ENT 136 Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices ASTM F2504–05 B. General Hospital/General Plastic Surgery 160 Sterile Single-Use Syringes, With or Without Needle, for Insulin ISO 8537: 1991/Amendment 1: 2000 161 Sterile, Single-Use Intravascular Catheters—Part 1: General Requirements 162 Infusion Equipment for Medical Use—Part 1: Infusion Glass Bottles 163 Stainless Steel Needle Tubing for the Manufacture of Medical Devices 164 Sterile, Single-Use Intravascular Catheters—Part 5: Over-Needle Peripheral Catheters 165 Standard Specification for Polychloroprene Examination Gloves for Medical Application ASTM D6977–04 166 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps ASTM F2132–01 ISO 10555–1: 1996/Amendment 1: 1999, Amendment 2: 2004 ISO 8536–1: 2000/Amendment 1: 2004 ISO 9626: 1991/Amendment 1: 2001 ISO 10555–5: 1996/Amendment 1: 1999, Corrigendum 1: 2002 C. In Vitro Diagnostics Fluorescence Calibration and Quantitative Measurement of Fluorescence Intensity; Approved Guideline 125 mstockstill on PROD1PC68 with NOTICES 124 CLSI/NCCLS I/LA24–A Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline CLSI M28–A2, Vol. 25, No. 16 126 Susceptibility Testing of Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes CLSI M24–A, Vol. 23, No. 18 D. OB-GYN/Gastroenterology VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1 64724 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices TABLE 3.—Continued Item No. Title of Standard Reference No. and Date 38 Optics and Optical Instruments—Medical Endoscopes and Endoscopic Accessories Part 3: Determination of Field of View and Direction of View of Endoscopes with Optics ISO 8600–3: 1997/Amendment 1: 2003 39 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 5: Determination of Optical Resolution of Rigid Endoscopes with Optics ISO 8600–5: 2005 40 Optics and Photonics—Medical Endoscopes and Endotherapy Devices—Part 6: Vocabulary ISO 8600–6: 2005 E. Radiology 145 Medical Electrical Equipment—Dosimeters with Ionization Chambers and/or SemiConductor Detectors as Used in X-Ray Diagnostic Imaging IEC 61674 (1997), (2002), Amendment 1 148 Medical Electrical Equipment—Part 2–37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment IEC 60601–2–37 (2005), Amendment 2 F. Software 8 Medical Device Software—Software Life Cycle Processes IEC 62304 ed. 1.0 (2006) G. Sterility 193 Packaging for Terminally Sterilized Medical Devices—Part 1: Requirements for Materials, Sterile Barrier Systems, and Packaging Systems, 3d ed. ANSI/AAMI/ISO 11607–1: 2006 194 Packaging for Terminally Sterilized Medical Devices—Part 2: Validation Requirements for Forming, Sealing, and Assembly Processes, 1st ed. ANSI/AAMI/ISO 11607–2: 2006 195 Sterilization of Health Care Products—Chemical Indicators—Part 1: General Requirements, 2d ed. ANSI/AAMI/ISO 11140–1: 2005 mstockstill on PROD1PC68 with NOTICES IV. List of Recognized Standards FDA maintains the agency’s current list of FDA recognized consensus standards in a searchable database that may be accessed directly at FDA’s Web site at https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfStandards/ search.cfm. FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary. V. Recommendation of Standards for Recognition by FDA Any person may recommend consensus standards as candidates for recognition under section 514 of the act by submitting such recommendations, with reasons for the recommendation, to the contact person (see FOR FURTHER INFORMATION CONTACT). To be properly considered such recommendations should contain, at a minimum, the following information: (1) Title of the standard, (2) any reference number and date, (3) name and address of the VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 national or international standards development organization, (4) a proposed list of devices for which a declaration of conformity to this standard should routinely apply, and (5) a brief identification of the testing or performance or other characteristics of the device(s) that would be addressed by a declaration of conformity. VI. Electronic Access You may obtain a copy of ‘‘Guidance on the Recognition and Use of Consensus Standards’’ by using the Internet. CDRH maintains a site on the Internet for easy access to information including text, graphics, and files that you may download to a personal computer with access to the Internet. Updated on a regular basis, the CDRH home page includes the guidance as well as the current list of recognized standards and other standards related documents. After publication in the Federal Register, this notice announcing ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 016’’ will be available on the CDRH home page. You may access the CDRH home page at https:// www.fda.gov/cdrh. You may access ‘‘Guidance on the Recognition and Use of Consensus Standards,’’ and the searchable database PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 for ‘‘FDA Recognized Consensus Standards’’ through the hyperlink at https://www.fda.gov/cdrh/stdsprog.html. This Federal Register document on modifications in FDA’s recognition of consensus standards is available at https://www.fda.gov/cdrh/fedregin.html. VII. Submission of Comments and Effective Date Interested persons may submit to the contact person (see FOR FURTHER INFORMATION