[Federal Register Volume 71, Number 62 (Friday, March 31, 2006)]
[Notices]
[Pages 16313-16317]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-4695]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0226]
Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 014
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: 014'' (Recognition List Number: 014), 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: 014'' 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 301-443-8818. Submit written
comments concerning this document, or recommendations for additional
standards for recognition, to the contact person (see FOR FURTHER
INFORMATION CONTACT). Submit electronic comments by e-mail:
[email protected]. This document may also be accessed on FDA's
Web site at http://www.fda.gov/cdrh/fedregin.html. See section VI of
this document for electronic access to the searchable database for the
current list of FDA recognized consensus standards, including
Recognition List Number: 014 modifications and other standards related
information.
FOR FURTHER INFORMATION CONTACT: Carol L. Herman, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 12720
Twinbrook Pkwy., Rockville, MD 20857, 301-827-0021.
SUPPLEMENTARY INFORMATION:
I. Background
Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Amended
section 514 allows FDA to recognize consensus standards developed by
international and national organizations for use in satisfying portions
of device premarket review submissions or other requirements.
In a notice published in the Federal Register of February 25, 1998
(63 FR 9561), FDA announced the availability of a guidance entitled
``Recognition and Use of Consensus Standards.'' The notice described
how FDA would implement its standard recognition program and provided
the initial list of recognized standards.
In Federal Register notices published on 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), and November 8, 2005 (70 FR 67713), FDA
modified its initial list of FDA recognized consensus standards. These
notices describe the addition, withdrawal, and revision of certain
standards recognized by FDA. The agency maintains ``hypertext markup
language'' (HTML) and ``portable document format'' (PDF) versions of
the list of ``FDA Recognized Consensus Standards.'' Both versions are
publicly accessible at the agency's Web site. See section VI of this
document for electronic access information. Interested persons should
review the supplementary information sheet for the standard to
understand fully the extent to which FDA recognizes the standard.
II. Modifications to the List of Recognized Standards, Recognition List
Number: 014
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: 014'' to identify these current
modifications.
In table 1 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others, (2) the correction of errors made by FDA in listing previously
recognized standards, and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
In section III of this document, FDA lists modifications the agency
is making that involve the initial addition of standards not previously
recognized by FDA.
Table 1.
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Old Item Replacement Item
No. Standard Change No.
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A. Anesthesia
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[[Page 16314]]
32 ISO 7767: 1997: Oxygen Withdrawn .................
Monitors for Monitoring
Patient Breathing
Mixtures--Safety
Requirements
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33 ISO 9918: 1993: Withdrawn .................
Capnometers for Use with
Humans--Requirements
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41 NFPA 99: 2005: Standard Withdrawn and 67
for Health Care replaced
Facilities Chapter 20-- with newer
Hyperbaric Facilities version
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B. Dental/Ear, Nose, and Throat
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52 ANSI/ADA Specification Date .................
No. 27: 1997, Resin-
Based Filling Materials
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60 ANSI/ADA Specification Date and .................
No. 96: 2000, Dental- title
Water-Based Cements--
Adoption of ISO 9917:
1991
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114 ANSI/ADA Specification Date .................
No. 48: 2004,
Ultraviolet Activator
and Disclosing Lights
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C. General Hospital/General Plastic Surgery
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47 ASTM D5712-05 Standard Withdrawn and 144
Test Method for Analysis replaced
of Aqueous Extractable with newer
Protein in Natural version
Rubber and Its Products
Using the Modified Lowry
Method
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77 ASTM F1862-00a Standard Contact .................
Test Method for person
Resistance of Medical
Face Masks to
Penetration by Synthetic
Blood (Horizontal
Projection of Fixed
Volume at a Known
Velocity)
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86 ASTM D3578-05 Standard Withdrawn and 145
Specification for Rubber replaced
Examination Gloves with newer
version
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96 ASTM F2101-01 Standard Contact .................
Test Method for person
Evaluating the Bacterial
Filtration Efficiency
(BFE) of Medical Face
Mask Materials, Using a
Biological Aerosol of
Staphylococcus Aureus
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112 AAMI/ANSI PB70: 2003 Contact .................
Liquid barrier person
performance and
classification of
protective apparel and
drapes intended for use
in health care
facilities
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113 ASTM F2100-04 Standard Contact .................
Specification for person
Performance of Materials
Used in Medical Face
Masks
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120 ASTM F1054-01 Standard Withdrawn .................
Specification for
Conical Fittings
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128 ASTM F1670-03 Standard Contact .................
