61148 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 

• When and where they viewed the 

video. 

• Whom they recommended to view 

the video. 

• What they learned from watching 

the video. 

• What actions they may take because 

of the video. 

• Whether they plan to change 

behaviors and knowledge about their 

State’s activities. 

The process assessment of the State 

videos will be conducted using 

telephone interviews with the State 

points of contact. This interview should 

take 10 minutes (0.167 hours). The 

outcome assessment of the State videos 

will be collected using an online form 

that will be completed by no more than 

26 respondents and will require only 1 

response per respondent. It will take an 

average of 10 minutes (0.167 hours) to 

review the instructions, complete the 

form, and submit it electronically. 

Dissemination updates will be 

requested from each State point of 

contact every 6 months if there have 

been changes during that time period. 

These updates will be submitted 

electronically, and it should take 

approximately 5 minutes (0.083 hours) 

to review the instructions, complete the 

short form, and submit it electronically. 

The burden estimate is based on 

comments from several potential 

respondents who completed the online 

form, submitted it, and provided 

feedback on how long it would take 

them to complete it. The respondents 

will be employees of the State. 

A short survey will also be used to 

collect data from viewers of the State 

videos. An estimated 1,000 viewers will 

voluntarily choose to complete this 

online survey, which will take 10 

minutes (0.167 hours) to review, 

complete, and submit. The viewers are 

expected to represent the general public. 

Form name Number of 

respondents 

Responses 

per 

respondent 

Burden per 

response 

(hrs.) 

Total burden 

Process Interview ............................................................................................ 26 1 0.167 4.34 

Dissemination Outcome ................................................................................... 26 1 0.167 4.34 

Dissemination Updates .................................................................................... 26 1 0.083 2.16 

Viewers Survey ................................................................................................ 1,000 1 0.167 167

Total .......................................................................................................... 1,078 ........................ ........................ 177.84 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent by November 3, 2010 to: 

SAMHSA Desk Officer, Human 

Resources and Housing Branch, Office 

of Management and Budget, New 

Executive Office Building, Room 10235, 

Washington, DC 20503; due to potential 

delays in OMB’s receipt and processing 

of mail sent through the U.S. Postal 

Service, respondents are encouraged to 

submit comments by fax to: 202–395– 

5806. 

Dated: September 28, 2010. 

Elaine Parry 

Director, Office of Management Technology 

and Operations. 

[FR Doc. 2010–24849 Filed 10–1–10; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2004–N–0451] (formerly 

Docket No. 2004N–0226) 

Food and Drug Administration 

Modernization Act of 1997: 

Modifications to the List of Recognized 

Standards, Recognition List Number: 

025 

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: 025’’ (Recognition List 

Number: 025), will assist manufacturers 

who elect to declare conformity with 

consensus standards to meet certain 

requirements for medical devices. 

DATES: Submit either electronic or 

written 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: 025’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Silver Spring, MD 20993–0002. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

requests, or fax your request to 301– 

847–8149. 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 email: standards@cdrh.fda.gov. This 

document may also be accessed on 

FDA’s Internet site at http://

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. 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: 025 

modifications and other standards 

related information. 

FOR FURTHER INFORMATION CONTACT: 

Carol L. Herman, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 3632, Silver Spring, 

MD 20993–0002, 301–796–6574. 

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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 61149 

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 of this document. 

TABLE 1.—PREVIOUS PUBLICATIONS

OF STANDARD RECOGNITION LISTS

February 25, 1998 

(63 FR 9561) 

November 8, 2005 

(70 FR 67713) 

October 16, 1998 

(63 FR 55617) 

March 31, 2006 (71 

FR 16313) 

July 12, 1999 (64 

FR 37546) 

June 23, 2006 (71 

FR 36121) 

November 15, 2000 

(65 FR 69022) 

November 3, 2006 

(71 FR 64718) 

May 7, 2001 (66 FR 

23032) 

May 21, 2007 (72 

FR 28500) 

January 14, 2002 

(67 FR 1774) 

September 12, 2007 

(72 FR 52142) 

October 2, 2002 (67 

FR 61893) 

December 19, 2007 

(72 FR 71924) 

April 28, 2003 (68 

FR 22391) 

September 9, 2008 

(73 FR 52358) 

TABLE 1.—PREVIOUS PUBLICATIONS

OF STANDARD RECOGNITION

LISTS—Continued 

March 8, 2004 (69 

FR 10712) 

March, 18, 2009 (74 

FR 11586) 

June 18, 2004 (69 

FR 34176) 

September 8, 2009 

(74 FR 46203) 

October 4, 2004 (69 

FR 59240) 

May 5, 2010 (75 FR 

24711) 

May 27, 2005 (70 

FR 30756) 

June 10, 2010 (75 

FR 32943) 

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: 025 

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: 025’’ 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.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS

Old 

Recognition No. 

