[Federal Register Volume 79, Number 170 (Wednesday, September 3, 2014)]
[Notices]
[Pages 52404-52405]
[FR Doc No: 2014-20991]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection(s): Flight
Engineers and Flight Navigators

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our

intention to request the Office of Management and Budget (OMB) approval
to renew an information collection. Information collected is used to
determine certification eligibility of Flight Engineers and Flight
Navigators.

DATES: Written comments should be submitted by November 3, 2014.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, ASP-110, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0007.
    Title: Flight Engineers and Flight Navigators.
    Form Numbers: FAA Form 8400-3.
    Type of Review: Renewal of an information collection.
    Background: FAA Form 8400-3, Application for an Airman Certificate
and/or Rating (for flight engineer and flight navigator) and
applications for approval of related training courses are submitted to
FAA for evaluation. The information is reviewed to determine applicant
eligibility and compliance with prescribed provisions of FAR Part 63,
Certification: Flight Crewmembers Other Than Pilots.
    Respondents: Approximately 1,004 flight engineers and flight
navigators.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 15 minutes.
    Estimated Total Annual Burden: 498 hours.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on August 27, 2014.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, ASP-110.
[FR Doc. 2014-20991 Filed 9-2-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Proposed Rules]
[Pages 15308-15310]
[FR Doc No: 2017-06086]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0216]
RIN 1625-AA08

Safety Zone; Roar on the River Fireworks, Detroit River, Trenton
Channel, Trenton, MI

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish a temporary safety zone
for certain waters of the Detroit River. This action is necessary to
provide for the safety of life on these navigable waters near Elizabeth
Park, Trenton, MI, during a fireworks display on July 14, 2017. If
inclement weather, this event will take place on July 15, 2017. This
proposed rulemaking would prohibit persons and vessels from being in
the safety zone unless authorized by the Captain of the Port Detroit or
a designated representative. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before April 27, 2017.

ADDRESSES: You may submit comments identified by docket number USCG-
2017-0216 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email call or email Tracy Girard,
Prevention Department, Sector Detroit, Coast Guard; telephone 313-568-
9564, or email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code
COTP Captain of the Port

II. Background, Purpose, and Legal Basis

    On February 16, 2017, Great Lakes Firewoks, LLC., notified the
Coast Guard that it will be conducting a fireworks display from 10 to
10:30 p.m. on July 14, 2017. In the event of inclement weather the
fireworks display will be on July 15, 2017. The fireworks are to be
launched from a barge off Elizabeth Park, Trenton, MI. Hazards from
firework displays include accidental discharge of fireworks, dangerous
projectiles, and falling hot embers or other debris. The Captain of the
Port Detroit (COTP) has determined that potential hazards associated
with the fireworks to be used in this display would be a safety concern
for anyone within a 350 foot radius of the fireworks barge.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a 350-foot radius of the fireworks
barge, during, and after the scheduled event. The Coast Guard proposes
this rulemaking under authority in 33 U.S.C. 1231.

III. Discussion of Proposed Rule

    The COTP proposes to establish a safety zone from 10 to 10:30 p.m.
on July 14, 2017. In the event of inclement weather, the fireworks
display will be on July 15, 2017. The safety zone would cover all
navigable waters within 350 feet of the fireworks launch site on the
Detroit River, Trenton Channel, Trenton, MI. The duration of the zone
is intended to ensure the safety of vessels and these navigable waters
before, during, and after the scheduled 10 to 10:30 p.m. fireworks
display. No vessel or person would be permitted to enter the safety
zone without obtaining permission from the COTP or a designated
representative. The regulatory text we are proposing appears at the end
of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility. Executive Order 13771 (``Reducing
Regulation and Controlling Regulatory Costs''), directs agencies to
reduce regulation and control regulatory costs and provides that ``for
every one new regulation issued, at least two prior regulations be
identified for elimination, and that the cost of planned regulations be
prudently managed and controlled through a budgeting process.''
    This NPRM has not been designated a ``significant regulatory
action,'' under Executive Order 12866. Accordingly, the NPRM has not
been reviewed by the Office of Management and Budget. As this rule is
not a significant regulatory action, this rule is exempt from the
requirements of Executive Order 13771. See OMB's Memorandum titled
``Interim Guidance Implementing Section 2 of the Executive Order of
January 30, 2017 titled `Reducing Regulation and Controlling Regulatory
Costs' '' (February 2, 2017).
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
would be able to safely transit around this safety zone which would
impact a small designated area of the Detroit River less than 1 hour
during the evening when vessel traffic is normally low. Moreover, the
Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM
marine channel 16 about the zone, and the rule would allow vessels to
seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on

small entities during rulemaking. The term ``small entities'' comprises
small businesses, not-for-profit organizations that are independently
owned and operated and are not dominant in their fields, and
governmental jurisdictions with populations of less than 50,000. The
Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule
would not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting less than 1 hour that would prohibit entry within 350 feet
of the fireworks barge. Normally such actions are categorically
excluded from further review under paragraph 34(g) of Figure 2-1 of
Commandant Instruction M16475.lD. A preliminary environmental analysis
checklist and Categorical Exclusion Determination are available in the
docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that Web site's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR parts 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
0170.1.