Test Method for person
Resistance of Materials
Used in Protective
Clothing to Penetration
by Synthetic Blood
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D. Materials
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14 ASTM F688-05: Standard Withdrawn and 119
Specification for replaced
Wrought Cobalt-35Nickel- with newer
20Chromium-10Molybdenum version
Alloy Plate, Sheet, and
Foil for Surgical
Implants (UNS R30035)
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38 ASTM F2005-00: Standard Withdrawn .................
Terminology for Nickel-
Titanium Shape Memory
Alloys
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78 ASTM F560-05: Standard Withdrawn and 120
Specification for replaced
Unalloyed Tantalum for with newer
Surgical Implant version
Applications (UNS
R05200, UNS R05400)
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100 ASTM F2005-05: Standard Withdrawn and 121
Terminology for Nickel- replaced
Titanium Shape Memory with newer
Alloys version
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E. OB-GYN/Gastroenterology
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[[Page 16315]]
19 ISO 8600-1: 2005 Optics Withdrawn and 37
and photonics--Medical replaced
endoscopes and with newer
endotherapy devices-- version
Part 1: General
requirements
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F. Orthopedic/Physical Medicine
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162 ASTM F564-02: Standard Extent of .................
Specification and Test recognition,
Methods for Metallic type of
Bone Staples standard,
contact
person and
related Code
of Federal
Regulations
citation and
product
codes
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164 ASTM F1541-02: Standard Devices .................
Specification and Test affected,
Methods for External processes
Skeletal Fixation affected,
Devices extent of
recognition,
type of
standard,
and contact
person
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182 ASTM F1800-04: Standard Processes .................
Test Method for Cyclic affected and
Fatigue Testing of Metal relevant
Tibial Tray Components guidance
of Total Knee Joint
Replacements
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G. Radiology
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1 ISO 9236-1: 2004 Withdrawn and 136
Photography--Sensitometr replaced
y of screen/film systems with newer
for medical radiography-- version
Part 1: Determination of
sensitometric curve
shape, speed and Average
Gradient
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2 ISO 4090: 2001 Withdrawn and 137
Photography--Medical replaced
radiographic cassettes/ with newer
screens/films and hard- version
copy imaging films--
Dimensions and
specifications
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5 ISO 5799: 1991 Withdrawn and 138
Photography--Direct- replaced
exposing medical and with newer
dental radiographic film/ version
process systems--
Determination of ISO
Speed and ISO average
gradient
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37 IEC 60601-2-11-2004 Withdrawn and 133
Amendment 1--Medical replaced
electrical equipment-- with newer
Part 2-11: Particular version
requirements for the
safety of gamma beam
therapy equipment
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44 AOMS-2005 Acoustic Output Withdrawn and 139
Measurement Standard for replaced
Diagnostic Ultrasound with newer
Equipment version
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46 RTD1-2005 Standard for Withdrawn and 140
Real-Time Display of replaced
Thermal and Mechanical with newer
Acoustic Output Indices version
on Diagnostic Ultrasound
Equipment Revision 1
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101 ANSI/IESNA RP-27.1-1996 Title .................
Recommended Practice for
Photobiological Safety
for Lamps and Lamp
Systems--General
Requirements
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102 ANSI/IESNA RP-27.2-2000 Title .................
Recommended Practice for
Photobiological Safety
for Lamps and Lamp
Systems--Measurement
Techniques
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103 ANSI/IESNA RP-27.3-1996 Title .................
Recommended Practice for
Photobiological Safety
Lamps--Risk Group
Classification and
Labeling
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128 IEEE N42.13-2004 Withdrawn and 141
Calibration and Usage of replaced
``Dose Calibrator'' with newer
Ionization Chambers for version
the Assay of
Radionuclides
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H. Sterility
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53 ANSI/AAMI ST66, Relevant .................
Sterilization of health guidance
care products--Chemical
indicators--Part 2:
Indicators for Air
Removal Test Sheets and
Packs
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74 ANSI/AAMI ST60, Extent of .................
Sterilization of health recognition
care products--Chemical and relevant
indicators--Part 1: guidance
General requirements
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[[Page 16316]]
92 ASTM F2097-05, Standard Withdrawn and 167
Guide for Design and replaced
Evaluation of Primary with newer
Packaging for Medical version
Products
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151 ASTM F2338-05, Standard Withdrawn and 168
Test Method for replaced
Nondestructive Detection with newer
of Leaks in Packages by version
Vacuum Decay Method
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III. Listing of New Entries
The listing of new entries and consensus standards added as
modifications to the list of recognized standards under Recognition
List Number: 014, follows:
Table 2.
