[Federal Register: March 18, 2009 (Volume 74, Number 51)]
[Notices]
[Page 11586-11593]
[DOCID:fr18mr09-71]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-N-0451]

Food and Drug Administration Modernization Act of 1997:
Modifications to the List of Recognized Standards, Recognition List
Number: 021

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing a
publication containing modifications the agency is making to the list
of standards FDA recognizes for use in premarket reviews (FDA
recognized consensus standards). This publication, entitled
``Modifications to the List of Recognized Standards, Recognition List
Number: 021'' (Recognition List Number: 021), 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: 021'' 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<PHONE_NUMBER>. Submit
written comments concerning this document, or recommendations for
additional standards for recognition, to the contact person (see FOR
FURTHER INFORMATION CONTACT). Submit electronic comments by e-mail:
<EMAIL_ADDRESS>This document may also be accessed on FDA's
Internet site at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfTopic/cdrhnew.cfm. See section VI of this document for electronic
access to the searchable database for the current list of FDA
recognized consensus standards, including Recognition List Number: 021
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, 7520
Standish Place, Rockville, MD 20855,<PHONE_NUMBER>.

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.
    Modifications to the initial list of recognized standards, as
published in the Federal Register, are identified in table 1.

                   Table 1--Federal Register Citation
------------------------------------------------------------------------

------------------------------------------------------------------------
October 16, 1998 (63 FR 55617)       May 27, 2005 (70 FR 30756)
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July 12, 1999 (64 FR 37546)          November 8, 2005 (70 FR 67713)
------------------------------------------------------------------------
November 15, 2000 (65 FR 69022)      March 31, 2006 (71 FR 16313)
------------------------------------------------------------------------
May 7, 2001 (66 FR 23032)            June 23, 2006 (71 FR 36121)
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January 14, 2002 (67 FR 1774)        November 3, 2006 (71 FR 64718)
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October 2, 2002 (67 FR 61893)        May 21, 2007 (72 FR 28500)
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April 28, 2003 (68 FR 22391)         September 12, 2007 (72 FR 52142)
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March 8, 2004 (69 FR 10712)          December 19, 2007 (72 FR 71924)
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June 18, 2004 (69 FR 34176)          September 9, 2008 (73 FR 52358)
------------------------------------------------------------------------
October 4, 2004 (69 FR 59240)        ...................................
------------------------------------------------------------------------

    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: 021

    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: 021'' to identify these current
modifications.
    In table 2 of this document, FDA describes the following
modifications: (1) The withdrawal of standards and their replacement by
others; (2) the correction of errors made by FDA in listing previously
recognized standards; and (3) the changes to the supplementary
information sheets of recognized standards that describe revisions to
the applicability of the standards.
    In section III of this document, FDA lists modifications the agency
is making that involve the initial addition of standards not previously
recognized by FDA.

                                                     Table 2
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                            Replacement
 Old Recognition No.      Recognition No.                      Standard                           Change
----------------------------------------------------------------------------------------------------------------
A. Anesthesia
----------------------------------------------------------------------------------------------------------------
1-49                   .....................  ASTM F 1981-99 Standard Specification for   Withdrawn
                                               Suction Catheters for use in the
                                               Respiratory Tract
----------------------------------------------------------------------------------------------------------------
1-63                   1-77                   CGA V-1:2005 Standard for Compressed Gas    Withdrawn and replaced
                                               Cylinder Valve Outlet and Inlet             with newer version
                                               Connection
----------------------------------------------------------------------------------------------------------------
1-64                   1-78                   ASME PVHO-1-2007 Safety Standard for        Withdrawn and replaced
                                               Pressure Vessels for Human Occupancy        with newer version
----------------------------------------------------------------------------------------------------------------

1-71                   .....................  ISO 10651-5:2006 Lung Ventilators for       Withdrawn duplicate
                                               Medical Use--Particular requirements for
                                               Basic Safety and Essential Performance--
                                               Part 5: Gas-powered Emergency
                                               Resuscitators
----------------------------------------------------------------------------------------------------------------
1-74                   .....................  ISO 5360:2006 Anaesthetic Vaporizers--      Contact person
                                               Agent Specific Filling Systems
----------------------------------------------------------------------------------------------------------------
1-76                   1-79                   ISO 26825:2008 (E) Anaesthetic And          Withdrawn and replaced
                                               Respiratory Equipment--User-Applied         with newer version
                                               Labels For Syringes Containing Drugs Used
                                               During Anaesthesia--Colours, Design and
                                               Performance
----------------------------------------------------------------------------------------------------------------
B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-71                   2-133                  ASTM F1408-97 (2008) Standard Practice for  Withdrawn and replaced
                                               Subcutaneous Screening Test for Implant     with newer version
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-73                   2-134                  ASTM F2065-00(2006) Standard Practice for   Withdrawn and replaced
                                               Testing for Alternative Pathway             with newer version
                                               Complement Activation in Serum by Solid
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-87                   .....................  AAMI/ANSI/ISO 10993-10:2002 Biological      Extent of Recognition,
                                               Evaluation of Medical Devices--Part 10:     Relevant Guidance,
                                               Tests for Irritation and Delayed-Type       and Contact Person
                                               Hypersensitivity
----------------------------------------------------------------------------------------------------------------
2-88                   2-135                  AAMI/ANSI/ISO 10993-12:2007 Biological      Withdrawn and replaced
                                               Evaluation of Medical Devices--Part 12:     with newer version
                                               Sample Preparation and Reference
                                               Materials
----------------------------------------------------------------------------------------------------------------
2-127                  .....................  ANSI/AAMI BE 78:2002/A1:2006 Biological     Withdrawn
                                               Evaluation of Medical Devices--Part 10:
                                               Tests For Irritation and Delayed-Type
                                               Hypersensitivity--Amendment 1
----------------------------------------------------------------------------------------------------------------
C. Cardiovascular/Neurology
----------------------------------------------------------------------------------------------------------------
3-67                   .....................  ASTM F2129-06 Standard Test Method for      Offices, Devices
                                               Conducting Cyclic Potentiodynamic           Affected, Relevant
                                               Polarization Measurements to Determine      Guidance, CFR
                                               the Corrosion Susceptibility of Small       Citation and Product
                                               Implant Devices                             Codes, Contact Person
----------------------------------------------------------------------------------------------------------------
D. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-29                   .....................  IEC 60601-2-19 1996-10: Amendment 1--       Relevant guidance
                                               Medical Electrical Equipment Part 2:
                                               Particular Requirements for Safety of
                                               Baby Incubators
----------------------------------------------------------------------------------------------------------------
6-32                   .....................  IEC 60601-2-20 1996-10: Amendment 1--       Relevant guidance
                                               Medical Electrical Equipment Part 2:
                                               Particular Requirements for the Safety Of
                                               Transport Incubators
----------------------------------------------------------------------------------------------------------------
6-62                   .....................  ISO 8536-6:1995 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 6: Freeze Drying
                                               Closures for Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-63                   .....................  ISO 8536-7-1999: Infusion Equipment for     Relevant guidance
                                               Medical Use--Part 7: Caps Made of
                                               Aluminum-Plastics Combinations For
                                               Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-64                   .....................  ISO 8536-3-1999, Infusion Equipment for     Relevant guidance
                                               Medical Use--Part 3: Aluminum Caps for
                                               Infusion Bottles
----------------------------------------------------------------------------------------------------------------
6-119                  .....................  ANSI/AAMI BF7:1989/(R)2002/(R)2007 Blood    Reaffirmation 2007,
                                               Transfusion Micro-Filters                   Title, SDO, Date of
                                                                                standard, Relevant
                                                                                guidance
----------------------------------------------------------------------------------------------------------------
6-122                  .....................  ISO 8536-5-2004:, Infusion Equipment for    Relevant guidance
                                               Medical Use--Part 5: Burette Infusion
                                               Sets for Single Use, Gravity Feed
----------------------------------------------------------------------------------------------------------------
6-127                  .....................  ISO 1135-4-2004: Transfusion Equipment for  Relevant guidance
                                               Medical Use--Part 4: Transfusion Sets for
                                               Single Use
----------------------------------------------------------------------------------------------------------------
6-142                  .....................  ANSI/AAMI II36:2004 Medical Electrical      Title, Relevant
                                               Equipment--Part 2: Particular               guidance
                                               Requirements for Safety of Baby
                                               Incubators
----------------------------------------------------------------------------------------------------------------
6-143                  .....................  ANSI/AAMI II51:2004, Medical Electrical     Title, Relevant
                                               Equipment--Part 2: Particular               guidance
                                               Requirements for Safety of Transport
                                               Incubators
----------------------------------------------------------------------------------------------------------------