0
2. Add Sec.  165.T09-0216 to read as follows:

Sec.  165.T09-0216  Safety Zone; Roar on the River Fireworks, Detroit
River, Trenton, MI.

    (a) Location. A safety zone is established to include all U.S.
navigable waters of Detroit River, Trenton Channel, Trenton, MI, within
a 350-ft radius of fireworks barge in position 42[deg]07.812' N.,
083[deg]10.446 W. (NAD 83).
    (b) Enforcement period. The regulated area described in paragraph
(a) will be enforced from 10 through 10:30 p.m. on July 14, 2017. In
the event of inclement weather the regulated area will be enforced from
10 through 10:30 p.m. on July 15, 2017.
    (c) Regulations.
    (1) No vessel or person may enter, transit through, or anchor
within the safety zone unless authorized by the Captain of the Port
Detroit, or his on-scene representative.
    (2) The safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Detroit or his on-scene
representative.
    (3) The ``on-scene representative'' of the Captain of the Port
Detroit is any Coast Guard commissioned, warrant or petty officer or
Federal, State, or local law enforcement officer designated by or
assisting the Captain of the Port Detroit to act on his behalf.
    (4) Vessel operators shall contact the Captain of the Port Detroit
or his on-scene representative to obtain permission to enter or operate
within the safety zone. The Captain of the Port Detroit or his on-scene
representative may be contacted via VHF Channel 16 or at<PHONE_NUMBER>.
Vessel operators given permission to enter or operate in the regulated
area must comply with all directions given to them by the Captain of
the Port Detroit or his on-scene representative.

    Dated: March 22, 2017.
Scott B. Lemasters,
Commander, U.S. Coast Guard, Captain of the Port Detroit.
[FR Doc. 2017-06086 Filed 3-27-17; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: July 28, 2010 (Volume 75, Number 144)]
[Rules and Regulations]
[Page 44141]
[DOCID:fr28jy10-10]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[USCG-2010-0647]
RIN 1625-AA00

Safety Zone; Milwaukee Harbor, Milwaukee, WI

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce the safety zones for annual
fireworks events in the Captain of the Port Sector Lake Michigan zone
from 9:15 p.m. on August 7, 2010, through 10:00 p.m. on August 22,
2010. This action is necessary and intended to ensure safety of life on
the navigable waters immediately prior to, during, and immediately
after fireworks events. This safety zone imposes restrictions upon, and
control movement of, vessels in a specified area immediately prior to,
during, and immediately after firework events. During the enforcement
period, no person or vessel may enter the safety zones without
permission of the Captain of the Port, Sector Lake Michigan.

DATES: The regulations in 33 CFR 165.935 will be enforced as detailed
below from 9:15 p.m. on August 7, 2010, through 10 p.m. on August 22,
2010.

FOR FURTHER INFORMATION CONTACT: If you have questions on this notice,
call or e-mail BM1 Adam Kraft, Prevention Department, Coast Guard
Sector Lake Michigan, Milwaukee, WI at<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety zone
listed in 33 CFR 165.935, Safety Zone, Milwaukee Harbor, Milwaukee, WI,
for the following events:
    (1) Arab World Festival fireworks display on August 7, 2010 from
9:15 p.m. through 10 p.m.
    (2) Irish Festival fireworks display on August 22, 2010 from 9:15
p.m. through 10 p.m.
    All vessels must obtain permission from the Captain of the Port or
his or her on-scene representative to enter, move within or exit the
safety zone. Vessels and persons granted permission to enter the safety
zone shall obey all lawful orders or directions of the Captain of the
Port or a designated representative. While within a safety zone, all
vessels shall operate at the minimum speed necessary to maintain a safe
course.
    This notice is issued under authority of 33 CFR 165.935 Safety
Zone, Milwaukee Harbor, Milwaukee, WI and 5 U.S.C. 552(a). In addition
to this notice in the Federal Register, the Coast Guard will provide
the maritime community with advance notification of these enforcement
periods via Broadcast Notice to Mariners or Local Notice to Mariners.
The Captain of the Port, Sector Lake Michigan will issue a Broadcast
Notice to Mariners notifying the public when enforcement of the safety
zone established by this section is suspended. If the Captain of the
Port, Sector Lake Michigan, determines that the safety zone need not be
enforced for the full duration stated in this notice, he or she may use
a Broadcast Notice to Mariners to grant general permission to enter the
safety zone. The Captain of the Port, Sector Lake Michigan, or his or
her on-scene representative may be contacted via VHF Channel 16.

