Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 021, 11586-11593 [E9-5858]

Download as PDF 11586 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices INA 412(c)(1)(B) states that formula funds shall be allocated based on the total number of refugees, taking into account secondary migration. In order to meet the statutory requirements, ORR requires each state to submit disaggregated individual records containing certain data elements for eligible refugee populations. This revised collection differs from the ORR– 11 Refugee State-of-Origin Report process, whereby states submitted the ORR–11 form containing aggregate data on the number of refugees and entrants served whose ‘‘area numbers’’ (the first three digits of the social security number) fell into each of several designated numerical ranges. ORR used the information on the ORR–11 to measure secondary migration for the purposes of formula funds allocation to states. The revision is proposed due to the realization that: (1) The Social Security Administration states that the first three digits of social security numbers (area number) should not be used for any other purpose than as an individual identifier for book-keeping purposes. (2) It is possible for individuals to apply for Social Security Numbers from any Social Security office, not just offices in the state in which they were born or first resided. This is particularly likely in metropolitan statistical areas where individuals may live in one of several states (e.g., the Washington Metropolitan Area). In these cases, the area number of the Social Security Number may be unreliable as a measure of refugees’ state of initial resettlement. (3) In recent years, the Social Security Administration has begun to issue Social Security Numbers whose area number is not connected to any specific state. The submission of individual records via the Refugee Data Submission System for Formula Funds Allocations Web site is a more reliable and secure process for collecting data for the purposes of tracking secondary migration and allocating formula funds. Data submitted by the States via the secure Web site are compiled and analyzed by the ORR statistician for the purpose of refugee secondary services formula funds allocation. The statistician also prepares a summary report, which is included in ORR’s Annual Report to Congress. Respondents: States and the District of Columbia. ANNUAL BURDEN ESTIMATES Instrument Number of respondents Number of responses per respondent Average burden hours per response Total burden hours Refugee Data Submission for Formula Funds Allocations ............................. 50 1 20 1,000 tjames on PRODPC61 with NOTICES Estimated Total Annual Burden Hours: 1,000. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Administration, Office of Information Services, 370 L’Enfant Promenade, SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. All requests should be identified by the title of the information collection. E-mail address: infocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project. Fax: 202–395–6974. Attn: Desk Officer for the Administration for Children and Families. Dated: March 13, 2009. Janean Chambers, Reports Clearance Officer. [FR Doc. E9–5814 Filed 3–17–09; 8:45 am] BILLING CODE 4184–01–P VerDate Nov<24>2008 14:48 Mar 17, 2009 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2004–N–0451] Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 021 AGENCY: Food and Drug Administration, HHS. ACTION: 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 consensus standards). This publication, entitled ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 021’’ (Recognition List Number: 021), 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. PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 ADDRESSES: Submit written requests for single copies of ‘‘Modifications to the List of Recognized Standards, Recognition List Number: 021’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological 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 240–276–3151. 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 Internet site at https://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfTopic/ cdrhnew.cfm. 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: 021 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, 7520 Standish Place, Rockville, MD 20855, 240–276– 8714. E:\FR\FM\18MRN1.SGM 18MRN1 11587 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices 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. Modifications to the initial list of recognized standards, as published in the Federal Register, are identified in table 1. TABLE 1—FEDERAL REGISTER CITATION October 16, 1998 (63 FR 55617) May 27, 2005 (70 FR 30756) July 12, 1999 (64 FR 37546) November 8, 2005 (70 FR 67713) November 15, 2000 (65 FR 69022) March 31, 2006 (71 FR 16313) May 7, 2001 (66 FR 23032) June 23, 2006 (71 FR 36121) January 14, 2002 (67 FR 1774) November 3, 2006 (71 FR 64718) October 2, 2002 (67 FR 61893) May 21, 2007 (72 FR 28500) April 28, 2003 (68 FR 22391) September 12, 2007 (72 FR 52142) March 8, 2004 (69 FR 10712) December 19, 2007 (72 FR 71924) June 18, 2004 (69 FR 34176) September 9, 2008 (73 FR 52358) October 4, 2004 (69 FR 59240) 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 Internet 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: 021 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: 021’’ to identify these current modifications. In table 2 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 Recognition No. Replacement Recognition No. Standard Change A. Anesthesia 1–49 ASTM F 1981–99 Standard Specification for Suction Catheters for use in the Respiratory Tract Withdrawn tjames on PRODPC61 with NOTICES 1–63 1–77 CGA V–1:2005 Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection Withdrawn and replaced with newer version 1–64 1–78 ASME PVHO–1–2007 Safety Standard for Pressure Vessels for Human Occupancy Withdrawn and replaced with newer version VerDate Nov<24>2008 14:48 Mar 17, 2009 Jkt 217001 PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1 11588 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices TABLE 2—Continued Old Recognition No. Replacement Recognition No. Standard Change 1–71 ISO 10651–5:2006 Lung Ventilators for Medical Use—Particular requirements for Basic Safety and Essential Performance—Part 5: Gas-powered Emergency Resuscitators Withdrawn duplicate 1–74 ISO 5360:2006 Anaesthetic Vaporizers—Agent Specific Filling Systems Contact person 1–79 ISO 26825:2008 (E) Anaesthetic And Respiratory Equipment—User-Applied Labels For Syringes Containing Drugs Used During Anaesthesia—Colours, Design and Performance Withdrawn and replaced with newer version 2–71 2–133 ASTM F1408–97 (2008) Standard Practice for Subcutaneous Screening Test for Implant Materials Withdrawn and replaced with newer version 2–73 2–134 ASTM F2065–00(2006) Standard Practice for Testing for Alternative Pathway Complement Activation in Serum by Solid Materials Withdrawn and replaced with newer version AAMI/ANSI/ISO 10993–10:2002 Biological Evaluation of Medical Devices— Part 10: Tests for Irritation and Delayed-Type Hypersensitivity Extent of Recognition, Relevant Guidance, and Contact Person AAMI/ANSI/ISO 10993–12:2007 Biological Evaluation of Medical Devices— Part 12: Sample Preparation and Reference Materials Withdrawn and replaced with newer version ANSI/AAMI BE 78:2002/A1:2006 Biological Evaluation of Medical Devices—Part 10: Tests For Irritation and Delayed-Type Hypersensitivity— Amendment 1 Withdrawn ASTM F2129–06 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices Offices, Devices Affected, Relevant Guidance, CFR Citation and Product Codes, Contact Person 1–76 B. Biocompatibility 2–87 2–88 2–135 2–127 C. Cardiovascular/Neurology 3–67 D. General Hospital/General Plastic Surgery IEC 60601–2–19 1996–10: Amendment 1—Medical Electrical Equipment Part 2: Particular Requirements for Safety of Baby Incubators Relevant guidance 6–32 IEC 60601–2–20 1996–10: Amendment 1—Medical Electrical Equipment Part 2: Particular Requirements for the