6-172                  .....................  ISO 8536-1:2006 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 1: Infusion Glass
                                               Bottles
----------------------------------------------------------------------------------------------------------------
6-173                  .....................  ISO 8536-2:2001 Corrigendum 1:2003,         Relevant guidance
                                               Infusion Equipment for Medical Use--Part
                                               2: Closures for Infusion Bottles
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6-182                  .....................  IEC 60601-2-38 1996/Amendment 1:1999,       Relevant guidance
                                               Medical Electrical Equipment--Part 2-38:
                                               Particular Requirements for the Safety of
                                               Electrically Operated Hospital Beds
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6-201                  .....................  ISO 8536-4:2007 Infusion Equipment for      Relevant guidance
                                               Medical Use--Part 4: Infusion Sets for
                                               Single Use, Gravity Feed
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6-215                  .....................  ASTM F2132-01(2008)E1 Standard              Title
                                               Specification for Puncture Resistance of
                                               Materials Used in Containers for
                                               Discarded Medical Needles and Other
                                               Sharps
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E. IVD
----------------------------------------------------------------------------------------------------------------
7-138                  7-169                  CLSI M27-A3 Reference Method for Broth      Withdrawn and replaced
                                               Dilution Antifungal Susceptibility          with newer version
                                               Testing of Yeasts
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7-54                   .....................  CLSI D12-A2, Immunoprecipitin Analyses:     Title
                                               Procedures for Evaluating the Performance
                                               of Materials--Second Edition; Approved
                                               Guideline
----------------------------------------------------------------------------------------------------------------
7-71                   .....................  CLSI H15-A3, Reference and Selected         Contact person
                                               Procedures for the Quantitative
                                               Determination of Hemoglobin in Blood;
                                               Approved Standard--Third Edition
----------------------------------------------------------------------------------------------------------------
7-145                  .....................  CLSI H42-A2, Enumeration of                 Contact person
                                               Immunologically Defined Cell Populations
                                               by Flow Cytometry.
----------------------------------------------------------------------------------------------------------------
7-73                   7-170                  CLSI ILA21-A2 Clinical Evaluation of        Withdrawn and replaced
                                               Immunoassays                                with newer version
----------------------------------------------------------------------------------------------------------------
7-130                  .....................  CLSI H20-A2, Reference Leucocyte            Contact person
                                               Differential Count (Proportional) and
                                               Evaluation of Instrumental Methods;
                                               Approved Standard--Second Edition
----------------------------------------------------------------------------------------------------------------
7-164                  .....................  CLSI GP 28-A Microwave Device Use in the    Contact person
                                               Histology Laboratory; Approved Guideline
----------------------------------------------------------------------------------------------------------------
7-168                  7-171                  CLSI M38-A2 Reference Method for Broth      Withdrawn and replaced
                                               Dilution Antifungal Susceptibility          with newer version
                                               Testing of Filamentous Fungi
----------------------------------------------------------------------------------------------------------------
F. Neurology
----------------------------------------------------------------------------------------------------------------
3-3                    17-1                   AAMI NS28:1988/(R) 2006 Intracranial        Transferred, Date of
                                               Pressure Monitoring Devices                 standard, Extent of
                                                                                recognition, Relevant
                                                                                guidance
----------------------------------------------------------------------------------------------------------------
3-32                   17-2                   ASTM F1542-94(2000) Standard Specification  Transferred, Offices,
                                               for the Requirements and Disclosure of      Type of standard,
                                               Self-Closing Aneurysm Clips                 Extent of
                                                                                recognition, Relevant
                                                                                guidance, Contact
                                                                                person
----------------------------------------------------------------------------------------------------------------
3-33                   17-3                   ISO 7197:2006 Neurosurgical implants--      Transferred--Withdrawn
                                               Sterile, Single-use hydrocephalus Shunts    and replaced with
                                               and Components                              newer version
----------------------------------------------------------------------------------------------------------------
3-39                   17-4                   ASTM F647-94(2006) Standard Practice for    Transferred--Withdrawn
                                               Evaluating and Specifying Implantable       and replaced with
                                               Shunt Assemblies for Neurosurgical          newer version
                                               Application
----------------------------------------------------------------------------------------------------------------
3-60                   17-5                   IEC 60601-2-10 1987/Amendment 1 2001        Transferred, Title
                                               Medical Electrical Equipment--Part 2-10:    change, Date of
                                               Particular Requirements for the Safety of   standard, Relevant
                                               Nerve and Muscle Stimulators                guidance, Contact
                                                                                person
----------------------------------------------------------------------------------------------------------------
3-67                   17-6                   ASTM F2129-06 Standard Test Method for      Offices, Devices
                                               Conducting Cyclic Potentiodynamic           affected, Type of
                                               Polarization Measurements to Determine      Standard, Product
                                               the Corrosion Susceptibility of Small       code, Relevant
                                               Implant Devices                             guidance, Contact
                                                                                person
----------------------------------------------------------------------------------------------------------------
G. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------