    Dated: July 6, 2010.
L. Barndt,
Captain, U.S. Coast Guard, Captain of the Port, Sector Lake Michigan.
[FR Doc. 2010-18521 Filed 7-27-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 77, Number 161 (Monday, August 20, 2012)]
[Notices]
[Pages 50114-50121]
[FR Doc No: 2012-20323]

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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: 029

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: 029'' (Recognition List Number: 029), 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: 029'' to
the Division of Small Manufacturers, International and Consumer
Assistance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Silver Spring, MD
20993. 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 email:
<EMAIL_ADDRESS>This document may also be accessed on FDA's
Internet site 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: 029 modifications and other standards related
information.

FOR FURTHER INFORMATION CONTACT: Scott A. Colburn, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3628, Silver Spring, MD 20993, 301-796-
6574.

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, are identified in table 1 of this
document.

       Table 1--Previous Publication of Standard Recognition Lists
------------------------------------------------------------------------

-------------------------------------------------------------------------
February 25, 1998 (63 FR 9561).
October 16, 1998 (63 FR 55617).
July 12, 1999 (64 FR 37546).
November 15, 2000 (65 FR 69022).
May 7, 2001 (66 FR 23032).
January 14, 2002 (67 FR 1774).
October 2, 2002 (67 FR 61893).
April 28, 2003 (68 FR 22391).
March 8, 2004 (69 FR 10712).
June 18, 2004 (69 FR 34176).
October 4, 2004 (69 FR 59240).
May 27, 2005 (70 FR 30756).
November 8, 2005 (70 FR 67713).
March 31, 2006 (71 FR 16313).
June 23, 2006 (71 FR 36121).
November 3, 2006 (71 FR 64718).
May 21, 2007 (72 FR 28500).
September 12, 2007 (72 FR 52142).
December 19, 2007 (72 FR 71924).
September 9, 2008 (73 FR 52358).
March, 18, 2009 (74 FR 11586).
September 8, 2009 (74 FR 46203).
May 5, 2010 (75 FR 24711).
June 10, 2010 (75 FR 32943).
October 4, 2010 (75 FR 61148).
March 14, 2011 (76 FR 13631).
August 2, 2011 (76 FR 46300).
March 16, 2012 (77 FR 15765).
------------------------------------------------------------------------

    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: 029

    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: 029'' 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--Modifications to the List of Recognized Standards
----------------------------------------------------------------------------------------------------------------
                              Replacement recognition
   Old  recognition No.                 No.                  Title of standard \1\               Change
----------------------------------------------------------------------------------------------------------------
                                               A. Biocompatibility
----------------------------------------------------------------------------------------------------------------
2-115.....................  2-189.....................  ASTM F895-11 Standard Test      Withdrawn and replaced
                                                         Method for Agar Diffusion       with newer version.
                                                         Cell Culture Screening for
                                                         Cytotoxicity.
2-164.....................  2-190.....................  ANSI/AAMI/ISO 10993-13:2010     Withdrawn and replaced
                                                         Biological evaluation of        with newer version.
                                                         medical devices--Part 13:
                                                         Identification and
                                                         quantification of degradation
                                                         products from polymeric
                                                         medical devices.
2-165.....................  ..........................  ANSI/AAMI/ISO 10993-14:2001/    Reaffirmation.
                                                         (R)2011 Biological evaluation
                                                         of medical devices--Part 14:
                                                         Identification and
                                                         quantification of degradation
                                                         products from ceramics.
----------------------------------------------------------------------------------------------------------------
                                                B. Cardiovascular
----------------------------------------------------------------------------------------------------------------
3-37......................  1-87......................  IEC 60601-2-23(1999-12)         Transferred to
                                                         Medical electrical equipment--  Anesthesia.
                                                         Part 2-23: Particular
                                                         requirements for the safety,
                                                         including essential
                                                         performance, of
                                                         transcutaneous partial
                                                         pressure monitoring equipment.
3-44......................  ..........................  ANSI/AAMI BP22:1994/(R)2011     Reaffirmation.
                                                         Blood pressure transducers.
3-55......................  ..........................  ASTM F1830-97 (Reapproved       Extent of recognition.
                                                         2005) Standard Practice for
                                                         Selection of Blood for in
                                                         vitro Evaluation of Blood
                                                         Pumps.
3-56......................  ..........................  ASTM F1841-97 (Reapproved       Extent of recognition.
                                                         2005) Standard Practice for
                                                         Assessment of Hemolysis in
                                                         Continuous Flow Blood Pumps.

