Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13631 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Total number 

of waiver 

requests 

annually 

Annual 

frequency per 

response 

Number of 

sponsors/ 

applicants 

Total average 

burden hours Total hours 

Federal Food, Drug, and Cosmetic Act Section 736 .......... 90 1.2 75 16 1,440 

Reconsideration Requests ................................................... 3 1 3 24 72 

Appeal Requests .................................................................. 1 1 1 12 12 

Total .............................................................................. ........................ ........................ ........................ ........................ 1,524 

1There are no capital operating and maintenance costs associated with this collection of information. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://www.fda.

gov.BiologicsBloodVaccines/Guidance

ComplianceRegulatoryInformation/

guidances/default.htm, or http:// 

www.regulations.gov. 

Dated: March 4, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5737 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

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: 

026 

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: 026’’ (Recognition List 

Number: 026), 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: 026’’ 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. Send two selfaddressed 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 e-mail: 

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: 026 

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, 301–796–6574. 

I. Background 

Section 204 of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Pub. L. 105–115) 

amended section 514 of the Federal 

Food, Drug, and Cosmetic Act (the 

FD&C 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 as follows: 

TABLE 1—PREVIOUS PUBLICATIONS OF

STANDARD RECOGNITION LISTS

February 25, 1998 (63 FR 9561). 

October 16, 1998 (63 FR 55617). 

July 12, 1999 (64 FR 37546). 

November 15, 2000 (65 FR 69022). 

May 7, 2001 (66 FR 23032). 

January 14, 2002 (67 FR 1774). 

October 2, 2002 (67 FR 61893). 

April 28, 2003 (68 FR 22391). 

March 8, 2004 (69 FR 10712). 

June 18, 2004 (69 FR 34176). 

October 4, 2004 (69 FR 59240). 

May 27, 2005 (70 FR 30756). 

November 8, 2005 (70 FR 67713). 

March 31, 2006 (71 FR 16313). 

June 23, 2006 (71 FR 36121). 

November 3, 2006 (71 FR 64718). 

May 21, 2007 (72 FR 28500). 

September 12, 2007 (72 FR 52142). 

December 19, 2007 (72 FR 71924). 

September 9, 2008 (73 FR 52358). 

March, 18, 2009 (74 FR 11586). 

September 8, 2009 (74 FR 46203). 

May 5, 2010 (75 FR 24711). 

June 10, 2010 (75 FR 32943). 

October 4, 2010 (75 FR 61148). 

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13632 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

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: 026 

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: 026’’ 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 standard 1 Change 

A. Anesthesia 

1–56 .............. ........................ CGA V–7.1 1997 (R2003) (2008) Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases—First Edition.Reaffirmation. 

B. Biocompatibility 

2–96 .............. 2–162 ASTM F1903–10 Standard Practice for Testing For Biological Responses to Particles In Vitro.Withdrawn and replaced with newer 

version. 

2–117 ............ ........................ ANSI/AAMI/ISO 10993–3:2003/(R)2009 Biological evaluation of medical 

devices—Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.

Extent of recognition. 

C. Cardiovascular 

3–54 .............. ........................ ANSI/AAMI/ISO 7198:1998/2001/(R)2010 Cardiovascular implants—Tubular vascular prostheses.Reaffirmation. 

3–58 .............. ........................ ANSI/AAMI/ISO 5840:2005/(R)2010 Cardiovascular implants—Cardiac 

valve prostheses.

Reaffirmation. 

3–66 .............. ........................ ASTM F 2081–06 Standard Guide for Characterization and Presentation 

of the Dimensional Attributes of Vascular Stents.

Device affected, Processes impacted, Type of standard, CFR citation and product codes, and 

Contact person. 

D. Dental/ENT 

4–89 .............. ........................ ADA Specification No. 53 Polymer-Based Crowns and Bridge Resins .... Reaffirmation. 

4–111 ............ ........................ ADA Specification No. 13 Denture Cold-Curing Repair Resins: 1981 

(Reaffirmed 2006).

Withdrawn. 

4–112 ............ ........................ ADA Specification No. 16 Dental Impression Paste—Zinc Oxide Eugenol 

Type.

Withdrawn. 

4–124 ............ 4–191 ANSI/ASA S3.22–2009 American National Standard Specification of 

Hearing Aid Characteristics.