9-30                   9-55                   ANSI/ AAMI RD62:2006 Water Treatment        Withdrawn and replaced
                                               Equipment for Hemodialysis Applications     with newer version
----------------------------------------------------------------------------------------------------------------
9-32                   9-56                   ASTM D3492-08 Standard Specification for    Withdrawn and replaced
                                               Rubber Contraceptives (Male Condoms)        with newer version
----------------------------------------------------------------------------------------------------------------
9-34                   .....................  ISO 4074:2002/Cor.1:2003(E): Natural Latex  Extent of recognition,
                                               Rubber Condoms--Requirements and Test       Product codes,
                                               Methods, Technical Corrigendum 1            Relevant guidance
----------------------------------------------------------------------------------------------------------------
H. Radiology
----------------------------------------------------------------------------------------------------------------
12-48                  .....................  AIUM AOL, Acoustic Output Labeling          Relevant guidance
                                               Standard for Diagnostic Ultrasound
                                               Equipment: A Standard for How
                                               Manufacturers Should Specify Acoustic
                                               Output Data
----------------------------------------------------------------------------------------------------------------
12-55                  12-186                 IEC 60601-2-29 (2008) Medical Electrical    Withdrawn and replaced
                                               Equipment--Part 2-29: Particular            with newer version
                                               Requirements for the Basic Safety and
                                               Essential Performance of Radiotherapy
                                               Simulators--Third Edition
----------------------------------------------------------------------------------------------------------------
12-66                  .....................  AIUM MUS, Medical Ultrasound Safety         Relevant guidance
----------------------------------------------------------------------------------------------------------------
12-96                  12-187                 NEMA MS 3-2008 Determination of Image       Withdrawn and replaced
                                               Uniformity in Diagnostic Magnetic           with newer version
                                               Resonance Images
----------------------------------------------------------------------------------------------------------------
12-97                  12-188                 NEMA MS 1-2008 Determination of Signal-to-  Withdrawn and replaced
                                               Noise Ratio (SNR) in Diagnostic Magnetic    with newer version
                                               Resonance Imaging
----------------------------------------------------------------------------------------------------------------
12-100                 .....................  NEMA UD 3-2004, Standard for Real Time      Relevant guidance
                                               Display of Thermal and Mechanical
                                               Acoustic Output Indices on Diagnostic
                                               Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
12-105                 .....................  NEMA UD 2-2004, Acoustic Output             Title, Relevant
                                               Measurement Standard for Diagnostic         guidance
                                               Ultrasound Equipment Version 3
----------------------------------------------------------------------------------------------------------------
12-139                 .....................  AIUM AOMS-2005, Acoustic Output             Relevant guidance
                                               Measurement Standard for Diagnostic
                                               Ultrasound Equipment
----------------------------------------------------------------------------------------------------------------
12-140                 .....................  AIUM RTD1-2005, Standard for Real-Time      Relevant guidance
                                               Display of Thermal and Mechanical
                                               Acoustic Output Indices on Diagnostic
                                               Ultrasound Equipment Revision 1
----------------------------------------------------------------------------------------------------------------
12-161                 12-189                 IEC 60601-2-33 (2008) Medical Electrical    Withdrawn and replaced
                                               Equipment--Part 2-33: Particular            with a newer version
                                               Requirements for the Safety of Magnetic
                                               Resonance Equipment for Medical Diagnosis
                                               Consolidated Edition 2.2
----------------------------------------------------------------------------------------------------------------
12-182                 .....................  IEC 60601-2-37:2007, Medical Electrical     Relevant guidance
                                               Equipment--Part 2-37: Particular
                                               Requirements for the Basic Safety and
                                               Essential Performance of Ultrasonic
                                               Medical Diagnostic and Monitoring
                                               Equipment
----------------------------------------------------------------------------------------------------------------
12-184                 12-190                 IEC 61217 (2008) Radiotherapy Equipment--   Withdrawn and replaced
                                               Coordinates, Movements, and Scales          with newer version
                                               Consolidated Edition 1.2
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-120                 14-257                 ASTM D3078--02(2008) Standard Test Method   Withdrawn and replaced
                                               for Determination of Leaks in Flexible      with newer version
                                               Packaging by Bubble Emission
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14-148                 14-258                 ASTM F2250--03(2008) Standard Practice for  Withdrawn and replaced
                                               Evaluation of Chemical Resistance of        with newer version
                                               Printed Inks and Coatings on Flexible
                                               Packaging Materials
----------------------------------------------------------------------------------------------------------------
14-149                 14-259                 ASTM F2251--03(2008) Standard Test Method   Withdrawn and replaced
                                               for Thickness Measurement of Flexible       with newer version
                                               Packaging Material
----------------------------------------------------------------------------------------------------------------
14-150                 14-260                 ASTM F2252--03(2008) Standard Practice for  Withdrawn and replaced
                                               Evaluating Ink or Coating Adhesion to       with newer version
                                               Flexible Packaging Materials Using Tape
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J. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-11                  15-13                  ASTM F2212-02(2008)e1, Standard Guide for   Withdrawn and replaced
                                               Characterization of Type I Collagen as a    with newer version
                                               Starting Material for Surgical Implants
                                               and Substrates for Tissue Engineered
                                               Medical Products
----------------------------------------------------------------------------------------------------------------

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: 021.