CONTACT) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. FDA will consider any comments received in determining whether to amend the current listing of modifications to the list of recognized standards, Recognition List Number: 016. These modifications to the list of recognized standards are effective upon publication of this notice in the Federal Register. E:\FR\FM\03NON1.SGM 03NON1 64725 Federal Register / Vol. 71, No. 213 / Friday, November 3, 2006 / Notices Dated: October 27, 2006. Linda S. Kahan, Deputy Director, Center for Devices and Radiological Health. [FR Doc. E6–18604 Filed 11–2–06; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration (HRSA) publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on (301)–443–1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Drug Pricing Program Reporting Requirements (OMB No. 0915–0176)—Extension Section 602 of Pub. L. 102–585, the Veterans Health Care Act of 1992, enacted section 340B of the Public Health Service Act (PHS Act) ‘‘Limitation on Prices of Drugs Purchased by Covered Entities.’’ Section 340B provides that a manufacturer who sells covered outpatient drugs to eligible entities must sign a pharmaceutical pricing agreement with the Secretary of Health and Human Services in which the manufacturer agrees to charge a price for covered outpatient drugs that will not exceed an amount determined under a statutory formula. Covered entities which choose to participate in the section 340B drug discount program must comply with the requirements of 340B(a)(5) of the PHS Act. Section 340B(a)(5)(A) prohibits a covered entity from accepting a discount for a drug that would also generate a Medicaid rebate. Further, section 340B(a)(5)(B) prohibits a covered entity from reselling or otherwise transferring a discounted drug to a person who is not a patient of the entity. In response to the statutory mandate of section 340B(a)(5)(C) to develop audit guidelines and because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA Office of Pharmacy Affairs (OPA) has developed a dispute resolution process for manufacturers and covered entities as well as manufacturer guidelines for audit of covered entities. Audit Guidelines: A manufacturer will be permitted to conduct an audit only when there is reasonable cause to believe a violation of section 340B(a)(5)(A) or (B) has occurred. The manufacturer must notify the covered entity in writing when it believes the covered entity has violated the provisions of 340B. If the problem Number of respondents Reporting requirement Responses per respondent cannot be resolved, the manufacturer must then submit an audit work plan describing the audit and evidence in support of the reasonable cause standard to the HRSA OPA for review. The office will review the documentation to determine if reasonable cause exists. Once the audit is completed, the manufacturer will submit copies of the audit report to the HRSA OPA for review and resolution of the findings, as appropriate. The manufacturer will also submit an informational copy of the audit report to the HHS Office of Inspector General. Dispute Resolution Guidelines: Because of the potential for disputes involving covered entities and participating drug manufacturers, the HRSA OPA has developed an informal dispute resolution process which can be used if an entity or manufacturer is believed to be in violation of section 340B. Prior to filing a request for resolution of a dispute with the HRSA OPA, the parties must attempt, in good faith, to resolve the dispute. All parties involved in the dispute must maintain written documentation as evidence of a good faith attempt to resolve the dispute. If the dispute is not resolved and dispute resolution is desired, a party must submit a written request for a review of the dispute to the HRSA OPA. A committee appointed to review the documentation will send a letter to the party alleged to have committed a violation. The party will be asked to provide a response to or a rebuttal of the allegations. The estimates of annualized burden are as follows: Total responses Hours per response Total burden hours Audits Audit Notification of Entity* ................................................ Audit Work Plan ................................................................. Audit Report ....................................................................... Entity Response ................................................................. 2 1 1 0 1 1 1 0 2 1 1 0 4 8 1 0 8 8 1 0 10 16 80 32 Dispute Resolution Mediation Request ............................................................. Rebuttal .............................................................................. 2 2 4 1 8 2 Total Reporting ........................................................... 8 ........................ 14 .......................... 129 Recordkeeping Requirement mstockstill on PROD1PC68 with NOTICES Dispute Records ................................................................ 10 1 10 .5 5 Total Recordkeeping ................................................... 10 ........................ ........................ .......................... 5 * Prepared by the manufacturer. VerDate Aug<31>2005 15:24 Nov 02, 2006 Jkt 211001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 E:\FR\FM\03NON1.SGM 03NON1