Safety Of Transport Incubators Relevant guidance 6–62 ISO 8536–6:1995 Infusion Equipment for Medical Use—Part 6: Freeze Drying Closures for Infusion Bottles Relevant guidance 6–63 ISO 8536–7–1999: Infusion Equipment for Medical Use—Part 7: Caps Made of Aluminum-Plastics Combinations For Infusion Bottles Relevant guidance 6–64 ISO 8536–3–1999, Infusion Equipment for Medical Use—Part 3: Aluminum Caps for Infusion Bottles Relevant guidance 6–119 ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood Transfusion Micro-Filters Reaffirmation 2007, Title, SDO, Date of standard, Relevant guidance 6–122 ISO 8536–5–2004:, Infusion Equipment for Medical Use—Part 5: Burette Infusion Sets for Single Use, Gravity Feed Relevant guidance 6–127 tjames on PRODPC61 with NOTICES 6–29 ISO 1135–4–2004: Transfusion Equipment for Medical Use—Part 4: Transfusion Sets for Single Use Relevant guidance 6–142 ANSI/AAMI II36:2004 Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Baby Incubators Title, Relevant guidance 6–143 ANSI/AAMI II51:2004, Medical Electrical Equipment—Part 2: Particular Requirements for Safety of Transport Incubators Title, Relevant guidance VerDate Nov<24>2008 14:48 Mar 17, 2009 Jkt 217001 PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1 11589 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices TABLE 2—Continued Old Recognition No. Replacement Recognition No. Standard Change 6–172 ISO 8536–1:2006 Infusion Equipment for Medical Use—Part 1: Infusion Glass Bottles Relevant guidance 6–173 ISO 8536–2:2001 Corrigendum 1:2003, Infusion Equipment for Medical Use—Part 2: Closures for Infusion Bottles Relevant guidance 6–182 IEC 60601–2–38 1996/Amendment 1:1999, Medical Electrical Equipment— Part 2–38: Particular Requirements for the Safety of Electrically Operated Hospital Beds Relevant guidance 6–201 ISO 8536–4:2007 Infusion Equipment for Medical Use—Part 4: Infusion Sets for Single Use, Gravity Feed Relevant guidance 6–215 ASTM F2132–01(2008)E1 Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps Title CLSI M27–A3 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts Withdrawn and replaced with newer version 7–54 CLSI D12–A2, Immunoprecipitin Analyses: Procedures for Evaluating the Performance of Materials—Second Edition; Approved Guideline Title 7–71 CLSI H15–A3, Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard—Third Edition Contact person 7–145 CLSI H42–A2, Enumeration of Immunologically Defined Cell Populations by Flow Cytometry. Contact person CLSI ILA21–A2 Clinical Evaluation of Immunoassays Withdrawn and replaced with newer version 7–130 CLSI H20–A2, Reference Leucocyte Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard—Second Edition Contact person 7–164 CLSI GP 28–A Microwave Device Use in the Histology Laboratory; Approved Guideline Contact person 7–171 CLSI M38–A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi Withdrawn and replaced with newer version 3–3 17–1 AAMI NS28:1988/(R) 2006 Intracranial Pressure Monitoring Devices Transferred, Date of standard, Extent of recognition, Relevant guidance 3–32 17–2 ASTM F1542–94(2000) Standard Specification for the Requirements and Disclosure of Self-Closing Aneurysm Clips Transferred, Offices, Type of standard, Extent of recognition, Relevant guidance, Contact person 3–33 17–3 ISO 7197:2006 Neurosurgical implants—Sterile, Single-use hydrocephalus Shunts and Components Transferred—Withdrawn and replaced with newer version 3–39 17–4 ASTM F647–94(2006) Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application Transferred—Withdrawn and replaced with newer version 3–60 17–5 IEC 60601–2–10 1987/Amendment 1 2001 Medical Electrical Equipment— Part 2–10: Particular Requirements for the Safety of Nerve and Muscle Stimulators Transferred, Title change, Date of standard, Relevant guidance, Contact person 3–67 17–6 ASTM F2129–06 Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices Offices, Devices affected, Type of Standard, Product code, Relevant guidance, Contact person E. IVD 7–138 7–73 7–168 7–169 7–170 tjames on PRODPC61 with NOTICES F. Neurology G. OB-GYN/Gastroenterology VerDate Nov<24>2008 14:48 Mar 17, 2009 Jkt 217001 PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1 11590 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices TABLE 2—Continued Old Recognition No. Replacement Recognition No. Standard Change 9–30 9–55 ANSI/ AAMI RD62:2006 Water Treatment Equipment for Hemodialysis Applications Withdrawn and replaced with newer version 9–32 9–56 ASTM D3492–08 Standard Specification for Rubber Contraceptives (Male Condoms) Withdrawn and replaced with newer version ISO 4074:2002/Cor.1:2003(E): Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 1 Extent of recognition, Product codes, Relevant guidance AIUM AOL, Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment: A Standard for How Manufacturers Should Specify Acoustic Output Data Relevant guidance IEC 60601–2–29 (2008) Medical Electrical Equipment—Part 2–29: Particular Requirements for the Basic Safety and Essential Performance of Radiotherapy Simulators—Third Edition Withdrawn and replaced with newer version AIUM MUS, Medical Ultrasound Safety Relevant guidance 9–34 H. Radiology 12–48 12–55 12–186 12–66 12–96 12–187 NEMA MS 3–2008 Determination of Image Uniformity in Diagnostic Magnetic Resonance Images Withdrawn and replaced with newer version 12–97 12–188 NEMA MS 1–2008 Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging Withdrawn and replaced with newer version 12–100 NEMA UD 3–2004, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Relevant guidance 12–105 NEMA UD 2–2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Version 3 Title, Relevant guidance 12–139 AIUM AOMS–2005, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Relevant guidance 12–140 AIUM RTD1–2005, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment Revision 1 Relevant guidance IEC 60601–2–33 (2008) Medical Electrical Equipment—Part 2–33: Particular Requirements for the Safety of Magnetic Resonance Equipment for Medical Diagnosis Consolidated Edition 2.2 Withdrawn and replaced with a newer version IEC 60601–2–37:2007, Medical Electrical Equipment—Part 2–37: Particular Requirements for the Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic and Monitoring Equipment Relevant guidance 12–190 IEC 61217 (2008) Radiotherapy Equipment—Coordinates, Movements, and Scales Consolidated Edition 1.2 Withdrawn and replaced with newer version 14–120 14–257 ASTM D3078—02(2008) Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission Withdrawn and replaced with newer version 14–148 14–258 ASTM F2250—03(2008) Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials Withdrawn and replaced with newer version 14–149 14–259 ASTM F2251—03(2008) Standard Test Method for Thickness Measurement of Flexible Packaging Material Withdrawn and replaced with newer version 14–150 14–260 ASTM F2252—03(2008) Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape Withdrawn and replaced with newer version ASTM F2212–02(2008)e1, Standard Guide for Characterization of Type I Collagen as a Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products Withdrawn and replaced with newer version 12–161 12–189 12–182 12–184 tjames on PRODPC61 with NOTICES I. Sterility J. Tissue Engineering 15–11 VerDate Nov<24>2008 15–13 14:48 Mar 17, 2009 Jkt 217001 PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices III. Listing of New Entries In table 3 of this document, FDA provides the listing of new entries and consensus standards added as modifications to the list of recognized 11591 standards under Recognition List Number: 021. TABLE 3 Recognition No. Title of Standard Reference No. & Date A. Dental/ENT 4–160 Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms ANSI ASA S3.1–1999 (R 2003) 4–161 Method for Measuring the Intelligibility of Speech Over Communication Systems ANSI ASA S3.2–1989 (R 1999) 4–162 Procedure for the Computation of Loudness of Steady Sounds ANSI ASA S3.4–2007 4–163 Methods for Calculation of the Speech Intelligibility Index ANSI ASA S3.5–1997 (R 2007) 4–164 Method for Coupler