Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 015, 36121-36125 [E6-9959]
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Federal Register / Vol. 71, No. 121 / Friday, June 23, 2006 / Notices
outpatient glucose monitoring is a
determinant of glycemic control and
clinical outcomes in the Medicare
populations. The role of variables such
as the type of diabetes, the therapeutic
regimen employed, the age of
hyperglycemic onset, the duration of
diabetes, the duration of poor glycemic
control, the level of hyperglycemia, and
concomitant disease will be discussed.
The impediments to glucose monitoring
and use of monitoring data will be
considered. In addition to evaluating the
available data, the Committee will
identify areas in which the current data
are deficient and in which additional
research is warranted.
Background information about this
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(Catalog of Federal Domestic Assistance
Program No. 93.774, Medicare—
Supplementary Medical Insurance Program)
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36121
Dated: June 7, 2006.
Barry M. Straube,
Chief Medical Officer and Director, Office
of Clinical Standards and Quality, Centers
for Medicare & Medicaid Services.
[FR Doc. E6–9480 Filed 6–22–06; 8:45 am]
BILLING CODE 4120–01–P
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:
015
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: 015’’ (Recognition List
Number: 015), 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: 015’’ to the
Division of Small Manufacturers,
International and Consumer Assistance,
Center for Devices and Radiological
Health (HFZ–220), Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850. Send two selfaddressed adhesive labels to assist that
office in processing your requests, or fax
your request to 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:
standards@cdrh.fda.gov. This document
may also be accessed on FDA’s Internet
site at https://www.fda.gov/cdrh/
fedregin.html. See section VI of this
document for electronic access to the
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Federal Register / Vol. 71, No. 121 / Friday, June 23, 2006 / Notices
searchable database for the current list
of FDA recognized consensus standards,
including Recognition List Number: 015
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., 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), November 8, 2005
(70 FR 67713), and March 31, 2006 (71
FR 16313), 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 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: 015
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: 015’’ 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.
Old Item No.
Standard
Change
Replacement
Item No.
A. Biocompatibility
AAMI/ANSI/ISO10993–11:1993, Biological Evaluation of
Medical Devices—Part 11: Tests for Systemic Toxicity
Extent of recognition
66
ASTM F2148–01, Standard Practice for Evaluation of
Delayed Contact Hypersensitivity Using the Murine
Local Lymph Node Assay
Contact person, processes affected,
and extent of recognition
67
ASTM F756–00, Standard Practice for Assessment of
Hemolytic Properties of Materials
Contact person, processes affected,
and extent of recognition
73
ASTM F2065–00e1, Standard Practice for Testing for
Alternative Pathway Complement Activation in Serum
by Solid Materials
Contact person, processes affected,
and extent of recognition
82
ASTM F2147–01, Standard Practice for Guinea Pigs:
Split Adjuvant and Closed Patch Testing for Contact
Allergens
Contact person, and processes affected
101
USP 29–NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Direct Contact Test
Withdrawn and replaced with newer
version
109
102
USP 29–NF21Biological Tests <87>, Biological Reactivity Test, In Vitro—Elution Test
Withdrawn and replaced with newer
version
110
103
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21
USP 29–NF21Biological Tests <88>, Biological Reactivity Test, In Vivo Procedure—Preparation of Sample
Withdrawn and replaced with newer
version
111
104
USP 29–NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—
Intracutaneous Test
Withdrawn and replaced with newer
version
112
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36123
TABLE 1.—Continued
Old Item No.
105
Standard
Change
USP 29–NF21Biological Tests <88>, Biological Reactivity Test, In Vitro, Classification of Plastics—Systemic Injection Test
Withdrawn and replaced with newer
version
Replacement
Item No.
