[Federal Register: April 17, 2008 (Volume 73, Number 75)]
[Notices]
[Page 20975-20976]
[DOCID:fr17ap08-99]

-----------------------------------------------------------------------

SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon written request, Copies available from: Securities and Exchange
Commission, Office of Investor Education and Advocacy, Washington, DC
20549-0213.

Extension:
    Rule 15g-9; SEC File No. 270-325 ; OMB Control No. 3235-0385.

    Notice is hereby given that pursuant to the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et. seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comment on the collection of
information described below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Section 15(c)(2) of the Securities Exchange Act of 1934 (15 U.S. C.
78a et seq.) (the ``Exchange Act'') authorizes the Commission to
promulgate rules that prescribe means reasonably designed to prevent
fraudulent, deceptive, or manipulative practices in connection with
over-the-counter (``OTC'') securities transactions. Pursuant to this
authority, the Commission in 1989 adopted Rule 15a-6 (the ``Rule''),
which was subsequently redesignated as Rule 15g-9, 17 CFR 240.15g-9.
The Rule requires broker-dealers to produce a written suitability
determination for, and to obtain a written customer agreement to,
certain recommended transactions in low-priced stocks that are not
registered on a national securities exchange or authorized for trading
on NASDAQ, and whose issuers do not meet certain minimum financial
standards. The Rule is intended to prevent the indiscriminate use by
broker-dealers of fraudulent, high pressure telephone sales campaigns
to sell low-priced securities to unsophisticated customers.
    The Commission staff estimates that there are approximately 240
broker-dealers subject to the Rule. The burden of the Rule on a
respondent varies widely depending on the frequency with which new
customers are solicited. On the average for all respondents, the staff
has estimated that respondents process three new customers per week, or
approximately 156 new customer suitability determinations per year. We
also estimate that a broker-dealer would expend approximately one-half
hour per new customer in obtaining, reviewing, and processing
(including transmitting to the customer) the information required by
Rule 15g-9, and each respondent would consequently spend 78 hours
annually (156 customers x .5 hours) obtaining the information required
in the rule. We determined, based on the estimate of 240 broker-dealer
respondents, that the current annual burden of Rule 15g-9 is 18,720
hours (240 respondents x 78 hours).
    In addition, we estimate that if tangible communications alone are
used to transmit the documents required by Rule 15g-9, each customer
should take: (1) No more than eight minutes to review, sign and return
the suitability determination document; and (2) no more than two
minutes to either read and return or produce the customer agreement for
a particular recommended transaction in penny stocks, listing the
issuer and number of shares of the particular penny stock to be
purchased, and send it to the broker-dealer. Thus, the total current
customer respondent burden is approximately 10 minutes per response,
for an aggregate total of 1,560 minutes for each broker-dealer
respondent. Since there are 240 respondents, the annual burden for
customer responses is 374,400 minutes (1,560 customer minutes per each
of the 240 respondents) or 6,240 hours.
    In addition, we estimate that, if tangible means of communications
alone are used, broker-dealers could incur a recordkeeping burden under
Rule 15g-9 of approximately two minutes per response. Since there are
approximately 240 broker-dealer respondents and each respondent would
have approximately 156 responses annually, respondents would incur an
aggregate recordkeeping burden of 74,880 minutes (240 respondents x 156
responses x 2 minutes per response), or 1,248 hours. Accordingly, the
aggregate annual hour burden associated with Rule 15g-9 is 26,208 hours
(18,720 hours to prepare the suitability statement and agreement +
6,240 hours for customer review + 1,248 recordkeeping hours).
    We recognize that under the amendments to Rule 15g-9, the burden
hours may be slightly reduced if the transaction agreement required
under the rule is provided through electronic means such as e-mail from
the customer to the broker-dealer (e.g., the customer may take only one
minute, instead of the two minutes estimated above, to provide the
transaction agreement by e-mail rather than regular mail). If each of
the customer respondents estimated above communicates with his or her
broker-dealer electronically, the total burden hours on the customers
would be reduced from 10 minutes to 9 minutes per response, or an
aggregate total of 1,404 minutes per respondent (156 customers x 9
minutes for each customer). Since there are 240 respondents, the annual
customer respondent burden, if electronic communications were used by
all customers, would be approximately 336,960 minutes (240 respondents
x 1,404 minutes per each respondent), or 5,616 hours. We do not believe
the hour burden on broker-dealers in obtaining, reviewing, and
processing the suitability determination would change through use of
electronic communications. In addition, we do not believe that, based
on information currently available to us, recordkeeping burdens under
Rule 15g-9 would change where the required documents were sent or
received through means of electronic communication. Thus, if all
broker-dealer respondents obtain and send the documents required under
the rule electronically, the aggregate annual hour burden associated
with Rule 15g-9 would be 25,584 hours (18,720 hours to prepare the
suitability statement and agreement + 5,616 hours for customer review +
1,248 recordkeeping hours).
    We cannot estimate how many broker-dealers and customers will
choose to communicate electronically. If we assume that 50 percent of
respondents would continue to provide documents and obtain signatures
in tangible form, and 50 percent would choose to communicate
electronically in satisfaction of the requirements of Rule 15g-9, the
total aggregate hour burden would be 25,896 burden hours ((26,208
aggregate burden hours for documents and signatures in tangible form x
0.50 of the respondents = 13,104 hours) + (25,584 aggregate burden
hours for electronically signed and transmitted documents x 0.50 of the
respondents = 12,792 hours)).
    Written comments are invited on: (a) Whether the proposed
collection of information is 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 estimates of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information on
respondents; 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. Consideration will be given to
comments and suggestions submitted in writing within 60 days of this
publication.
    Comments should be directed to: R. Corey Booth, Director/Chief
Information Officer, Securities and Exchange Commission, C/O Shirley
Martinson, 6432 General Green Way, Alexandria, Virginia 22312; or
comments may be sent by e-mail to<EMAIL_ADDRESS>Comments must
be submitted within 60 days of this notice.

