[Federal Register Volume 69, Number 117 (Friday, June 18, 2004)]
[Notices]
[Pages 34176-34182]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-13725]


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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: 010

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 of the List of Recognized Standards, Recognition List 
Number: 010'' (Recognition List Number: 010), 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 on a 3.5'' 
diskette of ``Modification to the List of Recognized Standards, 
Recognition List Number: 010'' to the Division of Small Manufacturers 
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

[[Page 34177]]

requests, or fax your request to 301-443-8818. Submit written comments 
concerning this document or to recommend 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 Internet 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: 010 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, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4766, ext. 156.

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 document 
entitled ``Recognition and Use of Consensus Standards.'' This notice 
described how FDA will 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), and March 8, 2004 (69 
FR 10712), FDA modified its initial list of recognized standards. These 
notices described 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: 010

    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: 010'' to identify these current 
modifications.
    In the following table, FDA describes modifications that involve: 
(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.

A. Anesthesia

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
19          ISO 8382:1988,            Processes                       19
             Resuscitators Intended    impacted, extent
             for Use with Humans       of recognition,
                                       relevant guidance
------------------------------------------------------------------------
42          ISO 5360:1993,            Devices affected,               42
             Anaesthetic vaporizers--  processes
             Agent-specific filling    impacted, extent
             systems                   of recognition
------------------------------------------------------------------------

B. General

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
2           IEC 60601-1, Medical      Contact person                   2
             Electrical Equipment--
             Part 1: General
             Requirements for Safety
------------------------------------------------------------------------
28          IEC 60601-1-2 (Second     Contact person                  28
             Edition, 2001) Medical
             Electrical Equipment--
             Part 1: General
             Requirements for
             Safety; Electromagnetic
             Compatibility--Requirem
             ents and Tests
------------------------------------------------------------------------
30          ANSI/AAMI/IEC 60601-1-    Correct title of                30
             2:2001, Medical           standard
             Electrical Equipment--
             Parts 1 to 2: General
             Requirements for
             Safety--Collateral
             Standard:
             Electromagnetic
             Compatibility--Requirem
             ents and Tests
------------------------------------------------------------------------

C. General Hospital/General Plastic Surgery

[[Page 34178]]



------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
3           ASTM F754-88, Standard    Withdrawn and                  108
             Specification for         replaced with new
             Implantable               version
             Polytetrafluoroethylene
             (PTFE) Polymer
             Fabricated in Sheet,
             Tube and Rod Shapes
------------------------------------------------------------------------
4           ASTM F881-94, Standard    Withdrawn and                  109
             Specification for         replaced with
             Elastomer Facial          newer version
             Implants
------------------------------------------------------------------------
6           ASTM F1441-92, Standard   Withdrawn and                  110
             Specification for Soft    replaced with
             Tissue Expanders          newer version
------------------------------------------------------------------------
10          IEC 60601-2-38, Medical   Withdrawn and                  111
             Electrical Equipment--    replaced with
             Part 2: Particular        newer version
             Requirements for the
             Safety of Electrically
             Operated Hospital Beds
------------------------------------------------------------------------

D. In Vitro Diagnostic

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
47          NCCLS MM2-A2              Withdrawn and                   98
             Immunoglobulin and T-     replaced with
             Cell Receptor Gene        newer version
             Rearrangement Assays;
             Approved Guideline--
             Second Edition
------------------------------------------------------------------------
84          CEN 13640, Stability      Correction to date              84
             Testing of In Vitro       of standard
             Diagnostic Reagents
------------------------------------------------------------------------