3-62......................  3-102.....................  IEC 60601-2-31 Edition 2.1      Withdrawn and replaced
                                                         2011-09 Medical electrical      with newer version.
                                                         equipment--Part 2-31:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         external cardiac pacemakers
                                                         with internal power source.
----------------------------------------------------------------------------------------------------------------
                                                   C. General
----------------------------------------------------------------------------------------------------------------
5-28......................  ..........................  IEC 60601-1-2, (Second          Withdrawn.
                                                         Edition, 2001), Medical
                                                         Electrical Equipment--Part 1-
                                                         2: General Requirements for
                                                         Safety--Collateral Standard:
                                                         Electromagnetic
                                                         Compatibility--Requirements
                                                         and Tests.
5-30......................  ..........................  ANSI/AAMI/IEC 60601-1-2:2001,   Withdrawn.
                                                         Medical Electrical Equipment--
                                                         Part 1-2: General
                                                         Requirements for Safety--
                                                         Collateral Standard:
                                                         Electromagnetic
                                                         Compatibility--Requirements
                                                         and Tests.
5-40......................  ..........................  ISO 14971 Second edition 2007-  Extent of recognition.
                                                         03-01, Medical devices--
                                                         Application of risk
                                                         management to medical devices.
5-52......................  5-71......................  ANSI/AAMI ES60601-1:2005/       Withdrawn and replaced
                                                         (R)2012 and C1:2009/(R)2012     with new version.
                                                         and A2:2010/(R)2012
                                                         (Consolidated Text), Medical
                                                         electrical equipment--Part 1:
                                                         General requirements for
                                                         basic safety and essential
                                                         performance (IEC 60601-
                                                         1:2005, MOD).
5-56......................  ..........................  ISO 15223-2 First edition 2010- Contact person.
                                                         01-15, Medical devices--
                                                         Symbols to be used with
                                                         medical devices labels,
                                                         labeling, and information to
                                                         be supplied--Part 2: Symbol
                                                         development, selection and
                                                         validation.
5-59......................  5-72......................  ISO/FDIS 15223-1 2012 Medical   Withdrawn and replaced
                                                         devices--Symbols to be used     with new version.
                                                         with medical device labels,
                                                         labeling and information to
                                                         be supplied--Part 1: General
                                                         requirements.
5-61......................  ..........................  ANSI/AAMI/ISO 15223-1:2007,     Withdrawn.
                                                         Medical devices--Symbols to
                                                         be used with medical device
                                                         labels, labeling, and
                                                         information to be supplied--
                                                         Part 1: General requirements.
----------------------------------------------------------------------------------------------------------------
                                   D. General Hospital/General Plastic Surgery
----------------------------------------------------------------------------------------------------------------
6-110.....................  ..........................  ASTM F 882-84 (Reapproved       Withdrawn.
                                                         2002), Standard Performance
                                                         and Safety Specification for
                                                         Cryosurgical Medical
                                                         Instruments.
6-114.....................  6-274.....................  ISO 11608-1 Second edition      Withdrawn and replaced
                                                         2012-04-01 Needle-based         with newer version.
                                                         injection systems for medical
                                                         use--Requirements and test
                                                         methods--Part 1: Needle-based
                                                         injection systems.
6-115.....................  6-275.....................  ISO 11608-2 Second edition      Withdrawn and replaced
                                                         2012-04-01 Needle-based         with newer version.
                                                         injection systems for medical
                                                         use--Requirements and test
                                                         methods--Part 2: Needles.
6-117.....................  ..........................  ASTM F2172-02 (Reapproved       Contact person.
                                                         2011), Standard Specification
                                                         for Blood/Intravenous Fluid/
                                                         Irrigation Fluid Warmers.
6-118.....................  ..........................  ASTM F2196-02, Standard         Withdrawn. See 6-238.
                                                         Specification for Circulating
                                                         Liquid and Forced Air Patient
                                                         Temperature Management
                                                         Devices.
6-119.....................  ..........................  ANSI/AAMI BF7:1989/(R)2011      Reaffirmation.
                                                         Blood transfusion
                                                         microfilters.
6-132.....................  ..........................  ISO 11810-1 First edition 2005- Contact person.
                                                         02-15, Lasers and laser-
                                                         related equipment--Test
                                                         method and classification for
                                                         the laser-resistance of
                                                         surgical drapes and/or
                                                         patient-protective covers--
                                                         Part 1: Primary ignition and
                                                         penetration.
6-172.....................  6-276.....................  ISO 8536-1 Fourth edition 2011- Withdrawn and replaced
                                                         09-01 Infusion equipment for    with newer version.
                                                         medical use--Part 1: Infusion
                                                         glass bottles.
6-175.....................  ..........................  ASTM D5151-06 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Detection of Holes in
                                                         Medical Gloves.
6-178.....................  ..........................  ASTM D6124-06 (Reapproved       Reaffirmation and
                                                         2011) Standard Test Method      Contact person.
                                                         for Residual Powder on
                                                         Medical Gloves.
6-183.....................  ..........................  ASTM D5250-06 (Reapproved       Reaffirmation and
                                                         2011) Standard Specification    contact person.
                                                         for Poly(vinyl chloride)
                                                         Gloves for Medical
                                                         Application.
6-202.....................  ..........................  ISO 11810-2:2007, Lasers and    Title and contact
                                                         laser-related equipment--Test   person.
                                                         method and classification for
                                                         the laser-resistance of
                                                         surgical drapes and/or
                                                         patient-protective covers--
                                                         Part 2: Secondary ignition.
6-236.....................  ..........................  IEC 80601-2-59 Edition 1.0      Title and contact
                                                         2008-10 Medical electrical      person.
                                                         equipment--Part 2-59:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         screening thermographs for
                                                         human febrile temperature
                                                         screening.
6-237.....................  ..........................  IEC 80601-2-59 (First edition-- Title and contact
                                                         2008) Medical electrical        person.
                                                         equipment--Part 2-59:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         screening thermographs for
                                                         human febrile temperature
                                                         screening CORRIGENDUM1.
6-238.....................  ..........................  IEC 80601-2-35 Edition 2.0      Contact person.
                                                         2009-10, Medical electrical
                                                         equipment--Part 2-35:
                                                         Particular requirements for
                                                         the basic safety and
                                                         essential performance of
                                                         heating devices using
                                                         blankets, pads or mattresses
                                                         and intended for heating in
                                                         medical use.