    Dated: April 10, 2008.
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-8183 Filed 4-16-08; 8:45 am]

BILLING CODE 8010-01-P


Range
------------------------------------------------------------------------
16-20         ............  ISO 7176-5:1986             Contact person
                             Wheelchairs--Part 5:        and Type of
                             Determination of Overall    standard
                             Dimensions, Mass and
                             Turning Space
------------------------------------------------------------------------
16-23         ............  ISO 7176-10:1988            Contact person
                             Wheelchairs--Part 10:       and Type of
                             Determination of Obstacle-  standard
                             Climbing Ability of
                             Electric Wheelchairs
------------------------------------------------------------------------
16-24         ............  ISO 7176-11:1992            Contact person
                             Wheelchairs--Part 11:       and Type of
                             Test Dummies                standard
------------------------------------------------------------------------
16-25         ............  ISO 7176-13:1989            Contact person
                             Wheelchairs--Part 13:       and Type of
                             Determination of            standard
                             Coefficient of Friction
                             of Test Surfaces
------------------------------------------------------------------------
16-26         ............  ISO 7176-14:1997            Contact person
                             Wheelchairs--Part 14:       and Type of
                             Power and Control Systems   standard
                             for Electric Wheelchairs--
                             Requirements and Test
                             Methods
------------------------------------------------------------------------
16-27         ............  ISO 7176-15:1996            Contact person
                             Wheelchairs--Part 15:       and Type of
                             Requirements for            standard
                             Information Disclosure,
                             Documentation and
                             Labeling
------------------------------------------------------------------------
16-28         ............  ISO 7176-16: 1997           Contact person
                             Wheelchairs--Part 16:       and Type of
                             Resistance to Ignition of   standard
                             Upholstered Parts--
                             Requirements and Test
                             Methods
------------------------------------------------------------------------
16-29         ............  ISO 7176-6:2001             Contact person
                             Wheelchairs--Part 6:        and Type of
                             Determination of Maximum    standard
                             Speed, Acceleration and
                             Deceleration of Electric
                             Wheelchairs
------------------------------------------------------------------------
16-30         ............  ISO 7176-9:2001             Contact person
                             Wheelchairs--Part 9:        and Type of
                             Climatic Tests for          standard
                             Electric Wheelchairs
------------------------------------------------------------------------
16-31         ............  ANSI/RESNA WC/Volume 1-     Contact person
                             1998 Section 1:             and Type of
                             Determination of Static     standard
                             Stability
------------------------------------------------------------------------
16-32         ............  ANSI/RESNA WC/Volume 2-     Contact person
                             1998 Section 2:             and Type of
                             Determination of Dynamic    standard
                             Stability of Electric
                             Wheelchairs
------------------------------------------------------------------------
16-33         ............  ANSI/RESNA WC/Volume 2-     Contact person
                             1998 Section 3: Test        and Type of
                             Methods and Requirements    standard
                             for the Effectiveness of
                             Brakes
------------------------------------------------------------------------
16-34         ............  ANSI/RESNA WC/Volume 2-     Contact person
                             1998 Section 4:             and Type of
                             Determination of Energy     standard
                             Consumption of Electric
                             Wheelchairs
------------------------------------------------------------------------
16-35         ............  ANSI/RESNA WC/Volume 1-     Contact person
                             1998 Section 5:             and Type of
                             Determination of Overall    standard
                             Dimensions, Mass, and
                             Turning Space--Wheelchair
------------------------------------------------------------------------

16-36         ............  ANSI/RESNA WC/Volume 2-     Contact person
                             1998 Section 6:             and Type of
                             Determination of Maximum    standard
                             Speed, Acceleration, and
                             Retardation of Electric
                             Wheelchairs
------------------------------------------------------------------------
16-37         ............  ANSI/RESNA WC/Volume 1-     Contact person
                             1998 Section 7:             and Type of
                             Wheelchairs -               standard
                             Determination of Seating
                             and Wheel Dimensions
------------------------------------------------------------------------
16-38         ............  ANSI/RESNA WC/Volume 1-     Contact person
                             1998 Section 8:             and Type of
                             Wheelchairs--Static,        standard
                             Impact and Fatigue
                             Strength Tests
------------------------------------------------------------------------
16-39         ............  ANSI/RESNA WC/Volume 2 -    Contact person
                             1998 Section 9: Climatic    and Type of
                             Tests for Electric          standard
                             Wheelchairs
------------------------------------------------------------------------
16-40         ............  ANSI/RESNA WC/Volume 2 -    Contact person
                             1998 Section 10:            and Type of
                             Determination of the        standard
                             Obstacle-Climbing Ability
                             of Electric Wheelchairs
------------------------------------------------------------------------
16-41         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 11:            and Type of
                             Wheelchairs--Test Dummies   standard
------------------------------------------------------------------------
16-42         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 13:            and Type of
                             Determination of            standard
                             Coefficient of Friction
                             of Test Surfaces
------------------------------------------------------------------------
16-43         ............  ANSI/RESNA WC/Volume 2 -    Contact person
                             1998 Section 14:            and Type of
                             Wheelchairs--Testing of     standard
                             Power and Control Systems
                             for Electric Wheelchairs
------------------------------------------------------------------------
16-44         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 15:            and Type of
                             Wheelchairs--Requirements   standard
                             for Information
                             Disclosures,
                             Documentation and
                             Labeling
------------------------------------------------------------------------
16-45         ............  ANSI/RESNA WC/Volume 1 -    Title change,
                             1998 Section 16:            Contact person
                             Wheelchairs--Determinatio   and Type of
                             n of Flammability           standard
------------------------------------------------------------------------
16-46         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 20:            and Type of
                             Wheelchairs--Determinatio   standard
                             n of the Performance of
                             Stand-Up Wheelchairs
------------------------------------------------------------------------
16-47         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 22:            and Type of
                             Wheelchairs--Set Up         standard
                             Procedures
------------------------------------------------------------------------
16-48         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 93: Maximum    and Type of
                             Overall Dimensions          standard
------------------------------------------------------------------------
16-49         ............  ANSI/RESNA WC/Volume 1 -    Contact person
                             1998 Section 0:             and Type of
                             Nomenclature, Terms, and    standard
                             Definitions
------------------------------------------------------------------------
16-50         ............  ISO 7176-3:2003             Contact person
                             Wheelchairs--Part 3:        and Type of
                             Determination of            standard
                             Effectiveness of Brakes
------------------------------------------------------------------------
16-158        ............  ISO 7176-1:1999             Contact person
                             Wheelchairs--Part 1:        and Type of
                             Determination of Static     standard
                             Stability
------------------------------------------------------------------------
16-159        ............  ISO 7176-2:2001             Contact person
                             Wheelchairs--Part 2:        and Type of
                             Determination of Dynamic    standard
                             Stability of Electric
                             Wheelchairs
------------------------------------------------------------------------
M. Radiology
------------------------------------------------------------------------
12-17         ............  NEMA MS 8-1993 (2000),      Relevant
                             Characterization of the     guidance and
                             Specific Absorption Rate    Contact person
                             for Magnetic Resonance
                             Imaging Systems
------------------------------------------------------------------------
12-61         12-177        UL 122 (2007): Standard     Withdrawn and
                             for Photographic            replaced with
                             Equipment--Ed. 5.0          newer version
------------------------------------------------------------------------
12-64         12-178        IEC 60601-2-45 Ed. 2.0,     Withdrawn and
                             (2006) Medical Electrical   replaced with
                             Equipment--Part 2-45:       newer version
                             Particular Requirements
                             for the Safety of
                             Mammographic X-ray
                             Equipment and
                             Mammographic Stereotactic
                             Devices
------------------------------------------------------------------------

