[Federal Register Volume 81, Number 247 (Friday, December 23, 2016)]
[Notices]
[Pages 94388-94394]
[FR Doc No: 2016-31008]

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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: 046

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) 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: 046'' (Recognition List Number: 046), will assist manufacturers
who elect to declare conformity with consensus standards to meet
certain requirements for medical devices.

DATES: Submit electronic or written comments concerning this document
at any time. These modifications to the list of recognized standards
are effective December 23, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2004-N-0451 for ``Food and Drug Administration Modernization Act of
1997: Modifications to the List of Recognized Standards, Recognition
List Number: 046.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday. 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: 046.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of Recognition List Number: 046 is available on
the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. 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: 046 modifications and other standards related
information. Submit written requests for a single hard copy of the
document entitled ``Modifications to the List of Recognized Standards,
Recognition List Number: 046'' to Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993,<PHONE_NUMBER>. Send
one self-addressed adhesive label to assist that office in processing
your request, or fax your request to<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Scott Colburn, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5514, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    Section 204 of the Food and Drug Administration Modernization Act
of 1997 (FDAMA) (Pub. L. 105-115) amended section 514 of the Federal
Food, Drug, and Cosmetic Act (the FD&C 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, can be accessed at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm.
    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: 046

    FDA is announcing the addition, withdrawal, correction, and
revision of certain consensus standards the Agency will recognize for
use in premarket submissions 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: 046'' to identify these current
modifications.
    In table 1, FDA describes the following modifications: (1) The
withdrawal of standards and their replacement by others, if applicable;
(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, FDA lists modifications the Agency is making that
involve the initial addition of standards not previously recognized by
FDA.

                           Table 1--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                                     Replacement
       Old recognition No.           recognition         Title of standard \1\                  Change
                                         No.
----------------------------------------------------------------------------------------------------------------
                                                A. Anesthesiology
----------------------------------------------------------------------------------------------------------------
1-44.............................           1-117  ISO 5366 First edition 2016-10-   Withdrawn and replaced with
                                                    01 Anaesthetic and respiratory    newer version.
                                                    equipment--Tracheostomy tubes
                                                    and connectors.
1-93.............................           1-118  ISO 5361 Third edition 2016-09-   Withdrawn and replaced with
                                                    01 Anaesthetic and respiratory    newer version.
                                                    equipment--Tracheal tubes and
                                                    connectors.
----------------------------------------------------------------------------------------------------------------
                                               B. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-93.............................  ..............  ASTM F763-04 (Reapproved 2016)    Reaffirmation.
                                                    Standard Practice for Short-
                                                    Term Screening of Implant
                                                    Materials.
2-94.............................  ..............  ASTM F981-04 (Reapproved 2016)    Reaffirmation.