Agencies

[Federal Register Volume 71, Number 213 (Friday, November 3, 2006)]
[Notices]
[Pages 64718-64725]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-18604]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0226]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 016

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a 
publication containing modifications the agency is making to the list 
of standards FDA recognizes for use in premarket reviews (FDA 
recognized consensus standards). This publication, entitled 
``Modifications to the List of Recognized Standards, Recognition List 
Number: 016'' (Recognition List Number: 016), will assist manufacturers 
who elect to declare conformity with consensus standards to meet 
certain requirements for medical devices.

DATES: Submit written or electronic comments concerning this document 
at any time. See section VII of this document for the effective date of 
the recognition of standards announced in this document.

ADDRESSES: Submit written requests for single copies of ``Modifications 
to the List of Recognized Standards, Recognition List Number: 016'' to 
the Division of Small Manufacturers, International and Consumer 
Assistance, Center for Devices and Radiological

[[Page 64719]]

Health (HFZ-220), Food and Drug Administration, 1350 Piccard Dr., 
Rockville, MD 20850. Send two self-addressed adhesive labels to assist 
that office in processing your requests, or fax your request to 301-
443-8818. Submit written comments concerning this document, or 
recommendations for additional standards for recognition, to the 
contact person (see FOR FURTHER INFORMATION CONTACT). Submit electronic 
comments by e-mail: standards@cdrh.fda.gov. This document may also be 
accessed on FDA's Web site at https://www.fda.gov/cdrh/fedregin.html. 
See section VI of this document for electronic access to the searchable 
database for the current list of FDA recognized consensus standards, 
including Recognition List Number: 016 modifications and other 
standards related information.

FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices 
and Radiological Health (HFZ-84), Food and Drug Administration, 12720 
Twinbrook Pkwy., Rockville, MD 20857, 301-827-0021.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal 
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended 
section 514 allows FDA to recognize consensus standards developed by 
international and national organizations for use in satisfying portions 
of device premarket review submissions or other requirements.
    In a notice published in the Federal Register of February 25, 1998 
(63 FR 9561), FDA announced the availability of a guidance entitled 
``Recognition and Use of Consensus Standards.'' The notice described 
how FDA would implement its standard recognition program and provided 
the initial list of recognized standards.
    FDA has modified its initial list of recognized standards in the 
following Federal Register notices:

                                Table 1.
------------------------------------------------------------------------
                          Federal Register Cite
-------------------------------------------------------------------------
October 16, 1998 (63 FR 55617)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240)
------------------------------------------------------------------------
May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------

    These notices describe the addition, withdrawal, and revision of 
certain standards recognized by FDA. The agency maintains ``hypertext 
markup language'' (HTML) and ``portable document format'' (PDF) 
versions of the list of ``FDA Recognized Consensus Standards.'' Both 
versions are publicly accessible at the agency's Web site. See section 
VI of this document for electronic access information. Interested 
persons should review the supplementary information sheet for the 
standard to understand fully the extent to which FDA recognizes the 
standard.

II. Modifications to the List of Recognized Standards, Recognition List 
Number: 016

    FDA is announcing the addition, withdrawal, correction, and 
revision of certain consensus standards the agency will recognize for 
use in satisfying premarket reviews and other requirements for devices. 
FDA will incorporate these modifications in the list of FDA Recognized 
Consensus Standards in the agency's searchable database. FDA will use 
the term ``Recognition List Number: 016'' to identify these current 
modifications.
    In table 1 of this document, FDA describes the following 
modifications: (1) The withdrawal of standards and their replacement by 
others, (2) the correction of errors made by FDA in listing previously 
recognized standards, and (3) the changes to the supplementary 
information sheets of recognized standards that describe revisions to 
the applicability of the standards.
    In section III of this document, FDA lists modifications the agency 
is making that involve the initial addition of standards not previously 
recognized by FDA.

                                Table 2.
------------------------------------------------------------------------
Old Item                                                   Replacement
   No.               Standard                Change          Item No.
------------------------------------------------------------------------
A. Anesthesia
------------------------------------------------------------------------
39        CGA V-5: 2005, Diameter-Index  Withdrawn and                68
           Safety System                  replaced with
           (Noninterchangeable Low        newer version
           Pressure Connections for
           Medical Gas Applications)
------------------------------------------------------------------------
53        ASTM F1464-93 (2005),          Withdrawn and                69
           Standard Specification for     replaced with
           Oxygen Concentrators for       newer version
           Domiciliary Use
------------------------------------------------------------------------
65        ISO 21647: 2005, Medical       Devices         ...............
           Electrical Equipment--         affected,
           Particular Requirements for    Code of
           the Basic Safety and           Federal
           Essential Performance of       Regulations
           Respiratory Gas Monitors       citation, and
                                          relevant
                                          guidance
------------------------------------------------------------------------
B. Biocompatibility
------------------------------------------------------------------------
107       ASTM F1877-05, Standard        Withdrawn and               114
           Practice for                   replaced with
           Characterization of            newer version
           Particles
------------------------------------------------------------------------
108       ASTM F1905-98 (2003),          Title           ...............
           Standard Practice for
           Selecting Tests for
           Determining the Propensity
           of Materials for Cause
           Immunotoxicity
------------------------------------------------------------------------