12-69         ............  NEMA MS 6-1991 (R2000)      Relevant
                             Characterization of         guidance,
                             Special Purpose Coils for   Contact person
                             Diagnostic Magnetic         and CFR
                             Resonance Images            Citations
------------------------------------------------------------------------
12-95         ............  NEMA MS 2-2003              Relevant
                             Determination of Two-       guidance and
                             Dimensional Geometric       Contact person
                             Distortion in Diagnostic
                             Magnetic Resonance Images
------------------------------------------------------------------------
12-96         ............  NEMA MS 3-2003              Relevant
                             Determination of Image      guidance and
                             Uniformity in Diagnostic    Contact person
                             Magnetic Resonance Images
------------------------------------------------------------------------
12-97         ............  NEMA MS-1-2001              Relevant
                             Determination of Signal-    guidance,
                             to-Noise Ratio (SNR) in     Contact person
                             Diagnostic Magnetic         and CFR
                             Resonance Imaging           Citations
------------------------------------------------------------------------
12-103        12-179        ANSI / IESNA RP-27.3-2007   Withdrawn and
                             Recommended Practice for    replaced with
                             Photobiological Safety      newer version
                             for Lamps--Risk Group
                             Classification and
                             Labeling
------------------------------------------------------------------------
12-120        ............  IEC 60601-2-44 (2002-11):   Relevant
                             Medical Electrical          guidance and
                             Equipment--Part 2-44:       CFR Citations
                             Particular Requirements
                             for the Safety of X-ray
                             Equipment for Computed
                             Tomography--Ed. 2.1
------------------------------------------------------------------------
12-123        12-180        IEC 61689:2007              Withdrawn and
                             Ultrasonics--Physiotherap   replaced with
                             y Systems--Field            newer version
                             Specifications and
                             Methods of Measurement in
                             the Frequency Range 0,5
                             MHz to 5 MHz Ed. 2.0
------------------------------------------------------------------------
12-125        ............  NEMA MS 5-2003              Relevant
                             Determination of Slice      guidance and
                             Thickness in Diagnostic     Contact person
                             Magnetic Resonance
                             Imaging
------------------------------------------------------------------------
12-129        12-181        NU 1-2007 Performance       Withdrawn and
                             Measurements of Gamma       replaced with
                             Cameras                     newer version
------------------------------------------------------------------------
12-131        12-184        IEC 61217 2002              Withdrawn and
                             Consolidated Ed. 1.1,       replaced with
                             2007 Amendment 2 Ed. 1.0    newer version
                             Radiotherapy Equipment--
                             Coordinates, Movements,
                             and Scales
------------------------------------------------------------------------
12-150        ............  IEC / ISO 10918-1:1994      Relevant
                             Technical Corrigendum       guidance,
                             1:2005 Information          Contact person,
                             Technology--Digital         CFR Citations,
                             Compression and Coding of   Product code,
                             Continuous-Tone Still       and Devices
                             Images--Part 1:             affected
                             Requirements
------------------------------------------------------------------------
12-151        ............  NEMA MS 4 (2006) Acoustic   Relevant
                             Noise Measurement           guidance,
                             Procedure for Diagnosing    Contact person
                             Magnetic Resonance          and CFR
                             Imaging Devices             Citations
------------------------------------------------------------------------
12-158        ............  NEMA MS 10-2006             Relevant
                             Determination of Local      guidance,
                             Specific Absorption Rate    Contact person
                             (SAR) in Diagnostic         and CFR
                             Magnetic Resonance          Citations
                             Imaging
------------------------------------------------------------------------
12-159        ............  NEMA MS 11-2006             Relevant
                             Determination of Gradient-  guidance,
                             Induced Electric Fields     Contact person
                             in Diagnostic Magnetic      and CFR
                             Resonance Imaging           Citations
------------------------------------------------------------------------
12-160        ............  NEMA MS 12-2006             Relevant
                             Quantification and          guidance,
                             Mapping of Geometric        Contact person
                             Distortion for Special      and CFR
                             Applications                Citations
------------------------------------------------------------------------
12-161        ............  IEC 60601-2-33 (2006),      Relevant
                             Medical Electrical          guidance and
                             Equipment--Part 2-33:       Contact person
                             Particular Requirements
                             for the Safety of
                             Magnetic Resonance
                             Equipment for Medical
                             Diagnosis
------------------------------------------------------------------------
12-164        12-182        IEC 60601-2-37:2007         Withdrawn and
                             Medical Electrical          replaced with
                             Equipment--Part 2-37:       newer version
                             Particular Requirements
                             for the Basic Safety and
                             Essential Performance of
                             Ultrasonic Medical
                             Diagnostic and Monitoring
                             Equipment
------------------------------------------------------------------------
12-165        ............  NEMA XR 22-2006 ``Quality   Relevant
                             Control Manual'' Template   guidance
                             for Manufacturers of
                             Displays and Workstations
                             Labeled for Final
                             Interpretation in Full-
                             Field Digital Mammography
------------------------------------------------------------------------
12-166        ............  NEMA XR 23-2006 ``Quality   Relevant
                             Control Manual'' Template   guidance
                             for Manufacturers of
                             Hardcopy Output Devices
                             Labeled for Final
                             Interpretation in Full-
                             Field Digital Mammography
------------------------------------------------------------------------
12-168        ............  IEC 60825-1 Ed. 2.0 (2007)  Contact person
                             Safety of Laser Products--  and Processes
                             Part 1: Equipment           impacted
                             Classification, and
                             Requirements
------------------------------------------------------------------------