6-241.....................  ..........................  ISO 1135-4 Fourth edition 2010- Contact person.
                                                         04-15, Transfusion equipment
                                                         for medical use--Part 4:
                                                         Transfusion sets for single
                                                         use.
6-242.....................  ..........................  ISO 8536-2 Third edition 2010-  Contact person.
                                                         03-15, Infusion equipment for
                                                         medical use--Part 2: Closures
                                                         for infusion bottles.
6-245.....................  ..........................  ISO 8536-4 Fifth edition 2010-  Contact person.
                                                         10-01, Infusion equipment for
                                                         medical use--Part 4: Infusion
                                                         sets for single use, gravity
                                                         feed.
6-273.....................  ..........................  ISO 23908 First edition 2011-   Contact person.
                                                         06-11, Sharps injury
                                                         protection--Requirements and
                                                         test methods--Sharps
                                                         protection features for
                                                         single-use hypodermic
                                                         needles, introducers for
                                                         catheters and needles used
                                                         for blood sampling.
----------------------------------------------------------------------------------------------------------------
                                             E. In Vitro Diagnostics
----------------------------------------------------------------------------------------------------------------
7-54......................  ..........................  CLSI D12-A2, Immunoprecipitin   Withdrawn.
                                                         Analyses: Procedures for
                                                         Evaluating the Performance of
                                                         Materials--Second Edition;
                                                         Approved Guideline.
7-76......................  ..........................  NCCLS M15-A, Laboratory         Contact person and type
                                                         Diagnosis of Blood-borne        of standard.
                                                         Parasitic Diseases; Approved
                                                         Guideline.
7-146.....................  ..........................  CLSI M6-A2, Protocols for       Contact person and
                                                         Evaluating Dehydrated Mueller-  title.
                                                         Hinton Agar; Approved
                                                         Standard--Second Edition.
7-148.....................  ..........................  CLSI M28-A2, Procedures for     Contact person and
                                                         the Recovery and                title.
                                                         Identification of Parasites
                                                         From the Intestinal Tract;
                                                         Approved Guideline--Second
                                                         Edition.
7-157.....................  7-228.....................  CLSI M11-A8, Methods for        Withdrawn and replaced
                                                         Antimicrobial Susceptibility    with newer version.
                                                         Testing of Anaerobic
                                                         Bacteria; Approved Standard-
                                                         Eighth Edition.
7-171.....................  ..........................  CLSI M38-A2, Reference Method   Contact person and
                                                         for Broth Dilution Antifungal   title.
                                                         Susceptibility Testing of
                                                         Filamentous Fungi; Approved
                                                         Standard--Second Edition.
7-179.....................  ..........................  CLSI M27-S3, Reference Method   Contact person and
                                                         for Broth Dilution Antifungal   title.
                                                         Susceptibility Testing of
                                                         Yeasts; Third Informational
                                                         Supplement.
7-184.....................  ..........................  CLSI M40-A, Quality Control of  Contact person and
                                                         Microbiological Transport       title.
                                                         Systems; Approved Standard.
7-195.....................  7-229.....................  CLSI M02-A11, Performance       Withdrawn and replaced
                                                         Standards for Antimicrobial     with newer version.
                                                         Disk Susceptibility Tests;
                                                         Approved Standard--Eleventh
                                                         Edition.
7-196.....................  7-230.....................  CLSI M07-A9, Methods for        Withdrawn and replaced
                                                         Dilution Antimicrobial          with newer version.
                                                         Susceptibility Tests for
                                                         Bacteria That Grow
                                                         Aerobically; Approved
                                                         Standard--Ninth Edition.
7-197.....................  ..........................  CLSI M35-A2, Abbreviated        Contact person and
                                                         Identification of Bacteria      title.
                                                         and Yeast; Approved
                                                         Guideline--Second Edition.
7-198.....................  ..........................  CLSI M23-A3, Development of In  Contact person and
                                                         Vitro Susceptibility Testing    title.
                                                         Criteria and Quality Control
                                                         Parameters; Approved
                                                         Guideline--Third Edition.
7-200.....................  ..........................  CLSI M48-A, Laboratory          Contact person and
                                                         Detection and Identification    title.
                                                         of Mycobacteria; Approved
                                                         Guideline.
7-215.....................  ..........................  CLSI M44-A2, Method for         Contact person.
                                                         Antifungal Disk Diffusion
                                                         Susceptibility Testing of
                                                         Yeast; Approved Guideline-
                                                         Second Edition.
7-216.....................  7-231.....................  CLSI M100-S22, Performance      Withdrawn and replaced
                                                         Standards for Antimicrobial     with newer version.
                                                         Susceptibility Testing;
                                                         Twenty-Second Informational
                                                         Supplement.
7-217.....................  ..........................  CLSI M44-S3, Zone Diameter      Contact person.
                                                         Interpretive Standards,
                                                         Corresponding Minimal
                                                         Inhibitory Concentration
                                                         (MIC) Interpretive
                                                         Breakpoints, and Quality
                                                         Control Limits for Antifungal
                                                         Disk Diffusion Susceptibility
                                                         Testing of Yeasts; Third
                                                         Informational Supplement.
7-218.....................  ..........................  CLSI M45-A2, Methods for        Contact person.
                                                         Antimicrobial Dilution and
                                                         Disk Susceptibility Testing
                                                         of Infrequently Isolated or
                                                         Fastidious Bacteria; Approved
                                                         Guideline--Second Edition.
----------------------------------------------------------------------------------------------------------------
                                                  F. Materials
----------------------------------------------------------------------------------------------------------------
8-108.....................  8-216.....................  ASTM F1295-11 Standard          Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Titanium-6Aluminum-7Niobium
                                                         Alloy for Surgical Implant
                                                         Applications (UNS R56700).
8-111.....................  ..........................  ASTM F1160-05 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Shear and Bending Fatigue
                                                         Testing of Calcium Phosphate
                                                         and Metallic Medical and
                                                         Composite Calcium Phosphate/
                                                         Metallic Coatings.
8-112.....................  ..........................  ASTM F1044-05 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Shear Testing of Calcium
                                                         Phosphate Coatings and
                                                         Metallic Coatings.
8-113.....................  ..........................  ASTM F1147-05 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Tension Testing of
                                                         Calcium Phosphate and
                                                         Metallic Coatings.
8-127.....................  ..........................  ISO 5834-2:2006, Implants for   Withdrawn. See 8-208.
                                                         surgery--Ultra-high-molecular-
                                                         weight polyethylene--Part 2:
                                                         Moulded forms.
8-128.....................  ..........................  ASTM F2213-06 (Reapproved       Reaffirmation and
                                                         2011) Standard Test Method      relevant guidance.
                                                         for Measurement of
                                                         Magnetically Induced Torque
                                                         on Medical Devices in the
                                                         Magnetic Resonance
                                                         Environment.