Replacement 

Recognition 

No. 

Title of Standard1 Change 

A. Anesthesia 

1–61 1–82 IEC 60601–2–13 Edition 3.1 2009–08 Medical electrical equipment—Part 

2–13: Particular requirements for the safety and essential performance of 

anaesthetic systems 

Withdrawn and replaced with 

newer version 

B. Biocompatibility 

2–96 ASTM F 1903–98 (Reapproved 2003) Standard Practice for Testing For Biological Responses to Particles in vitro Type of standard and Contact 

person 

2–98 2–156 ANSI/AAMI/ISO 10993–1:2009 Biological evaluation of medical devices— 

Part 1: Evaluation and testing within a risk management process 

Withdrawn and replaced with 

newer version 

2–100 ASTM E1372–95 (2003) Standard Test Method for Conducting a 90-Day 

Oral Toxicity Study in Rats 

Withdrawn 

2–115 ASTM F 895—84 (Reapproved 2006) Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity Title, Type of standard , Relevant guidance and Contact 

person 

2–117 ANSI/AAMI/ISO 10993–3:2003/(R)2009 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive 

toxicity 

Reaffirmation, CDRH Office(s) 

and Division(s) associated 

with recognized standard 

and Contact person 

2–118 ANSI/AAMI/ISO 10993–11:2006 Biological evaluation of medical devices— 

Part 11: Tests for systemic toxicity 

Contact person 

2–119 ASTM F 813–07 Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices Title, Type of standard and 

Contact person 

2–135 ANSI/AAMI/ISO 10993–12:2007 Biological evaluation of medical devices— 

Part 12: Sample preparation and reference materials 

Title and Contact person 


jlentini on DSKJ8SOYB1PROD with NOTICES
61150 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

Recognition No. 

Replacement 

Recognition 

No. 

Title of Standard1 Change 

2–147 2–157 USP 33—NF 28 2010 Biological Tests <87> Biological Reactivity Test, In 

Vitro—Direct Contact Test 

Withdrawn and replaced with 

newer version 

2–148 2–158 USP 33–NF28 2010 Biological Tests <87> Biological Reactivity Test, In 

Vitro—Elution Test 

Withdrawn and replaced with 

newer version 

2–149 2–159 USP 33–NF28 2010 Biological Tests <88> Biological Reactivity Tests, In 

Vivo, Procedure—Preparation of Sample 

Withdrawn and replaced with 

newer version 

2–150 2–160 USP 33–NF28 2010 Biological Tests <88> Biological Reactivity Tests, In 

Vivo, Classification of Plastics—Intracutaneous Test 

Withdrawn and replaced with 

newer version 

2–151 2–161 USP 33–NF28 2010 Biological Tests <88> Biological Reactivity Tests, In 

Vivo, Classification of Plastics—Systemic Injection Test 

Withdrawn and replaced with 

newer version 

C. Cardiology 

3–74 3–79 ASTM F 2079—09 Standard Test Method for Measuring Intrinsic Elastic 

Recoil of Balloon-Expandable Stents 

Withdrawn and replaced with 

newer version 

3–75 ANSI/AAMI SP10:2002/(R)2008 & ANSI/AAMI SP10:2002/A1:2003/(R)2008 

& ANSI/AAMI SP10:2002/A2:2006/(R)2008 Manual, electronic or automated sphygmomanometers 