Calibration of Earphones ANSI ASA S3.7–1995 (R 2003) 4–165 Mechanical Coupler for Measurement of Bone Vibrators ANSI ASA S3.13–1987 (R 2007) 4–166 Bioacoustical Terminology ANSI ASA S3.20–1995 (R 2003) 4–167 Methods for Manual Pure-Tone Threshold Audiometry ANSI ASA S3.21–2004 4–168 Occluded Ear Simulator ANSI ASA S3.25–1989 (R 2003) 4–169 Method of Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions ANSI ASA S3.35–2004 4–170 Specification for a Manikin for Simulated in situ Airborne Acoustic Measurements ANSI ASA S3.36–1985 (R 2006) 4–171 Preferred Earhook Nozzle Thread for Postauricular Hearing Aids ANSI ASA S3.37–1987 (R 2007) 4–172 Testing Hearing Aids with a Broad-Band Noise Signal ANSI ASA S3.42–1992 (R 2007) 4–173 Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment ANSI ASA S3.44–1996 (R 2006) 4–174 Procedures for Testing Basic Vestibular Function ANSI ASA S3.45–1999 4–175 Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids ANSI ASA S3.46–1997 (R 2002) 4–176 Criteria for Evaluating Room Noise ANSI ASA S12.2–1995 (R 1999) 4–177 Rating Noise with Respect to Speech Interference ANSI ASA S12.65–2006 Standard Practice for Performance Testing of Packages for Single Delivery Systems ASTM D7386–08 7–172 Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory C28–P3 7–173 Harmonization of Glycohemoglobin Measurements C44–A 7–174 Estimation of Total Analytical Error for Clinical Laboratory EP21–A 7–175 Apolipoprotein Immunoassays: Development and Recommended Performance Characteristics ILA15–A 7–176 Immunoassay Interference by Endogenous Antibodies ILA30–A B. General 5–45 tjames on PRODPC61 with NOTICES C. IVD VerDate Nov<24>2008 14:48 Mar 17, 2009 Jkt 217001 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1 11592 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / Notices TABLE 3—Continued Recognition No. Title of Standard Reference No. & Date 7–177 Performance Standards for Antimicrobial Susceptibility Testing M100–S18 7–178 Quality Control for Commercially Prepared Microbiological Culture Media M22–A3 7–179 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts M27–S3 7–180 Western Blot Assay for Antibodies to Borrelia burgdorferi M34–A 7–181 Abbreviated Identification of Bacteria and Yeasts M35–A 7–182 Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii M36–A 7–183 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi M38–A2 7–184 Quality Control of Microbiological Transport Systems M40–A 7–185 Viral Culture M41–A 7–186 Methods for Antifungal Disk Diffusion Susceptibility Testing M44–A 7–187 Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeast M44–S2 7–188 Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria M45–A 7–189 Principles and Procedures for Blood Cultures M47–A 7–190 Quality Control for Commercial Microbial Identification Systems M50–A 7–191 Collection, Transport, Preparation, and Storage of Specimens MM13–A 7–192 Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing MM18–A 7–193 Evaluation of the Linearity of Quantitative Measurement EP06–A 7–194 Protocols for Determination of Limits of Detection and Limits of Quantitation EP17–A Neurosurgical implants—Sterile, Single-use Hydrocephalus Shunts and Components ISO 7197:2006/Technical Corrigendum1:2007 D. Neurology 17–7 E. OB-GYN/Gastroenterology 9–57 Natural Latex Rubber Condoms—Requirements and Test Methods, Technical Corrigendum 2 ISO 4074:2002/Cor.2:2008(E) Laser Systems for Corneal Reshaping ANSI Z80.11–2007 Ultrasonics—Field Characterization—Test Methods for the Determination of Thermal and Mechanical Indices Related to Medical Diagnostic Ultrasonic Fields IEC 62359:2005 F. Ophthalmic 10–58 G. Radiology 12–191 H. Software/Informatic Managing and Validating Laboratory Information Systems; Approved Guideline CLSI AUTO8–A 13–26 Autoverification of Clinical Laboratory Test Results; Approved Guideline CLSI AUTO10–A 13–27 IT Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard CLSI AUTO11–A 13–28 tjames on PRODPC61 with NOTICES 13–25 Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard CLSI AUTO9–A Sterilization of Health Care Products—Moist Heat—Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices ANSI/AAMI/ISO 17665– 1:2006 I. Sterility 14–261 VerDate Nov<24>2008 14:48 Mar 17, 2009 Jkt 217001 PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 E:\FR\FM\18MRN1.SGM 18MRN1 Federal Register / Vol. 74, No. 51 / Wednesday, March 18, 2009 / 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 Internet site at https:// www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications and minor revisions described in this document 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 the new provision of 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. tjames on PRODPC61 with NOTICES 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 document announcing ‘‘Modification to the List of Recognized Standards, Recognition List Number: 021’’ 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 VerDate Nov<24>2008 14:48 Mar 17, 2009 Jkt 217001 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. Two copies of any mailed comments are to be submitted, 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: 021. These modifications to the list or recognized standards are effective upon publication of this document in the Federal Register. Dated: March 10, 2009. Daniel G. Schultz, Director, Center for Devices and Radiological Health. [FR Doc. E9–5858 Filed 3–17–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Proposed Collection; Comment Request In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276– 1243. Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate PO 00000 Frm 00074 Fmt 4703 Sfmt 4703 11593 of the burden of the proposed collection of information; (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 respondents, including through the use of automated collection techniques or other forms of information technology. Proposed Project: National Evaluation of the Comprehensive Community Mental Health Services for Children and Their Families Program: Phase VI— NEW. The Substance Abuse and Mental Health Services Administration (SAMHSA), Center of Mental Health Services is responsible for the national evaluation of the Comprehensive Community Mental Health Services for Children and Their Families Program (Children’s Mental Health Initiative— CMHI) that will collect data on child mental health outcomes, family life, and service system development and performance. Data will be collected on 26 service systems, and approximately 5,541 children and families. Data collection for this evaluation will be conducted over a five-year period. Child and family outcomes of interest will be collected at intake and during subsequent follow-up sessions at sixmonth intervals. The length of time that individual families will participate in the study ranges from 12 to 24 months depending upon when they enter the evaluation. The outcome measures include the following: Child symptomatology and functioning, family functioning, satisfaction, and caregiver strain. The core of service system data will be collected every 18– 24 months throughout the 5-year evaluation period, with a sustainability survey conducted in years 3 and 5. Service utilization and cost data will be tracked and submitted to the national evaluation every six months using two tools: The Flex Fund Tool and the Services and Costs Data Tool to estimate average cost of treatment per child, distribution of costs, and allocation of costs across service categories. Service delivery and system variables of interest include the following: Maturity of system of care development in funded system of care communities, adherence to the system of care program model, and client service experience. We will also conduct a comprehensive evaluation of the CMHI’s data driven technical assistance; this component of the evaluation will employ a mixedmethods approach, combining qualitative and quantitative data to provide a comprehensive assessment of the continuous quality improvement (CQI) process in funded system of care E:\FR\FM\18MRN1.SGM 18MRN1