8-130.....................  8-217.....................  ASTM F620-11 Standard           Withdrawn and replaced
                                                         Specification for Titanium      with newer version.
                                                         Alloy Forgings for Surgical
                                                         Implants in the Alpha Plus
                                                         Beta Condition.
8-131.....................  8-218.....................  ASTM F799-11 Standard           Withdrawn and replaced
                                                         Specification for Cobalt-       with newer version.
                                                         28Chromium-6Molybdenum Alloy
                                                         Forgings for Surgical
                                                         Implants (UNS R31537, R31538,
                                                         R31539).
8-164.....................  8-219.....................  ASTM F136-11 Standard           Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Titanium-6Aluminum-4Vanadium
                                                         ELI (Extra Low Interstitial)
                                                         Alloy for Surgical Implant
                                                         Applications (UNS R56401).
8-174.....................  8-220.....................  ASTM F629-11 Standard Practice  Withdrawn and replaced
                                                         for Radiography of Cast         with newer version.
                                                         Metallic Surgical Implants.
8-180.....................  8-221.....................  ASTM F2066-11 Standard          Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Titanium-15 Molybdenum Alloy
                                                         for Surgical Implant
                                                         Applications (UNS R58150).
8-182.....................  8-222.....................  ASTM F1537-11 Standard          Withdrawn and replaced
                                                         Specification for Wrought       with newer version.
                                                         Cobalt-28Chromium-6Molybdenum
                                                         Alloys for Surgical Implants
                                                         (UNS R31537, UNS R31538, and
                                                         UNS R31539).
8-186.....................  8-223.....................  ASTM F2759-11 Standard Guide    Withdrawn and replaced
                                                         for Assessment of the Ultra     with newer version.
                                                         High Molecular Weight
                                                         Polyethylene (UHMWPE) Used in
                                                         Orthopedic and Spinal Devices.
8-210.....................  8-227.....................  ASTM F2182-11a Standard Test    Withdrawn and replaced
                                                         Method for Measurement of       with newer version.
                                                         Radio Frequency Induced
                                                         Heating On or Near Passive
                                                         Implants During Magnetic
                                                         Resonance Imaging.
----------------------------------------------------------------------------------------------------------------
                                                 G. Orthopedics
----------------------------------------------------------------------------------------------------------------
11-175....................  ..........................  ASTM F1582-98 (Reapproved       Reaffirmation.
                                                         2011) Standard Terminology
                                                         Relating to Spinal Implants.
11-185....................  ..........................  ASTM F2267-04 (Reapproved       Reaffirmation.
                                                         2011) Standard Test Method
                                                         for Measuring Load Induced
                                                         Subsidence of Intervertebral
                                                         Body Fusion Device Under
                                                         Static Axial Compression.
11-186....................  11-235....................  ASTM F2077-11 Test Methods For  Withdrawn and replaced
                                                         Intervertebral Body Fusion      with newer version.
                                                         Devices.
11-195....................  ..........................  ASTM F1612-95 (2005), Standard  Withdrawn. See 11-225.
                                                         Practice for Cyclic Fatigue
                                                         Testing of Metallic Stemmed
                                                         Hip Arthroplasty Femoral
                                                         Components with Torsion.
11-203....................  ..........................  ASTM F1541-02 (Reapproved       Reaffirmation and
                                                         2011) Standard Specification    contact person.
                                                         and Test Methods for External
                                                         Skeletal Fixation Devices.
11-220....................  ..........................  ASTM F2068-09, Standard         Extent of recognition
                                                         Specification for Femoral       and CFR citations.
                                                         Prostheses--Metallic Implants.
11-230....................  11-236....................  ASTM F1717-11a Standard Test    Withdrawn and replaced
                                                         Methods for Spinal Implant      with newer version.
                                                         Constructs in a Vertebrectomy
                                                         Model.
----------------------------------------------------------------------------------------------------------------
                                              H. Physical Medicine
----------------------------------------------------------------------------------------------------------------
16-172....................  ..........................  ANSI/RESNA WC/Volume 1--1998,   Duplicate. See 16-188.
                                                         Section 5: Determination of
                                                         Overall Dimensions, Mass, and
                                                         Turning Space--Wheelchair.
16-186....................  16-189....................  ASME A18.1-2011 (Revision of    Withdrawn and replaced
                                                         ASME A18.1-2008) Safety         with newer version.
                                                         Standard for Platform Lifts
                                                         and Stairway Chairlifts.
----------------------------------------------------------------------------------------------------------------
                                                  I. Radiology
----------------------------------------------------------------------------------------------------------------
12-102....................  ..........................  ANSI/IESNA RP-27.2-00           CFR citation and product
                                                         Recommended Practice for        codes, devices
                                                         Photobiological Safety for      affected, processes
                                                         Lamps & Lamp Systems--          impacted, and contact
                                                         Measurement Techniques.         person.
12-153....................  ..........................  ANSI/IESNA RP-27.1-05           CFR citation and product
                                                         Recommended Practice for        codes, devices
                                                         Photobiological Safety for      affected, processes
                                                         Lamps and Lamp Systems--        impacted, and contact
                                                         General Requirements.           person.
12-179....................  ..........................  ANSI/IESNA RP-27.3-07           Extent of recognition,
                                                         Recommended Practice for        CFR citation and
                                                         Photobiological Safety for      product codes, devices
                                                         Lamps--Risk Group               affected, processes
                                                         Classification and Labeling.    impacted, type of
                                                                                standard, contact
                                                                                person, and relevant
                                                                                guidance.
----------------------------------------------------------------------------------------------------------------
                                             J. Software/Informatics
----------------------------------------------------------------------------------------------------------------
13-8......................  ..........................  IEC 62304 First edition 2006-   Extent of recognition.
                                                         05 Medical device software--
                                                         Software life cycle processes.
----------------------------------------------------------------------------------------------------------------