Title and Extent of recognition 

D. Dental/ENT 

4–86 ANSI/ADA Specification No. 38 2000 (Reaffirmed 2010) Metal-Ceramic 

Dental Restorative Systems 

Reaffirmation 

4–91 ANSI/ADA Specification No. 80 2001 (Reaffirmed 2007) Dental Materials— 

Determination of Color Stability Test Procedure 

Reaffirmation 

4–107 4–188 ISO 9917–2 Second edition 2010–04–15 Dentistry—Water-based cements—Part 2: Resin-modified cements Withdrawn and replaced with 

newer version 

4–117 ANSI/ADA Specification No. 12 2002 (Reaffirmed 2007) Denture Base 

Polymers 

Reaffirmation 

4–119 ANSI/ADA Specification No. 82 1998 (Reaffirmed 2009)—Dental Reversible/Irreversible Hydrocolloid Impression Material Systems Reaffirmation 

4–139 ANSI/ADA Specification No. 48-Visible Light Curing Units: 2004, Reaffirmed 

2009 

Reaffirmation 

4–160 ANSI/ASA S3.1–1999 (Reaffirmed 2003) (Reaffirmed 2008) Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms Reaffirmation 

4–164 ANSI/ASA S3.7–1997 (Reaffirmed 2003) (Reaffirmed 2008) Methods for 

Coupler Calibration of Earphones 

Reaffirmation 

4–166 ANSI/ASA S3.20–1995 (Reaffirmed 2003) (Reaffirmed 2008) Bioacoustical 

Terminology 

Reaffirmation 

4–167 ANSI/ASA S3.21–2004 (Reaffirmed 2009) Methods for Manual Pure-Tone 

Threshold Audiometry 

Reaffirmation 

4–169 4–190 ANSI/ASA S3.35–2010 (Revision of ANSI S3.35–2004) Method of Measurement of Performance Characteristics of Hearing Aids Under Simulated 

Real-Ear Working Conditions 

Withdrawn and replaced with 

newer version 

E. General 

5–31 ISO 15223:2000 Medical device symbols to be used with medical device labels, labeling and information to be supplied—First Edition: Amendment 

1: 08/01/2002; Amendment 2: 02/15/2004 

Withdrawn 

5–32 CEN EN 980:1996+A1:1999+A2:2001 Graphical Symbols for Use in the Labelling of Medical Devices Withdrawn 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 61151 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

Recognition No. 

Replacement 

Recognition 

No. 

Title of Standard1 Change 

5–38 5–62 ANSI/ASQ Z1.4–2008 Sampling Procedures and Tables for Inspection by 

Attributes 

Withdrawn and replaced with 

newer version 

F. General Hospital/General Plastic Surgery 

6–62 6–239 ISO 8536–6 Second edition 2009–11–15 Infusion equipment for medical 

use—Part 6: Freeze drying closures for infusion bottles 

Withdrawn and replaced with 

newer version 

6–64 6–240 ISO 8536–3 Third edition 2009–06–01 Infusion equipment for medical 

use— Part 3: Aluminum caps for infusion bottles 

Withdrawn and replaced with 

newer version 

6–70 ASTM E825–98 (Reapproved 2009) Standard Specification for Phase 

Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature 

Reaffirmation 

6–110 ASTM F 1441–03 (Reapproved 2009) Standard Specification for Soft-Tissue Expander Devices Reaffirmation 

6–112 ANSI/AAMI PB70:2003/(R)2009 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities Reaffirmation 

6–123 ASTM E667–98 (Reapproved 2009) Standard Specification for Mercury-inGlass, Maximum Self-Registering Clinical Thermometers Reaffirmation 

6–124 ASTM E1104–98 (Reapproved 2009) Standard Specification for Clinical 

Thermometer Probe Covers and Sheaths 

Reaffirmation 

6–125 ASTM E1965–98 (Reapproved 2009) Standard Specification for Infrared 

Thermometers for Intermittent Determination of Patient Temperature 

Reaffirmation 

6–127 6–241 ISO 1135–4 Forth edition 2010–04–15 Transfusion equipment for medical 

use—Part 4: Transfusion sets for single use 

Withdrawn and replaced with 

newer version 

6–173 6–242 ISO 8536–2 Third edition 2010–03–15 Infusion equipment for medical 

use—Part 2: Closures for infusion bottles 

Withdrawn and replaced with 

newer version 

G. IVD 

7–49 7–210 CLSI H26–A2 Validation, Verification, and Quality Assurance of Automated 