Agencies

[Federal Register Volume 74, Number 51 (Wednesday, March 18, 2009)]
[Notices]
[Pages 11586-11593]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-5858]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]


Food and Drug Administration Modernization Act of 1997: 
Modifications to the List of Recognized Standards, Recognition List 
Number: 021

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: 021'' (Recognition List Number: 021), 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: 021'' to the Division of Small Manufacturers, International and 
Consumer Assistance, Center for Devices and Radiological 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 240-276-3151. 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 
Internet site at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfTopic/cdrhnew.cfm. 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: 021 
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, 7520 
Standish Place, Rockville, MD 20855, 240-276-8714.

[[Page 11587]]


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.
    Modifications to the initial list of recognized standards, as 
published in the Federal Register, are identified in table 1.

                   Table 1--Federal Register Citation
------------------------------------------------------------------------
 
------------------------------------------------------------------------
October 16, 1998 (63 FR 55617)       May 27, 2005 (70 FR 30756)
------------------------------------------------------------------------
July 12, 1999 (64 FR 37546)          November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022)      March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032)            June 23, 2006 (71 FR 36121)
------------------------------------------------------------------------
January 14, 2002 (67 FR 1774)        November 3, 2006 (71 FR 64718)
------------------------------------------------------------------------
October 2, 2002 (67 FR 61893)        May 21, 2007 (72 FR 28500)
------------------------------------------------------------------------
April 28, 2003 (68 FR 22391)         September 12, 2007 (72 FR 52142)
------------------------------------------------------------------------
March 8, 2004 (69 FR 10712)          December 19, 2007 (72 FR 71924)
------------------------------------------------------------------------
June 18, 2004 (69 FR 34176)          September 9, 2008 (73 FR 52358)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240)        ...................................
------------------------------------------------------------------------

    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 Internet 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: 021

    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: 021'' to identify these current 
modifications.
    In table 2 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
----------------------------------------------------------------------------------------------------------------
                            Replacement
 Old Recognition No.      Recognition No.                      Standard                           Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-49                   .....................  ASTM F 1981-99 Standard Specification for   Withdrawn
                                               Suction Catheters for use in the
                                               Respiratory Tract
----------------------------------------------------------------------------------------------------------------
1-63                   1-77                   CGA V-1:2005 Standard for Compressed Gas    Withdrawn and replaced
                                               Cylinder Valve Outlet and Inlet             with newer version
                                               Connection
----------------------------------------------------------------------------------------------------------------
1-64                   1-78                   ASME PVHO-1-2007 Safety Standard for        Withdrawn and replaced
                                               Pressure Vessels for Human Occupancy        with newer version
----------------------------------------------------------------------------------------------------------------

[[Page 11588]]