                                                  K. Sterility
----------------------------------------------------------------------------------------------------------------
14-55.....................  14-358....................  ANSI/AAMI/ISO 14160:2011        Withdrawn and replaced
                                                         Sterilization of health care    with newer version.
                                                         products--Liquid chemical
                                                         sterilizing agents for single-
                                                         use medical devices utilizing
                                                         animal tissues and their
                                                         derivatives--Requirements for
                                                         characterization,
                                                         development, validation and
                                                         routine control of a
                                                         sterilization process for
                                                         medical devices.
14-123....................  14-359....................  ASTM F2096-11 Standard Test     Withdrawn and replaced
                                                         Method for Detecting Gross      with newer version.
                                                         Leaks in Packaging by
                                                         Internal Pressurization
                                                         (Bubble Test).
14-227....................  ..........................  ANSI/AAMI/ISO 11737-1:2006 (R)  Reaffirmation and
                                                         2011, Sterilization of health   contact person.
                                                         care products--
                                                         Microbiological methods--Part
                                                         1: Determination of the
                                                         population of microorganisms
                                                         on product.
14-229....................  ..........................  ASTM F1980-07 (Reapproved       Reaffirmation.
                                                         2011) Standard Guide for
                                                         Accelerated Aging of Sterile
                                                         Barrier Systems for Medical
                                                         Devices.
14-264....................  ..........................  AAMI/ANSI ST8:2008, Hospital    Contact person.
                                                         steam sterilizers.
14-277....................  ..........................  ISO TS 17665-2:2009,            Extent of recognition
                                                         Sterilization of health care    and contact person.
                                                         products--Moist heat--Part 2:
                                                         Guidance on the application
                                                         of ISO 17665-1.
14-292....................  14-360....................  ANSI/AAMI ST72:2011 Bacterial   Withdrawn and replaced
                                                         endotoxins--Test methods,       with newer version.
                                                         routine monitoring, and
                                                         alternatives to batch testing.
14-311....................  ..........................  AAMI/ANSI ST55:2010, Table-top  Contact person.
                                                         steam sterilizers.
----------------------------------------------------------------------------------------------------------------
\1\ All standard titles in this table conform to the style requirements of the respective organizations.