Hematology Analyzers; Approved Standard-Second Edition 

Withdrawn and replaced with 

newer version 

7–82 7–211 CLSI C34–A3 Sweat Testing: Sample Collection and Quantitative Chloride 

Analysis; Approved Guideline-Third Edition 

Withdrawn and replaced with 

newer version 

7–96 7–212 CLSI EP18–A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline-Second Edition Withdrawn and replaced with 

newer version 

7–100 ISO 15197 First edition 2003–05–01 In vitro diagnostic test systems—Requirements for blood-glucose monitoring systems for self testing in managing diabetes mellitus Title 

7–141 7–213 CLSI H18–A4 Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition Withdrawn and replaced with 

newer version 

7–181 7–214 CLSI M35–A2 Abbreviated Identification of Bacteria and Yeast; Approved 

Guideline-Second Edition 

Withdrawn, see 7–197 

7–186 7–215 CLSI M44–A2 Method for Antifungal Disk Diffusion Susceptibility Testing of 

Yeasts; Approved Guideline-Second Edition 

Withdrawn and Replaced with 

newer version 

7–199 7–216 CLSI M100–S20 Performance Standards for Antimicrobial Susceptibility 

Testing; Twentieth Informational Supplement 

Withdrawn and Replaced with 

newer version 

7–208 7–217 CLSI M44–S3, Zone Diameter Interpretive Standards, Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints, and Quality 

Control Limits for Antifungal Disk Diffusion Susceptibility Testing of 

Yeasts; Third Informational Supplement 

Withdrawn and replaced with 

newer version 

H. Materials 


jlentini on DSKJ8SOYB1PROD with NOTICES
61152 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

Recognition No. 

Replacement 

Recognition 

No. 

Title of Standard1 Change 

8–66 8–191 ISO 6474–1 First edition Implants for surgery—Ceramic materials—Part 1: 

Ceramic materials based on high purity alumina 

Withdrawn and replaced with 

newer version 

8–71 8–192 ASTM F2182—09 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic 

Resonance Imaging 

Withdraw and replaced with 

newer version 

8–85 8–193 ASTM F 1854—09 Standard Test Method for Stereological Evaluation of 

Porous Coatings on Medical Implants 

Withdraw and replaced with 

newer version 

8–88 ASTM F2024–00 Standard Practice for X-ray Diffraction Determination of 

Phase Content of Plasma-Sprayed Hydroxyapatite Coatings 

Type of standard and Contact 

person 

8–130 ASTM F 620—06 Standard Specification for Alpha Plus Beta Titanium Alloy 

Forgings for Surgical Implants 

Type of standard 

8–131 ASTM F 799—06 Standard Specification for Cobalt-28Chromium6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, 

R31538, R31539) 

Type of standard 

8–137 ASTM F 75—07, Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS 

R30075) 

Type of standard 

8–138 ASTM F 745—07 Standard Specification for 18Chromium-12.5Nickel2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical 

Implant Applications 

Type of standard 

8–156 ASTM F 139—08 Standard Specification for Wrought 18Chromium14Nickel-2.5Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) Type of standard 

8–183 ASTM F 560—08 Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) Type of standard 

I. Neurology 

17–2 ASTM F1542–94 (2000) Standard Specification for the Requirements and 

Disclosure of Self-Closing Aneurysm Clips 

Withdrawn 

17–6 17–9 ASTM F 2129–08 Standard Test Method for Conducting Cyclic 

Potentiodynamic Polarization Measurements to Determine the Corrosion 

Susceptibility of Small Implant Devices 

Withdrawn and replaced with 

newer version 

J. OB-GYN/Gastroenterology 

9–23 ASTM F1518–00 Standard Practice for Cleaning and Disinfection of Flexible Fiberoptic and Video Endoscopes Used in the Examination of the 

Hollow Viscera 

Withdrawn 

K. Ophthalmic 

10–12 10–59 ISO 11980 Second edition 2009–10–15 Ophthalmic optics—Contact lenses 

and contact lens care products—Guidance for clinical investigations 

Withdrawn and replaced with 

newer version 

10–30 ANSI Z80.7 (2002) Ophthalmics—Intraocular Lenses Withdrawn 

10–34 ANSI Z80.20 (2004) Ophthalmics—Contact lenses- Standard Terminology, 

Tolerances, Measurements and Physicochemical Properties 

Withdrawn 

10–44 10–60 ISO 11981 Second edition 2009–07–01 Ophthalmic optics—Contact lenses 

and contact lens care products- Determination of physical compatibility of 

contact lens care products with contact lenses 

Withdrawn and replaced with 

newer version 

L. Orthopedics 

11–171 ASTM F 1814—97a (Reapproved 2009) Standard Guide for Evaluating 

Modular Hip and Knee Joint Components 

Reaffirmation 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 61153 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

Recognition No. 