[[Page 64720]]

 
C. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
49        ANSI/ADA Specification No.     Withdrawn and               130
           17: 1983 (R1999), Denture      replaced with
           Base Temporary Relining        newer version
           Resins
------------------------------------------------------------------------
64        ISO 3107: 2004, Dental Zinc    Withdrawn and               131
           Oxide/Eugenol Cements and      replaced with
           Zinc Oxide Non-Eugenol         newer version
           Cements
------------------------------------------------------------------------
66        ISO 4049: 1988, Dentistry--    Withdrawn.      ...............
           Resin-Based Filling            Refer to item
           Materials                      no. 99
------------------------------------------------------------------------
70        ISO 6874: 2005, Dental Resin-  Withdrawn and               132
           Based Pit and Fissure          replaced with
           Sealants                       newer version
------------------------------------------------------------------------
71        ISO 6876: 2001, Dental Root    Withdrawn and               133
           Canal Sealing Materials        replaced with
                                          newer version
------------------------------------------------------------------------
74        ISO 7494-1: 2004, Dentistry--  Withdrawn and               134
           Dental Units--Part 1:          replaced with
           General Requirements and       newer version
           Test Methods
------------------------------------------------------------------------
114       ANSI/ADA Specification No.     Title           ...............
           48: 1989, Visible Curing
           Units
------------------------------------------------------------------------
116       ISO 10139-1: 2005, Dentistry-- Withdrawn and               135
           Soft Lining Materials for      replaced with
           Removable Dentures--Part 1:    newer version
           Materials for Short-Term Use
------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
83        ASTM D6319-00a (2005),         Withdrawn and               167
           Standard Specification for     replaced with
           Nitrile Examination Gloves     newer version
           for Medical Application
------------------------------------------------------------------------
87        ASTM D3577-06, Standard        Withdrawn and               168
           Specification for Rubber       replaced with
           Surgical Gloves                newer version
------------------------------------------------------------------------
106       ASTM D3772-01 (2005),          Withdrawn and               169
           Standard Specification for     replaced with
           Natural Rubber Finger Cots     newer version
------------------------------------------------------------------------
E. In Vitro Diagnostics
------------------------------------------------------------------------
003       CLSI/NCCLS GP10-A 1995,        Contact person  ...............
           Assessment of the Clinical
           Accuracy of Laboratory Tests
           Using Receiver Operating
           Characteristic (ROC) Plots;
           Approved Guideline
------------------------------------------------------------------------
004       CLSI/NCCLS GP14-A 1996,        Contact person  ...............
           Labeling of Home-Use In
           Vitro Testing Products;
           Approved Guideline
------------------------------------------------------------------------
007       CLSI/NCCLS LA1-A2 1994,        Contact person  ...............
           Assessing the Quality of
           Radioimmunoassay Systems--2d
           ed.; Approved Guideline
------------------------------------------------------------------------
012       CLSI/NCCLS C12-A, Definitions  Contact person  ...............
           of Quantities and
           Conventions Related to Blood
           pH and Gas Analysis;
           Approved Standard
------------------------------------------------------------------------
013       CLSI/NCCLS C21-A, Performance  Contact person  ...............
           Characteristics for Devices
           Measuring PO2 and PCO2 in
           Blood Samples; Approved
           Standard
------------------------------------------------------------------------
015       CLSI/NCCLS C25-A, Fractional   Contact person  ...............
           Oxyhemoglobin, Oxygen
           Content and Saturation, and
           Related Quantities in Blood:
           Terminology, Measurement,
           and Reporting; Approved
           Guideline
------------------------------------------------------------------------
016       CLSI/NCCLS C27-A, Blood Gas    Contact person  ...............
           Preanalytical
           Considerations: Specimen
           Collection, Calibration, and
           Controls; Approved Guideline
------------------------------------------------------------------------
018       CLSI/NCCLS C30-A, Ancillary    Contact person  ...............
           (Bedside) Blood Glucose
           Testing
------------------------------------------------------------------------
038       CLSI/NCCLS I/LA10-A,           Contact person  ...............
           Choriogonadotropin Testing:
           Nomenclature, Reference
           Preparations, Assay
           Performance, and Clinical
           Application; Approved
           Guideline
------------------------------------------------------------------------
039       CLSI/NCCLS I/LA17-A,           Contact person  ...............
           Assessing the Quality of
           Systems for Alpha-
           Fetoprotein (AFP) Assays
           Used in Prenatal Screening
           and Diagnosis of Neural Tube
           Defects; Approved Guideline
------------------------------------------------------------------------