 
1-71                   .....................  ISO 10651-5:2006 Lung Ventilators for       Withdrawn duplicate
                                               Medical Use--Particular requirements for
                                               Basic Safety and Essential Performance--
                                               Part 5: Gas-powered Emergency
                                               Resuscitators
----------------------------------------------------------------------------------------------------------------
1-74                   .....................  ISO 5360:2006 Anaesthetic Vaporizers--      Contact person
                                               Agent Specific Filling Systems
----------------------------------------------------------------------------------------------------------------
1-76                   1-79                   ISO 26825:2008 (E) Anaesthetic And          Withdrawn and replaced
                                               Respiratory Equipment--User-Applied         with newer version
                                               Labels For Syringes Containing Drugs Used
                                               During Anaesthesia--Colours, Design and
                                               Performance
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-71                   2-133                  ASTM F1408-97 (2008) Standard Practice for  Withdrawn and replaced
                                               Subcutaneous Screening Test for Implant     with newer version
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-73                   2-134                  ASTM F2065-00(2006) Standard Practice for   Withdrawn and replaced
                                               Testing for Alternative Pathway             with newer version
                                               Complement Activation in Serum by Solid
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-87                   .....................  AAMI/ANSI/ISO 10993-10:2002 Biological      Extent of Recognition,
                                               Evaluation of Medical Devices--Part 10:     Relevant Guidance,
                                               Tests for Irritation and Delayed-Type       and Contact Person
                                               Hypersensitivity
----------------------------------------------------------------------------------------------------------------
2-88                   2-135                  AAMI/ANSI/ISO 10993-12:2007 Biological      Withdrawn and replaced
                                               Evaluation of Medical Devices--Part 12:     with newer version
                                               Sample Preparation and Reference
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-127                  .....................  ANSI/AAMI BE 78:2002/A1:2006 Biological     Withdrawn
                                               Evaluation of Medical Devices--Part 10:
                                               Tests For Irritation and Delayed-Type
                                               Hypersensitivity--Amendment 1
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular/Neurology
----------------------------------------------------------------------------------------------------------------
3-67                   .....................  ASTM F2129-06 Standard Test Method for      Offices, Devices
                                               Conducting Cyclic Potentiodynamic           Affected, Relevant
                                               Polarization Measurements to Determine      Guidance, CFR
                                               the Corrosion Susceptibility of Small       Citation and Product
                                               Implant Devices                             Codes, Contact Person
----------------------------------------------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-29                   .....................  IEC 60601-2-19 1996-10: Amendment 1--       Relevant guidance
                                               Medical Electrical Equipment Part 2:
                                               Particular Requirements for Safety of
                                               Baby Incubators
----------------------------------------------------------------------------------------------------------------
6-32                   .....................  IEC 60601-2-20 1996-10: Amendment 1--       Relevant guidance
                                               Medical Electrical Equipment Part 2:
                                               Particular Requirements for the Safety Of
                                               Transport Incubators
----------------------------------------------------------------------------------------------------------------
6-62                   .....................  ISO 8536-6:1995 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 6: Freeze Drying
                                               Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-63                   .....................  ISO 8536-7-1999: Infusion Equipment for     Relevant guidance
                                               Medical Use--Part 7: Caps Made of
                                               Aluminum-Plastics Combinations For
                                               Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-64                   .....................  ISO 8536-3-1999, Infusion Equipment for     Relevant guidance
                                               Medical Use--Part 3: Aluminum Caps for
                                               Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-119                  .....................  ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood    Reaffirmation 2007,
                                               Transfusion Micro-Filters                   Title, SDO, Date of
                                                                                           standard, Relevant
                                                                                           guidance
----------------------------------------------------------------------------------------------------------------
6-122                  .....................  ISO 8536-5-2004:, Infusion Equipment for    Relevant guidance
                                               Medical Use--Part 5: Burette Infusion
                                               Sets for Single Use, Gravity Feed
----------------------------------------------------------------------------------------------------------------
6-127                  .....................  ISO 1135-4-2004: Transfusion Equipment for  Relevant guidance
                                               Medical Use--Part 4: Transfusion Sets for
                                               Single Use
----------------------------------------------------------------------------------------------------------------
6-142                  .....................  ANSI/AAMI II36:2004 Medical Electrical      Title, Relevant
                                               Equipment--Part 2: Particular               guidance
                                               Requirements for Safety of Baby
                                               Incubators
----------------------------------------------------------------------------------------------------------------
6-143                  .....................  ANSI/AAMI II51:2004, Medical Electrical     Title, Relevant
                                               Equipment--Part 2: Particular               guidance
                                               Requirements for Safety of Transport
                                               Incubators
----------------------------------------------------------------------------------------------------------------

[[Page 11589]]