113
B. Dental/Ear, Nose, and Throat
83
ISO 11498 Dental Handpieces: Dental Low Voltage
Electrical Motors
Contact person, and processes affected
127
ANSI/ADA Specification No. 58:2004, Root Canal Files,
Type H (Hedstrom)
Contact person
C. General Hospital/General Plastic Surgery
133
USP 29: 2006 Nonabsorbable Surgical Suture
Withdrawn and replaced with newer
version
151
134
USP 29<11>: 2006 Sterile Sodium Chloride for Irrigation
Withdrawn and replaced with newer
version
152
135
USP 29: 2006 Absorbable Surgical Suture
Withdrawn and replaced with newer
version
153
136
USP 29<881>: 2006 Tensile Strength
Withdrawn and replaced with newer
version
154
137
USP 29<861>: 2006 Sutures—Diameter
Withdrawn and replaced with newer
version
155
138
USP 29<871>: 2006 Sutures Needle Attachment
Withdrawn and replaced with newer
version
156
139
USP 29<11>: 2006 Sterile Water for Irrigation
Withdrawn and replaced with newer
version
157
140
USP 29<11>: 2006 Heparin Lock Flush Solution
Withdrawn and replaced with newer
version
158
141
USP 29<11>: 2006 Sodium Chloride Injection
Withdrawn and replaced with newer
version
159
52
ANSI/AAMI ST59:1999, Sterilization of Health Care
Products—Biological Indicators Part 1: General
Contact person and relevant guidance
70
AAMI/ANSI/ISO 14161:2000, Sterilization of Health
Care Products—Biological Indicators—Guidance for
the Selection, Use and Interpretation of Results, 2 ed.
Contact person
72
ANSI/AAMI ST33:1996, Guidelines for the Selection
and Use of Reusable Rigid Sterilization Container
Systems for Ethylene Oxide Sterilization in Health
Care Facilities
Contact person and processes affected
94
AOAC 6.2.01:2005, Official Method 955.14, Testing Disinfectants Against Salmonella Choleraesuis, Use-Dilution Method
Withdrawn and replaced with newer
version
172
95
AOAC 6.2.02:2005, Official Method 991.47, Testing Disinfectants Against Salmonella Choleraesuis, Hard
Surface Carrier Test Method
Withdrawn and replaced with newer
version
173
96
AOAC 6.2.03:2005, Official Method 991.48, Testing Disinfectants Against Staphylococcus Aureus, Hard Surface Carrier Test Method
Withdrawn and replaced with newer
version
174
97
AOAC 6.2.04:2005, Official Method 955.15, Testing Disinfectants Against Staphylococcus Aureus, Use-Dilution Method
Withdrawn and replaced with newer
version
175
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D. Sterility
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36124
Federal Register / Vol. 71, No. 121 / Friday, June 23, 2006 / Notices
TABLE 1.—Continued
Old Item No.
Standard
Change
Replacement
Item No.
AOAC 6.2.05:2005, Official Method 991.49, Testing Disinfectants Against Pseudomonas Aeruginosa, Hard
Surface Carrier Test Method
Withdrawn and replaced with newer
version
176
99
AOAC 6.2.06:2005, Official Method 964.02, Testing Disinfectants Against Pseudomonas Aeruginosa, Use-Dilution Method
Withdrawn and replaced with newer
version
177
100
AOAC 6.3.02:2005, Official Method 955.17, Fungicidal
Activity of Disinfectants Using Trichophyton
Mentagrophytes
Withdrawn and replaced with newer
version
178
101
AOAC 6.3.05:2005, Official Method 966.04, Sporicidal
Activity of Disinfectants
Withdrawn and replaced with newer
version
179
102
AOAC 6.3.06:2005, Official Method 965.12,
Tuberculocidal Activity of Disinfectants
Withdrawn and replaced with newer
version
180
104
AAMI/ANSI ST58:2005, Safe Use and Handling of
Glutaraldehyde-Based Products in Health Care Facilities
Withdrawn and replaced with newer
version
181
116
ANSI/AAMI ST72:2002, Bacterial Endotoxins—Test
Methodologies, Routine Monitoring, and Alternatives
to Batch Testing
Relevant guidance
117
ANSI/AAMI ST35:2003, Safe Handling and Biological
Decontamination of Medical Devices in Health Care
Facilities and in Nonclinical Settings
Relevant guidance
153
USP 29:2006, Biological Indicator for Dry Heat Sterilization, Paper Carrier
Withdrawn and replaced with newer
version
182
154
USP 29:2006, Biological Indicator for Ethylene Oxide
Sterilization, Paper Carrier
Withdrawn and replaced with newer
version
183
155
USP 29:2006, Biological Indicator for Steam Sterilization, Paper Carrier
Withdrawn and replaced with newer
version
184
156
USP29:2006, <61> Microbial Limits Test
Withdrawn and replaced with newer
version
185
157
USP 29:2006, <71>, Microbiological Tests, Sterility
Tests
Withdrawn and replaced with newer
version
186
158
USP29:2006, <85>, Biological Tests and Assays, Bacterial Endotoxin Test (LAL)
Withdrawn and replaced with newer
version
187
159
USP29:2006 <151>, Pyrogen Test (USP Rabbit Test)
Withdrawn and replaced with newer
version
188
160
USP29:2006 <1211>, Sterilization and Sterility Assurance of Compendial Articles
Withdrawn
161
USP29:2006 <161>, Transfusion and Infusion Assemblies and Similar Medical Devices
Withdrawn and replaced with newer
version
189
162
USP 29:2006, Biological Indicator for Steam Sterilization—Self-Contained
Withdrawn and replaced with newer
version
190
164
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98
ANSI/AAMI ST81:2004, Sterilization of Medical Devices—Information to be Provided by the Manufacturer for the Processing of Resterilizable Devices
Relevant guidance
III. Listing of New Entries
The listing of new entries and
consensus standards added as
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modifications to the list of recognized
standards under Recognition List
Number: 015, follows:
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36125
TABLE 2.