12-169        ............  IEC 60601-2-22 Ed. 3.0      Contact person,
                             (2007) Medical Electrical   Processes
                             Equipment--Part 2-22:       impacted and
                             Particular Requirements     Title
                             for Basic Safety and
                             Essential Performance of
                             Surgical, Cosmetic,
                             Therapeutic and
                             Diagnostic Laser
                             Equipment
------------------------------------------------------------------------
12-170        12-183        NEMA PS 3.1 - 3.18 (2008)   Withdrawn and
                             Digital Imaging and         replaced with
                             Communications in           newer versions
                             Medicine (DICOM) Set
------------------------------------------------------------------------
5-7           12-185        IEC 60601-1-3 2008 Edition  Transferred
                             2.0 Medical Electrical
                             Equipment--Part 1-
                             3:General Requirements
                             for Basic Safety and
                             Essential Performance--
                             Collateral Standard:
                             Radiation Protection in
                             Diagnostic X-ray
                             Equipment
------------------------------------------------------------------------
N. Software/Informatics
------------------------------------------------------------------------
13-4          ............  ANSI/UL 1998, Software in   CFR Citations,
                             Programmable Components     Product codes,
                                                         Relevant
                                                         guidance and
                                                         Extent of
                                                         recognition
------------------------------------------------------------------------
13-5          ............  IEEE 1074:1997, Standard    Withdrawn
                             for Developing Software
                             Life Cycle Processes
------------------------------------------------------------------------
13-8          ............  IEC 62304 Ed. 1.0, Medical  CFR Citations,
                             Device Software--Software   Product codes,
                             Life Cycle Processes        Relevant
                                                         guidance, and
                                                         Extent of
                                                         recognition
------------------------------------------------------------------------
7-59          13-9          CLSI AUTO2-A2 Laboratory    Transferred
                             Automation: Bar Codes for
                             Specimen Container
                             Identification; Approved
                             Standard
------------------------------------------------------------------------
7-60          13-10         CLSI AUTO1-A Laboratory     Transferred
                             Automation: Specimen
                             Container/Specimen
                             Carrier; Approved
                             Standard
------------------------------------------------------------------------
7-61          13-11         CLSI AUTO3-A Laboratory     Transferred
                             Automation:
                             Communications with
                             Automated Clinical
                             Laboratory Systems,
                             Instruments, Devices, and
                             Information Systems;
                             Approved Standard
------------------------------------------------------------------------
7-62          13-12         CLSI AUTO4-A Laboratory     Transferred
                             Automation: Systems
                             Operational Requirements,
                             Characteristics, and
                             Information Elements;
                             Approved Standard
------------------------------------------------------------------------
7-63          13-13         CLSI AUTO5-A Laboratory     Transferred
                             Automation:
                             Electromechanical
                             Interfaces; Approved
                             Standard
------------------------------------------------------------------------
7-64          13-14         CLSI POCT1-A2 Point-of-     Transferred
                             Care Connectivity;
                             Approved Standard
------------------------------------------------------------------------
7-68          13-15         CLSI GP19-A2 Laboratory     Transferred
                             Instruments and Data
                             Management Systems:
                             Design of Software User
                             Interfaces and End-User
                             Software Systems
                             Validation, Operation,
                             and Monitoring; Approved
                             Guideline--Second Edition
------------------------------------------------------------------------
7-114         13-16         CLSI LIS01-A Standard       Transferred
                             Specification for Low-
                             Level Protocol to
                             Transfer Messages Between
                             Clinical Laboratory
                             Instruments and Computer
                             Systems
------------------------------------------------------------------------
7-115         13-17         CLSI LIS02-A2 Standard      Transferred
                             Specification for
                             Transferring Information
                             Between Clinical
                             Instruments and Computer
                             Systems; Approved
                             Standard-Second Edition
------------------------------------------------------------------------
7-116         13-18         CLSI LIS03-A Standard       Transferred
                             Guide for Selection of a
                             Clinical Laboratory
                             Information Management
                             System
------------------------------------------------------------------------
7-117         13-19         CLSI LIS04-A Standard       Transferred
                             Guide for Documentation
                             of Clinical Laboratory
                             Computer Systems
------------------------------------------------------------------------
7-118         13-20         CLSI LIS05-A Standard       Transferred
                             Specification for
                             Transferring Clinical
                             Observations Between
                             Independent Computer
                             Systems
------------------------------------------------------------------------
7-119         13-21         CLSI LIS06-A Standard       Transferred
                             Practice for Reporting
                             Reliability of Clinical
                             Laboratory Information
                             Systems
------------------------------------------------------------------------

7-120         13-22         CLSI LIS07-A Standard       Transferred
                             Specification for Use of
                             Bar Codes on Specimen
                             Tubes in the Clinical
                             Laboratory
------------------------------------------------------------------------
7-121         13-23         CLSI LIS08-A Standard       Transferred
                             Guide for Functional
                             Requirements of Clinical
                             Laboratory Information
                             Management Systems
------------------------------------------------------------------------
7-122         13-24         CLSI LIS09-A Standard       Transferred
                             Guide for Coordination of
                             Clinical Laboratory
                             Services within the
                             Electronic Health Record
                             Environment and Networked
                             Architectures
------------------------------------------------------------------------
O. Sterility
------------------------------------------------------------------------
14-24         ............  AAMI/ANSI/ISO 11134:1993    Withdrawn
                             Sterilization of Health
                             Care Products--
                             Requirements for
                             Validation and Routine
                             Control-Industrial Moist
                             Heat Sterilization
------------------------------------------------------------------------
14-53         ............  AAMI/ANSI ST66:1996         Withdrawn
                             Sterilization of Health
                             Care Products--Chemical
                             Indicators--Part 2:
                             Indicators for Air
                             Removal Test Sheets and
                             Packs
------------------------------------------------------------------------
14-54         ............  AAMI/ANSI/ISO 11737-2:1998  CFR Citations,
                             Sterilization of Medical    Product codes
                             Devices--Microbiological    and Devices
                             Methods--Part 2: Tests of   affected
                             Sterility Performed in
                             the Validation of a
                             Sterilization Process
------------------------------------------------------------------------
14-55         ............  AAMI/ANSI/ISO 14160:1998    Relevant
                             Sterilization of Single-    guidance
                             Use Medical Devices
                             Incorporating Materials
                             of Animal Origin--
                             Validation and Routine
                             Control of Sterilization
                             by Liquid Chemical
                             Sterilants
------------------------------------------------------------------------
14-60         ............  ASTM F1327:1998 Standard    Withdrawn
                             Terminology Relating to
                             Barrier Materials for
                             Medical Packaging
------------------------------------------------------------------------
14-63         ............  ASTM F1886: 1998 (2004)     CFR Citations
                             Standard Test Method for    and Product
                             Determining Integrity of    codes
                             Seals for Medical
                             Packaging by Visual
                             Inspection
------------------------------------------------------------------------
14-64         ............  ASTM F1929:1998 (2004)      CFR Citations
                             Standard Test Method for    and Product
                             Detecting Seal Leaks in     codes
                             Porous Medical Packaging
                             by Dye Penetration
------------------------------------------------------------------------
14-70         ............  AAMI/ANSI/ISO 14161:2000    CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--Biological   and Devices
                             Indicators--Guidance for    affected
                             the Selection, Use and
                             Interpretation of
                             Results, 2ed.
------------------------------------------------------------------------
14-76         ............  AAMI/ANSI/ISO 10993-7:1995  CFR Citations,
                             (R) 2001 Biological         Product codes
                             Evaluation of Medical       and Contact
                             Devices--Part 7: Ethylene   person
                             Oxide Sterilization
                             Residuals
------------------------------------------------------------------------
14-88         ............  AAMI/ANSI/ISO 14937:2000    CFR Citations
                             Sterilization of Health     and Product
                             Care Products--General      codes
                             Requirements for
                             Characterization of a
                             Sterilizing Agent and the
                             Development, Validation,
                             and Routine Control of a
                             Sterilization Process for
                             Medical Devices
------------------------------------------------------------------------
14-90         14-256        ASTM F2095-07 Standard      Withdrawn and
                             Test Methods for Pressure   replaced with
                             Decay Leak Test for         newer version
                             Nonporous Flexible
                             Packages With and Without
                             Restraining Plates
------------------------------------------------------------------------
14-116        ............  AAMI ST72:2002 Bacterial    CFR Citations,
                             endotoxins--Test            Product codes,
                             Methodologies, Routine      Type of
                             Monitoring, and             standard,
                             Alternatives to Batch       Guidance and
                             Testing                     Extent of
                                                         recognition
------------------------------------------------------------------------
14-120        ............  ASTM D3078:2002 Standard    CFR Citations,
                             Test Method for             Product codes
                             Determination of Leaks in   and Type of
                             Flexible Packaging by       standard
                             Bubble Emission
------------------------------------------------------------------------
14-123        ............  ASTM F2096-04 Standard      CFR Citations,
                             Test Method for Detecting   Product codes,
                             Gross Leaks in Medical      CDRH Office and
                             Packaging by Internal       Division
                             Pressurization (Bubble      associated with
                             Test)                       recognized
                                                         standard
------------------------------------------------------------------------