                                                    Standard Practice for
                                                    Assessment of Compatibility of
                                                    Biomaterials for Surgical
                                                    Implants with Respect to Effect
                                                    of Materials on Muscle and
                                                    Insertion into Bone.
2-126............................           2-244  ASTM F748-16 Standard Practice    Withdrawn and replaced with
                                                    for Selecting Generic             newer version, Extent of
                                                    Biological Test Methods for       recognition.
                                                    Materials and Devices.
2-134............................  ..............  ASTM F2065-00 (Reapproved 2010)   Withdrawn.
                                                    Standard Practice for Testing
                                                    for Alternative Pathway
                                                    Complement Activation in Serum
                                                    by Solid Materials.
2-189............................  ..............  ASTM F895-11 (Reapproved 2016)    Reaffirmation.
                                                    Standard Test Method for Agar
                                                    Diffusion Cell Culture
                                                    Screening for Cytotoxicity.
2-225............................  ..............  ASTM F2567-06 (Reapproved 2010)   Withdrawn.
                                                    Standard Practice for Testing
                                                    for Classical Complement
                                                    Activation in Serum by Solid
                                                    Materials.
----------------------------------------------------------------------------------------------------------------
                                                C. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-58.............................  ..............  ANSI/AAMI/ISO 5840:2005/(R)2010   Withdrawn.
                                                    Cardiovascular implants--
                                                    Cardiac valve prostheses.
3-90.............................           3-144  ISO 7198 Second edition 2016-08-  Withdrawn and replaced with
                                                    01 Cardiovascular implants and    newer version.
                                                    extracorporeal systems--
                                                    Vascular prostheses--Tubular
                                                    vascular grafts and vascular
                                                    patches.
3-91.............................  ..............  ISO 5840 Fourth edition 2005-03-  Withdrawn.
                                                    01 Cardiovascular implants--
                                                    Cardiac valve prostheses.
----------------------------------------------------------------------------------------------------------------
                                      D. Dental/Ear, Nose, and Throat (ENT)
----------------------------------------------------------------------------------------------------------------
                                   ..............  No modifications at this time     ...........................
----------------------------------------------------------------------------------------------------------------
                             E. General I (Quality Systems/Risk Management) (QS/RM)
----------------------------------------------------------------------------------------------------------------
5-79.............................           5-113  ASTM D7386-16 Standard Practice   Withdrawn and replaced with
                                                    for Performance Testing of        newer version.
                                                    Packages for Single Parcel
                                                    Delivery Systems.
5-87.............................  ..............  IEC 62366 Edition 1.1 2014-01     Transition.
                                                    Consolidated Version Medical
                                                    devices--Application of
                                                    usability engineering to
                                                    medical devices.