Item No.
Title of Standard
Reference No. and Date
A. Sterility
191
Aseptic Processing of Health Care Products—Part 4: Clean-inPlace Technologies
IV. List of Recognized Standards
FDA maintains the agency’s current
list of FDA recognized consensus
standards in a searchable database that
may be accessed directly at FDA’s
Internet site at https://
www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA
will incorporate the modifications and
minor revisions described in this 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.
jlentini on PROD1PC65 with NOTICES
V. Recommendation of Standards for
Recognition by FDA
Any person may recommend
consensus standards as candidates for
recognition under section 514 of the act
by submitting such recommendations,
with reasons for the recommendation, to
the contact person (see FOR FURTHER
INFORMATION CONTACT). To be properly
considered such recommendations
should contain, at a minimum, the
following information: (1) Title of the
standard, (2) any reference number and
date, (3) name and address of the
national or international standards
development organization, (4) a
proposed list of devices for which a
declaration of conformity to this
standard should routinely apply, and (5)
a brief identification of the testing or
performance or other characteristics of
the device(s) that would be addressed
by a declaration of conformity.
VI. Electronic Access
You may obtain a copy of ‘‘Guidance
on the Recognition and Use of
Consensus Standards’’ by using the
Internet. CDRH maintains a site on the
Internet for easy access to information
including text, graphics, and files that
you may download to a personal
computer with access to the Internet.
Updated on a regular basis, the CDRH
home page includes the guidance as
well as the current list of recognized
standards and other standards related
documents. After publication in the
Federal Register, this notice
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announcing ‘‘Modifications to the List
of Recognized Standards, Recognition
List Number: 015’’ will be available on
the CDRH home page. You may access
the CDRH home page at https://
www.fda.gov/cdrh.
You may access ‘‘Guidance on the
Recognition and Use of Consensus
Standards,’’ and the searchable database
for ‘‘FDA Recognized Consensus
Standards’’ through the hyperlink at
https://www.fda.gov/cdrh/stdsprog.html.
This Federal Register document on
modifications in FDA’s recognition of
consensus standards is available at
https://www.fda.gov/cdrh/fedregin.html.
VII. Submission of Comments and
Effective Date
Interested persons may submit to the
contact person (see FOR FURTHER
INFORMATION CONTACT) written or
electronic comments regarding this
document. 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:
015. These modifications to the list of
recognized standards are effective upon
publication of this notice in the Federal
Register.
Dated: June 13, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and
Radiological Health.
[FR Doc. E6–9959 Filed 6–22–06; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Agency Information Collection
Activities: Proposed Collection;
Comment Request
In compliance with section
3506(c)(2)(A) of the Paperwork
PO 00000
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ISO 13408–4:2005
Reduction Act of 1995 concerning
opportunity for public comment on
proposed collections of information, the
Substance Abuse and Mental Health
Services Administration (SAMHSA)
will publish periodic summaries of
proposed projects. To request more
information on the proposed projects or
to obtain a copy of the information
collection plans, call the SAMHSA
Reports Clearance Officer on (240) 276–
1243.