Withdrawn and replaced with newer 

version. 

4–127 ............ 4–192 ADA Specification 58 Root Canal Files, Type H (Hedstrom) 2007 ........... Withdrawn and replaced with newer 

version. 

4–138 ............ 4–193 ADA Specification No. 15 Artificial Teeth for Dental Prostheses .............. Withdrawn and replaced with newer 

version. 

4–148 ............ 4–194 ADA Specification No. 78 Dental Obturating Cones ................................. Withdrawn and replaced with newer 

version. 

4–158 ............ ........................ ISO 10139–1:2005 Dentistry—Soft lining materials for removable dentures—Part 1: Materials for short-term use Technical Corrigendum 

1:2006.

Withdrawn duplicate. See 4–189. 

E. General Hospital/General Plastic Surgery 

6–144 ............ 6–243 ASTM D5712–10 Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.Withdrawn and replaced with a 

newer version. 

6–145 ............ ........................ ASTM D3578–05 Standard Specification for Rubber Examination Gloves Reaffirmation. 

6–149 ............ ........................ ASTM D7160–05 (Reapproved 2010) Standard Practice for Determination of Expiration Dating for Medical Gloves.Reaffirmation. 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

6–150 ............ ........................ ASTM D7161–05 (Reapproved 2010) Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored 

Under Typical Warehouse Conditions.

Reaffirmation. 

6–165 ............ ........................ ASTM D6977–04 (Reapproved 2010) Standard Specification for 

Polychloroprene Examination Gloves for Medical Application.

Reaffirmation. 

6–167 ............ 6–244 ASTM D6319–10 Standard Specification for Nitrile Examination Gloves 

for Medical Application.

Withdrawn and replaced with newer 

version. 

6–169 ............ ........................ ASTM D3772–01 (Reapproved 2010) Standard Specification for Natural 

Rubber Finger Cots.

Reaffirmation. 

6–201 ............ 6–245 ISO 8536–4 Fifth edition 2010–10–01 Infusion equipment for medical 

use—Part 4: Infusion sets for single use, gravity feed.

Withdrawn and replaced with newer 

version. 

6–218 ............ 6–246 USP 33–NF 28 2010 <11> Nonabsorbable Surgical Suture ..................... Withdrawn and replaced with newer 

version. 

6–220 ............ 6–247 USP 33–NF 28 2010 Absorbable Surgical Suture .................................... Withdrawn and replaced with newer 

version. 

6–221 ............ 6–248 USP 33–NF 28 2010 <881> Tensile Strength ........................................... Withdrawn and replaced with newer 

version. 

6–222 ............ 6–249 USP 33–NF 28 2010 <861> Suture–Diameter .......................................... Withdrawn and replaced with newer 

version. 

6–223 ............ 6–250 USP 33–NF 28 2010 <871> Sutures—Needle Attachment ...................... Withdrawn and replaced with newer

version. 

6–224 ............ 6–251 USP 33 NF–28 2010 <11> Sterile Water for Irrigation ............................. Withdrawn and replaced with newer 

version. 

6–225 ............ 6–252 USP 33 NF–28 2010 <11> Heparin Lock Flush Solution ......................... Withdrawn and replaced with newer 

version. 

F. IVD 

7–183 ............ ........................ CLSI M38–A2 Reference Method for Broth Dilution Antifungal Susceptibility Testing of Filamentous Fungi.Withdrawn duplicate. See 7–171. 

7–188 ............ 7–218 CLSI M45–A2 Methods for Antimicrobial Dilution and Disk Susceptibility 

Testing of Infrequently Isolated or Fastidious Bacteria; Approved 

Guideline—Second Edition.

Withdrawn and replaced with newer 

version. 

G. Materials 

8–10 .............. ........................ ASTM F603–00 Standard Specification for High-Purity Dense Aluminum 

Oxide for Surgical Implant Application.

Withdrawn. 

8–88 .............. 8–195 ASTM F2024–10 Standard Practice for X–Ray Diffraction Determination 

of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings.

Withdrawn and replaced with newer 

version. 

8–101 ............ ........................ ASTM F 2118—03 (Reapproved 2009) Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone 

Cement Materials.

Reaffirmation. 

8–103 ............ ........................ ASTM F1801—97 (Reapproved 2009)e1 Standard Practice for Corrosion 

Fatigue Testing of Metallic Implant Materials.