5-95.............................           5-114  IEC 62366-1 Edition 1.0 2015-02   Withdrawn and replaced with
                                                    Medical Devices--Part 1:          newer version including
                                                    Application of Usability          corrigendum.
                                                    Engineering to Medical Devices
                                                    [Including CORRIGENDUM 1
                                                    (2016)].
----------------------------------------------------------------------------------------------------------------
                    F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
----------------------------------------------------------------------------------------------------------------
                                   ..............  No modifications at this time     ...........................
----------------------------------------------------------------------------------------------------------------
                              G. General Hospital/General Plastic Surgery (GH/GPS)
----------------------------------------------------------------------------------------------------------------
6-11.............................  ..............  ISO 594-1 First edition 1986-06-  Transition.
                                                    15 Conical fittings with a 6%
                                                    (Luer) taper for syringes,
                                                    needles and certain other
                                                    medical equipment--Part 1:
                                                    General requirements.
6-129............................  ..............  ISO 594-2 Second edition 1998-09- Transition.
                                                    01 Conical fittings with a 6%
                                                    (Luer) taper for syringes,
                                                    needles and certain other
                                                    medical equipment--Part 2: Lock
                                                    fittings.
6-165............................  ..............  ASTM D6977-04 (Reapproved 2016)   Reaffirmation.
                                                    Standard Specification for
                                                    Polychloroprene Examination
                                                    Gloves for Medical Application.
6-282............................           6-383  ASTM D6499-16 Standard Test       Withdrawn and replaced with
                                                    Method for The Immunological      newer version.
                                                    Measurement of Antigenic
                                                    Protein in Natural Rubber and
                                                    its Products.
----------------------------------------------------------------------------------------------------------------
                                          H. In Vitro Diagnostics (IVD)
----------------------------------------------------------------------------------------------------------------
7-149............................           7-267  CLSI C24 4th Edition Statistical  Withdrawn and replaced with
                                                    Quality Control for               newer version.
                                                    Quantitative Measurement
                                                    Procedures: Principles and
                                                    Definitions.
7-174............................           7-268  CLSI EP21 2nd Edition Evaluation  Withdrawn and replaced with
                                                    of Total Analytical Error for     newer version, Extent of
                                                    Quantitative Medical Laboratory   recognition.
                                                    Measurement Procedures.
----------------------------------------------------------------------------------------------------------------
                                                  I. Materials
----------------------------------------------------------------------------------------------------------------
8-350............................           8-435  ISO 5832-1 Fifth edition 2016-07- Withdrawn and replaced with
                                                    15 Implants for surgery--         newer version.
                                                    Metallic materials--Part 1:
                                                    Wrought stainless steel.
8-368............................  ..............  ASTM F2625-10 (Reapproved 2016)   Reaffirmation.
                                                    Standard Test Method for
                                                    Measurement of Enthalpy of
                                                    Fusion, Percent Crystallinity,
                                                    and Melting Point of Ultra-High-
                                                    Molecular Weight Polyethylene
                                                    by Means of Differential
                                                    Scanning Calorimetry.
8-376............................  ..............  ASTM F2102-13 Standard Guide for  Withdrawn. See 8-382.
                                                    Evaluating the Extent of
                                                    Oxidation in Ultra-High-
                                                    Molecular-Weight Polyethylene
                                                    Fabricated Forms Intended for
                                                    Surgical Implants.
8-384............................           8-436  ASTM F2026-16 Standard            Withdrawn and replaced with
                                                    Specification for                 newer version.
                                                    Polyetheretherketone (PEEK)
                                                    Polymers for Surgical Implant
                                                    Applications.
8-392............................           8-437  ASTM F2082/F2082M-16 Standard     Withdrawn and replaced with
                                                    Test Method for Determination     newer version.
                                                    of Transformation Temperature
                                                    of Nickel-Titanium Shape Memory
                                                    Alloys by Bend and Free
                                                    Recovery.
8-407............................           8-438  ISO/ASTM 52915 Second edition     Withdrawn and replaced with
                                                    2016-02-15 Specification for      newer version.
                                                    Additive Manufacturing File
                                                    Format (AMF) Version 1.2.
----------------------------------------------------------------------------------------------------------------
                                                J. Nanotechnology
----------------------------------------------------------------------------------------------------------------
                                   ..............  No modifications at this time     ...........................
----------------------------------------------------------------------------------------------------------------
                                                  K. Neurology
----------------------------------------------------------------------------------------------------------------
                                   ..............  No modifications at this time     ...........................
----------------------------------------------------------------------------------------------------------------
                      L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
----------------------------------------------------------------------------------------------------------------
                                   ..............  No modifications at this time     ...........................
----------------------------------------------------------------------------------------------------------------
                                                  M. Ophthalmic
----------------------------------------------------------------------------------------------------------------
                                   ..............  No modifications at this time     ...........................
----------------------------------------------------------------------------------------------------------------
                                                  N. Orthopedic
----------------------------------------------------------------------------------------------------------------
11-223...........................          11-311  ISO 14243-2 Third edition 2016-   Withdrawn and replaced with
                                                    09-01 Implants for surgery--      newer version.
                                                    Wear of total knee-joint
                                                    prostheses--Part 2: Methods of
                                                    measurement.