14-135        ............  AAMI/ANSI ST63:2002         CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--             and Type of
                             Requirements for the        standard
                             Development, Validation
                             and Routine Control of an
                             Industrial Sterilization
                             Process for Medical
                             Devices--Dry Heat
------------------------------------------------------------------------
14-136        ............  AAMI/ANSI ST67:2003         CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--             and Guidance
                             Requirements for Products
                             Labeled 'Sterile' 1st
                             Edition
------------------------------------------------------------------------
14-138        ............  ISO 13408-2:2003 Aseptic    CFR Citations,
                             Processing of Health Care   Product codes,
                             Products--Part 2:           Type of
                             Filtration                  standard and
                                                         Guidance
------------------------------------------------------------------------
14-139        ............  ISO 14644-1:1999            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 1: Classification of   standard
                             Air Cleanliness
------------------------------------------------------------------------
14-140        ............  ISO 14644-2:2000            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 2: Specification for   standard
                             Testing and Monitoring to
                             Prove Continued
                             Compliance With ISO 14644-
                             1
------------------------------------------------------------------------
14-141        ............  ISO 14644-4:2001            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 4: Design,             standard
                             Construction and Startup
------------------------------------------------------------------------
14-142        ............  ISO 14698-1:2003            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Biocontamination Control--  standard
                             Part 1: General
                             Principles and Methods
------------------------------------------------------------------------
14-143        ............  ISO 14698-2:2003            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Biocontamination Control--  standard
                             Part 2: Evaluation and
                             Interpretation of
                             Biocontamination Data
------------------------------------------------------------------------
14-148        ............  ASTM F2250-03 Standard      CFR Citations,
                             Practice for Evaluation     Product codes
                             of Chemical Resistance of   and Type of
                             Printed Inks and Coatings   standard
                             on Flexible Packaging
                             Materials
------------------------------------------------------------------------
14-149        ............  ASTM F2251-03e1 Standard    CFR Citations,
                             Test Method for Thickness   Product codes
                             Measurement of Flexible     and Type of
                             Packaging Material          standard
------------------------------------------------------------------------
14-150        ............  ASTM F2252-03 Standard      CFR Citations,
                             Practice for Evaluating     Product codes
                             Ink or Coating Adhesion     and Type of
                             to Flexible Packaging       standard
                             Materials Using Tape
------------------------------------------------------------------------
14-164        ............  AAMI/ANSI ST81:2004         CFR Citations,
                             Sterilization of Medical    Product codes,
                             Devices--Information to     and Devices
                             be Provided by the          affected
                             Manufacturer for the
                             Processing of
                             Resterilizable Devices
------------------------------------------------------------------------
14-165        ............  ISO 14644-5:2004            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 5: Operations          standard
------------------------------------------------------------------------
14-166        ............  ISO 14644-7:2004            CFR Citations,
                             Cleanrooms and Associated   Product codes
                             Controlled Environments--   and Type of
                             Part 7: Separative          standard
                             Devices (Clean Air Hoods,
                             Gloveboxes, Isolators and
                             Mini-Environments)
------------------------------------------------------------------------
14-168        14-245        ASTM F2338-07 Standard      Withdrawn and
                             Test Method for             replaced with
                             Nondestructive Detection    newer version
                             of Leaks in Packages by
                             Vacuum Decay Method
------------------------------------------------------------------------
14-169        ............  ASTM F2391-05 Standard      CFR Citations,
                             Test Method for Measuring   Product codes
                             Package and Seal            and Type of
                             Integrity Using Helium as   standard
                             Tracer Gas
------------------------------------------------------------------------
14-170        ............  ASTM F2475-05 Standard      CFR Citations,
                             Guide for                   Product codes
                             Biocompatibility            and Type of
                             Evaluation of Medical       standard
                             Device Packaging
                             Materials
------------------------------------------------------------------------
14-191        ............  ISO 13408-4:2005 Aseptic    CFR Citations,
                             Processing of Health care   Product codes,
                             Products--Part 4: Clean-    Type of
                             in-Place Technologies       standard and
                                                         Relevant
                                                         guidance
------------------------------------------------------------------------
14-193        ............  AAMI/ANSI/ISO 11607-1:2006  CFR Citations,
                             Packaging for terminally    Product codes,
                             Sterilized Medical          Devices
                             Devices--Part 1:            affected and
                             Requirements for            Relevant
                             Materials, Sterile          guidance
                             Barrier Systems and
                             Packaging Systems, 3d ed.
------------------------------------------------------------------------