Replacement 

Recognition 

No. 

Title of Standard1 Change 

11–179 11–220 ASTM F 2068—09 Standard Specification for Femoral Prostheses—Metallic 

Implants 

Withdrawn and replaced with 

newer version 

11–180 ASTM F 366—04 (Reapproved 2009) Standard Specification for Fixation 

Pins and Wires 

Reaffirmation 

11–181 11–221 ASTM F 1717—09 Standard Test Methods for Spinal Implant Constructs in 

a Vertebrectomy Model 

Withdrawn and replaced with 

newer version 

11–188 11–222 ISO 14243–1 Second edition 2009–11–15 Implants for surgery—Wear of 

total knee-joint prostheses—Part 1: Loading and displacement parameters for wear-testing machines with load control and corresponding environmental conditions for test 

Withdrawn and replaced with 

newer version 

11–189 11–223 ISO 14243–2 Second edition 2009–11–15 Implants for surgery—Wear of 

total knee-joint prostheses—Part 2: Methods of measurement 

Withdrawn and replaced with 

newer version 

11–197 ASTM F 983—86 (Reapproved 2009) Standard Practice for Permanent 

Marking of Orthopaedic Implant Components 

Reaffirmation 

11–199 ASTM F 565—04 (Reapproved 2009) ε Standard Practice for Care and 

Handling of Orthopedic Implants and Instruments 

Reaffirmation 

11–203 ASTM F 1541—02 (Reapproved 2007) ε Standard Specification and Test 

Methods for External Skeletal Fixation Devices 

Title, Type of standard and 

Relevant guidance 

11–210 ASTM F 543—07ε Standard Specification and Test Methods for Metallic 

Medical Bone Screws 

Title, Type of standard and 

Relevant guidance 

11–214 ASTM F 382—99 (Reapproved 2008) ε Standard Specification and Test 

Method for Metallic Bone Plates 

Title and Type of standard 

M. Sterility 

14–54 14–287 ANSI/AAMI/ISO 11737–2:2009 Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, 

validation and maintenance of a sterilization process 

Withdrawn and replaced with 

newer version 

14–55 AAMI/ANSI/ISO 14160:1998/(R)2008 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid chemical Contact person 

14–63 14–288 ASTM F1886/F1886M–09 Standard Test Method for Determining Integrity 

of Seals for Flexible Packaging by Visual Inspection 

Withdrawn and replaced with 

newer version 

14–77 14–290 ANSI/AAMI ST:24:1999/(R)2009 Automatic, general purpose ethylene oxide 

sterilizers and ethylene oxide sterilant sources intended for use in health 

care facilities 

Withdrawn and replaced with 

newer version 

14–88 14–291 ANSI/AAMI/ISO 14937:2009 Sterilization of health care products—General 

requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical 

devices 

Withdrawn and replaced with 

newer version 

14–116 14–292 ANSI/AAMI ST72:2002/(R)2010 Bacterial Endotoxins—Test methodologies, 

routine monitoring, and alternatives to batch testing 

Withdrawn and replaced with 

newer version 

14–118 14–293 ANSI/AAMI ST50:2004/(R)2010 Dry heat (heated air) sterilizers Withdrawn and replaced with 

newer version 

14–152 14–294 ANSI/AAMI ST40:2004/(R)2010 Table-top dry heat (heated air) sterilization 

and sterility assurance in health care facilities 

Withdrawn and replaced with 

newer version 

14–164 14–295 ANSI/AAMI ST81:2004/(R)2010 Sterilization of medical devices—Information to be provided by the manufacturer for the processing of 

resterilizable medical devices 

Withdrawn and replaced with 

newer version 

14–181 AAMI/ANSI ST58: 2005 Chemical sterilization and high-level disinfection in 

health care facilities 

Contact person 


jlentini on DSKJ8SOYB1PROD with NOTICES
61154 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

Recognition No. 