E. Materials

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.         Title of Standard           Change           Item No.
------------------------------------------------------------------------
26          ASTM F1314-01, Standard   Title change                    26
             Specification for
             Wrought Nitrogen
             Strengthened 22
             Chromium - 13 Nickel -
             5 Manganese - 2.5
             Molybdenum Stainless
             Steel Alloy Bar and
             Wire for Surgical
             Implants (UNS S20910)
------------------------------------------------------------------------
39          ASTM F2052-02, Standard   Recognizing a                   70
             Test Method for           newer version
             Measurement of            with a revised
             Magnetically Induced      title
             Displacement Force on
             medical Devices in the
             Magnetic Resonance
             Environment
------------------------------------------------------------------------
55          ASTM F2182-02a, Standard  Recognizing a                   71
             Test Method for           newer version
             Measurement of Radio
             Frequency Induced
             Heating Near Passive
             Implants During
             Magnetic Resonance
             Imaging
------------------------------------------------------------------------
62          ISO 5832-1:1997,          Transferred from                56
             Implants for Surgery--    Orthopedics 62 to
             Metallic materials--      Materials 56
             Part 1: Wrought
             stainless steel
------------------------------------------------------------------------
64          ISO 5832-3:1996,          Transferred from                58
             Implants for Surgery--    Orthopedics 64 to
             Metallic materials--      Materials 58
             Part 3: Wrought
             titanium 6-aluminum 4-
             vanadium alloy
------------------------------------------------------------------------
65          ISO 5832-4:1996,          Transferred from                59
             Implants for Surgery--    Orthopedics 65 to
             Metallic materials--      Materials 59
             Part 4: Cobalt-chromium-
             molybdenum casting
             alloy
------------------------------------------------------------------------
62          ISO 5832-1:1997,          Transferred from                56
             Implants for Surgery--    Orthopedics 62 to
             Metallic materials--      Materials 56
             Part 1: Wrought
             stainless steel
------------------------------------------------------------------------
64          ISO 5832-3:1996,          Transferred from                58
             Implants for Surgery--    Orthopedics 64 to
             Metallic materials--      Materials 58
             Part 3: Wrought
             titanium 6-aluminum 4-
             vanadium alloy
------------------------------------------------------------------------
65          ISO 5832-4:1996,          Transferred from                59
             Implants for Surgery--    Orthopedics 65 to
             Metallic materials--      Materials 59
             Part 4: Cobalt-chromium-
             molybdenum casting
             alloy
------------------------------------------------------------------------
66          ISO 5832-5:1993,          Transferred from                60
             Implants for Surgery--    Orthopedics 66 to
             Metallic materials--      Materials 60
             Part 5: Wrought cobalt-
             chromium-tungsten-
             nickel alloy
------------------------------------------------------------------------
67          ISO 5832-6:1997,          Transferred from                61
             Implants for Surgery--    Orthopedics 67 to
             Metallic materials--      Materials 61
             Part 6: Wrought cobalt-
             nickel-chromium-
             molybdenum alloy
------------------------------------------------------------------------
70          ISO 5832-11:1994,         Transferred from                63
             Implants for Surgery--    Orthopedics 70 to
             Metallic materials--      Materials 63
             Part 11: Wrought
             titanium 6-aluminum 7-
             niobium alloy
------------------------------------------------------------------------

[[Page 34179]]

 
71          ISO 5832-12:1996,         Transferred from                64
             Implants for Surgery--    Orthopedics 71 to
             Metallic materials--      Materials 64
             Part 12: Wrought cobalt-
             chromium-molybdenum
             alloy
------------------------------------------------------------------------
76          ISO 6474-94, Implants     Transferred from                66
             for surgery--Ceramic      Orthopedics 76 to
             materials based on high   Materials 66
             purity alumina
------------------------------------------------------------------------
84          ISO 13782:1996, Implants  Transferred from                68
             for surgery--Metallic     Orthopedics 84 to
             materials--Unalloyed      Materials 68
             tantalum for surgical
             implant applications
------------------------------------------------------------------------
117         ISO 5832-2:1999,          Transferred from                57
             Implants for Surgery--    Orthopedics 117
             Metallic Materials--      to Materials 57
             Part 2: Unalloyed
             Titanium
------------------------------------------------------------------------
118         ISO 5832-9:1992,          Transferred from                62
             Implants for Surgery--    Orthopedics 118
             Metallic Materials--      to Materials 62
             Part 9: Wrought High
             Nitrogen Stainless
             Steel
------------------------------------------------------------------------
119         ISO 5834-2:1998,          Transferred from                65
             Implants for Surgery--    Orthopedics 119
             Ultra-High-Molecular      to Materials 65
             Weight Polyethylene--
             Part 2: Moulded Forms
------------------------------------------------------------------------
143         ISO 7153-1:1991/Amd.      Transferred from                67
             1:1999, Surgical          Orthopedics 143
             instruments--Metallic     to Materials 67
             materials--Part 1:
             Stainless steel
------------------------------------------------------------------------