Comments are invited on: (a) Whether
the proposed collections of information
are necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Proposed Project: Regulations To
Implement SAMHSA’s Charitable
Choice Statutory Provisions—42 CFR
Parts 54 and 54a (OMB No. 0930–
0242)—Extension
Section 1955 of the Public Health
Service Act (42 U.S.C. 300x–65), as
amended by the Children’s Health Act
of 2000 (Pub. L. 106–310) and sections
581–584 of the Public Health Service
Act (42 U.S.C. 290kk et seq., as added
by the Consolidated Appropriations Act
(Pub. L. 106–554)), set forth various
provisions which aim to ensure that
religious organizations are able to
compete on an equal footing for Federal
funds to provide substance abuse
services. These provisions allow
religious organizations to offer
substance abuse services to individuals
without impairing the religious
character of the organizations or the
religious freedom of the individuals
who receive the services. The provisions
apply to the Substance Abuse
Prevention and Treatment Block Grant
(SAPT BG), to the Projects for
Assistance in Transition from
Homelessness (PATH) formula grant
program, and to certain Substance
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]]>Agencies
[Federal Register Volume 71, Number 121 (Friday, June 23, 2006)]
[Notices]
[Pages 36121-36125]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9959]
-----------------------------------------------------------------------
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: 015
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: 015'' (Recognition List Number: 015), 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: 015'' 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:
standards@cdrh.fda.gov. This document may also be accessed on FDA's
Internet site at https://www.fda.gov/cdrh/fedregin.html. See section VI
of this document for electronic access to the
[[Page 36122]]
searchable database for the current list of FDA recognized consensus
standards, including Recognition List Number: 015 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., 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), November 8, 2005 (70 FR 67713), and March 31,
2006 (71 FR 16313), 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 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: 015
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: 015'' 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.
----------------------------------------------------------------------------------------------------------------
Replacement
Old Item No. Standard Change Item No.
----------------------------------------------------------------------------------------------------------------
A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
21 AAMI/ANSI/ISO10993-11:1993, Biological Extent of recognition ...............
Evaluation of Medical Devices--Part
11: Tests for Systemic Toxicity
----------------------------------------------------------------------------------------------------------------
66 ASTM F2148-01, Standard Practice for Contact person, processes ...............
Evaluation of Delayed Contact affected, and extent of
Hypersensitivity Using the Murine recognition
Local Lymph Node Assay
----------------------------------------------------------------------------------------------------------------
67 ASTM F756-00, Standard Practice for Contact person, processes ...............
Assessment of Hemolytic Properties of affected, and extent of
Materials recognition
----------------------------------------------------------------------------------------------------------------
73 ASTM F2065-00e1, Standard Practice for Contact person, processes ...............
Testing for Alternative Pathway affected, and extent of
Complement Activation in Serum by recognition
Solid Materials
----------------------------------------------------------------------------------------------------------------
82 ASTM F2147-01, Standard Practice for Contact person, and processes ...............
Guinea Pigs: Split Adjuvant and Closed affected
Patch Testing for Contact Allergens
----------------------------------------------------------------------------------------------------------------
101 USP 29-NF21Biological Tests <87>, Withdrawn and replaced with 109
Biological Reactivity Test, In Vitro-- newer version
Direct Contact Test
----------------------------------------------------------------------------------------------------------------
102 USP 29-NF21Biological Tests <87>, Withdrawn and replaced with 110
Biological Reactivity Test, In Vitro-- newer version
Elution Test
----------------------------------------------------------------------------------------------------------------
103 USP 29-NF21Biological Tests <88>, Withdrawn and replaced with 111
Biological Reactivity Test, In Vivo newer version
Procedure--Preparation of Sample
----------------------------------------------------------------------------------------------------------------
104 USP 29-NF21Biological Tests <88>, Withdrawn and replaced with 112
Biological Reactivity Test, In Vitro, newer version
Classification of Plastics--
Intracutaneous Test
----------------------------------------------------------------------------------------------------------------
[[Page 36123]]
105 USP 29-NF21Biological Tests <88>, Withdrawn and replaced with 113
Biological Reactivity Test, In Vitro, newer version
Classification of Plastics--Systemic
Injection Test
----------------------------------------------------------------------------------------------------------------
B. Dental/Ear, Nose, and Throat
----------------------------------------------------------------------------------------------------------------
83 ISO 11498 Dental Handpieces: Dental Low Contact person, and processes ...............
Voltage Electrical Motors affected
----------------------------------------------------------------------------------------------------------------