 
6-172                  .....................  ISO 8536-1:2006 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 1: Infusion Glass
                                               Bottles
----------------------------------------------------------------------------------------------------------------
6-173                  .....................  ISO 8536-2:2001 Corrigendum 1:2003,         Relevant guidance
                                               Infusion Equipment for Medical Use--Part
                                               2: Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-182                  .....................  IEC 60601-2-38 1996/Amendment 1:1999,       Relevant guidance
                                               Medical Electrical Equipment--Part 2-38:
                                               Particular Requirements for the Safety of
                                               Electrically Operated Hospital Beds
----------------------------------------------------------------------------------------------------------------
6-201                  .....................  ISO 8536-4:2007 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 4: Infusion Sets for
                                               Single Use, Gravity Feed
----------------------------------------------------------------------------------------------------------------
6-215                  .....................  ASTM F2132-01(2008)E1 Standard              Title
                                               Specification for Puncture Resistance of
                                               Materials Used in Containers for
                                               Discarded Medical Needles and Other
                                               Sharps
----------------------------------------------------------------------------------------------------------------
E. IVD
----------------------------------------------------------------------------------------------------------------
7-138                  7-169                  CLSI M27-A3 Reference Method for Broth      Withdrawn and replaced
                                               Dilution Antifungal Susceptibility          with newer version
                                               Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
7-54                   .....................  CLSI D12-A2, Immunoprecipitin Analyses:     Title
                                               Procedures for Evaluating the Performance
                                               of Materials--Second Edition; Approved
                                               Guideline
----------------------------------------------------------------------------------------------------------------
7-71                   .....................  CLSI H15-A3, Reference and Selected         Contact person
                                               Procedures for the Quantitative
                                               Determination of Hemoglobin in Blood;
                                               Approved Standard--Third Edition
----------------------------------------------------------------------------------------------------------------
7-145                  .....................  CLSI H42-A2, Enumeration of                 Contact person
                                               Immunologically Defined Cell Populations
                                               by Flow Cytometry.
----------------------------------------------------------------------------------------------------------------
7-73                   7-170                  CLSI ILA21-A2 Clinical Evaluation of        Withdrawn and replaced
                                               Immunoassays                                with newer version
----------------------------------------------------------------------------------------------------------------
7-130                  .....................  CLSI H20-A2, Reference Leucocyte            Contact person
                                               Differential Count (Proportional) and
                                               Evaluation of Instrumental Methods;
                                               Approved Standard--Second Edition
----------------------------------------------------------------------------------------------------------------
7-164                  .....................  CLSI GP 28-A Microwave Device Use in the    Contact person
                                               Histology Laboratory; Approved Guideline
----------------------------------------------------------------------------------------------------------------
7-168                  7-171                  CLSI M38-A2 Reference Method for Broth      Withdrawn and replaced
                                               Dilution Antifungal Susceptibility          with newer version
                                               Testing of Filamentous Fungi
----------------------------------------------------------------------------------------------------------------
F. Neurology
----------------------------------------------------------------------------------------------------------------
3-3                    17-1                   AAMI NS28:1988/(R) 2006 Intracranial        Transferred, Date of
                                               Pressure Monitoring Devices                 standard, Extent of
                                                                                           recognition, Relevant
                                                                                           guidance
----------------------------------------------------------------------------------------------------------------
3-32                   17-2                   ASTM F1542-94(2000) Standard Specification  Transferred, Offices,
                                               for the Requirements and Disclosure of      Type of standard,
                                               Self-Closing Aneurysm Clips                 Extent of
                                                                                           recognition, Relevant
                                                                                           guidance, Contact
                                                                                           person
----------------------------------------------------------------------------------------------------------------
3-33                   17-3                   ISO 7197:2006 Neurosurgical implants--      Transferred--Withdrawn
                                               Sterile, Single-use hydrocephalus Shunts    and replaced with
                                               and Components                              newer version
----------------------------------------------------------------------------------------------------------------
3-39                   17-4                   ASTM F647-94(2006) Standard Practice for    Transferred--Withdrawn
                                               Evaluating and Specifying Implantable       and replaced with
                                               Shunt Assemblies for Neurosurgical          newer version
                                               Application
----------------------------------------------------------------------------------------------------------------
3-60                   17-5                   IEC 60601-2-10 1987/Amendment 1 2001        Transferred, Title
                                               Medical Electrical Equipment--Part 2-10:    change, Date of
                                               Particular Requirements for the Safety of   standard, Relevant
                                               Nerve and Muscle Stimulators                guidance, Contact
                                                                                           person
----------------------------------------------------------------------------------------------------------------
3-67                   17-6                   ASTM F2129-06 Standard Test Method for      Offices, Devices
                                               Conducting Cyclic Potentiodynamic           affected, Type of
                                               Polarization Measurements to Determine      Standard, Product
                                               the Corrosion Susceptibility of Small       code, Relevant
                                               Implant Devices                             guidance, Contact
                                                                                           person
----------------------------------------------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------

[[Page 11590]]

 
9-30                   9-55                   ANSI/ AAMI RD62:2006 Water Treatment        Withdrawn and replaced
                                               Equipment for Hemodialysis Applications     with newer version
----------------------------------------------------------------------------------------------------------------
9-32                   9-56                   ASTM D3492-08 Standard Specification for    Withdrawn and replaced
                                               Rubber Contraceptives (Male Condoms)        with newer version
----------------------------------------------------------------------------------------------------------------
9-34                   .....................  ISO 4074:2002/Cor.1:2003(E): Natural Latex  Extent of recognition,
                                               Rubber Condoms--Requirements and Test       Product codes,
                                               Methods, Technical Corrigendum 1            Relevant guidance
----------------------------------------------------------------------------------------------------------------
H. Radiology
----------------------------------------------------------------------------------------------------------------
12-48                  .....................  AIUM AOL, Acoustic Output Labeling          Relevant guidance
                                               Standard for Diagnostic Ultrasound
                                               Equipment: A Standard for How
                                               Manufacturers Should Specify Acoustic
                                               Output Data
----------------------------------------------------------------------------------------------------------------
12-55                  12-186                 IEC 60601-2-29 (2008) Medical Electrical    Withdrawn and replaced
                                               Equipment--Part 2-29: Particular            with newer version
                                               Requirements for the Basic Safety and
                                               Essential Performance of Radiotherapy
                                               Simulators--Third Edition
----------------------------------------------------------------------------------------------------------------
12-66                  .....................  AIUM MUS, Medical Ultrasound Safety         Relevant guidance
----------------------------------------------------------------------------------------------------------------
12-96                  12-187                 NEMA MS 3-2008 Determination of Image       Withdrawn and replaced
                                               Uniformity in Diagnostic Magnetic           with newer version
                                               Resonance Images
----------------------------------------------------------------------------------------------------------------
12-97                  12-188                 NEMA MS 1-2008 Determination of Signal-to-  Withdrawn and replaced
                                               Noise Ratio (SNR) in Diagnostic Magnetic    with newer version
                                               Resonance Imaging
----------------------------------------------------------------------------------------------------------------
12-100                 .....................  NEMA UD 3-2004, Standard for Real Time      Relevant guidance
                                               Display of Thermal and Mechanical
                                               Acoustic Output Indices on Diagnostic
                                               Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
12-105                 .....................  NEMA UD 2-2004, Acoustic Output             Title, Relevant
                                               Measurement Standard for Diagnostic         guidance
                                               Ultrasound Equipment Version 3
----------------------------------------------------------------------------------------------------------------
12-139                 .....................  AIUM AOMS-2005, Acoustic Output             Relevant guidance
                                               Measurement Standard for Diagnostic
                                               Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
12-140                 .....................  AIUM RTD1-2005, Standard for Real-Time      Relevant guidance
                                               Display of Thermal and Mechanical
                                               Acoustic Output Indices on Diagnostic
                                               Ultrasound Equipment Revision 1
----------------------------------------------------------------------------------------------------------------
12-161                 12-189                 IEC 60601-2-33 (2008) Medical Electrical    Withdrawn and replaced
                                               Equipment--Part 2-33: Particular            with a newer version
                                               Requirements for the Safety of Magnetic
                                               Resonance Equipment for Medical Diagnosis
                                               Consolidated Edition 2.2
----------------------------------------------------------------------------------------------------------------
12-182                 .....................  IEC 60601-2-37:2007, Medical Electrical     Relevant guidance
                                               Equipment--Part 2-37: Particular
                                               Requirements for the Basic Safety and
                                               Essential Performance of Ultrasonic
                                               Medical Diagnostic and Monitoring
                                               Equipment
----------------------------------------------------------------------------------------------------------------
12-184                 12-190                 IEC 61217 (2008) Radiotherapy Equipment--   Withdrawn and replaced
                                               Coordinates, Movements, and Scales          with newer version
                                               Consolidated Edition 1.2
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-120                 14-257                 ASTM D3078--02(2008) Standard Test Method   Withdrawn and replaced
                                               for Determination of Leaks in Flexible      with newer version
                                               Packaging by Bubble Emission
----------------------------------------------------------------------------------------------------------------
14-148                 14-258                 ASTM F2250--03(2008) Standard Practice for  Withdrawn and replaced
                                               Evaluation of Chemical Resistance of        with newer version
                                               Printed Inks and Coatings on Flexible
                                               Packaging Materials
----------------------------------------------------------------------------------------------------------------
14-149                 14-259                 ASTM F2251--03(2008) Standard Test Method   Withdrawn and replaced
                                               for Thickness Measurement of Flexible       with newer version
                                               Packaging Material
----------------------------------------------------------------------------------------------------------------
14-150                 14-260                 ASTM F2252--03(2008) Standard Practice for  Withdrawn and replaced
                                               Evaluating Ink or Coating Adhesion to       with newer version
                                               Flexible Packaging Materials Using Tape
----------------------------------------------------------------------------------------------------------------
J. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-11                  15-13                  ASTM F2212-02(2008)e1, Standard Guide for   Withdrawn and replaced
                                               Characterization of Type I Collagen as a    with newer version
                                               Starting Material for Surgical Implants
                                               and Substrates for Tissue Engineered
                                               Medical Products
----------------------------------------------------------------------------------------------------------------