                                                     Table 3
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    Recognition No.                           Title of Standard                          Reference No. & Date
----------------------------------------------------------------------------------------------------------------
A. Dental/ENT
----------------------------------------------------------------------------------------------------------------
4-160                   Maximum Permissible Ambient Noise Levels for Audiometric      ANSI ASA S3.1-1999 (R
                         Test Rooms                                                    2003)
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4-161                   Method for Measuring the Intelligibility of Speech Over       ANSI ASA S3.2-1989 (R
                         Communication Systems                                         1999)
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4-162                   Procedure for the Computation of Loudness of Steady Sounds    ANSI ASA S3.4-2007
----------------------------------------------------------------------------------------------------------------
4-163                   Methods for Calculation of the Speech Intelligibility Index   ANSI ASA S3.5-1997 (R
                                                                                2007)
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4-164                   Method for Coupler Calibration of Earphones                   ANSI ASA S3.7-1995 (R
                                                                                2003)
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4-165                   Mechanical Coupler for Measurement of Bone Vibrators          ANSI ASA S3.13-1987 (R
                                                                                2007)
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4-166                   Bioacoustical Terminology                                     ANSI ASA S3.20-1995 (R
                                                                                2003)
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4-167                   Methods for Manual Pure-Tone Threshold Audiometry             ANSI ASA S3.21-2004
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4-168                   Occluded Ear Simulator                                        ANSI ASA S3.25-1989 (R
                                                                                2003)
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4-169                   Method of Measurement of Performance Characteristics of       ANSI ASA S3.35-2004
                         Hearing Aids under Simulated Real-Ear Working Conditions
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4-170                   Specification for a Manikin for Simulated in situ Airborne    ANSI ASA S3.36-1985 (R
                         Acoustic Measurements                                         2006)
----------------------------------------------------------------------------------------------------------------
4-171                   Preferred Earhook Nozzle Thread for Postauricular Hearing     ANSI ASA S3.37-1987 (R
                         Aids                                                          2007)
----------------------------------------------------------------------------------------------------------------
4-172                   Testing Hearing Aids with a Broad-Band Noise Signal           ANSI ASA S3.42-1992 (R
                                                                                2007)
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4-173                   Determination of Occupational Noise Exposure and Estimation   ANSI ASA S3.44-1996 (R
                         of Noise-Induced Hearing Impairment                           2006)
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4-174                   Procedures for Testing Basic Vestibular Function              ANSI ASA S3.45-1999
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4-175                   Methods of Measurement of Real-Ear Performance                ANSI ASA S3.46-1997 (R
                         Characteristics of Hearing Aids                               2002)
----------------------------------------------------------------------------------------------------------------
4-176                   Criteria for Evaluating Room Noise                            ANSI ASA S12.2-1995 (R
                                                                                1999)
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4-177                   Rating Noise with Respect to Speech Interference              ANSI ASA S12.65-2006
----------------------------------------------------------------------------------------------------------------
B. General
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5-45                    Standard Practice for Performance Testing of Packages for     ASTM D7386-08
                         Single Delivery Systems
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C. IVD
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7-172                   Defining, Establishing, and Verifying Reference Intervals in  C28-P3
                         the Clinical Laboratory
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7-173                   Harmonization of Glycohemoglobin Measurements                 C44-A
----------------------------------------------------------------------------------------------------------------
7-174                   Estimation of Total Analytical Error for Clinical Laboratory  EP21-A
----------------------------------------------------------------------------------------------------------------
7-175                   Apolipoprotein Immunoassays: Development and Recommended      ILA15-A
                         Performance Characteristics
----------------------------------------------------------------------------------------------------------------
7-176                   Immunoassay Interference by Endogenous Antibodies             ILA30-A
----------------------------------------------------------------------------------------------------------------

7-177                   Performance Standards for Antimicrobial Susceptibility        M100-S18
                         Testing
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7-178                   Quality Control for Commercially Prepared Microbiological     M22-A3
                         Culture Media
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7-179                   Reference Method for Broth Dilution Antifungal                M27-S3
                         Susceptibility Testing of Yeasts
----------------------------------------------------------------------------------------------------------------
7-180                   Western Blot Assay for Antibodies to Borrelia burgdorferi     M34-A
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7-181                   Abbreviated Identification of Bacteria and Yeasts             M35-A
----------------------------------------------------------------------------------------------------------------
7-182                   Clinical Use and Interpretation of Serologic Tests for        M36-A
                         Toxoplasma gondii
----------------------------------------------------------------------------------------------------------------
7-183                   Reference Method for Broth Dilution Antifungal                M38-A2
                         Susceptibility Testing of Filamentous Fungi
----------------------------------------------------------------------------------------------------------------
7-184                   Quality Control of Microbiological Transport Systems          M40-A
----------------------------------------------------------------------------------------------------------------
7-185                   Viral Culture                                                 M41-A
----------------------------------------------------------------------------------------------------------------
7-186                   Methods for Antifungal Disk Diffusion Susceptibility Testing  M44-A
----------------------------------------------------------------------------------------------------------------
7-187                   Zone Diameter Interpretive Standards, Corresponding Minimal   M44-S2
                         Inhibitory Concentration (MIC) Interpretive Breakpoints,
                         and Quality Control Limits for Antifungal Disk Diffusion
                         Susceptibility Testing of Yeast
----------------------------------------------------------------------------------------------------------------
7-188                   Methods for Antimicrobial Dilution and Disk Susceptibility    M45-A
                         Testing of Infrequently Isolated or Fastidious Bacteria
----------------------------------------------------------------------------------------------------------------
7-189                   Principles and Procedures for Blood Cultures                  M47-A
----------------------------------------------------------------------------------------------------------------
7-190                   Quality Control for Commercial Microbial Identification       M50-A
                         Systems
----------------------------------------------------------------------------------------------------------------
7-191                   Collection, Transport, Preparation, and Storage of Specimens  MM13-A
----------------------------------------------------------------------------------------------------------------
7-192                   Interpretive Criteria for Identification of Bacteria and      MM18-A
                         Fungi by DNA Target Sequencing
----------------------------------------------------------------------------------------------------------------
7-193                   Evaluation of the Linearity of Quantitative Measurement       EP06-A
----------------------------------------------------------------------------------------------------------------
7-194                   Protocols for Determination of Limits of Detection and        EP17-A
                         Limits of Quantitation
----------------------------------------------------------------------------------------------------------------
D. Neurology
----------------------------------------------------------------------------------------------------------------
17-7                    Neurosurgical implants--Sterile, Single-use Hydrocephalus     ISO 7197:2006/Technical
                         Shunts and Components                                         Corrigendum1:2007
----------------------------------------------------------------------------------------------------------------
E. OB-GYN/Gastroenterology
----------------------------------------------------------------------------------------------------------------
9-57                    Natural Latex Rubber Condoms--Requirements and Test Methods,  ISO 4074:2002/
                         Technical Corrigendum 2                                       Cor.2:2008(E)
----------------------------------------------------------------------------------------------------------------
F. Ophthalmic
----------------------------------------------------------------------------------------------------------------
10-58                   Laser Systems for Corneal Reshaping                           ANSI Z80.11-2007
----------------------------------------------------------------------------------------------------------------
G. Radiology
----------------------------------------------------------------------------------------------------------------
12-191                  Ultrasonics--Field Characterization--Test Methods for the     IEC 62359:2005
                         Determination of Thermal and Mechanical Indices Related to
                         Medical Diagnostic Ultrasonic Fields
----------------------------------------------------------------------------------------------------------------
H. Software/Informatic
----------------------------------------------------------------------------------------------------------------
13-25                   Managing and Validating Laboratory Information Systems;       CLSI AUTO8-A
                         Approved Guideline
----------------------------------------------------------------------------------------------------------------
13-26                   Autoverification of Clinical Laboratory Test Results;         CLSI AUTO10-A
                         Approved Guideline
----------------------------------------------------------------------------------------------------------------
13-27                   IT Security of In Vitro Diagnostic Instruments and Software   CLSI AUTO11-A
                         Systems; Approved Standard
----------------------------------------------------------------------------------------------------------------
13-28                   Remote Access to Clinical Laboratory Diagnostic Devices via   CLSI AUTO9-A
                         the Internet; Approved Standard
----------------------------------------------------------------------------------------------------------------
I. Sterility
----------------------------------------------------------------------------------------------------------------
14-261                  Sterilization of Health Care Products--Moist Heat--Part 1:    ANSI/AAMI/ISO 17665-1:2006
                         Requirements for the Development, Validation, and Routine
                         Control of a Sterilization Process for Medical Devices
----------------------------------------------------------------------------------------------------------------