Reaffirmation. 

8–107 ............ ........................ ASTM F746—04 (Reapproved 2009) e1 Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials.Reaffirmation. 

8–117 ............ ........................ ASTM F86—04 (Reapproved 2009) Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants.Reaffirmation. 

H. OB–GYN/Gastroenterology 

9–47 .............. ........................ AAMI RD16 Cardiovascular implants and artificial organs— 

Hemodialyzers, hemodiafilters.

Withdrawn. See 9–65. 

9–48 .............. ........................ AAMI RD17 Cardiovascular implants and artificial organs— 

Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and 

hemofilters.

Withdrawn. See 9–66. 

9–50 .............. ........................ ANSI/AAMI RD52:2004/(R)2010 and ANSI/AAMI RD52:2004/A1:2007/ 

(R)2010, A2:2007/(R)2010, A3:2009, & A4:2009 (Consolidated Text) 

Dialysate for haemodialysis.

Reaffirmation. 

9–51 .............. 9–65 ANSI/AAMI/ISO 8637:2010 Cardiovascular implants and extracorporeal 

systems—Hemodialyzers, hemodiafilters, hemofilters and 

hemoconcentrators.

Withdrawn and replaced with newer 

version. 

9–52 .............. 9–66 ANSI/AAMI/ISO 8638:2010 Cardiovascular implants and extracorporeal 

systems—Extracorporeal blood circuit for hemodialyzers, 

hemodiafilters and hemofilters.

Withdrawn and replaced with newer 

version. 

9–55 .............. ........................ ANSI/AAMI RD62:2006 and ANSI/AAMI RD62:2006/A1:2009 Water 

treatment equipment for haemodialysis applications.

Reaffirmation. 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

I. Orthopedics 

11–168 .......... ........................ ASTM F 1781–03 (Reapproved 2009) Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants.Reaffirmation. 

11–183 .......... ........................ ASTM F1875–98 (Reapproved 2009) Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore 

and Cone Taper Interface.

Reaffirmation. 

J. Physical Medicine 

16–30 ............ 16–167 ISO 7176–9: Third edition, 2009–11–15 Wheelchairs—Part 9: Climatic 

tests for electric wheelchairs.

Withdrawn and replaced with newer 

version. 

16–31 ............ 16–168 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 1: Determination of static stability.

Withdrawn and replaced with newer 

version. 

16–32 ............ 16–169 RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) 

with Electrical Systems Section 2: Determination of dynamic stability 

of electrically powered wheelchairs.

Withdrawn and replaced with newer 

version. 

16–33 ............ 16–170 RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) 

with Electrical Systems Section 3: Determination of effectiveness of 

brakes.

Withdrawn and replaced with newer 

version. 

16–34 ............ 16–171 RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) 

with Electrical Systems Section 4: Energy consumption of electrically 

powered wheelchairs and scooters for determination of theoretical distance range.

Withdrawn and replaced with newer 

version. 

16–35 ............ 16–172 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 5: Determination of dimensions, mass and maneuvering space.

Withdrawn and replaced with newer 

version. 

16–36 ............ 16–173 RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) 

with Electrical Systems Section 6: Determination of maximum speed, 

acceleration and deceleration of electrically powered wheelchairs.

Withdrawn and replaced with newer 

version. 

16–37 ............ 16–174 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 7: Method of Measurement of Seating and Wheel 

Dimensions.

Withdrawn and replaced with newer 

version. 

16–38 ............ 16–175 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 8: Requirements and test methods for static, impact 

and fatigue strengths.

Withdrawn and replaced with newer 

version. 

16–39 ............ 16–176 RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) 

with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs.

Withdrawn and replaced with newer 

version. 

16–40 ............ 16–177 RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) 

with Electrical Systems Section 10: Determination of obstacle-climbing 

ability of electrically powered wheelchairs.

Withdrawn and replaced with newer 

version. 

16–41 ............ 16–178 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 11: Test dummies.

Withdrawn and replaced with newer 

version. 

16–42 ............ 16–179 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 13: Determination of coefficient of friction of test 

surfaces.

Withdrawn and replaced with newer 

version. 

16–43 ............ 16–180 RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) 

with Electrical Systems Section 14: Power and control systems for 

electrically powered wheelchairs—Requirements and test methods.