11-225...........................          11-312  ISO 7206-4 Third edition 2010-06- Withdrawn and replaced with
                                                    15 Implants for surgery--         newer version including
                                                    Components for partial and        amendment.
                                                    total knee joint prostheses--
                                                    Part 2: Articulating surfaces
                                                    made of metal, ceramic and
                                                    plastics materials [Including
                                                    AMENDMENT 1 (2016)].
11-231...........................          11-313  ISO 7207-2 Second edition 2011-   Withdrawn and replaced with
                                                    07-01 Implants for surgery--      newer version including
                                                    Components for partial and        amendment.
                                                    total knee joint prostheses--
                                                    Part 2: Articulating surfaces
                                                    made of metal, ceramic and
                                                    plastics materials [Including
                                                    AMENDMENT 1 (2016)].
11-249...........................          11-314  ISO 14242-2 Second edition 2016-  Withdrawn and replaced with
                                                    09-15 Implants for surgery--      newer version.
                                                    Wear of total hip-joint
                                                    prostheses--Part 2: Methods of
                                                    measurement.
11-268...........................          11-315  ASTM F1829-16 Standard Test       Withdrawn and replaced with
                                                    Method for Static Evaluation of   newer version.
                                                    Anatomic Glenoid Locking
                                                    Mechanism in Shear.
11-287...........................  ..............  ASTM F382-14 Standard             Withdrawn. See 11-297.
                                                    Specification and Test Method
                                                    for Metallic Bone Plates.
11-298...........................          11-316  ASTM F1264-16 Standard            Withdrawn and replaced with
                                                    Specification and Test Methods    newer version.
                                                    for Intramedullary Fixation
                                                    Devices.
----------------------------------------------------------------------------------------------------------------
                                              O. Physical Medicine
----------------------------------------------------------------------------------------------------------------
                                   ..............  No modifications at this time     ...........................
----------------------------------------------------------------------------------------------------------------
                                                  P. Radiology
----------------------------------------------------------------------------------------------------------------
12-49............................          12-303  IEC 61303 Edition 1.0 1994-09     Withdrawn and replaced with
                                                    Medical electrical equipment--    new version including
                                                    Radionuclide calibrators--        corrigendum.
                                                    Particular methods for
                                                    describing performance
                                                    [Including CORRIGENDUM 1
                                                    (2016)].
12-235...........................          12-304  IEC 60731 Edition 3.1 2016-04     Withdrawn and replaced with
                                                    Consolidated Version Medical      newer version.
                                                    electrical equipment--
                                                    Dosimeters with ionization
                                                    chambers as used in
                                                    radiotherapy.
12-263...........................          12-305  ISO 13694 Second edition 2015-11- Withdrawn and replaced with
                                                    15 Optics and Photonics--Lasers   newer version.
                                                    and laser-related equipment--
                                                    Test methods for laser beam
                                                    power (energy) density
                                                    distribution.
----------------------------------------------------------------------------------------------------------------
                                             Q. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-27............................           13-85  CLSI AUTO11-A2 October 2014       Withdrawn and replaced with
                                                    Information Technology Security   newer version.