F. Radiology

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
5           ANSI Ph 2.50-1983,        Title correction                 5
             Photography--Direct-
             Exposing Medical and
             Dental Radiographic
             Film/Process Systems--
             Determination of ISO
             Speed and Average
             Gradient
------------------------------------------------------------------------
7           ISO/IEC 10918-1:1994,     Title correction                 7
             Information Technology--
             Digital Compression and
             Coding of Continuous--
             Tone Still Images:
             Requirements and
             Guidelines
------------------------------------------------------------------------
8           IEC 60336 (R1993), X-ray  Title correction                 8
             Tube Assemblies for
             Medical Diagnosis
             Characteristics of
             Focal Spots
------------------------------------------------------------------------
17          NEMA MS 8-1993 (2000),    Reaffirmation                   17
             Characterization of the
             Specific Absorption
             Rate for Magnetic
             Resonance Imaging
             Systems
------------------------------------------------------------------------
22          NEMA XR 5-1992 (R1999),   Reaffirmation                   22
             Measurement of
             Dimensions and
             Properties of Focal
             Spots of Diagnostic X-
             ray Tubes
------------------------------------------------------------------------
23          NEMA XR 10-1986 (R1992,   Reaffirmation                   23
             R1998), Measurement of
             the Maximum Symmetrical
             Radiation Field from a
             Rotating Node X-ray
             Tube used for Medical
             Diagnosis
------------------------------------------------------------------------
24          NEMA XR 11-1993 (R1999),  Title correction                24
             Test Standard for
             Determination of the
             Limiting Spatial
             Resolution of X-ray
             Image Intensifier
             Systems
------------------------------------------------------------------------
25          NEMA XR 15-1991 (R1996,   Reaffirmation                   25
             R2001), Test Standard
             for the Determination
             of the Visible Entrance
             Field Size of an X-ray
             Image Intensifier
             System
------------------------------------------------------------------------
26          NEMA XR 16-1991 (R1996,   Reaffirmation                   26
             R2001), Test Standard
             for the Determination
             of the System Contrast
             Ratio and the System
             Veiling Glare Index of
             an X-ray Image
             Intensifier System
------------------------------------------------------------------------
27          NEMA XR 17-1993 (R1999),  Reaffirmation                   27
             Test Standard for the
             Measurement of the
             Image Signal Uniformity
             of an X-ray Image
             Intensifier System
------------------------------------------------------------------------
28          NEMA XR 18-1993 (R1999),  Reaffirmation                   28
             Test Standard for the
             Determination of the
             Radial Image Distortion
             of an X-ray Image
             Intensifier System
------------------------------------------------------------------------
29          NEMA XR 19-1993 (R1999),  Reaffirmation                   29
             Thermal and Loading
             Characteristics of X-
             ray Tubes used for
             Medical Diagnosis
------------------------------------------------------------------------

[[Page 34180]]

 
44          AIUM AOMS--Acoustic       Title correction                44
             Output Measurement        and reaffirmation
             Standard for Diagnostic
             Ultrasound Equipment
------------------------------------------------------------------------
46          AIUM RTD1--Standard for   Title correction                46
             Real-Time Display of      and reaffirmation
             Thermal and Mechanical
             Acoustic Output Indices
             on Diagnostic
             Ultrasound Equipment
             Revision 1
------------------------------------------------------------------------
48          AIUM AOL--Acoustic        Title correction                48
             Output Labeling
             Standard for Diagnostic
             Ultrasound Equipment: A
             Standard for How
             Manufacturers Should
             Specify Acoustic Output
             Data
------------------------------------------------------------------------
61          UL 122-1999, Standard     Title correction                61
             for Safety of
             Photographic Equipment--
             4th Edition
------------------------------------------------------------------------
66          AIUM MUS--Medical         Title correction                66
             Ultrasound Safety         and reaffirmation
------------------------------------------------------------------------
72          NEMA UD 3-1998, Revision  Title correction                72
             1, Standard for Real
             Time Display of Thermal
             and Mechanical Acoustic
             Output Indices on
             Diagnostic Ultrasound
             Equipment
------------------------------------------------------------------------
11          NEMA MS 2-2003,           Withdrawn and                   95
             Determination of Two-     replaced with
             Dimensional Geometric     newer version
             Distortion in
             Diagnostic Magnetic
             Resonance Images
------------------------------------------------------------------------
12          NEMA MS 3-2003,           Withdrawn and                   96
             Determination of Image    replaced with
             Uniformity in             newer version
             Diagnostic Magnetic
             Resonance Images
------------------------------------------------------------------------
77          NEMA MS-1-2001,           Withdrawn and                   97
             Determination of Signal   replaced with
             to Noise Ratio (SNR) in   newer version
             Diagnostic Magnetic
             Resonance Images
------------------------------------------------------------------------
69          NEMA MS 6-1991 (R2000),   Reaffirmation                   69
             Characterization of
             Special Purpose Coils
             for Diagnostic Magnetic
             Resonance Images
------------------------------------------------------------------------
3           ANSI IT1.49-1995,         Withdrawn and       ..............
             Photography (Films)--     replaced with
             Medical Radiographic      Item 98
             Cassettes/Screens/Films-
             Dimensions
------------------------------------------------------------------------
14          NEMA MS 5-2003,           Withdrawn and                   99
             Determination of Slice    replaced with
             Thickness in Diagnostic   newer version
             Magnetic Resonance
             Imaging
------------------------------------------------------------------------