[[Page 11591]]

III. Listing of New Entries

    In table 3 of this document, FDA provides the listing of new 
entries and consensus standards added as modifications to the list of 
recognized standards under Recognition List Number: 021.

                                                     Table 3
----------------------------------------------------------------------------------------------------------------
    Recognition No.                           Title of Standard                          Reference No. & Date
----------------------------------------------------------------------------------------------------------------
A. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-160                   Maximum Permissible Ambient Noise Levels for Audiometric      ANSI ASA S3.1-1999 (R
                         Test Rooms                                                    2003)
----------------------------------------------------------------------------------------------------------------
4-161                   Method for Measuring the Intelligibility of Speech Over       ANSI ASA S3.2-1989 (R
                         Communication Systems                                         1999)
----------------------------------------------------------------------------------------------------------------
4-162                   Procedure for the Computation of Loudness of Steady Sounds    ANSI ASA S3.4-2007
----------------------------------------------------------------------------------------------------------------
4-163                   Methods for Calculation of the Speech Intelligibility Index   ANSI ASA S3.5-1997 (R
                                                                                       2007)
----------------------------------------------------------------------------------------------------------------
4-164                   Method for Coupler Calibration of Earphones                   ANSI ASA S3.7-1995 (R
                                                                                       2003)
----------------------------------------------------------------------------------------------------------------
4-165                   Mechanical Coupler for Measurement of Bone Vibrators          ANSI ASA S3.13-1987 (R
                                                                                       2007)
----------------------------------------------------------------------------------------------------------------
4-166                   Bioacoustical Terminology                                     ANSI ASA S3.20-1995 (R
                                                                                       2003)
----------------------------------------------------------------------------------------------------------------
4-167                   Methods for Manual Pure-Tone Threshold Audiometry             ANSI ASA S3.21-2004
----------------------------------------------------------------------------------------------------------------
4-168                   Occluded Ear Simulator                                        ANSI ASA S3.25-1989 (R
                                                                                       2003)
----------------------------------------------------------------------------------------------------------------
4-169                   Method of Measurement of Performance Characteristics of       ANSI ASA S3.35-2004
                         Hearing Aids under Simulated Real-Ear Working Conditions
----------------------------------------------------------------------------------------------------------------
4-170                   Specification for a Manikin for Simulated in situ Airborne    ANSI ASA S3.36-1985 (R
                         Acoustic Measurements                                         2006)
----------------------------------------------------------------------------------------------------------------
4-171                   Preferred Earhook Nozzle Thread for Postauricular Hearing     ANSI ASA S3.37-1987 (R
                         Aids                                                          2007)
----------------------------------------------------------------------------------------------------------------
4-172                   Testing Hearing Aids with a Broad-Band Noise Signal           ANSI ASA S3.42-1992 (R
                                                                                       2007)
----------------------------------------------------------------------------------------------------------------
4-173                   Determination of Occupational Noise Exposure and Estimation   ANSI ASA S3.44-1996 (R
                         of Noise-Induced Hearing Impairment                           2006)
----------------------------------------------------------------------------------------------------------------
4-174                   Procedures for Testing Basic Vestibular Function              ANSI ASA S3.45-1999
----------------------------------------------------------------------------------------------------------------
4-175                   Methods of Measurement of Real-Ear Performance                ANSI ASA S3.46-1997 (R
                         Characteristics of Hearing Aids                               2002)
----------------------------------------------------------------------------------------------------------------
4-176                   Criteria for Evaluating Room Noise                            ANSI ASA S12.2-1995 (R
                                                                                       1999)
----------------------------------------------------------------------------------------------------------------
4-177                   Rating Noise with Respect to Speech Interference              ANSI ASA S12.65-2006
----------------------------------------------------------------------------------------------------------------
B. General
----------------------------------------------------------------------------------------------------------------
5-45                    Standard Practice for Performance Testing of Packages for     ASTM D7386-08
                         Single Delivery Systems
----------------------------------------------------------------------------------------------------------------
C. IVD
----------------------------------------------------------------------------------------------------------------
7-172                   Defining, Establishing, and Verifying Reference Intervals in  C28-P3
                         the Clinical Laboratory
----------------------------------------------------------------------------------------------------------------
7-173                   Harmonization of Glycohemoglobin Measurements                 C44-A
----------------------------------------------------------------------------------------------------------------
7-174                   Estimation of Total Analytical Error for Clinical Laboratory  EP21-A
----------------------------------------------------------------------------------------------------------------
7-175                   Apolipoprotein Immunoassays: Development and Recommended      ILA15-A
                         Performance Characteristics
----------------------------------------------------------------------------------------------------------------
7-176                   Immunoassay Interference by Endogenous Antibodies             ILA30-A
----------------------------------------------------------------------------------------------------------------