                                                    of In Vitro Diagnostic
                                                    Instruments and Software
                                                    Systems; Approved Standard--
                                                    Second Edition.
----------------------------------------------------------------------------------------------------------------
                                                  R. Sterility
----------------------------------------------------------------------------------------------------------------
14-169...........................  ..............  ASTM F2391-05 (Reapproved 2016)   Reaffirmation.
                                                    Standard Test Method for
                                                    Measuring Package and Seal
                                                    Integrity Using Helium as the
                                                    Tracer Gas.
14-197...........................          14-496  ASTM F1608-16 Standard Test       Withdrawn and replaced with
                                                    Method for Microbial Ranking of   newer version.
                                                    Porous Packaging Materials
                                                    (Exposure Chamber Method).
14-229...........................          14-497  ASTM F1980-16 Standard Guide for  Withdrawn and replaced with
                                                    Accelerated Aging of Sterile      newer version.
                                                    Barrier Systems for Medical
                                                    Devices.
14-285...........................  ..............  ANSI/AAMI/ISO 14161-2009/(R)2014  Reaffirmation.
                                                    Sterilization of health care
                                                    products--Biological
                                                    indicators--Guidance for the
                                                    selection, use and
                                                    interpretation of results.
14-311...........................  ..............  ANSI/AAMI ST55:2010/(R)2014       Reaffirmation.
                                                    Table-top steam sterilizers.
14-339...........................  ..............  ANSI/AAMI/ISO 20857:2010/(R)2015  Reaffirmation.
                                                    (Revision of ANSI/AAMI/
                                                    ST63:2002) Sterilization of
                                                    health care products--Dry heat--
                                                    Requirements for the
                                                    development, validation and
                                                    routine control of a
                                                    sterilization process for
                                                    medical devices.
14-349...........................  ..............  ANSI/AAMI/ISO 13408-3:2006/       Reaffirmation.
                                                    (R)2015 Aseptic processing of
                                                    health care products--Part 3:
                                                    Lyophilization.
14-360...........................  ..............  ANSI/AAMI ST72:2011/(R)2016       Reaffirmation.
                                                    Bacterial endotoxins--Test
                                                    methods, routine monitoring,
                                                    and alternatives to batch
                                                    testing.
14-453...........................          14-498  ASTM F2097-16 Standard Guide for  Withdrawn and replaced with
                                                    Design and Evaluation of          newer version.
                                                    Primary Flexible Packaging for
                                                    Medical Products.
14-462...........................          14-499  ASTM D4169-16 Standard Practice   Withdrawn and replaced with
                                                    for Performance Testing of        newer version.
                                                    Shipping Containers and Systems.
14-479...........................          14-500  ISO 14644-1 Second edition 2015-  Withdrawn and replaced with
                                                    12-15 Cleanrooms and associated   new recognition number.
                                                    controlled environments--Part
                                                    1: Classification of air
                                                    cleanliness by particle
                                                    concentration.
14-489...........................  ..............  USP 39-NF34:2016 Biological       Withdrawn.
                                                    Indicator for Steam
                                                    Sterilization--Self Contained.
14-490...........................  ..............  USP 39-NF34:2016 Biological       Withdrawn.
                                                    Indicator for Dry-Heat
                                                    Sterilization, Paper Carrier.