Withdrawn and replaced with newer 

version. 

16–44 ............ 16–181 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 15: Requirements for information disclosure, documentation and labeling.

Withdrawn and replaced with newer 

version. 

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

Old 

recognition 

No. 

Replacement 

recognition 

No. 

Title of standard 1 Change 

16–45 ............ 16–182 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 16: Resistance to ignition of upholstered parts—Requirements and test methods.

Withdrawn and replaced with newer 

version. 

16–46 ............ 16–183 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 20: Determination of the performance of stand-up 

type wheelchairs.

Withdrawn and replaced with newer 

version. 

16–47 ............ 16–184 RESNA WC–1: 2009 American National Standard for Wheelchairs-Volume 1: Requirements and Test Methods for Wheelchairs (including 

Scooters) Section 22: Set-up procedures.

Withdrawn and replaced with newer 

version. 

16–48 ............ ........................ ANSI/RESNA WC/Volume 1–1998, Section 93: Maximum Overall Dimensions.Withdrawn. 

16–49 ............ ........................ ANSI/RESNA WC/Volume 1–1998, Section 0: Nomenclature, Terms, 

and Definitions.

Withdrawn. 

16–160 .......... 16–185 RESNA WC–2: 2009 American National Standard for Wheelchairs-Volume 2: Additional Requirements for Wheelchairs (including Scooters) 

with Electrical Systems Section 21: Requirements and test methods 

for electromagnetic compatibility of electrically powered wheelchairs 

and motorized scooters.

Withdrawn and replaced with newer 

version. 

16–161 .......... 16–186 ASME A18.1–2008 (Revision of ASME A18.1–2005) Safety Standard for 

Platform Lifts and Stairway Chairlifts.

Withdrawn and replaced with newer 

version. 

K. Radiology 

12–122 .......... 12–217 IEC 62083 Edition 2.0:2009–09 Medical electrical equipment—Requirements for the safety of radiotherapy treatment planning systems.Withdrawn and replaced with newer 

version. 

12–36 ............ ........................ IEC 60601–2–9 (1996–10) Medical electrical equipment—Part 2: Particular requirements for the safety of patient contact dosimeters used 

in radiotherapy with electrically connected radiation detectors—Ed. 

2.0..

Withdrawn. 

12–183 .......... 12–218 NEMA PS 3.1—3.18 (2009) Digital Imaging and Communications in 

Medicine (DICOM) Set.

Withdrawn and replaced with newer 

version. 

L. Software/Informatics 

13–4 .............. ........................ UL 1998 Standard for Safety Software in Programmable Components, 

Second Edition.

Reaffirmation. 

M. Sterility 

14–265 .......... 14–301 USP 33:2010 <61> Microbiological Examination of Nonsterile Products: 

Microbial Enumeration Tests.

Withdrawn and replaced with newer 

version. 

14–266 .......... 14–302 USP 33: 2010 <71> Sterility Tests ............................................................ Withdrawn and replaced with newer 

version. 

14–267 .......... 14–303 USP 33:2010 <85> Bacterial Endotoxins Test .......................................... Withdrawn and replaced with newer 

version. 

14–268 .......... 14–304 USP 33:2010 <151> Pyrogen Test ............................................................ Withdrawn and replaced with newer 

version. 

14–269 .......... 14–305 USP 33:2010 <161> Transfusion and Infusion Assemblies and Similar 

Medical Devices.

Withdrawn and replaced with newer 

version. 

14–270 .......... 14–306 USP 33:2010 Biological Indicators for Steam Sterilization, Self-Contained.Withdrawn and replaced with newer 

version. 

14–271 .......... 14–307 USP 33:2010 Biological Indicator for Dry-Heat Sterilization, Paper Carrier.Withdrawn and replaced with newer 

version. 

14–272 .......... 14–308 USP 33:2010 Biological Indicator for Ethylene Oxide Sterilization, Paper 

Carrier.

Withdrawn and replaced with newer 

version. 

14–273 .......... 14–309 USP 33:2010 Biological Indicator for Steam Sterilization, Paper Carrier Withdrawn and replaced with newer

version. 

14–278 .......... 14–310 USP 33:2010 <62> Microbiological Examination of Nonsterile Products: 

Tests for Specified Microorganisms.

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: 026. 