[[Page 64721]]

 
043       CLSI/NCCLS LA4-A3, Blood       Contact person  ...............
           Collection on Filter Paper
           for Neonatal Screening
           Programs; Approved Standard--
           3d ed.
------------------------------------------------------------------------
048       CLSI/NCCLS T/DM6-A, Blood      Contact person  ...............
           Alcohol Testing in the
           Clinical Laboratory;
           Approved Guideline
------------------------------------------------------------------------
051       CLSI/NCCLS GP 27-A, Using      Contact person  ...............
           Proficiency Testing (PT) to
           Improve the Clinical
           Laboratory; Approved
           Guideline
------------------------------------------------------------------------
052       CLSI/NCCLS NRSCL 8-A,          Contact person  ...............
           Terminology and Definitions
           for Use in National
           Committee for Clinical
           Laboratory Standards (NCCLS)
           Documents; Approved Standard
------------------------------------------------------------------------
055       CLSI/NCCLS H18-A2, Procedures  Contact person  ...............
           for the Handling and
           Processing of Blood
           Specimens; Approved
           Guideline
------------------------------------------------------------------------
059       CLSI/NCCLS AUTO2-A,            Contact person  ...............
           Laboratory Automation: Bar
           Codes for Specimen Container
           Identification; Approved
           Standard
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
40        ASTM F2063-05, Standard        Withdrawn and               122
           Specification for Wrought      replaced with
           Nickel-Titanium Shape Memory   newer version
           Alloys for Medical Devices
           and Surgical Implants
------------------------------------------------------------------------
48        ASTM F899-02, Standard         Contact person  ...............
           Specification for Stainless
           Steel for Surgical
           Instruments
------------------------------------------------------------------------
60        ISO 5832-5: 2005, Implants     Withdrawn and               123
           for Surgery--Metallic          replaced with
           Materials--Part 5: Wrought     newer version
           Cobalt-Chromium-Tungsten-
           Nickel Alloy
------------------------------------------------------------------------
65        ISO 5834-2: 2006, Implants     Withdrawn and               127
           for Surgery--Ultra-High-       replaced with
           Molecular-Weight               newer version
           Polyethylene--Part 2:
           Moulded Forms
------------------------------------------------------------------------
67        ISO 7153-1: 1991/Amd. 1:       Contact person  ...............
           1999, Surgical Instruments--
           Metallic Materials--Part 1:
           Stainless Steel
------------------------------------------------------------------------
70        ASTM F2052-06e1, Standard      Withdrawn and               124
           Test Method for Measurement    replaced with
           of Magnetically Induced        newer version
           Displacement Force on
           Medical Devices in the
           Magnetic Resonance
           Environment
------------------------------------------------------------------------
72        ASTM F2213-06, Standard Test   Withdrawn and               128
           Method for Measurement of      replaced with
           Magnetically Induced Torque    newer version
           on Passive Implants in the
           Magnetic Resonance
           Environment
------------------------------------------------------------------------
85        ASTM F1854-01, Standard Test   Contact person  ...............
           Method for Stereological
           Evaluation of Porous
           Coatings on Medical Implants
------------------------------------------------------------------------
86        ASTM F1926-03, Standard Test   Contact person  ...............
           Method for Evaluation of the
           Environmental Stability of
           Calcium Phosphate Coatings
------------------------------------------------------------------------
88        ASTM F2024-00, Standard        Contact person  ...............
           Practice for X-Ray
           Diffraction Determination of
           Phase Content of Plasma-
           Sprayed Hydroxyapatite
           Coatings
------------------------------------------------------------------------
89        ASTM F1873-98, Standard        Contact person  ...............
           Specification for High-
           Purity Dense Yttria
           Tetragonal Zirconium Oxide
           Polycrystal (Y-TZP) for
           Surgical Implant
           Applications
------------------------------------------------------------------------
94        ASTM F601-03, Standard         Contact person  ...............
           Practice for Fluorescent
           Penetrant Inspection of
           Metallic Surgical Implants
------------------------------------------------------------------------
99        ASTM F2004-05, Standard Test   Withdrawn and               125
           Method for Transformation      replaced with
           Temperature of Nickel-         newer version
           Titanium Alloys by Thermal
           Analysis
------------------------------------------------------------------------
103       ASTM F1801-97 (2004),          Contact person  ...............
           Standard Practice for
           Corrosion Fatigue Testing of
           Metallic Implant Materials
------------------------------------------------------------------------
106       ASTM F648-04, Standard         Contact person  ...............
           Specification for Ultra-High-
           Molecular-Weight
           Polyethylene Powder and
           Fabricated Form for Surgical
           Implants
------------------------------------------------------------------------
109       ASTM F561-05a, Standard        Withdrawn and               126
           Practice for Retrieval and     replaced with
           Analysis of Medical Devices,   newer version
           and Associated Tissues and
           Fluids
------------------------------------------------------------------------