14-491...........................  ..............  USP 39-NF34:2016 Biological       Withdrawn.
                                                    Indicator for Ethylene Oxide
                                                    Sterilization, Paper Carrier.
14-492...........................  ..............  USP 39-NF34:2016 Biological       Withdrawn.
                                                    Indicator for Steam
                                                    Sterilization, Paper Carrier.
----------------------------------------------------------------------------------------------------------------
                                              S. Tissue Engineering
----------------------------------------------------------------------------------------------------------------
15-34............................           15-48  ASTM F2605-16 Standard Test       Withdrawn and replaced with
                                                    Method for Determining the        newer version.
                                                    Molar Mass of Sodium Alginate
                                                    by Size Exclusion
                                                    Chromatography with Multi-angle
                                                    Light Scattering Detection (SEC-
                                                    MALS).
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

III. Listing of New Entries

    In table 2, FDA provides the listing of new entries and consensus
standards added as modifications to the list of recognized standards
under Recognition List Number: 046.

        Table 2--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
     Recognition No.         Title of standard \1\           date
------------------------------------------------------------------------
                            A. Anesthesiology
------------------------------------------------------------------------
1-119....................  Tracheal tubes designed   ISO 14408 Third
                            for laser surgery--       edition 2016-02-
                            Requirements for          15.
                            marking and
                            accompanying
                            information.
1-120....................  Anaesthetic and           ISO 18190 First
                            respiratory equipment--   edition 2016-11-
                            General requirements      01.
                            for airways and related
                            equipment.
------------------------------------------------------------------------
                           B. Biocompatibility
------------------------------------------------------------------------
2-245....................  Biological evaluation of  ISO 10993-5 Third
                            medical devices--Part     edition 2009-06-
                            5: Tests for in vitro     01.
                            cytotoxicity.
------------------------------------------------------------------------
                            C. Cardiovascular
------------------------------------------------------------------------
3-145....................  Cardiovascular implants-- ISO 5840-1:2015
                            Cardiac valve             First edition 2015-
                            prostheses--Part 1:       09-15.
                            General requirements.
3-146....................  Cardiovascular implants-- ANSI/AAMI/ISO 5840-
                            Cardiac valve             1: 2015.
                            prostheses--Part 1:
                            General requirements.
3-147....................  Cardiovascular implants-- ISO 5840-2: 2015
                            Cardiac valve             First edition 2015-
                            prostheses--Part 2:       09-15.
                            Surgically implanted
                            heart valve substitutes.
3-148....................  Cardiovascular implants-- ANSI/AAMI/ISO 5840-
                            Cardiac valve             2: 2015.
                            prostheses -- Part 2:
                            Surgically implanted
                            heart valve substitutes.
------------------------------------------------------------------------
                  D. Dental/Ear, Nose, and Throat (ENT)
------------------------------------------------------------------------
4-229....................  Medical electrical        IEC 80601-2-60
                            equipment--Part 2-60:     Edition 1.0 2012-
                            Particular requirements   02.
                            for the basic safety
                            and essential
                            performance of dental
                            equipment.
------------------------------------------------------------------------
         E. General I (Quality Systems/Risk Management) (QS/RM)
------------------------------------------------------------------------
5-115....................  Small-bore connectors     ISO 80369-7 First
                            for liquids and gases     edition 2016-10-
                            in healthcare             15.
                            applications--Part 7:
                            Connectors for
                            intravascular or
                            hypodermic applications.
5-116....................  Graphical symbols--       ISO 7010 Second
                            Safety colours and        edition 2011-06-
                            safety signs--            01.
                            Registered safety signs
                            [Including AMENDMENT 1
                            (2012) through
                            AMENDMENT 7 (2016)].
------------------------------------------------------------------------
F. General II (Electrical Safety/Electromagnetic Compatibility) (ES/EMC)
------------------------------------------------------------------------
19-19....................  Medical electrical        IEC TR 60601-4-2
                            equipment--Part 4-2:      Edition 1.0 2016-
                            Guidance and              05.
                            interpretation--Electro
                            magnetic immunity:
                            Performance of medical
                            electrical equipment
                            and medical electrical
                            systems.
19-20....................  American National         ANSI C63.16-2016
                            Standard Guide for        (Revision of ANSI
                            Electrostatic Discharge   C63.16-1993).
                            Test Methodologies and
                            Acceptance Criteria for
                            Electronic Equipment.
19-21....................  Medical Electrical        AIM Standard Rev.
                            Equipment and System      1.00 2016-08-22.
                            Electromagnetic
                            Immunity Test for
                            Exposure to Radio
                            Frequency
                            Identification Readers--
                            An AIM Standard.
------------------------------------------------------------------------
          G. General Hospital/General Plastic Surgery (GH/GPS)
------------------------------------------------------------------------
                           No new entries at this
                            time.
------------------------------------------------------------------------