G. Sterility

------------------------------------------------------------------------
 Old Item                                                   Replacement
    No.             Standard                Change           Item No.
------------------------------------------------------------------------
76          AAMI/ANSI/ISO 10993-      Deleted                         76
             7:1995 (R) 2001,          ``Hemodialyzers''
             Biological Evaluation     from Extent of
             of Medical Devices--      Recognition
             Part 7: Ethylene Oxide
             Sterilization Residuals
------------------------------------------------------------------------

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: 010, is as follows:

A. Anesthesia

----------------------------------------------------------------------------------------------------------------
      Item No.                               Title of Standard                           Reference No. and Date
----------------------------------------------------------------------------------------------------------------
47                   Ancillary devices for expired air resuscitation                    AS 4259-1995
----------------------------------------------------------------------------------------------------------------
48                   Standard Specification for Electrically Powered Home Care          ASTM F1246-91(1999)
                      Ventilators, Part 1--Positive-Pressure Ventilators and
                      Ventilator Circuits
----------------------------------------------------------------------------------------------------------------
49                   Standard Specification for Suction Catheters for Use in the        ASTM F1981-99
                      Respiratory Tract
----------------------------------------------------------------------------------------------------------------

B. General

[[Page 34181]]



----------------------------------------------------------------------------------------------------------------
      Item No.                               Title of Standard                           Reference No. and Date
----------------------------------------------------------------------------------------------------------------
33                   Medical Electrical Equipment--Parts 1 to 8: General requirements   IEC 60601-1-8:2003
                      for safety--Collateral Standard: Alarm systems--Requirements,
                      tests, and guidelines--General requirements and guidelines for
                      alarm systems in medical equipment
----------------------------------------------------------------------------------------------------------------

C. In Vitro Diagnostic

----------------------------------------------------------------------------------------------------------------
      Item No.                               Title of Standard                           Reference No. and Date
----------------------------------------------------------------------------------------------------------------
99                   Nucleic Acid Amplification Assays for Molecular Hematopathology;   NCCLS MM5-A:2000
                      Approved Guideline
----------------------------------------------------------------------------------------------------------------
100                  In Vitro Diagnostic Test Systems--Requirements for In Vitro Whole  ISO 15197:2003
                      Blood Glucose Monitoring Systems Intended for Use by Patients
                      for Self Testing in Management of Diabetes Mellitus, First
                      Edition
----------------------------------------------------------------------------------------------------------------
101                  Assays of vonWillebrand Factor Antigen and Ristocetin Cofactor     NCCLS H51-A:2002
                      Activity; Approved Guideline
----------------------------------------------------------------------------------------------------------------

D. Materials

----------------------------------------------------------------------------------------------------------------
      Item No.                               Title of Standard                           Reference No. and Date
----------------------------------------------------------------------------------------------------------------
72                   Standard Test Method for Measurement of Magnetically Induced       ASTM F2213-04
                      Torque on Medical Devices in the Magnetic Resonance Environment
----------------------------------------------------------------------------------------------------------------

E. Radiology

----------------------------------------------------------------------------------------------------------------
      Item No.                               Title of Standard                           Reference No. and Date
----------------------------------------------------------------------------------------------------------------
98                   Medical Electrical Equipment--Dosimeters with Ionization Chambers  IEC 60731--Amendment 1
                      as Used in Radiotherapy                                            2002-06
----------------------------------------------------------------------------------------------------------------

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

    In order to receive ``Guidance on the Recognition and Use of 
Consensus Standards'' via your fax machine, call the 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 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 ``Modification to the List of 
Recognized Standards, Recognition List Number: 010'' 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 hyperlink at http://www.fda.gov/cdrh/stdsprog.html. This Federal Register notice of modifications in FDA's 
recognition of consensus standards will be available, upon publication, 
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. Two copies of any mailed comments are to be submitted, 
except that individuals may submit one paper copy. Comments are to be 
identified

[[Page 34182]]

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: 010.'' These 
modifications to the list or recognized standards are effective upon 
publication of this notice in the Federal Register.

    Dated: June 2, 2004.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 04-13725 Filed 6-17-04; 8:45 am]
BILLING CODE 4160-01-S