[[Page 11592]]

 
7-177                   Performance Standards for Antimicrobial Susceptibility        M100-S18
                         Testing
----------------------------------------------------------------------------------------------------------------
7-178                   Quality Control for Commercially Prepared Microbiological     M22-A3
                         Culture Media
----------------------------------------------------------------------------------------------------------------
7-179                   Reference Method for Broth Dilution Antifungal                M27-S3
                         Susceptibility Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
7-180                   Western Blot Assay for Antibodies to Borrelia burgdorferi     M34-A
----------------------------------------------------------------------------------------------------------------
7-181                   Abbreviated Identification of Bacteria and Yeasts             M35-A
----------------------------------------------------------------------------------------------------------------
7-182                   Clinical Use and Interpretation of Serologic Tests for        M36-A
                         Toxoplasma gondii
----------------------------------------------------------------------------------------------------------------
7-183                   Reference Method for Broth Dilution Antifungal                M38-A2
                         Susceptibility Testing of Filamentous Fungi
----------------------------------------------------------------------------------------------------------------
7-184                   Quality Control of Microbiological Transport Systems          M40-A
----------------------------------------------------------------------------------------------------------------
7-185                   Viral Culture                                                 M41-A
----------------------------------------------------------------------------------------------------------------
7-186                   Methods for Antifungal Disk Diffusion Susceptibility Testing  M44-A
----------------------------------------------------------------------------------------------------------------
7-187                   Zone Diameter Interpretive Standards, Corresponding Minimal   M44-S2
                         Inhibitory Concentration (MIC) Interpretive Breakpoints,
                         and Quality Control Limits for Antifungal Disk Diffusion
                         Susceptibility Testing of Yeast
----------------------------------------------------------------------------------------------------------------
7-188                   Methods for Antimicrobial Dilution and Disk Susceptibility    M45-A
                         Testing of Infrequently Isolated or Fastidious Bacteria
----------------------------------------------------------------------------------------------------------------
7-189                   Principles and Procedures for Blood Cultures                  M47-A
----------------------------------------------------------------------------------------------------------------
7-190                   Quality Control for Commercial Microbial Identification       M50-A
                         Systems
----------------------------------------------------------------------------------------------------------------
7-191                   Collection, Transport, Preparation, and Storage of Specimens  MM13-A
----------------------------------------------------------------------------------------------------------------
7-192                   Interpretive Criteria for Identification of Bacteria and      MM18-A
                         Fungi by DNA Target Sequencing
----------------------------------------------------------------------------------------------------------------
7-193                   Evaluation of the Linearity of Quantitative Measurement       EP06-A
----------------------------------------------------------------------------------------------------------------
7-194                   Protocols for Determination of Limits of Detection and        EP17-A
                         Limits of Quantitation
----------------------------------------------------------------------------------------------------------------
D. Neurology
----------------------------------------------------------------------------------------------------------------
17-7                    Neurosurgical implants--Sterile, Single-use Hydrocephalus     ISO 7197:2006/Technical
                         Shunts and Components                                         Corrigendum1:2007
----------------------------------------------------------------------------------------------------------------
E. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-57                    Natural Latex Rubber Condoms--Requirements and Test Methods,  ISO 4074:2002/
                         Technical Corrigendum 2                                       Cor.2:2008(E)
----------------------------------------------------------------------------------------------------------------
F. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-58                   Laser Systems for Corneal Reshaping                           ANSI Z80.11-2007
----------------------------------------------------------------------------------------------------------------
G. Radiology
----------------------------------------------------------------------------------------------------------------
12-191                  Ultrasonics--Field Characterization--Test Methods for the     IEC 62359:2005
                         Determination of Thermal and Mechanical Indices Related to
                         Medical Diagnostic Ultrasonic Fields
----------------------------------------------------------------------------------------------------------------
H. Software/Informatic
----------------------------------------------------------------------------------------------------------------
13-25                   Managing and Validating Laboratory Information Systems;       CLSI AUTO8-A
                         Approved Guideline
----------------------------------------------------------------------------------------------------------------
13-26                   Autoverification of Clinical Laboratory Test Results;         CLSI AUTO10-A
                         Approved Guideline
----------------------------------------------------------------------------------------------------------------
13-27                   IT Security of In Vitro Diagnostic Instruments and Software   CLSI AUTO11-A
                         Systems; Approved Standard
----------------------------------------------------------------------------------------------------------------
13-28                   Remote Access to Clinical Laboratory Diagnostic Devices via   CLSI AUTO9-A
                         the Internet; Approved Standard
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-261                  Sterilization of Health Care Products--Moist Heat--Part 1:    ANSI/AAMI/ISO 17665-1:2006
                         Requirements for the Development, Validation, and Routine
                         Control of a Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------


[[Page 11593]]

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 Internet site at https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications 
and minor revisions described in this document 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 the new provision of 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 document announcing ``Modification to the List of 
Recognized Standards, Recognition List Number: 021'' 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. Two copies of any mailed comments are to be submitted, 
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: 021. These modifications 
to the list or recognized standards are effective upon publication of 
this document in the Federal Register.

    Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-5858 Filed 3-17-09; 8:45 am]
BILLING CODE 4160-01-S

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