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TABLE 3—NEW ENTRIES TO THE LIST OF RECOGNIZED STANDARDS

Recognition 

No. Title of standard 1 Reference No. and date 

A. Anesthesia 

1–84 .............. Anaesthetic and respiratory equipment—Tracheostomy tubes—Part 3: 

Paediatric tracheostomy tubes TECHNICAL CORRIGENDUM 1.

ISO 5366–3:2001 TECHNICAL CORRIGENDUM 1. 

B. Biocompatibility 

2–163 ............ Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products.ANSI/AAMI/ISO 10993–9:2009. 

2–164 ............ Biological evaluation of medical devices—Part 13: Identification and 

quantification of degradation products from polymeric medical devices.

ANSI/AAMI/ISO 10993–13:2010. 

2–165 ............ Biological evaluation of medical devices—Part 14: Identification and 

quantification of degradation products from ceramics.

ANSI/AAMI/ISO 10993–14:2001. 

2–166 ............ Biological evaluation of medical devices—Part 16: Toxicokinetic study 

design for degradation products and leachables.

ANSI/AAMI/ISO 10993–16:2010. 

2–167 ............ Biological evaluation of medical devices—Part 19: Physico-chemical, 

morphological and topographical characterization of materials.

ISO/TS 10993–19 First edition 2006–06–01. 

2–168 ............ Biological evaluation of medical devices— Part 9: Framework for identification and quantification of potential degradation products.ISO 10993–9 Second edition 2009–12–15. 

2–169 ............ Biological evaluation of medical devices—Part 13: Identification and 

quantification of degradation products from polymeric medical devices.

ISO 10993–13 First edition 1998–11–15. 

2–170 ............ Biological evaluation of medical devices—Part 14: Identification and 

quantification of degradation products from ceramics.

ISO 10993–14 First edition 2001–11–15. 

2–171 ............ Biological evaluation of medical devices—Part 16: Toxicokinetic study 

design for degradation products and leachables.

ISO 10993–16 Second edition 2010–02–15. 

2–172 ............ Biological evaluation of medical devices—Part 19: Physico-chemical, 

morphological, and topographical characterization of materials.

ANSI/AAMI/ISO TIR10993–19:2006. 

C. Cardiovascular 

3–83 .............. Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices.ANSI/AAMI/ISO 14708–5:2010. 

3–84 .............. Cardiovascular implants—Endovascular devices—Part 1: Endovascular 

prostheses Amendment 1: Test methods.

ANSI/AAMI/ISO 25539–1:2003/A1:2005/(R)2009. 

3–85 .............. Cardiovascular implants—Endovascular devices—Part 2: Vascular 

stents.

ANSI/AAMI/ISO 25539–2:2008. 

3–86 .............. Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System.ASTM F 2394–07. 

3–87 .............. Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents.ASTM F 2477–07. 

3–88 .............. Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular 

Stents Subjected to Uniform Radial Loading.

ASTM F 2514–08. 

3–89 .............. Active implantable medical devices—Four-pole connector system for 

implantable cardiac rhythm management devices—Dimensional and 

test requirements.

ISO 27186 First edition 2010–03–15. 

3–90 .............. Cardiovascular implants—Tubular vascular prostheses ........................... ISO 7198 First edition 1998–08–01. 

3–91 .............. Cardiovascular implants—Cardiac valve prostheses ................................ ISO 5840 Fourth edition 2005–03–01. 

3–92 .............. Implants for surgery—Active implantable medical devices—Part 5: Circulatory support devices.ISO 14708–5 First edition 2010–02–01. 

3–93 .............. Cardiovascular implants—Endovascular device—Part 1: Endovascular 

prostheses AMENDMENT 1: Test methods.

ISO 25539–1 First edition 2001–11–13 AMENDMENT 

1 2005–07–15. 

3–94 .............. Cardiovascular implants—Endovascular devices—Part 2: Vascular 

stents.

ISO 25539–2 First edition 2008–09–01. 

D. General 

5–63 .............. Small-bore connectors for liquids and gases in healthcare applications—Part 1: General requirements.ISO 80369–1 First edition 2010–12–15. 

5–64 .............. Small bore connectors for liquids and gases in healthcare applications—Part 1: General requirements.AAMI/ISO/FDS–1 80369–01 2010. 