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Reference No. and
Item No. Title of Standard Date
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A. Cardiovascular/Neurology
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58 Cardiovascular implants--Cardiac ANSI/AAMI/ISO 5840:
valve prostheses 2005
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B. General Hospital/General Plastic Surgery
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146 Medical electrical equipment--Part ANSI/AAMI/IEC 60601-
2: Particular requirements for 2-21 and 60601-2-
safety of infant radiant warmers 21 amendment 1:
2000
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147 Standard Practice for Assessment of ASTM D6978-05
Resistance of Medical Gloves to
Permeation by Chemotherapy Drugs
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148 Sterile hypodermic syringes for ISO 7886-3: 2005
single use--Part 3: Auto-disable
syringes for fixed-dose
immunization
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149 Standard Practice for Determination ASTM D7160-05
of Expiration Dating for Medical
Gloves
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150 Standard Practice for Determination ASTM D7161-05
of Real Time Expiration Dating of
Mature Medical Gloves Stored Under
Typical Warehouse Conditions
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C. Orthopedic/Physical Medicine
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183 Standard Practice for Fretting ASTM F1875-98
Corrosion Testing of Modular (2004)
Implant Interfaces: Hip Femoral
Head-bore and Cone Taper Interface
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184 Implants for Surgery--Staples with ISO 8827: 1988
parallel legs for orthopaedic use--
General requirements
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185 Standard Test Method for Measuring ASTM F2267-04
Load Induced Subsidence of an
Intervertebral Body Fusion Device
Under Static Axial Compression
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186 Test Methods for Intervertebral ASTM F2077-03
Body Fusion Devices
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187 Standard Specifications and Test ASTM F2193-02
Methods for Components Used in the
Surgical Fixation of the Spinal
Skeletal System
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188 Implants for surgery--Wear of total ISO 14243-1: 2002
knee-joint prostheses--Part 1:
Loading and displacement
parameters for wear-testing
machines with load control and
corresponding environmental
conditions for test
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189 Implants for surgery--wear of total ISO 14243-2: 2000
knee-joint prostheses--Part 2:
Methods of measurement
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190 Implants for surgery--wear of total ISO 14243-3: 2004
knee-joint prostheses--Part 3:
Loading and displacement
parameters for wear-testing
machines with displacement control
and corresponding environmental
conditions for test
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191 Implants for surgery--Total knee- ISO 14879-1: 2000
joint prostheses--Part 1:
Determination of endurance
properties of knee tibial trays
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192 Standard Test Method for ASTM F1223-05
Determination of Total Knee
Replacement Constraint
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193 Standard Specification for Total ASTM F2083-04
Knee Prosthesis
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[[Page 16317]]
D. Radiology
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142 Lasers and laser-related equipment-- ISO 11146-2: 2005
Test methods for laser beam
widths, Divergence angles, and
beam propagation ratios--Part 2:
General astigmatic beams
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143 Lasers and laser-related equipment-- ISO 15367-2: 2005
Test methods for determination of
the shape of a laser beam
wavefront--Part 2: Shack-Hartmann
sensors
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E. Sterility
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169 Standard Test Method for Measuring ASTM F2391-05
Package and Seal Integrity Using
Helium as Tracer Gas
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170 Standard Guide for Biocompatibility ASTM F2475-05
Evaluation of Medical Device
Packaging Materials
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171 Chemical Indicators--Guidance on ANSI/AAMI/ISO
the selection, use, and 15882: 2003
interpretation of results
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IV. List of Recognized Standards
FDA maintains the agency's current list of FDA recognized consensus
standards in a searchable database that may be accessed directly at
FDA's Web site at 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
In order to receive ``Guidance on the Recognition and Use of
Consensus Standards'' on your fax machine, call the Center for Devices
and Radiological Health (CDRH) Facts-On-Demand system at 800-899-0381
or 301-827-0111 from a touch-tone telephone. Press 1 to enter the
system. At the second voice prompt press 1 to order a document. Enter
the document number 321 followed by the pound sign. Follow the
remaining voice prompts to complete your request.
You may also obtain a copy of ``Guidance on the Recognition and Use
of Consensus Standards'' by using the Internet. CDRH maintains a site
on the Internet for easy access to information including text,
graphics, and files that you may download to a personal computer with
access to the Internet. Updated on a regular basis, the CDRH home page
includes the guidance as well as the current list of recognized
standards and other standards related documents. After publication in
the Federal Register, this notice announcing ``Modifications to the
List of Recognized Standards, Recognition List Number: 014'' will be
available on the CDRH home page. You may access the CDRH home page at
http://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 http://www.fda.gov/cdrh/stdsprog.html.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/cdrh/fedregin.html.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. FDA will consider any
comments received in determining whether to amend the current listing
of modifications to the list of recognized standards, Recognition List
Number: 014. These modifications to the list of recognized standards
are effective upon publication of this notice in the Federal Register.
Dated: March 23, 2006
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-4695 Filed 3-30-06; 8:45 am]
BILLING CODE 4160-01-S