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 document 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

    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 document announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 021'' will be available
on the CDRH home page. You may access the CDRH home page at http://
www.fda.gov/cdrh.
    You may access ``Guidance on the Recognition and Use of Consensus
Standards,'' and the searchable database for ``FDA Recognized Consensus
Standards'' through the hyperlink at http://www.fda.gov/cdrh/
stdsprog.html.
    This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/
cdrh/fedregin.html.

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) written or electronic comments regarding
this document. 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: 021. These modifications
to the list or recognized standards are effective upon publication of
this document in the Federal Register.

    Dated: March 10, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-5858 Filed 3-17-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 76, Number 202 (Wednesday, October 19, 2011)]
[Notices]
[Page 64958]
[FR Doc No: 2011-27056]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4031-DR; Docket ID FEMA-2011-0001]

New York; Amendment No. 6 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of New York (FEMA-4031-DR), dated September 13, 2011, and
related determinations.

DATES: Effective Date: October 4, 2011.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of New York is hereby amended to include the following
areas among those areas determined to have been adversely affected by
the event declared a major disaster by the President in his declaration
of September 13, 2011.

Oneida and Ulster Counties for Individual Assistance.
Orange County for Individual Assistance (already designated for
Public Assistance).
Ulster County for Public Assistance.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030, Community
Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, Disaster Unemployment
Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048,
Disaster Housing Assistance to Individuals and Households in
Presidentially Declared Disaster Areas; 97.049, Presidentially
Declared Disaster Assistance--Disaster Housing Operations for
Individuals and Households; 97.050, Presidentially Declared Disaster
Assistance to Individuals and Households--Other Needs; 97.036,
Disaster Grants--Public Assistance (Presidentially Declared
Disasters); 97.039, Hazard Mitigation Grant.)

    Dated: October 13, 2011.
W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-27056 Filed 10-18-11; 8:45 am]
BILLING CODE 9111-23-P


Richard Daye/ARTD/R7/USEPA/US

04/26/2007 07:28 PM

To

Pekar.Zachary@epamail.epa.gov@EPA

cc

Deirdre Murphy/RTP/USEPA/US@EPA, Gwen Yoshimura/ARTD/R7/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS>"Lee, Rodney \(Mark\)" <EMAIL_ADDRESS>"Overton, Robert"<EMAIL_ADDRESS> Subject

Re: MDNR - Re: Fw: Modeling input/output files?

Zach

  I believe that these are the files you want.  The input file isc3p.inp.cnt299.mdnr.final is the file for current SIP attainment demonstration.  The hourly emission files (hrly--q-.dat) are for each quarter.  The met files (met--q-.asc) are also for each quarter.  The met files should be the as what you have.  Plume depletion is consider but deposition is not.   Read the readme file first.   Call me if you have any questions.  Good luck!!

      Mick


[Federal Register Volume 78, Number 39 (Wednesday, February 27, 2013)]
[Notices]
[Pages 13338-13339]
[FR Doc No: 2013-04407]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2009-0879; FRL-9379-7]

Exposure Modeling Public Meeting; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: An Exposure Modeling Public Meeting (EMPM) will be held for
one day on March 19, 2013. This notice announces the location and time
for the meeting and sets forth the tentative agenda topics.

DATES: The meeting will be held on March 19, 2013 from 9:00 a.m. to
4:00 p.m. Requests to participate in the meeting must be received on or
before March 11, 2013.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at the Environmental Protection
Agency, Office of Pesticide Programs (OPP), One Potomac Yard (North
Building), Fourth Floor Conference Center (N-4830), 2777 S. Crystal
Drive, Arlington, VA 22202.

FOR FURTHER INFORMATION CONTACT: Gabe Rothman, Environmental Fate and
Effects Division, Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are required
to conduct testing of chemical substances under the Toxic Substances
Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA),
or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action. The following list of North American Industrial
Classification System (NAICS) codes is not intended to be exhaustive,
but rather provides a guide to help readers determine whether this
document applies to them. Potentially affected entities may include:
     Agriculture, Forestry, Fishing and Hunting NAICS code 11
     Utilities NAICS code 22
     Professional, Scientific and Technical NAICS code 54

B. How can I get copies of this document and other related information?

    The docket for this action, identified by docket identification
(ID) number EPA-HQ-OPP-2009-0879, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

II. Background

    On a biannual interval, an Exposure Modeling Public Meeting will be
held for presentation and discussion of current issues related to
modeling pesticide fate, transport, and exposure of risk assessment in
a regulatory

context. Meeting dates and abstract requests are announced through the
``empmlist'' forum on the LYRIS list server at https://lists.epa.gov/read/all_forums/.

III. How can I request to participate in this meeting?

    You may submit a request to participate in this meeting to the
person listed under FOR FURTHER INFORMATION CONTACT. Do not submit any
information in your request that is considered CBI. Requests to
participate in the meeting, identified by docket ID number EPA-HQ-OPP-
2009-0879, and must be received on or before March 11, 2013.

IV. Tentative Topics for the Meeting

Update on Development of the Spatial Aquatic Model (SAM).
Pesticide Root Zone Model for Ground Water Model (PRZM-GW)
Implementation.
Pesticide Flooded Application Model (PFAM) Implementation.
Recent Developments for Drinking Water Intakes Percent Cropped Area
(DWI PCA) Guidance.
Other topics related to environmental exposure modeling and monitoring
of pesticides in surface water, ground water, soil, air, and biota.

List of Subjects

    Environmental protection, pesticide exposure assessment, exposure
modeling, pesticide monitoring, groundwater, PRZM-GW, SAM, PFAM, DWI
PCA.