[[Page 64722]]

 
111       ASTM F1160-05, Standard Test   Contact person  ...............
           Method for Shear and Bending
           Fatigue Testing of Calcium
           Phosphate and Metallic
           Medical and Composite
           Calcium Phosphate/Metallic
           Coatings
------------------------------------------------------------------------
112       ASTM F1044-05, Standard Test   Contact person  ...............
           Method for Shear Testing of
           Calcium Phosphate Coatings
           and Metallic Coatings
------------------------------------------------------------------------
113       ASTM F1147-05, Standard Test   Contact person  ...............
           Method for Tension Testing
           of Calcium Phosphate and
           Metal Coatings
------------------------------------------------------------------------
117       ASTM F86-04, Standard          Contact person  ...............
           Practice for Surface
           Preparation and Marking of
           Metallic Surgical Implants
------------------------------------------------------------------------
G. Obstetrics-Gynecology (OB-GYN)/Gastroenterology
------------------------------------------------------------------------
28        ANSI/AAMI RD16: 1996/A1: 2002/ Reaffirmation   ...............
           (R)2005, Hemodialyzers
------------------------------------------------------------------------
29        ANSI/AAMI RD17: 1994/A1: 2002/ Reaffirmation   ...............
           (R)2005, Hemodialyzer Blood
           Tubing
------------------------------------------------------------------------
31        ANSI/AAMI ID54: 1996/(R)2005,  Reaffirmation   ...............
           Enteral Feeding Set Adapters
           and Connectors
------------------------------------------------------------------------
H. Ophthalmic
------------------------------------------------------------------------
20        ISO 11979-1: 1999, Ophthalmic  Contact person  ...............
           Implants--Intraocular
           Lenses--Part 1: Vocabulary
------------------------------------------------------------------------
22        ISO 11979-3: 1999, Ophthalmic  Contact person  ...............
           Implants--Intraocular
           Lenses--Part 3: Mechanical
           Properties and Test Methods
------------------------------------------------------------------------
32        ISO 11990: 2003, Optics and    Withdrawn and   ...............
           Optical Instruments--Lasers    transferred
           and Laser-Related Equipment--  to Radiology
           Determination of Laser
           Resistance of Tracheal Tube
           Shafts
------------------------------------------------------------------------
I. Orthopedic/Physical Medicine
------------------------------------------------------------------------
85        ISO 14630: 2005, Non-Active    Withdrawn and               194
           Surgical Implants--General     replaced with
           Requirements                   newer version
------------------------------------------------------------------------
141       ASTM F1612-95 (2005),          Withdrawn and               195
           Standard Practice for Cyclic   replaced with
           Fatigue Testing of Metallic    newer version
           Stemmed Hip Arthroplasty
           Femoral Components With
           Torsion
------------------------------------------------------------------------
142       ASTM F1672-95 (2005),          Withdrawn and               196
           Standard Specification for     replaced with
           Resurfacing Patellar           newer version
           Prosthesis
------------------------------------------------------------------------
150       ASTM F983-86 (2005), Standard  Withdrawn and               197
           Practice for Permanent         replaced with
           Marking of Orthopaedic         newer version
           Implant Components
------------------------------------------------------------------------
162       ASTM F564-02 (2006), Standard  Withdrawn and               201
           Specification and Test         replaced with
           Methods for Metallic Bone      newer version
           Staples
------------------------------------------------------------------------
174       ASTM F382-99 (2003) e1,        Withdrawn and               198
           Standard Specification and     replaced with
           Test Method for Metallic       newer version
           Bone Plates
------------------------------------------------------------------------
176       ASTM F565-04, Standard         Withdrawn and               199
           Practice for Care and          replaced with
           Handling of Orthopedic         newer version
           Implants and Instruments
------------------------------------------------------------------------
193       ASTM F2083-06, Standard        Withdrawn and               200
           Specification for Total Knee   replaced with
           Prosthesis                     newer version
------------------------------------------------------------------------
J. Radiology
------------------------------------------------------------------------
32        ISO 11990: 2003, Optics and    Transferred                 144
 (Opthal   Optical Instruments--Lasers    from
 mic)      and Laser-Related Equipment--  Ophthalmic,
           Determination of Laser         type of
           Resistance of Tracheal Tube    standard, and
           Shafts                         contact
                                          person
------------------------------------------------------------------------
92        IEC 61674 (1997-10), Medical   Withdrawn and               145
           Electrical Cquipment--         replaced
           Dosimeters With Ionization
           Chambers and/or Semi-
           Conductor Detectors as Used
           in X-Ray Diagnostic Imaging
------------------------------------------------------------------------