14-194        ............  AAMI/ANSI/ISO 11607-2:2006  CFR Citations,
                             Packaging for Terminally    Product codes,
                             Sterilized Medical          Devices
                             Devices--Part 2:            affected and
                             Validation Requirements     Relevant
                             for Forming, Sealing and    guidance
                             Assembly Processes, 1st
                             ed.
------------------------------------------------------------------------
14-197        ............  ASTM F1608:00(2004)         CFR Citations
                             Standard Test Method for    and Product
                             Microbial Ranking of        codes
                             Porous Packaging
                             Materials (Exposure
                             Chamber Method)
------------------------------------------------------------------------
14-199        ............  ASTM D4169-05 Standard      Related CFR
                             Practice for Performance    Citations and
                             Testing of Shipping         Product codes
                             Containers and Systems
------------------------------------------------------------------------
14-202        14-246        USP 31:2008 Biological      Withdrawn and
                             Indicator for Dry-Heat      replaced with
                             Sterilization, Paper        newer version
                             Carrier
------------------------------------------------------------------------
14-203        14-247        USP 31:2008 Biological      Withdrawn and
                             Indicator for Ethylene      replaced with
                             Oxide Sterilization,        newer version
                             Paper Carrier.
------------------------------------------------------------------------
14-204        14-248        USP 31:2008 Biological      Withdrawn and
                             Indicator for Steam         replaced with
                             Sterilization, Paper        newer version
                             Carrier
------------------------------------------------------------------------
14-205        14-249        USP 31:2008 <61> Microbial  Withdrawn and
                             Limits Test                 replaced with
                                                         newer version
------------------------------------------------------------------------
14-206        14-250        USP 31:2008 <71>            Withdrawn and
                             Microbiological Tests,      replaced with
                             Sterility Tests             newer version
------------------------------------------------------------------------
14-207        14-251        USP 31:2008 <85>            Withdrawn and
                             Biological Tests and        replaced with
                             Assays, Bacterial           newer version
                             Endotoxin Test (LAL)
------------------------------------------------------------------------
14-208        14-252        USP 31:2008 <151> Pyrogen   Withdrawn and
                             Test (USP Rabbit Test)      replaced with
                                                         newer version
------------------------------------------------------------------------
14-209        14-253        USP 31:2008 <161>           Withdrawn and
                             Transfusion and Infusion    replaced with
                             Assemblies and Similar      newer version
                             Medical Devices
------------------------------------------------------------------------
14-210        14-254        USP 31:2008 Biological      Withdrawn and
                             Indicator for Steam         replaced with
                             Sterilization--Self         newer version
                             Contained
------------------------------------------------------------------------
14-220        ............  AAMI/ANSI ST79:2006         Type of Standard
                             Comprehensive Guide to
                             Steam Sterilization and
                             Sterility Assurance in
                             Health Care Facilities
------------------------------------------------------------------------
14-221        ............  AAMI/ANSI/ISO TIR           CFR Citations,
                             11139:2006 Sterilization    Product codes,
                             of Health Care Products--   Title, Devices
                             Vocabulary                  affected, and
                                                         Type of
                                                         standard
------------------------------------------------------------------------
14-222        ............  AAMI/ANSI/ISO 18472:2006    Type of standard
                             Sterilization of Health
                             Care Products--Biological
                             and Chemical Indicators--
                             Test Equipment
------------------------------------------------------------------------
14-223        ............  ANSI/AAMI/ISO 11138-1:2006  Type of
                             Sterilization of Health     standard,
                             Care Products--Biological   Guidance and
                             Indicators--Part 1:         Extent of
                             General Requirements        recognition
------------------------------------------------------------------------
14-224        ............  AAMI/ANSI/ISO 11137-1:2006  CFR Citations,
                             Sterilization of Health     Product codes,
                             Care Products--Radiation--  and Type of
                             Part 1: Requirements for    standard
                             Development, Validation,
                             and Routine Control of a
                             Sterilization Process for
                             Medical Devices
------------------------------------------------------------------------
14-225        ............  AAMI/ANSI/ISO 11137-2:2006  CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--Radiation--  and Type of
                             Part 2: Establishing the    standard
                             Sterilization Dose
------------------------------------------------------------------------
14-226        ............  AAMI/ANSI/ISO 11137-3:2006  CFR Citations,
                             Sterilization of Health     Product codes
                             Care Products--Radiation--  and Type of
                             Part 3: Guidance on         standard
                             Dosimetric Aspects
------------------------------------------------------------------------

14-227        ............  AAMI/ANSI/ISO 11737-1:2006  CFR Citations,
                             Sterilization of Medical    Product codes,
                             Devices-Microbiological     Devices
                             Methods-Part 1:             affected, CDRH
                             Determination of the        Office and
                             Population of               Division
                             Microorganisms on           associated with
                             Products, 2d, ed.           recognized
                                                         standard
------------------------------------------------------------------------
14-228        ............  ANSI/AAMI/ISO 11135-1:2007  CFR Citations,
                             Sterilization of Health     Product codes,
                             Care Products--Ethylene     Devices
                             Oxide--Part 1:              affected, and
                             Requirements for the        Type of
                             Development, Validation,    standard
                             and Routine Control of a
                             Sterilization Process for
                             Medical Devices
------------------------------------------------------------------------
14-229        ............  ASTM F1980-07 Standard      CFR Citations
                             Guide for Accelerated       and Product
                             Aging of Sterile Barrier    codes
                             Systems for Medical
                             Devices
------------------------------------------------------------------------
14-230        ............  ASTM F2203-02(2007)         CFR Citations,
                             Standard Test Method for    Product codes
                             Linear Measurement Using    and Type of
                             Precision Steel Rule        standard
------------------------------------------------------------------------
14-231        ............  ASTM F2217-02(2007)         CFR Citations,
                             Standard Practice for       Product codes
                             Coating/Adhesive Weight     and Type of
                             Determination               standard
------------------------------------------------------------------------
14-232        ............  ASTM F2227-02(2007)         CFR Citations,
                             Standard Test Method for    Product codes
                             Non-Destructive Detection   and Type of
                             of Leaks in Non-Sealed      standard
                             and Empty Medical
                             Packaging Trays by CO2
                             Tracer Gas Method
------------------------------------------------------------------------
14-233        ............  ASTM F2228-02(2007)         CFR Citations,
                             Standard Test Method for    Product codes
                             Non-Destructive Detection   and Type of
                             of Leaks in Medical         standard
                             Packaging Which
                             Incorporates Porous
                             Barrier Material by CO2
                             Tracer Gas Method
------------------------------------------------------------------------
14-234        ............  ASTM F2097-07 Standard      CFR Citations,
                             Guide for Design and        Product codes
                             Evaluation of Primary       and Type of
                             Flexible Packaging for      standard
                             Medical Products
------------------------------------------------------------------------
14-235        ............  ASTM F1140-07 Standard      CFR Citations,
                             Test Methods for Internal   Product codes
                             Pressurization Failure      and Type of
                             Resistance of               standard
                             Unrestrained Packages
------------------------------------------------------------------------
14-236        ............  ASTM F2054-07 Standard      CFR Citations,
                             Test Method for Burst       Product codes
                             Testing of Flexible         and Type of
                             Package Seals Using         standard
                             Internal Air
                             Pressurization Within
                             Restraining Plates
------------------------------------------------------------------------
14-237        ............  ASTM F88-07 Standard Test   CFR Citations,
                             Method for Seal Strength    Product codes
                             of Flexible Barrier         and Type of
                             Materials                   standard
------------------------------------------------------------------------
14-239        ............  ISO 13408-3:2006 Aseptic    CFR Citations
                             Processing of Health Care   and Product
                             Products--Part 3:           codes
                             Lyophilization
------------------------------------------------------------------------
14-240        ............  ISO 13408-5:2006 Aseptic    CFR Citations
                             Processing of Health Care   and Product
                             Products--Part 5:           codes
                             Sterilization-in-Place
------------------------------------------------------------------------
14-241        ............  ISO 13408-6:2005 Aseptic    CFR Citations
                             Processing of Health Care   and Product
                             Products--Part 6:           codes
                             Isolator Systems
------------------------------------------------------------------------
14-242        ............  ISO 14644-3:2005            CFR Citations
                             Cleanrooms and Associated   and Product
                             Controlled Environments--   codes
                             Part 3: Test Methods
------------------------------------------------------------------------
14-243        ............  ISO 14644-6:2007            CFR Citations
                             Cleanrooms and Associated   and Product
                             Controlled Environments--   codes
                             Part 6: Vocabulary
------------------------------------------------------------------------
14-244        ............  ISO 14644-8:2006            CFR Citations
                             Cleanrooms and Associated   and Product
                             Controlled Environments--   codes
                             Part 8: Classification of
                             Airborne Molecular
                             Contamination
------------------------------------------------------------------------
P. Tissue Engineering
------------------------------------------------------------------------
15-12         ............  ASTM F2103-01(2007)e1       CFR Citations
                             Standard Guide for          and Product
                             Characterization and        codes, Relevant
                             Testing of Chitosan Salts   guidance, Type
                             as Starting Materials       of standard and
                             Intended for Use in         CDRH Office and
                             Biomedical and Tissue-      Division
                             Engineered Medical          associated with
                             Product Applications        recognized
                                                         standard
------------------------------------------------------------------------