E. Materials 

8–196 ............ Implants for surgery—Metallic materials—Part 1: Wrought stainless 

steel TECHNICAL CORRIGENDUM 1.

ISO 5832–1:2007 TECHNICAL CORRIGENDUM 1 

2008–04–15. 

8–197 ............ Implants for surgery—Metallic materials—Part 12: Wrought cobalt-chromium-molybdenum alloy TECHNICAL CORRIGENDUM 1.ISO 5832–12:2007 TECHNICAL CORRIGENDUM 1 

2008–09–15. 

8–198 ............ Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical 

Implants.

ASTM F 2102–06e1. 

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Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 13637 

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

Recognition 

No. Title of standard 1 Reference No. and date 

8–199 ............ Standard Specification for Wrought Seamless Nickel-Titanium Shape 

Memory Alloy Tube for Medical Devices and Surgical Implants.

ASTM F 2633–07. 

8–200 ............ Standard Practice for Accelerated Aging of Ultra-High Molecular Weight 

Polyethylene after Gamma Irradiation in Air.

ASTM F 2003–02 (Reapproved 2008). 

8–201 ............ Standard Test Method for In Situ Determination of Network Parameters 

of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE).

ASTM F 2214–02 (Reapproved 2008). 

8–202 ............ Standard Test Method for Small Punch Testing of Ultra-High Molecular 

Weight Polyethylene Used in Surgical Implants.

ASTM F 2183–02 (Reapproved 2008). 

F. Nanotechnology 

18–1 .............. Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS).ASTM E 2490–09. 

G. Ophthalmic 

10–62 ............ Ophthalmics—Ophthalmic Instruments—Tonometers .............................. ANSI Z80.10–2009. 

10–63 ............ Ophthalmic implants—Intraocular lenses—Guidance on assessment of 

the need for clinical investigation of intraocular lens design modifications.

ISO/TR 22979–2006. 

H. Radiology 

12–219 .......... Medical electrical equipment—X-ray tube assemblies for medical diagnosis—Characteristics of focal spots CORRIGENDUM 1.IEC 60336 (Fourth edition—2005). 

12–220 .......... Safety of laser products—Part 1: Equipment classification and requirements CORRIGENDUM 1.IEC 60825–1 (Second edition—2007). 

12–221 .......... Evaluation and routine testing in medical imaging departments—Part 3– 

4: Acceptance tests—Imaging performance of dental X-ray equipment.

IEC 61223–3–4 First edition 2000–03. 

12–222 .......... Evaluation and routine testing in medical imaging departments—Part 3– 

5: Acceptance tests—Imaging performance of computed tomography 

X-ray equipment.

IEC 61223–3–5 First edition 2004–08. 

12–223 .......... Evaluation and routine testing in medical imaging departments—Part 3– 

5: Acceptance tests—Imaging performance of computed tomography 

X-ray equipment CORRIGENDUM 1.

IEC 61223–3–5 (First edition 2004). 

12–224 .......... Medical electrical equipment—Part 2–44: Particular requirements for 

the basic safety and essential performance of X-ray equipment for 

computed tomography CORRIGENDUM 1.

IEC 60601–2–44 (Third edition—2009). 

12–225 .......... Computed Tomography Dose Check ........................................................ NEMA XR 25 2010. 

12–226 .......... Evaluation and routine testing in medical imaging departments—Part 2– 

6: Constancy tests—Imaging performance of computed tomography 

X-ray equipment.

IEC 61223–2–6 Second edition 2006–11. 

I. Tissue Engineering 

15–25 ............ ASTM F2312—10 Standard Terminology Relating to Tissue Engineered 

Medical Products.

ASTM F2312–10. 

15–26 ............ ASTM F2211—04 Standard Classification for Tissue Engineered Medical Products (TEMPs).ASTM F2211–04. 

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 FD&C 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 

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13638 Federal Register / Vol. 76, No. 49 / Monday, March 14, 2011 / Notices 

Internet for easy access to information 

including text, graphics, and files that 

you may download to a personal 

computer with access to the Internet. 

Updated on a regular basis, the CDRH 

home page includes the guidance as 

well as the current list of recognized 

standards and other standards related 

documents. After publication in the 

Federal Register, this notice 

announcing ‘‘Modification to the List of 

Recognized Standards, Recognition List 

Number: 026’’ 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’’ at http://www.fda.gov/

MedicalDevices/DeviceRegulationand

Guidance/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 send 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: 

026. These modifications to the list or 

recognized standards are effective upon 

publication of this notice in the Federal 

Register. 