Replacement 

Recognition 

No. 

Title of Standard1 Change 

14–197 ASTM F1608–00 (Reapproved 2009) Standard Test Method for Microbial 

Ranking of Porous Packaging Materials (Exposure Chamber Method) 

Reaffirmation 

14–211 AOAC 6.2.01:2006 Official Method 955.14 Testing Disinfectants against 

Salmonella choleraesuis, Use-Dilution Method 

Contact person 

14–212 AOAC 6.2.02:2006 Official Method 991.47 Testing Disinfectants against 

Salmonella choleraesuis, Hard Surface Carrier Test Method 

Contact person 

14–213 AOAC 6.2.03:2006 Official Method 991.48 Testing Disinfectant against 

Staphylococcus aureus, Hard Surface Carrier Test Method 

Contact person 

14–214 AOAC 6.2.04:2006 Official Method 955.15 Testing Disinfectants Against 

Staphylococcus aureus, Use-Dilution Method 

Contact person 

14–215 AOAC 6.2.05:2006 Official Method 991.49 Testing Disinfectants against 

Pseudomonas aeruginosa, Hard Surface Carrier Test Method 

Contact person 

14–216 AOAC 6.2.06:2006 Official Method 964.02 Testing Disinfectants against 

Pseudomonas aeruginosa, Use-Dilution Method 

Contact person 

14–217 AOAC 6.3.02:2006 Official Method 955.17 Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes Contact person 

14–218 AOAC 6.3.05:2006 Official Method 966.04 Sporicidal Activity of Disinfectants Method I Contact person 

14–219 AOAC 6.3.06:2006 Official Method 965.12 Tuberculocidal Activity of Disinfectants Contact person 

14–223 14–296 ANSI/AAMI/ISO 11138–1:2006/(R)2010 Sterilization of health care products—Biological indicators—Part 1: General requirements Withdrawn and replaced with 

newer version 

14–224 14–297 ANSI/AAMI/ISO 11137–1:2006/(R)2010 Sterilization of health care products—Radiation—Part 1: Requirements for development, validation, and 

routine control of a sterilization process for medical devices 

Withdrawn and replaced with 

newer version 

14–226 14–298 ANSI/AAMI/ISO 11137–3:2006/(R)2010 Sterilization of health care products—Radiation—Part 3: Guidance on dosimetric aspects Withdrawn and replaced with 

newer version 

14–234 14–299 ASTM F2097–10 Standard Guide for Design and Evaluation of Primary 

Flexible Packaging for Medical Products 

Withdrawn and replaced with 

newer version 

14–265 USP 32:2009 <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests Contact person 

14–266 USP 32:2009 <71> Sterility Tests Contact person 

14–267 USP 32:2009 <85> Bacterial Endotoxins Test Contact person 

14–268 USP 32:2009 <151> Pyrogen Test Contact person 

14–269 USP 32:2009 <161> Transfusion and Infusion Assemblies and Similar Medical Devices Contact person 

14–270 USP 32:2009 Biological Indicator for Steam Sterilization—Self Contained Contact person 

14–271 USP 32: 2009 Biological Indicator for Dry-Heat Sterilization, Paper Carrier Contact person 

14–272 USP 32:2009 Biological Indicator for Ethylene Oxide Sterilization, Paper 

Carrier 

Contact person 

14–273 USP 32:2009 Biological Indicator for Steam Sterilization, Paper Carrier Contact person 

14–278 USP 32:2009 <62> Microbiological Examination of Nonsterile Products: 

Tests for Specified Microorganisms 

Contact person 

14–280 AAMI/ANSI ST79:2006 and A1:2008, A2:2009 (Consolidated Text) Comprehensive guide to steam sterilization and sterility assurance in health 

care facilities 

Contact person 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 61155 

TABLE 2.—MODIFICATIONS TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Old 

Recognition No. 

Replacement 

Recognition 

No. 