                      H. In Vitro Diagnostics (IVD)
------------------------------------------------------------------------
7-269....................  Molecular Diagnostic      CLSI MM23 1st
                            Methods for Solid         Edition.
                            Tumors
                            (Nonhematological
                            Neoplasms).
------------------------------------------------------------------------
                              I. Materials
------------------------------------------------------------------------
8-439....................  Standard Specification    ASTM F3001-14.
                            for Additive
                            Manufacturing Titanium-
                            6 Aluminum-4 Vanadium
                            ELI (Extra Low
                            Interstitial) with
                            Powder Bed Fusion.
8-440....................  Standard Specification    ASTM F3091/F3091M-
                            for Powder Bed Fusion     14.
                            of Plastic Materials.
8-441....................  Standard Test Method for  ASTM F3109-16.
                            Verification of Multi-
                            Axis Force Measuring
                            Platforms.
8-442....................  Standard Guide for        ASTM F3127-16.
                            Validating Cleaning
                            Processes Used During
                            the Manufacture of
                            Medical Devices.
8-443....................  Standard Guide for        ASTM F3160-16.
                            Metallurgical
                            Characterization of
                            Absorbable Metallic
                            Materials for Medical
                            Implants.
8-444....................  Additive manufacturing--  ISO 17296-2 First
                            General principles--      edition 2015-01-
                            Part 2: Overview of       15.
                            process categories and
                            feedstock.
8-445....................  Additive manufacturing--  ISO 17296-4 First
                            General principles--      edition 2014-09-
                            Part 4: Overview of       01.
                            data processing.
8-446....................  Standard Specification    ASTM F2848-16.
                            for Medical-Grade Ultra-
                            High Molecular Weight
                            Polyethylene Yarns.
------------------------------------------------------------------------
                            J. Nanotechnology
------------------------------------------------------------------------
                           No new entries at this
                            time.
------------------------------------------------------------------------
                              K. Neurology
------------------------------------------------------------------------
                           No new entries at this
                            time.
------------------------------------------------------------------------
  L. Obstetrics-Gynecology/Gastroenterology/Urology (OB-Gyn/G/Urology)
------------------------------------------------------------------------
                           No new entries at this
                            time.
------------------------------------------------------------------------
                              M. Ophthalmic
------------------------------------------------------------------------
                           No new entries at this
                            time.
------------------------------------------------------------------------
                              N. Orthopedic
------------------------------------------------------------------------
11-317...................  Standard Guide for        ASTM F3129--16.
                            Characterization of
                            Material Loss from
                            Conical Taper Junctions
                            in Total Joint
                            Prostheses.
11-318...................  Standard Guide for Total  ASTM F3141--15.
                            Knee Replacement
                            Loading Profiles.
11-319...................  Implants for surgery--    ISO 7206-12 First
                            Partial and total hip     edition 2016-10-
                            joint prostheses--Part    01.
                            12: Deformation test
                            method for acetabular
                            shells.
11-320...................  Implants for surgery--    ISO 7206-13 First
                            Partial and total hip     edition 2016-07-
                            joint prostheses--Part    01.
                            13: Determination of
                            resistance to torque of
                            head fixation of
                            stemmed femoral
                            components..
------------------------------------------------------------------------
                          O. Physical Medicine
------------------------------------------------------------------------
16-199...................  Wheelchairs Part 28:      ISO 7176-28 First
                            Requirements and test     edition 2012-10-1.
                            methods for
                            stairclimbing devices.
------------------------------------------------------------------------
                              P. Radiology
------------------------------------------------------------------------
                           No new entries at this
                            time.
------------------------------------------------------------------------
                         Q. Software/Informatics
------------------------------------------------------------------------
13-86....................  Systems and software      ISO/IEC 15026-1
                            engineering--Systems      First edition 2013-
                            and software assurance--  11-01.
                            Part 1: Concepts and
                            vocabulary.
13-87....................  Systems and software      ISO/IEC 15026-2
                            engineering--Systems      First edition 2011-
                            and software assurance--  02-15.
                            Part 2: Assurance case.
------------------------------------------------------------------------
                              R. Sterility
------------------------------------------------------------------------
                           No new entries at this
                            time.
------------------------------------------------------------------------
                          S. Tissue Engineering
------------------------------------------------------------------------
                           No new entries at this
                            time.
------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements
  of the respective organizations.

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 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 revisions to the list of recognized consensus standards, as needed,
in the Federal Register once a year, or more often if necessary.
Beginning with Recognition List 033, FDA no longer announces minor
revisions to the list of recognized consensus standards such as
technical contact person, devices affected, processes affected, Code of
Federal Regulations citations, and product codes.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for
recognition under section 514 of the FD&C Act by submitting such
recommendations, with reasons for the recommendation, to
<EMAIL_ADDRESS>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. The Center for Devices and
Radiological Health (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, http://www.fda.gov/MedicalDevices,
includes a link to standards-related documents including the guidance
and the current list of recognized standards. After publication in the
Federal Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 046'' will be available
at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm. You may access ``Guidance on the Recognition
and Use of Consensus Standards,'' and the searchable database for ``FDA
Recognized Consensus Standards'' at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards.