Dated: March 8, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5815 Filed 3–11–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0135] 

Ensuring the Safety of Imported Foods 

and Animal Feed: Comparability of 

Food Safety Systems and Import 

Practices of Foreign Countries; Public 

Hearing; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing regarding new FDA 

initiatives for ensuring the safety of 

foods and animal feed imported into the 

United States. The purpose of the public 

hearing is to provide stakeholders the 

opportunity to discuss FDA’s use of 

international comparability assessments 

as a mechanism to enhance the safety of 

imported foods and animal feed and 

lessons learned through equivalence 

determinations. In addition, there will 

be a separate discussion of FDA’s efforts 

to gather information from regulators in 

other countries regarding the regulatory 

policies, practices, and programs they 

currently use to ensure the safety of 

foods and animal feed imported into 

their countries. In a separate notice 

published elsewhere in this issue of the 

Federal Register, FDA is announcing a 

1-day public meeting to discuss 

implementation of the imports 

provisions found in the FDA Food 

Safety Modernization Act (FSMA). 

DATES: See ‘‘How to Participate in the 

Hearing’’ in the SUPPLEMENTARY

INFORMATION section of this document. 

FOR FURTHER INFORMATION CONTACT: For 

questions about registration, to register 

orally, or to submit a notice of 

participation by mail, fax, or by e-mail: 

Courtney Treece, Planning Professionals 

Ltd., 1210 W. McDermott, suite 111, 

Allen, TX 75013, 704–258–4983, FAX: 

469–854–6992, e-mail: 

ctreece@planningprofessionals.com. 

For questions about the hearing, if 

special accommodations are needed 

due to a disability, to request onsite 

parking, or to submit the full text, 

comprehensive outline, or summary of 

an oral presentation: Juanita Yates, 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administation, 5100 Paint Branch 

Pkwy., College Park, MD 20740, 301– 

436–1731, e-mail: 

Juanita.Yates@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Federal Government and the food 

industry are pursuing proactive efforts 

to reduce the incidence of food borne 

illness. The President’s Food Safety 

Working Group (FSWG) has 

recommended that food regulators shift 

towards prioritizing prevention and 

move aggressively to implement 

sensible measures designed to prevent 

problems before they occur (Ref. 1). The 

newly enacted FSMA (Pub. L. 111–353) 

also embodies the principle of 

prevention by requiring those who 

produce and import food to have 

systems of preventive controls in place 

and empowering FDA to hold them 

accountable to meet their new 

responsibilities. 

FDA recognizes that to ensure the 

safety of imported foods and animal 

feed and fulfill its public health mission 

in a global age, it must embrace new 

approaches that take into account the 

entire supply chain and its complexity. 

Consistent with FSMA and the 

recommendation of the President’s 

FSWG, FDA is focusing on preventing 

problems at appropriate points along the 

global food supply chain. This public 

hearing is an opportunity for the Agency 

to obtain views from interested persons 

concerning certain key aspects of these 

food safety initiatives: (1) International 

comparability assessments and (2) 

gathering information on the policies, 

practices, and programs used by foreign 

regulators to ensure the safety of 

imported foods and animal feed. The 

public hearing will be conducted in 

accordance with part 15 (21 CFR part 

15), as described in the following 

paragraphs. (See ‘‘Notice of Hearing 

Under Part 15’’ in section III of this 

document.) 

FDA’s initiatives discussed at the 2- 

day public hearing align with and help 

support FSMA implementation. Day 

One of the hearing will open with a 

general discussion of FSMA from the 

perspectives of consumers, industry, 

legislators, and U.S. trading partners. 

Day Two will cover policies, practices, 

and programs used by foreign regulators 

to ensure the safety of imported foods 

and animal feed. In a separate notice 

published elsewhere in this issue of the 

Federal Register, FDA is announcing a 

1-day public meeting to discuss 

implementation of the imports 

provisions found in title III of FSMA. 

II. Topics for Discussion at the Hearing 

A. Day One of Hearing: International 

Comparability Assessments 

Under FDA’s proposed model, FDA 

will consider the food safety system of 

a foreign country to be ‘‘comparable’’ to 

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