    Dated: February 13, 2013.
Donald J. Brady,
Director, Environmental Fate and Effects Division, Office of Pesticide
Programs.
[FR Doc. 2013-04407 Filed 2-26-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 19 (Monday, January 29, 2018)]
[Rules and Regulations]
[Pages 3941-3944]
[FR Doc No: 2018-01572]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2017-0896; Product Identifier 2017-SW-034-AD; Amendment
39-19166; AD 2018-02-13]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are superseding Airworthiness Directive (AD) 2017-07-02 for
Sikorsky Aircraft Corporation (Sikorsky) Model 269D and Model 269D
Configuration A helicopters. AD 2017-07-02 required reducing the life
limit of and inspecting certain drive shafts. This new AD retains the
requirements of AD 2017-07-02 and requires repeating the inspections.
The actions of this AD are intended to detect and prevent an unsafe
condition on these products.

DATES: This AD is effective March 5, 2018.

ADDRESSES: For service information identified in this final rule,
contact Sikorsky Aircraft Corporation, Customer Service Engineering,
124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-
416-4299; email [email protected]. You may view this
referenced service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort
Worth, TX 76177.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov in Docket No. FAA-2017-0896; or in person at Docket
Operations between 9 a.m. and 5 p.m., Monday through Friday, except
Federal holidays. The AD docket contains this AD, the economic
evaluation, any comments received, and other information. The address
for Docket Operations (phone:<PHONE_NUMBER>) is Document Operations,
U.S. Department of Transportation, Docket Operations, M-30, West
Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Michael Schwetz, Aviation Safety
Engineer, Boston ACO Branch, Compliance and Airworthiness Division,
FAA, 1200 District Avenue, Burlington, Massachusetts 01803; telephone
(781) 238-7761; email [email protected].

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to remove AD 2017-07-02, Amendment 39-18840 (82 FR 15120, March
27, 2017) and add a new AD. AD 2017-07-02 applied to Sikorsky Model
269D and Model 269D Configuration A helicopters with a KAflex engine
side drive shaft part number (P/N) SKCP2738-7 and KAflex pulley side
drive shaft P/N SKCP2738-5 installed. AD 2017-07-02 required reducing
the life limit of the drive shafts and performing several inspections
of the drive shafts within 25 hours time-in-service (TIS). AD 2017-07-
02 also specified replacing the drive shaft assemblies as an optional
terminating action for the requirements of the AD. AD 2017-07-02 was
prompted by four incidents involving failure of the engine side drive
shaft. The actions required by AD 2017-07-02 were intended to prevent
failure of the drive shaft, loss of rotor drive, and subsequent loss of
control of the helicopter.
    The NPRM published in the Federal Register on September 22, 2017
(82 FR 44353) to provide the public an opportunity to comment on
proposed requirements with longer intervals. The NPRM proposed to
retain the requirements of AD 2017-07-02 and repeat some of the
inspections every 100 hours TIS or 400 hours TIS. Repeating these
inspections is necessary to detect and prevent the unsafe condition.

Comments

    We gave the public the opportunity to participate in developing
this AD, but we did not receive any comments on the NPRM.

FAA's Determination

    We have reviewed the relevant information and determined that an
unsafe condition exists and is likely to exist or develop on other
helicopters of these same type designs and that air safety and the
public interest require adopting the AD requirements as proposed.

Related Service Information

    We reviewed Appendix B to Sikorsky S-330 Model 269D Helicopter
Basic Handbook of Maintenance Instructions No. CSP-D-2, dated February
1, 1993, and revised October 15, 2014; and Appendix B to Sikorsky S-333
Model 269D Config. ``A'' Helicopter Basic Handbook of Maintenance
Instructions No. CSP-D-9, dated July 20, 2001, and revised October 15,
2014. This service information specifies repetitive inspection
procedures, overhaul and retirement schedules, and weight and balance
procedures. The Airworthiness Limitations section, which is included in
this service information, contains the life limits for drive shaft
assembly P/Ns SKCP2738-5 and SKCP2738-7.
    We also reviewed Sikorsky 269D Helicopter Alert Service Bulletin
DB-052, Basic Issue, dated January 16, 2014, for Sikorsky Model 269D
and Model 269D Configuration A helicopters. This service information
distributes the service life reduction information and implements a new
1,200-hour overhaul inspection for drive shaft assembly P/Ns SKCP2738-
3, SKCP2738-5, and SKCP2738-7.

Differences Between This AD and the Service Information

    The Sikorsky service information specifies a drive shaft assembly
service life of 3,000 hours TIS with a 1,200 hour overhaul inspection
for Model 269D Configuration A helicopters, while this AD specifies a
service life of 1,200 hours TIS.
    The Sikorsky service information specifies different inspection
procedures if there is spline engagement interference or resistance
while inspecting the drive shaft alignment. This AD specifies replacing
both the engine side and pulley side drive shafts if there is any
spline engagement interference or resistance.
    The Sikorsky service information specifies inspecting the working
fastener condition without any specific succeeding action regarding the
inspection. This AD specifies replacing both the engine side and pulley
side drive shafts if there is any joint movement.
    The Sikorsky service information specifies returning the drive
shaft assembly to Sikorsky if there is fretting dust or red metallic
residue at a joint. This AD specifies replacing both the engine side
and pulley side drive shafts if there is any fretting corrosion.

Costs of Compliance

    We estimate that this AD will affect 18 helicopters of U.S.
Registry. We estimate that operators may incur the following costs in
order to comply with this AD.
    Removing the engine side and pulley side drive shafts that have
reached the new life limit will take about 4 work-hours for a cost of
$340 per helicopter. Inspecting the lower pulley to engine alignment
using the belt alignment tool will take about 0.5 work-hour for an
estimated cost of $43 per helicopter and $774 for the U.S. fleet per
inspection cycle. Adjusting the engine elevation alignment will take
about 0.5 work-hour for an estimated cost of $43 per helicopter.
Inspecting the drive shaft alignment by checking spline engagement will
take about 1 work-hour for a cost of $85 per helicopter and $1,530 for
the U.S. fleet per inspection cycle. Inspecting the drive shafts for
damage will take about 1 work-hour for an estimated cost of $85 per
helicopter and $1,530 for the U.S. fleet per inspection cycle.
Inspecting the joints will take about 1 work-hour for an estimated cost
of $85 per helicopter and $1,530 for the U.S. fleet per inspection
cycle. Replacing the engine side and pulley side drive shafts, if
required, will take about 8 work-hours and parts will cost about
$20,000, for an estimated cost of $20,680 per helicopter.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We have determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have a
substantial direct effect on the States, on the relationship between
the national government and the States, or on the distribution of power
and responsibilities among the various levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska to the extent
that a regulatory distinction is required, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2017-07-02, Amendment 39-18840 (82 FR 15120, March 27, 2017), and
adding the following new AD:

2018-02-13 Sikorsky Aircraft Corporation (Sikorsky): Amendment 39-
19166; Docket No. FAA-2017-0896; Product Identifier 2017-SW-034-AD.