15-5          ............  ASTM F2347-03, Standard     CFR Citations
                             Guide for                   and Product
                             Characterization and        codes, Relevant
                             Testing of Hyaluronan as    guidance, Type
                             Starting Materials          of standard and
                             Intended for Use in         CDRH Office and
                             Biomedical and Tissue       Division
                             Engineered Medical          associated with
                             Product Applications        recognized
                                                         standard
------------------------------------------------------------------------
15-6          ............  ASTM F2450-04, Standard     CFR Citations
                             Guide for Assessing         and Product
                             Microstructure of           codes, Relevant
                             Polymeric Scaffolds for     guidance, Type
                             Use in Tissue Engineered    of standard and
                             Medical Products            CDRH Office and
                                                         Division
                                                         associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------
15-7          ............  ASTM F2315-03, Standard     CFR Citations
                             Guide for Immobilization    and Product
                             or Encapsulation of         codes, Relevant
                             Living Cells or Tissue in   guidance, Type
                             Alginate Gels               of standard and
                                                         CDRH Office and
                                                         Division
                                                         associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------
15-8          ............  ASTM F2064-00(2006),        CFR Citations
                             Standard Guide for          and Product
                             Characterization and        codes, Relevant
                             Testing of Alginates as     guidance, Type
                             Starting Materials          of standard and
                             Intended for use in         CDRH Office and
                             Biomedical and Tissue-      Division
                             Engineered Medical          associated with
                             Products Application        recognized
                                                         standard
------------------------------------------------------------------------
15-9          ............  ASTM F2311-06, Standard     CFR Citations
                             Guide for Classification    and Product
                             of Therapeutic Skin         codes, Relevant
                             Substitutes                 guidance, Type
                                                         of standard and
                                                         CDRH Office and
                                                         Division
                                                         associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------
15-10         ............  ASTM F2451-05, Standard     CFR Citations
                             Guide for in vivo           and Product
                             Assessment of Implantable   codes, Relevant
                             Devices Intended to         guidance, Type
                             Repair or Regenerate        of standard and
                             Articular Cartilage         CDRH Office and
                                                         Division
                                                         associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------
15-11         ............  ASTM F2212-02(2007)e1,      CFR Citations
                             Standard Guide for          and Product
                             Characterization of Type    codes, Relevant
                             I Collagen as a Starting    guidance, Type
                             Material for Surgical       of standard and
                             Implants and Substrates     CDRH Office and
                             for Tissue Engineered       Division
                             Medical Products            associated with
                                                         recognized
                                                         standard
------------------------------------------------------------------------

III. Listing of New Entries

    In table 3 of this document, FDA provides the listing of new
entries and consensus standards added as modifications to the list of
recognized standards under Recognition List Number: 020.

        Table 3.--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
  Recognition                                          Reference No. and
      No.                 Title of Standard                  Date
------------------------------------------------------------------------
A. Biocompatibility
------------------------------------------------------------------------
2-127           Biological Evaluation of Medical      ANSI/AAMI BE
                 Devices--Part 10: Tests for           78:2002/A1:2006
                 Irritation and Delayed-Type
                 Hypersensitivity--Amendment 1
------------------------------------------------------------------------
B. Cardiovascular/Neurology
------------------------------------------------------------------------
3-70            Manual, Electronic or Automated       ANSI/AAMI
                 Sphygmomanometers                     SP10:2002/
                                                       A1:2003--Amendmen
                                                       t 1 to ANSI/AAMI
                                                       SP10:2002
------------------------------------------------------------------------
3-71            Manual, Electronic and Automated      ANSI/AAMI
                 Sphygmomanometers                     SP10:2002/
                                                       A2:2006--Amendmen
                                                       t 2 to ANSI/AAMI
                                                       SP10:2002
------------------------------------------------------------------------
C. Dental/ Ear, Nose, and Throat
------------------------------------------------------------------------
4-151           Dentistry--Artificial Teeth for       ISO 22112:2005
                 Dental Prostheses
------------------------------------------------------------------------