127 ANSI/ADA Specification No. 58:2004, Contact person ...............
Root Canal Files, Type H (Hedstrom)
----------------------------------------------------------------------------------------------------------------
C. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
133 USP 29: 2006 Nonabsorbable Surgical Withdrawn and replaced with 151
Suture newer version
----------------------------------------------------------------------------------------------------------------
134 USP 29<11>: 2006 Sterile Sodium Withdrawn and replaced with 152
Chloride for Irrigation newer version
----------------------------------------------------------------------------------------------------------------
135 USP 29: 2006 Absorbable Surgical Suture Withdrawn and replaced with 153
newer version
----------------------------------------------------------------------------------------------------------------
136 USP 29<881>: 2006 Tensile Strength Withdrawn and replaced with 154
newer version
----------------------------------------------------------------------------------------------------------------
137 USP 29<861>: 2006 Sutures--Diameter Withdrawn and replaced with 155
newer version
----------------------------------------------------------------------------------------------------------------
138 USP 29<871>: 2006 Sutures Needle Withdrawn and replaced with 156
Attachment newer version
----------------------------------------------------------------------------------------------------------------
139 USP 29<11>: 2006 Sterile Water for Withdrawn and replaced with 157
Irrigation newer version
----------------------------------------------------------------------------------------------------------------
140 USP 29<11>: 2006 Heparin Lock Flush Withdrawn and replaced with 158
Solution newer version
----------------------------------------------------------------------------------------------------------------
141 USP 29<11>: 2006 Sodium Chloride Withdrawn and replaced with 159
Injection newer version
----------------------------------------------------------------------------------------------------------------
D. Sterility
----------------------------------------------------------------------------------------------------------------
52 ANSI/AAMI ST59:1999, Sterilization of Contact person and relevant ...............
Health Care Products--Biological guidance
Indicators Part 1: General
----------------------------------------------------------------------------------------------------------------
70 AAMI/ANSI/ISO 14161:2000, Sterilization Contact person ...............
of Health Care Products--Biological
Indicators--Guidance for the
Selection, Use and Interpretation of
Results, 2 ed.
----------------------------------------------------------------------------------------------------------------
72 ANSI/AAMI ST33:1996, Guidelines for the Contact person and processes ...............
Selection and Use of Reusable Rigid affected
Sterilization Container Systems for
Ethylene Oxide Sterilization in Health
Care Facilities
----------------------------------------------------------------------------------------------------------------
94 AOAC 6.2.01:2005, Official Method Withdrawn and replaced with 172
955.14, Testing Disinfectants Against newer version
Salmonella Choleraesuis, Use-Dilution
Method
----------------------------------------------------------------------------------------------------------------
95 AOAC 6.2.02:2005, Official Method Withdrawn and replaced with 173
991.47, Testing Disinfectants Against newer version
Salmonella Choleraesuis, Hard Surface
Carrier Test Method
----------------------------------------------------------------------------------------------------------------
96 AOAC 6.2.03:2005, Official Method Withdrawn and replaced with 174
991.48, Testing Disinfectants Against newer version
Staphylococcus Aureus, Hard Surface
Carrier Test Method
----------------------------------------------------------------------------------------------------------------
97 AOAC 6.2.04:2005, Official Method Withdrawn and replaced with 175
955.15, Testing Disinfectants Against newer version
Staphylococcus Aureus, Use-Dilution
Method
----------------------------------------------------------------------------------------------------------------
[[Page 36124]]
98 AOAC 6.2.05:2005, Official Method Withdrawn and replaced with 176
991.49, Testing Disinfectants Against newer version
Pseudomonas Aeruginosa, Hard Surface
Carrier Test Method
----------------------------------------------------------------------------------------------------------------
99 AOAC 6.2.06:2005, Official Method Withdrawn and replaced with 177
964.02, Testing Disinfectants Against newer version
Pseudomonas Aeruginosa, Use-Dilution
Method
----------------------------------------------------------------------------------------------------------------
100 AOAC 6.3.02:2005, Official Method Withdrawn and replaced with 178
955.17, Fungicidal Activity of newer version
Disinfectants Using Trichophyton
Mentagrophytes
----------------------------------------------------------------------------------------------------------------
101 AOAC 6.3.05:2005, Official Method Withdrawn and replaced with 179
966.04, Sporicidal Activity of newer version
Disinfectants
----------------------------------------------------------------------------------------------------------------
102 AOAC 6.3.06:2005, Official Method Withdrawn and replaced with 180
965.12, Tuberculocidal Activity of newer version
Disinfectants
----------------------------------------------------------------------------------------------------------------
104 AAMI/ANSI ST58:2005, Safe Use and Withdrawn and replaced with 181
Handling of Glutaraldehyde-Based newer version
Products in Health Care Facilities
----------------------------------------------------------------------------------------------------------------