(a) Applicability

    This AD applies to Sikorsky Model 269D and Model 269D
Configuration A helicopters with a KAflex engine side drive shaft
part number (P/N) SKCP2738-7 and KAflex pulley side drive shaft P/N
SKCP2738-5 installed, certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as failure of a drive
shaft. This condition could result in loss of rotor drive and
subsequent loss of control of the helicopter.

(c) Affected ADs

    This AD supersedes AD 2017-07-02, Amendment 39-18840 (82 FR
15120, March 27, 2017).

(d) Effective Date

    This AD becomes effective March 5, 2018.

(e) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(f) Required Actions

    (1) Before further flight:
    (i) For Model 269D helicopters, remove from service any KAflex
engine side drive shaft P/N SKCP2738-7 and any KAflex pulley side
drive shaft P/N SKCP2738-5 that has 6,000 or more hours time-in-
service (TIS). Thereafter, remove from service any KAflex engine
side drive shaft P/N SKCP2738-7 and any KAflex pulley side drive
shaft P/N SKCP2738-5 before accumulating 6,000 hours TIS.
    (ii) For Model 269D Configuration A helicopters, remove from
service any KAflex engine side drive shaft P/N SKCP2738-7 and any
KAflex pulley side drive shaft P/N SKCP2738-5 that has 1,200 or more
hours TIS. Thereafter, remove from service any KAflex engine side
drive shaft P/N SKCP2738-7 and any KAflex pulley side drive shaft P/
N SKCP2738-5 before accumulating 1,200 hours TIS.
    (iii) If interchanged between Model 269D and Model 269D
Configuration A helicopters, remove from service any KAflex engine
side drive shaft P/N SKCP2738-7 and any KAflex pulley side drive
shaft P/N SKCP2738-5 that has 1,200 or more hours TIS. Thereafter,
if interchanged between Model 269D and Model 269D Configuration A
helicopters, remove from service any KAflex engine side drive shaft
P/N SKCP2738-7 and any KAflex pulley side drive shaft P/N SKCP2738-5
before accumulating 1,200 hours TIS.
    (2) Within 25 hours TIS, and thereafter at intervals not to
exceed 25 hours TIS, using a belt drive alignment tool 269T3303-003,
inspect the lower pulley to engine alignment by engaging the tool on
the drive shaft and inserting in the lower pulley bore. Rotate the
tool 360[deg] around the drive shaft and inspect for interference.
If there is any interference with the rotation of the tool, before
further flight, adjust the engine elevation alignment to eliminate
the interference.
    (3) Within 25 hours TIS, and thereafter at intervals not to
exceed 100 hours TIS:
    (i) Remove the drive shaft to adapter bolt and inspect the drive
shaft alignment. Engage and disengage the splines a minimum of 3
times by sliding the engine power output shaft in and out of the
engine. Inspect the alignment at each 90[deg] interval by rotating
the lower pulley with the power shaft disengaged. Determine whether
the adapter slides on and off the drive shaft splines without spline
engagement interference or resistance along the entire length of
movement. If there is any spline engagement interference or
resistance, before further flight, replace both the engine side and
pulley side drive shafts.
    (ii) Inspect each drive shaft for a crack, any corrosion or
pitting, a nick, a dent, and a scratch. If there is a crack, any
corrosion or pitting, a nick, a dent, or a scratch that exceeds
allowable limits, before further flight, replace both the engine
side and pulley side drive shafts.
    (4) Within 25 hours TIS, and thereafter at intervals not to
exceed 400 hours TIS, remove the engine side drive shaft and pulley
side drive shaft and perform the following:
    (i) Inspect each flex frame (frame) bolted joint (joint) for
movement by hand. If there is any movement, before further flight,
replace both the engine side and pulley side drive shafts.
    (ii) Visually inspect each joint for fretting corrosion (which
might be indicated by metallic particles) and each frame and mount
bolt torque stripe for movement. If there is any fretting corrosion
or torque stripe movement, before further flight, replace both the
engine side and pulley side drive shafts.
    (iii) Using a 10x or higher power magnifying glass, visually
inspect each joint for fretting and for a crack around the bolt head
and washer side, and around the nut and washer side. Also inspect
both sides of each frame for a crack on the inside and outside
corner radii and radii edge (four). If there is any fretting, a
crack at any point over the full circumference (360[deg]) of the
bolt head and washer side or the nut and washer side, or a crack in
any of the corner radii edges, before further flight, replace both
the engine side and pulley side drive shafts.
    (5) As an optional terminating action to the repetitive
inspections in this AD, you may install KAflex engine side drive
shaft P/N SKCP2738-9 and KAflex pulley side drive shaft P/N
SKCP2738-101.

(g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Boston ACO Branch, FAA, may approve AMOCs for
this AD. Send your proposal to: Michael Schwetz, Aviation Safety
Engineer, Boston ACO Branch, Compliance and Airworthiness Division,
FAA, 1200 District Avenue, Burlington, Massachusetts 01803;
telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(h) Additional Information

    Appendix B of Sikorsky S-330 Model 269D Helicopter Basic
Handbook of Maintenance Instructions, No. CSP-D-2, dated February 1,
1993, and revised October 15, 2014; Appendix B of Sikorsky S-330
Model 269D Config. ``A'' Helicopter Basic Handbook of Maintenance
Instructions, No. CSP-D-9, dated July 20, 2001, and revised October
15, 2014; and Sikorsky 269D Helicopter Alert Service Bulletin DB-
052, Basic Issue, dated January 16, 2014, which are not incorporated
by reference, contain additional information about the subject of
this AD. For service information identified in this AD, contact
Sikorsky Aircraft Corporation, Customer Service Engineering, 124
Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-
416-4299; email [email protected]. You may review
a copy of the service information at the FAA, Office of the Regional
Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort
Worth, TX 76177.

(i) Subject

    Joint Aircraft Service Component (JASC) Code: 6310, Engine/
Transmission Coupling.

    Issued in Fort Worth, Texas, on January 17, 2018.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2018-01572 Filed 1-26-18; 8:45 am]
 BILLING CODE 4910-13-P


San Joaquin Valley Air Pollution Control District Comments on Exceptional and Natural Events Rulemaking Briefing for STAPPA/ ALAPCO, July 27, 2005 All comments are based on the " Exceptional and Natural Events Rulemaking" slide presentation given by Larry Wallace of EPA on the STAPPA/ ALAPCO conference call on July 27, 2005.

1. Time line options: Revising the time line from 180 days to 60 or 90 days would present a hardship to the local agencies. The time line is best left at 180 days, as in the current Natural Events Policy.