Title of Standard1 Change 

14–284 14–300 ASTM D4169–09 Standard Practice for Performance Testing of Shipping 

Containers and Systems 

Withdrawn and replaced with 

newer version 

14–285 AAMI/ANSI/ISO 14161:2009 Sterilization of health care products—Biological indicators—Guidance for the selection, use and interpretation of results Contact person 

N. Tissue Engineering 

15–16 15–19 ASTM F2450–10 Standard Guide for Assessing Microstructure of Polymeric 

Scaffolds for Use in Tissue-Engineered Medical Products 

Withdrawn and replaced with 

newer version 

1All standard titles in this table conform to the style requirements of the respective organizations. 

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: 025. 

TABLE 3.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

Recognition No. Title of Standard1 Reference No. & Date 

A. Anesthesia 

1–83 Medical electrical equipment—Particular requirements for the basic safety and essential 

performance of respiratory gas monitors 

ISO 21647:2004 TECHNICAL 

CORRIGENDUM 1 

B. Cardiology 

3–80 Non-invasive sphygmomanometers—Part 1: Requirements and test methods for non-automated measurement type ANSI/AAMI/ISO 81060– 

1:2007 

3–81 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement 

type 

ANSI/AAMI/ISO 81060– 

2:2009 

3–82 Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for 

implantable pacemakers TECHNICAL CORRIGENDUM 1 

IS0 5841 -3:2000 TECHNICAL CORRIGENDUM 1 

C. Dental/ENT 

4–189 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term 

use 

ISO 10139–1:2005 TECHNICAL CORRIGENDUM 1 

2006–03–01 

D. General 

5–56 Medical devices—Symbols to be used with medical device labels, labelling, and information to be supplied—Part 2: Symbol development, selection and validation ISO 15223–2 First edition 

2010–01–15 

5–57 Human factors engineering—Design of medical devices ANSI/AAMI HE75:2009 

5–58 Medical electrical equipment—Part 1–11: General requirements for basic safety and essential performance—Collateral Standard: Requirements for medical electrical equipment 

and medical electrical systems used in the home healthcare environment 

IEC 60601–1–11 Edition 1.0 

2010–04 

5–59 Medical devices - Symbols to be used with medical device labels, labelling and information 

to be supplied—Part 1: General requirements 

ISO 15223–1 First Edition 

2007 

5–60 Medical electrical equipment - Part 1–2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and 

tests, Interpretation Sheet 

IEC 60601–1–2 (2007) Third 

edition/I-SH 01 

5–61 Medical devices - Symbols to be used with medical device labels, labeling, and information 

to be supplied—Part 1: General requirements 

ANSI/AAMI/ISO 15223– 

1:2007 

E. Materials 

8–194 Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of 

Coiled Wire 

ASTM F 2754/F 2754M—09 


jlentini on DSKJ8SOYB1PROD with NOTICES
61156 Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 

TABLE 3.—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS—Continued 

Recognition No. Title of Standard1 Reference No. & Date 

8–195 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube 

for Medical Devices and Surgical Implants 

ASTM F 2633–07 

F. Ophthalmic 

10–61 Ophthalmic optics—Contact lenses—Part 1: Vocabulary, classification system and recommendations for labelling specifications AMENDMENT 1 ISO 18369–1 First edition 

2006–08–05 AMENDMENT 

1 2009–02–15 

G. Orthopedic 

11–224 Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model ASTM F 2706—08 

H. Radiology 

12–212 Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1: Determination of the detective quantum efficiency IEC 62220–1 First Edition 

2003–10 

12–213 Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1–2: 

Determination of the detective quantum efficiency—Detectors used in mammography 

IEC 62220–1–2 First Edition 

2007–06 

12–214 Medical electrical equipment—Characteristics of digital X-ray imaging devices—Part 1–3: 

Determination of the detective quantum efficiency—Detectors used in dynamic imaging 

IEC 62220–1–3 Edition 1.0 

2008–06 

12–215 Medical electrical equipment—Exposure index of digital X-ray imaging systems—Part 1: 

Definitions and requirements for general radiography 

IEC 62494–1 Edition 1.0 

2008–08 

12–216 Medical electrical equipment - Medical image display systems - Part 1: Evaluation methods IEC 62563–1 Edition 1.0 

2009–12 

I. Sterility 

14–289 Cleanrooms and associated controlled environments—Biocontamination control—Part 2: 

Evaluation and interpretation of biocontamination data 

ISO 14698–2:2003 TECHNICAL CORRIGENDUM 1 

J. Tissue Engineering 

15–20 Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products ASTM F 2027–08 

15–21 Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in TissueEngineered Medical Products ASTM F 2150–07 

15–22 Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions ASTM F 2791–00 

15–23 Standard Guide for Quantitating Cell Viability within Biomaterial Scaffolds ASTM F 2739–08 

15–24 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects ASTM F 2721–09 

1All standard titles in this table conform to the style requirements of the respective organizations. 