[[Page 64723]]

 
93        IEC 61674 (2002), Amendment    Withdrawn and               145
           1, Medical Electrical          replaced
           Equipment--Dosimeters With
           Ionization Chambers and/or
           Semi-Conductor Detectors as
           Used in X-Ray Diagnostic
           Imaging
------------------------------------------------------------------------
118       IEC 60601-2-17 (2005),         Withdrawn and               146
           Medical Electrical             replaced with
           Equipment--Part 2-17:          newer version
           Particular Requirements for
           the Safety of Automatically-
           Controlled Brachytherapy
           Afterloading Equipment
------------------------------------------------------------------------
135       IEC 60601-2-5 (2005), Medical  Withdrawn and               147
           Electrical Equipment--Part 2-  replaced with
           5: Particular Requirements     newer version
           for the Safety of Ultrasonic
           Physiotherapy Equipment ed.
           2.0
------------------------------------------------------------------------
8         IEC 60336 (2005), Medical      Withdrawn and               149
           Electrical Equipment--X-Ray    replaced with
           Tube Assemblies for Medical    newer version
           Diagnosis--Characteristics
           of Focal Spots
------------------------------------------------------------------------
K. Sterility
------------------------------------------------------------------------
74        ANSI/AAMI ST 60: 1996,         Withdrawn       ...............
           Sterilization of Health Care
           Products--Chemical
           Indicators--Part 1: General
           Requirements
------------------------------------------------------------------------
103       ISO 11607-2000, Packaging for  Withdrawn       ...............
           Terminally Sterilized
           Medical Devices
------------------------------------------------------------------------

III. Listing of New Entries

    The listing of new entries and consensus standards, added as 
modifications to the list of recognized standards under Recognition 
List Number: 016, follows:

                                                    Table 3.
----------------------------------------------------------------------------------------------------------------
        Item No.                         Title of Standard                         Reference No. and Date
----------------------------------------------------------------------------------------------------------------
A. Dental/ENT
----------------------------------------------------------------------------------------------------------------
136                      Standard Practice for Describing System Output                            ASTM F2504-05
                          of Implantable Middle Ear Hearing Devices
----------------------------------------------------------------------------------------------------------------
B. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
160                      Sterile Single-Use Syringes, With or Without           ISO 8537: 1991/Amendment 1: 2000
                          Needle, for Insulin
----------------------------------------------------------------------------------------------------------------
161                      Sterile, Single-Use Intravascular Catheters--      ISO 10555-1: 1996/Amendment 1: 1999,
                          Part 1: General Requirements                                         Amendment 2: 2004
----------------------------------------------------------------------------------------------------------------
162                      Infusion Equipment for Medical Use--Part 1:          ISO 8536-1: 2000/Amendment 1: 2004
                          Infusion Glass Bottles
----------------------------------------------------------------------------------------------------------------
163                      Stainless Steel Needle Tubing for the                  ISO 9626: 1991/Amendment 1: 2001
                          Manufacture of Medical Devices
----------------------------------------------------------------------------------------------------------------
164                      Sterile, Single-Use Intravascular Catheters--      ISO 10555-5: 1996/Amendment 1: 1999,
                          Part 5: Over-Needle Peripheral Catheters                           Corrigendum 1: 2002
----------------------------------------------------------------------------------------------------------------
165                      Standard Specification for Polychloroprene                                ASTM D6977-04
                          Examination Gloves for Medical Application
----------------------------------------------------------------------------------------------------------------
166                      Standard Specification for Puncture Resistance                            ASTM F2132-01
                          of Materials Used in Containers for Discarded
                          Medical Needles and Other Sharps
----------------------------------------------------------------------------------------------------------------
C. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
124                      Fluorescence Calibration and Quantitative                           CLSI/NCCLS I/LA24-A
                          Measurement of Fluorescence Intensity; Approved
                          Guideline
----------------------------------------------------------------------------------------------------------------
125                      Procedures for the Recovery and Identification             CLSI M28-A2, Vol. 25, No. 16
                          of Parasites from the Intestinal Tract;
                          Approved Guideline
----------------------------------------------------------------------------------------------------------------
126                      Susceptibility Testing of Mycobacteria,                     CLSI M24-A, Vol. 23, No. 18
                          Nocardiae, and Other Aerobic Actinomycetes
----------------------------------------------------------------------------------------------------------------
D. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------

[[Page 64724]]