After an air monitor sample is collected and shipped to a laboratory for weighing, EPA guidelines state that the data must be submitted to AQS ( Air Quality System) within 30 days of the end of the calendar quarter. The data does not become official until 90 days after submittal to AQS. A 60 or 90 day documentation requirement is not enough time to allow for this or the many other potentially time consuming phases of documentation preparation: filter speciation, meteorological data collection and analysis, review of relevant EPA policy, review of regional agency plans and BACM, staff coordination, writing and assembly of the natural event documentation, internal agency review, and public comment. This is not an issue of agency size; in spite of staff size, many agencies do not have enough people to do what they need to do as is without adding a natural or exceptional event to the workload. Natural and exceptional events are by their very nature unexpected, so there must be enough time for assigned staff to work on documentation as they continue their normal tasks.

EPA's concern over the " loss of data" ( slide 11) cannot outweigh the resources necessary for natural event documentation and mitigation plan preparation. Data collection is likely one of the earlier tasks that an agency will complete in this process, so losing data because of a lag between the event and the completion of documentation is unlikely. Even if an agency does not have portions of useful data, there are almost always other sources of data that can be used. In fact, third party data can greatly contribute to a more complete understanding of the event, but an agency needs time to identify and incorporate relevant external data.

With regard to addressing data quickly to take " appropriate action to protect public health," the data flagging itself is not as critical to public health as is the mitigation plan. It is advantageous to allow an agency time to develop a thorough understanding of the event and to develop effective programs that will address the complicated and varying characteristics of natural and exceptional events. Flagging of data for design value purposes can result in fewer controls on emissions, so it is important that the process not be unduly rushed. Simply expediting the data flagging process will not expedite the protection of the public.

I n addition, automatic EPA concurrence at the close of the review period is crucial if an agency is to meet mitigation plan commitments. An agency would not dedicate resources to a mitigation plan until it is certain that it is required ( that is, not before the data flag is approved), but mitigation plans need to be submitted within a specified time frame.

Therefore, an agency should have 180 days from the date of the exceedance to submit documentation, and there must be automatic concurrence from EPA at the close of their review period.

2. Existing mitigation plans If the policy for mitigation plans changes, how will the new policy apply to NEAPs in progress or already adopted? For areas that already have NEAPs in place or in progress for data that has already been flagged, it would be best for any mitigation plan changes required by the new policy to occur at the 5 year revision.

3. Clarifying " routine" The new policy needs to be very clear on what is meant by " routine." Slide 4 defines exceptional events as those events that are not expected to occur " routinely" at a given location. Are cyclical, seasonal wind events or emissions events such as harvesting considered exceptional, or routine? There needs to be clear boundaries on what can be presented as non routine.

4. Fireworks Slide 9 mentions fireworks emissions, but there is no other mention of fireworks in the presentation. Would PM2.5 violations after yearly, 4th of July fireworks be considered " routine?" More details on how fireworks could be handled would be of interest.

4. Special Events Policy Slide 5 on EPA policies does not mention the September 1994 policy, " Guidelines on the Identification and Handling of Ambient Air Quality Data Affected by Special Events or Special Conditions." Is this policy still in effect? Might it be included in the revised Natural and Exceptional Events Policy? Might the 5 year Recurrence Test ( Section 2.3) be revised? Since this policy also covers data from unusual circumstances, it should be included in the revised Natural and Exceptional Events Policy.

5. BAM and FRM data EPA's guidance should present EPA's viewpoint on real time BAM ( beta attenuation monitor) data and how it is to be used with official filter based FRM ( federal reference method) data. What if the BAM data is higher than the FRM data? Which is most important in terms of the data flagging process? Any data that can be used in an area's attainment calculations should be subject to flagging policies, so both BAM and FRM data should qualify.

6. High winds For " high winds," will the more rigid definition from the Exceptional Events Policy or the more flexible definition from the Natural Events Policy be used? Deposition from high wind source regions needs to be addressed as well. The San Joaquin Valley ( SJV) has had high wind events in its northern portion that affected low wind regions further south in the SJV. The Natural Events Policy definition of high winds is preferable as it allows for the variability among regions and events.

7. Wildland fires The definition of a wildland fire also needs clarification. Is an arson wildfire considered an exceptional event? If a catastrophic but routine wildland fire occurs and an exceedance is captured on a monitor, should that data be flagged? What about wildland fire use ( WFUs)? If a naturally ignited wildland fire occurs during a major stagnation event and lasts several days, is there a limitation on the number of consecutive days that can be flagged? Clearly defined classes of wildland fire data flags would allow various types of events to be flagged while ensuring that those viewing or using the data have as much information as possible regarding the nature of the event.

8. Data affecting attainment of the annual standard Currently, data flags are either accepted or rejected, and the flags denote the event causing the exceedance (" A" for high winds, " E" for wildfires, etc). Perhaps an additional type of flag can be introduced for events producing readings that are high enough to affect annual attainment status even if there was not a 24 hour violation. Since data from these types of events do not represent the same type of threat to public health as does a 24 hour violation and areas with these types of exceedances most likely have SIPs in place, a full mitigation plan may not be needed for these types of flags provided that the same documentation process is utilized.


[Federal Register Volume 83, Number 192 (Wednesday, October 3, 2018)]
[Proposed Rules]
[Pages 49903-49904]
[FR Doc No: 2018-21191]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2018-0627; FRL-9983-81]
RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 26 chemical substances which
were the subject of premanufacture notices (PMNs). The chemical
substances are subject to Orders issued by EPA pursuant to sections
5(e) and 5(f) of TSCA. This action would require persons who intend to
manufacture (defined by statute to include import) or process any of
these 26 chemical substances for an activity that is designated as a
significant new use by this rule to notify EPA at least 90 days before
commencing that activity. The required notification initiates EPA's
evaluation of the intended use within the applicable review period.
Persons may not commence manufacture or processing for the significant
new use until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required with that determination. In addition to this Notice of
Proposed Rulemaking, EPA is issuing the action as a direct final rule
elsewhere in this issue of the Federal Register.

DATES: Comments must be received on or before November 2, 2018.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2018-0627, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI)

or other information whose disclosure is restricted by statute.
     Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave. Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION: In addition to this Notice of Proposed
Rulemaking, EPA is issuing the action as a direct final rule elsewhere
in this issue of the Federal Register. For further information about
the proposed significant new use rules, please see the information
provided in the direct final action, with the same title, that is
located in the ``Rules and Regulations'' section of this issue of the
Federal Register.

List of Subjects in 40 CFR Part 721

    Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.

    Dated: September 14, 2018.
Jeffery T. Morris,
Director, Office of Pollution Prevention and Toxics.
[FR Doc. 2018-21191 Filed 10-2-18; 8:45 am]
BILLING CODE 6560-50-P