116 ANSI/AAMI ST72:2002, Bacterial Relevant guidance ...............
Endotoxins--Test Methodologies,
Routine Monitoring, and Alternatives
to Batch Testing
----------------------------------------------------------------------------------------------------------------
117 ANSI/AAMI ST35:2003, Safe Handling and Relevant guidance ...............
Biological Decontamination of Medical
Devices in Health Care Facilities and
in Nonclinical Settings
----------------------------------------------------------------------------------------------------------------
153 USP 29:2006, Biological Indicator for Withdrawn and replaced with 182
Dry Heat Sterilization, Paper Carrier newer version
----------------------------------------------------------------------------------------------------------------
154 USP 29:2006, Biological Indicator for Withdrawn and replaced with 183
Ethylene Oxide Sterilization, Paper newer version
Carrier
----------------------------------------------------------------------------------------------------------------
155 USP 29:2006, Biological Indicator for Withdrawn and replaced with 184
Steam Sterilization, Paper Carrier newer version
----------------------------------------------------------------------------------------------------------------
156 USP29:2006, <61> Microbial Limits Test Withdrawn and replaced with 185
newer version
----------------------------------------------------------------------------------------------------------------
157 USP 29:2006, <71>, Microbiological Withdrawn and replaced with 186
Tests, Sterility Tests newer version
----------------------------------------------------------------------------------------------------------------
158 USP29:2006, <85>, Biological Tests and Withdrawn and replaced with 187
Assays, Bacterial Endotoxin Test (LAL) newer version
----------------------------------------------------------------------------------------------------------------
159 USP29:2006 <151>, Pyrogen Test (USP Withdrawn and replaced with 188
Rabbit Test) newer version
----------------------------------------------------------------------------------------------------------------
160 USP29:2006 <1211>, Sterilization and Withdrawn ...............
Sterility Assurance of Compendial
Articles
----------------------------------------------------------------------------------------------------------------
161 USP29:2006 <161>, Transfusion and Withdrawn and replaced with 189
Infusion Assemblies and Similar newer version
Medical Devices
----------------------------------------------------------------------------------------------------------------
162 USP 29:2006, Biological Indicator for Withdrawn and replaced with 190
Steam Sterilization--Self-Contained newer version
----------------------------------------------------------------------------------------------------------------
164 ANSI/AAMI ST81:2004, Sterilization of Relevant guidance ...............
Medical Devices--Information to be
Provided by the Manufacturer for the
Processing of Resterilizable Devices
----------------------------------------------------------------------------------------------------------------
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: 015, follows:
[[Page 36125]]
Table 2.
------------------------------------------------------------------------
Item No. Title of Standard Reference No. and Date
------------------------------------------------------------------------
A. Sterility
------------------------------------------------------------------------
191 Aseptic Processing of ISO 13408-4:2005
Health Care Products--Part
4: Clean-in-Place
Technologies
------------------------------------------------------------------------
IV. List of Recognized Standards
FDA maintains the agency's current list of FDA recognized consensus
standards in a searchable database that may be accessed directly at
FDA's Internet site at https://www.accessdata.fda.gov/scripts/cdrh/
cfdocs/cfStandards/search.cfm. FDA will incorporate the modifications
and minor revisions described in this 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 section 514 of the act by submitting such
recommendations, with reasons for the recommendation, to the contact
person (see FOR FURTHER INFORMATION CONTACT). To be properly considered
such recommendations should contain, at a minimum, the following
information: (1) Title of the standard, (2) any reference number and
date, (3) name and address of the national or international standards
development organization, (4) a proposed list of devices for which a
declaration of conformity to this standard should routinely apply, and
(5) a brief identification of the testing or performance or other
characteristics of the device(s) that would be addressed by a
declaration of conformity.
VI. Electronic Access
You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
the guidance as well as the current list of recognized standards and
other standards related documents. After publication in the Federal
Register, this notice announcing ``Modifications to the List of
Recognized Standards, Recognition List Number: 015'' will be available
on the CDRH home page. You may access the CDRH home page at https://
www.fda.gov/cdrh.
You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at https://www.fda.gov/cdrh/
stdsprog.html.
This Federal Register document on modifications in FDA's
recognition of consensus standards is available at https://www.fda.gov/
cdrh/fedregin.html.
VII. Submission of Comments and Effective Date
Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. 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: 015. These modifications to the list of recognized standards
are effective upon publication of this notice in the Federal Register.
Dated: June 13, 2006.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E6-9959 Filed 6-22-06; 8:45 am]
BILLING CODE 4160-01-S