 
38                       Optics and Optical Instruments--Medical              ISO 8600-3: 1997/Amendment 1: 2003
                          Endoscopes and Endoscopic Accessories Part 3:
                          Determination of Field of View and Direction of
                          View of Endoscopes with Optics
----------------------------------------------------------------------------------------------------------------
39                       Optics and Photonics--Medical Endoscopes and                           ISO 8600-5: 2005
                          Endotherapy Devices--Part 5: Determination of
                          Optical Resolution of Rigid Endoscopes with
                          Optics
----------------------------------------------------------------------------------------------------------------
40                       Optics and Photonics--Medical Endoscopes and                           ISO 8600-6: 2005
                          Endotherapy Devices--Part 6: Vocabulary
----------------------------------------------------------------------------------------------------------------
E. Radiology
----------------------------------------------------------------------------------------------------------------
145                      Medical Electrical Equipment--Dosimeters with     IEC 61674 (1997), (2002), Amendment 1
                          Ionization Chambers and/or Semi-Conductor
                          Detectors as Used in X-Ray Diagnostic Imaging
----------------------------------------------------------------------------------------------------------------
148                      Medical Electrical Equipment--Part 2-37:             IEC 60601-2-37 (2005), Amendment 2
                          Particular Requirements for the Safety of
                          Ultrasonic Medical Diagnostic and Monitoring
                          Equipment
----------------------------------------------------------------------------------------------------------------
F. Software
----------------------------------------------------------------------------------------------------------------
8                        Medical Device Software--Software Life Cycle                   IEC 62304 ed. 1.0 (2006)
                          Processes
----------------------------------------------------------------------------------------------------------------
G. Sterility
----------------------------------------------------------------------------------------------------------------
193                      Packaging for Terminally Sterilized Medical                 ANSI/AAMI/ISO 11607-1: 2006
                          Devices--Part 1: Requirements for Materials,
                          Sterile Barrier Systems, and Packaging Systems,
                          3d ed.
----------------------------------------------------------------------------------------------------------------
194                      Packaging for Terminally Sterilized Medical                 ANSI/AAMI/ISO 11607-2: 2006
                          Devices--Part 2: Validation Requirements for
                          Forming, Sealing, and Assembly Processes, 1st
                          ed.
----------------------------------------------------------------------------------------------------------------
195                      Sterilization of Health Care Products--Chemical             ANSI/AAMI/ISO 11140-1: 2005
                          Indicators--Part 1: General Requirements, 2d
                          ed.
----------------------------------------------------------------------------------------------------------------

IV. List of Recognized Standards

    FDA maintains the agency's current list of FDA recognized consensus 
standards in a searchable database that may be accessed directly at 
FDA's Web site at https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA will incorporate the 
modifications and minor revisions described in this notice into the 
database and, upon publication in the Federal Register, this 
recognition of consensus standards will be effective. FDA will announce 
additional modifications and minor revisions to the list of recognized 
consensus standards, as needed, in the Federal Register once a year, or 
more often, if necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for 
recognition under section 514 of the act by submitting such 
recommendations, with reasons for the recommendation, to the contact 
person (see FOR FURTHER INFORMATION CONTACT). To be properly considered 
such recommendations should contain, at a minimum, the following 
information: (1) Title of the standard, (2) any reference number and 
date, (3) name and address of the national or international standards 
development organization, (4) a proposed list of devices for which a 
declaration of conformity to this standard should routinely apply, and 
(5) a brief identification of the testing or performance or other 
characteristics of the device(s) that would be addressed by a 
declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of 
Consensus Standards'' by using the Internet. CDRH maintains a site on 
the Internet for easy access to information including text, graphics, 
and files that you may download to a personal computer with access to 
the Internet. Updated on a regular basis, the CDRH home page includes 
the guidance as well as the current list of recognized standards and 
other standards related documents. After publication in the Federal 
Register, this notice announcing ``Modifications to the List of 
Recognized Standards, Recognition List Number: 016'' will be available 
on the CDRH home page. You may access the CDRH home page at https://
www.fda.gov/cdrh.
    You may access ``Guidance on the Recognition and Use of Consensus 
Standards,'' and the searchable database for ``FDA Recognized Consensus 
Standards'' through the hyperlink at https://www.fda.gov/cdrh/
stdsprog.html.
    This Federal Register document on modifications in FDA's 
recognition of consensus standards is available at https://www.fda.gov/
cdrh/fedregin.html.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR 
FURTHER INFORMATION CONTACT) written or electronic comments regarding 
this document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. FDA will consider any 
comments received in determining whether to amend the current listing 
of modifications to the list of recognized standards, Recognition List 
Number: 016. These modifications to the list of recognized standards 
are effective upon publication of this notice in the Federal Register.


[[Page 64725]]


    Dated: October 27, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-18604 Filed 11-2-06; 8:45 am]
BILLING CODE 4160-01-S
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