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 http://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 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 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 191 / Monday, October 4, 2010 / Notices 61157 

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 ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 025’’ will be available on the 

CDRH home page. You may access the 

CDRH home page at http://www.fda.gov/ 

MedicalDevices. 

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 

http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards. 

This Federal Register document on 

modifications in FDA’s recognition of 

consensus standards is available at 

http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

Standards/ucm123792.htm. 

VII. Submission of Comments and 

Effective Date 

Interested persons may submit to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) either electronic 

or written comments regarding this 

document. It is only necessary to send 

one set of comments. It is no longer 

necessary to sent two copies of mailed 

comments. 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: 

025. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: September 28, 2010. 

Nancy K. Stade, 

Deputy Director for Policy, Center for Devices 

and Radiological Health. 

[FR Doc. 2010–24788 Filed 10–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute on Aging; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, Relationships 

and Health. 

Date: November 16, 2010. 

Time: 1:30 p.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Suite 2C218, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: Alfonso R. Latoni, PhD, 

Deputy Chief and Scientific Review Officer, 

Scientific Review Branch, National Institute 

on Aging, 7201 Wisconsin Avenue, Suite 

2C218, Bethesda, MD 20892. 301–402–7702. 

Alfonso.Latoni@nih.gov. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, Aging Bone 

and Muscle. 

Date: November 18, 2010. 

Time: 1 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Suite 2C212, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: William Cruce, PhD, 

Scientific Review Officer, National Institute 

on Aging, Scientific Review Branch, Gateway 

Building 2C–212, 7201 Wisconsin Ave., 

Bethesda, MD 20814. 301–402–7704. 

crucew@nia.nih.gov. 

Name of Committee: National Institute on 

Aging Special Emphasis Panel, Restless Leg 

Syndrome. 

Date: November 22, 2010. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institute on Aging, 

Gateway Building, 7201 Wisconsin Avenue, 

Suite 2C212, Bethesda, MD 20892. 

(Telephone Conference Call.) 

Contact Person: William Cruce, PhD, 

Scientific Review Officer, National Institute 

on Aging, Scientific Review Branch, Gateway 

Building 2C–212, 7201 Wisconsin Ave., 

Bethesda, MD 20814. 301–402–7704. 

crucew@nia.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.866, Aging Research, 

National Institutes of Health, HHS) 

Dated: September 28, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24784 Filed 10–1–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center For Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Center for Scientific 

Review Special Emphasis Panel, 

October 19, 2010, 11 a.m. to October 19, 

2010, 5 p.m., National Institutes of 

Health, 6701 Rockledge Drive, Bethesda, 

MD 20892 which was published in the 

Federal Register on September 17, 2010, 

75 FR 57042–57043. 

The meeting will be two days— 

October 18, 2010, from 8 a.m. to October 

19, 2010, 5 p.m. The meeting location 

remains the same. The meeting is closed 

to the public. 

Dated: September 28, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–24783 Filed 10–1–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Statement of Organization, Functions 

and Delegations of Authority 

This notice amends Part R of the 

Statement of Organization, Functions 

and Delegations of Authority of the 

Department of Health and Human 

Services (HHS), Health Resources and 

Services Administration (HRSA) (60 FR 

56605, as amended November 6, 1995; 

as last amended at 75 FR 58416–58417 

dated September 24, 2010). 

This notice reflects organizational 

changes to the Health Resources and 

Services Administration and updates 

the functional statement for the Bureau 

of Primary Health Care (RC). 

Specifically, this notice (1) Creates the 

Office of Administrative Management 

(RCM) and the Office of Training and 

Technical Assistance Coordination 

(RCS); (2) abolishes the Division of 

Health Information Technology State 

and Community Assistance (RCR); (3) 

renames the Office of Minority and 

Special Populations (RCG) to the Office 


jlentini on DSKJ8SOYB1PROD with NOTICES