4-152           Metal-Ceramic Dental Restorative      ISO 9693:1999/
                 Systems                               Amendment 1:2005
------------------------------------------------------------------------
4-154           Dentistry--Elastometric Impression    ISO 4823:2000
                 Materials-Third Edition
------------------------------------------------------------------------
4-155           Dentistry--Elastomeric Impression     ISO 4823:2000
                 Materials Technical Corrigendum 1-    Technical
                 Third Edition                         Corrigendum
                                                       1:2004
------------------------------------------------------------------------
4-156           Dentistry--Elastomeric Impression     ISO 4823:2000
                 Materials Amendment 1-Third Edition   Amendment 1:2007
------------------------------------------------------------------------
4-157           Dentistry--Zinc Oxide/Eugenol and     ISO 3107: 2004
                 Zinc Oxide/Non-eugenol Cements-
                 Third Edition
------------------------------------------------------------------------
4-158           Dentistry--Soft Lining Materials for  ISO 10139-1:2005
                 Removable Dentures--Part 1:           Technical
                 Materials for Short-Term Use          Corrigendum
                 Technical Corrigendum 1               1:2006
------------------------------------------------------------------------
D. General Hospital/ General Plastic Surgery
------------------------------------------------------------------------
6-214           Standard Test Method for Human        ASTM D6355-07
                 Repeat Insult Patch Testing of
                 Medical Gloves
------------------------------------------------------------------------
E. In Vitro Diagnostic
------------------------------------------------------------------------
7-160           Abbreviated Identification of         CLSI M35-A,
                 Bacteria and Yeast; Approved
                 Guideline
------------------------------------------------------------------------
7-161           Laboratory Detection and              CLSI M48-P
                 Identification of Mycobacteria;
                 Proposed Guideline.
------------------------------------------------------------------------
7-162           Point-of-Care Monitoring of           CLSI H49-A
                 Anticoagulant Therapy; Approved
                 Guideline
------------------------------------------------------------------------
7-163           Body Fluid Analysis for Cellular      CLSI H56-A
                 Composition
------------------------------------------------------------------------
7-164           Microwave Device Use in the           CLSI GP28-A
                 Histology Laboratory; Approved
                 Guideline
------------------------------------------------------------------------
7-165           Reference Leukocyte (WBC)             CLSI H20-A2
                 Differential Count (Proportional)
                 and Evaluation of Instrumental
                 Methods; Approved Standard-Second
                 Edition
------------------------------------------------------------------------
7-166           Fine Needle Aspiration Biopsy (FNAB)  CLSI GP20-A2
                 Techniques; Approved Guideline--
                 Second Edition
------------------------------------------------------------------------
7-167           Nongynecologic Cytologic Specimens:   CLSI GP23-A
                 Collection and Cytopreparatory
                 Techniques; Approved Guideline
------------------------------------------------------------------------
7-168           Reference Method for Broth Dilution   CLSI M38-A
                 Antifungal Susceptibility Testing
                 of Filamentous Fungi; Approved
                 Standard
------------------------------------------------------------------------
F. Materials
------------------------------------------------------------------------
8-161           Standard Test Method for Tension      ASTM F2516-07
                 Testing of Nickel-Titanium
                 Superelastic Materials
------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-46            Medical Electrical Equipment--Part 2- ANSI/AAMI 60601-2-
                 2: Particular Requirements for the    2:2006
                 Safety of High Frequency Surgical
                 Equipment
------------------------------------------------------------------------
9-49            Concentrates for Hemodialysis         AAMI / ANSI
                                                       RD61:2006
------------------------------------------------------------------------
9-50            Dialysate for Hemodialysis            ANSI/AAMI
                                                       RD52:2004
------------------------------------------------------------------------
9-51            Cardiovascular Implants and           ISO 8637:2004
                 Artificial Organs--Haemodialysers,
                 Haemodiafilters, Haemofilters and
                 Haemoconcentrators
------------------------------------------------------------------------
9-52            Cardiovascular Implants and           ISO 8638:2004
                 Artificial Organs--Extracorporeal
                 Blood Circuit for Haemodialysers,
                 Haemodiafilters and Haemofilters
------------------------------------------------------------------------
9-53            Standard Practice for Reprocessing    ASTM F1992-
                 of Reusable, Heat-Stable Endoscopic   99(2007)
                 Accessory Instruments (EAI) Used
                 with Flexible Endoscopes
------------------------------------------------------------------------
9-54            Standard Specification for Rubber     ASTM D6976-08
                 Contraceptives--Vaginal Diaphragms
------------------------------------------------------------------------
H. Ophthalmic
------------------------------------------------------------------------
10-56           Ophthalmics Multifocal Intraocular    ANSI Z80.12-2007
                 Lenses
------------------------------------------------------------------------

10-57           Phakic Intraocular Lenses             ANSI Z80.13-2007
------------------------------------------------------------------------
I. Physical Medicine
------------------------------------------------------------------------
16-161          Safety Standard for Platform Lifts    ASME A18.1-2005
                 and Stairway Chairlifts
------------------------------------------------------------------------
J. Sterility
------------------------------------------------------------------------
14-255          Standard Terminology Relating to      ASTM F17-07a
                 Flexible Barrier Packaging
------------------------------------------------------------------------

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

    Persons interested in obtaining a copy of ``Guidance on the
Recognition and Use of Consensus Standards'' by using the Internet.
CDRH maintains an entry on the Internet for easy access to information
including text, graphics, and files that may be downloaded to a
personal computer with Internet access. Updated on a regular basis, the
CDRH home page includes device safety alerts, Federal Register
reprints, information on premarket submissions [including lists of
approved applications and manufacturers' addresses], small
manufacturer's assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH Web site may be accessed at http://www.fda.gov/
cdrh. A search capability for all CDRH guidance documents is available
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://www.regulations.gov.
    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. Two copies of any mailed comments are to be submitted,
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: 020. These modifications
to the list or recognized standards are effective upon publication of
this notice in the Federal Register.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

    Dated: August 27, 2008.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E8-20939 Filed 9-8-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 90 (Wednesday, May 12, 2021)]
[Notices]
[Pages 26126-26127]
[FR Doc No: 2021-10060]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Rule on Request To Dispose 10.3 Acres of Land
at Dillant-Hopkins Airport, Swanzey, NH

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Request for public comments.

-----------------------------------------------------------------------

SUMMARY: Notice is being given that the FAA is considering a request
from the City of Keene to dispose of 10.3 acres of land at Dillant-
Hopkins Airport, Swanzey, NH, under the provisions of 49 U.S.C.
47107(h)(2).
    The land is no longer needed for aviation purposes and may be
disposed of by the airport. Ninety percent of the proceeds will be
returned to the Federal Aviation Administration and used for a future
airport grant. The remaining ten percent will be remitted to the City
of Keene and placed in the airport's operation and maintenance fund. An
avigation easement will be placed over the property to ensure
compatibility with airport operations and airspace protection.

DATES: Comments must be received on or before June 11, 2021.

ADDRESSES: You may send comments using any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov, and follow the instructions on providing comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W 12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.

     Hand Delivery: Deliver to mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    Interested persons may inspect the request and supporting documents
by contacting the FAA at the address listed under FOR FURTHER
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Mr. Jorge E. Panteli, Compliance and
Land Use Specialist, Federal Aviation Administration New England Region
Airports Division, 1200 District Avenue, Burlington, Massachusetts
01803. Telephone:<PHONE_NUMBER>.

    Issued in Burlington, Massachusetts, on May 7, 2021.
Julie Seltsam-Wilps,
Deputy Director, ANE-600.
[FR Doc. 2021-10060 Filed 5-11-21; 8:45 am]
BILLING CODE P


[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Page 71594]
[FR Doc No: 2022-25602]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM01-5-000]

Electronic Tariff Filings; Notice of Revision to Validation Error
Codes Duplicative Version Numbers

    Take notice that on December 17, 2022, the Commission will be
deploying a new version of eTariff that will reject filings containing
tariff records that duplicate a previously used Version number. The
eTariff Implementation Guide requires a unique version number for a
tariff record,\1\ and this validation rule will ensure that filer has
not duplicated a previously used version number. The eTariff error code
for duplicating version numbers will be 177 with the error notice
``Record Version Number cannot be duplicated.''
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    \1\ Implementation Guide for Electronic Filing of Parts 35, 154,
284, 300, and 341 Tariff Filings, at 9, https://www.ferc.gov/sites/default/files/2020-05/OSEC%20Implementation%20Guide.pdf.
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    This error code will be added to the Validation Error Codes posted
on the Commission's eTariff website (https://www.ferc.gov/ferc-online/etariff), at https://www.ferc.gov/sites/default/files/2020-05/Validation%20Error%20Codes.csv. Filings containing duplicative version
numbers will receive the following rejection error in the Notice of
Rejection email.

--Error List

    Failed Code 177: Record Version Number cannot be duplicated.
    For more information, contact the eTariff Advisory Staff at
[email protected].

    Dated: November 17, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-25602 Filed 11-22-22; 8:45 am]
BILLING CODE 6717-01-P