    Dated: December 19, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-31008 Filed 12-22-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 2 (Wednesday, January 3, 2018)]
[Notices]
[Pages 383-384]
[FR Doc No: 2017-28337]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6759]

Establishing Effectiveness for Drugs Intended To Treat Male
Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Establishing Effectiveness for Drugs Intended to Treat Male
Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.''
This draft guidance provides key design considerations, including
recommendations for patient enrollment criteria and efficacy endpoints,
for clinical trials to establish effectiveness for drugs intended to
treat male hypogonadotropic hypogonadism associated with obesity and
other conditions that do not cause intrinsic damage to the hypothalamus
or pituitary gland. This draft guidance is consistent with
recommendations FDA received at the December 2014 advisory committee
meeting on the appropriate indicated population for testosterone
replacement therapy, and the December 2016 advisory committee meeting
on hypogonadotropic hypogonadism.

DATES: Submit either electronic or written comments on the draft
guidance by March 5, 2018 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and

identified, as confidential, if submitted as detailed in
``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-6759 for ``Establishing Effectiveness for Drugs Intended to
Treat Male Hypogonadotropic Hypogonadism Attributed to Non-Structural
Disorders.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
office between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Jeannie Roule, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5332, Silver Spring, MD 20993-0002, 301-
796-3993.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Establishing Effectiveness for Drugs Intended to Treat Male
Hypogonadotropic Hypogonadism Attributed to Non-Structural Disorders.''
This draft guidance is intended to assist sponsors in designing drug
development programs to demonstrate effectiveness of drugs intended to
treat male hypogonadotropic hypogonadism associated with obesity and
other conditions that do not cause intrinsic damage to the hypothalamus
or pituitary gland.
    Male hypogonadism is characterized by serum testosterone
concentrations below the lower limit of the normal range for young,
healthy men with associated symptoms (e.g., reduced libido) or signs
(e.g., loss of muscle mass with reduced muscle strength). Some men who
have had normal puberty and sexual development are subsequently
diagnosed with hypogonadotropic hypogonadism associated with obesity or
other acquired conditions in the absence of intrinsic damage to the
hypothalamus or pituitary. Although these men have serum testosterone
concentrations below the lower limit of the normal range for young,
healthy men, the associated symptoms often experienced in this
population (e.g., low energy, depressed mood) are nonspecific and
cannot definitively be attributed to the low testosterone
concentrations. In addition, it is unclear whether these testosterone
concentrations--in the absence of intrinsic damage to the hypothalamus
and pituitary gland--are inappropriately low and whether increasing
testosterone concentrations in these men confers clinical benefit.
    For these reasons, serum testosterone is not a validated surrogate
endpoint for establishing efficacy in these patients, and sponsors
would need to show that an increase in serum testosterone translates
into improvement in how patients feel, function, or survive.
    This draft guidance addresses the following topics in establishing
effectiveness of drugs for this population:

 Identification of patients for inclusion in clinical trials
and
 Efficacy endpoints.

    This draft guidance is consistent with recommendations FDA received
at the December 2014 advisory committee meeting on the appropriate
indicated population for testosterone replacement therapy, and the
December 2016 advisory committee meeting on hypogonadotropic
hypogonadism.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on establishing
effectiveness for drugs intended to treat male hypogonadotropic
hypogonadism attributed to non-structural disorders. It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.

II. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: December 27, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28337 Filed 1-2-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 103 (Wednesday, May 31, 2017)]
[Notices]
[Page 24985]
[FR Doc No: 2017-11217]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4308-DR; Docket ID FEMA-2017-0001]

California; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of California (FEMA-4308-DR), dated April 1, 2017, and
related determinations.

DATES: Effective Date: May 18, 2017.

FOR FURTHER INFORMATION CONTACT: Dean Webster, 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 California 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 April 1, 2017.

    Mono County and the Tule River Tribe located within Tulare
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.

Robert J. Fenton,
Acting Administrator, Federal Emergency Management Agency.
[FR Doc. 2017-11217 Filed 5-30-17; 8:45 am]
 BILLING CODE 9111-23-P