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: 029.

        Table 3--New Entries to the List of Recognized Standards
------------------------------------------------------------------------
                                                      Reference No. and
    Recognition No.        Title of standard \1\            date
------------------------------------------------------------------------
                              A. Anesthesia
------------------------------------------------------------------------
1-86..................  Respiratory tract           ISO 8185 Third
                         humidifiers for medical     edition 2007-07-01.
                         use--Particular
                         requirements for
                         respiratory
                         humidification systems.
1-87..................  Medical electrical          60601-2-23 Edition
                         equipment--Part 2-23:       3.0 2011-02.
                         Particular requirements
                         for the basic safety and
                         essential performance of
                         transcutaneous partial
                         pressure monitoring
                         equipment.
1-88..................  Medical electrical          ISO 80601-2-12 First
                         equipment--Part 2-12:       edition 2011-04-15.
                         Particular requirements
                         for basic safety and
                         essential performance of
                         critical care ventilators.
1-89..................  Medical electrical          ISO 80601-2-12:2011
                         equipment--Part 2-12:       TECHNICAL
                         Particular requirements     CORRIGENDUM 1.
                         for basic safety and
                         essential performance of
                         critical care ventilators.
------------------------------------------------------------------------
                            B. Cardiovascular
------------------------------------------------------------------------
3-101.................  Medical electrical          ANSI/AAMI/IEC 60601-
                         equipment--Part 2-27:       2-27:2011.
                         Particular requirements
                         for the basic safety and
                         essential performance of
                         electrocardiographic
                         monitoring equipment.
3-103.................  Cardiovascular implants--   ISO 25539-3 First
                         Endovascular devices--      edition 2011-12-01.
                         Part 3: Vena cava filters.
3-104.................  Standard Guide for          ASTM F2914-12.
                         Identification of Shelf-
                         life Test Attributes for
                         Endovascular Devices.
------------------------------------------------------------------------
               C. General Hospital/General Plastic Surgery
------------------------------------------------------------------------
6-277.................  Prefilled syringes--Part    ISO 11040-4 Second
                         4: Glass barrels for        edition 2007-02-01.
                         injectables.
6-278.................  Prefilled syringes--Part    ISO 11040-5 Third
                         5: Plunger stoppers for     edition 2012-01-15.
                         injectables.
6-279.................  Medical electrical          IEC 60601-2-19
                         equipment--Part 2-19:       (Second edition--
                         Particular requirements     2009).
                         for the basic safety and
                         essential performance of
                         infant incubators
                         CORRIGENDUM 1.
6-280.................  Medical electrical          IEC 60601-2-20
                         equipment--Part 2-20:       (Second edition--
                         Particular requirements     2009).
                         for the basic safety and
                         essential performance of
                         infant transport
                         incubators CORRIGENDUM 1.
6-281.................  Medical electrical          IEC 80601-2-35
                         equipment--Part 2-35:       (Second edition--
                         Particular requirements     2009).
                         for the basic safety and
                         essential performance of
                         heating devices using
                         blankets, pads or
                         mattresses and intended
                         for heating in medical
                         use CORRIGENDUM 1.
------------------------------------------------------------------------
                              D. Materials
------------------------------------------------------------------------
8-224.................  Standard Guide for          ASTM F2102--06
                         Evaluating the Extent of    [euro]\1\.
                         Oxidation in Ultra-High-
                         Molecular-Weight
                         Polyethylene Fabricated
                         Forms Intended for
                         Surgical Implants.

8-225.................  Standard Practice for       ASTM F2003--02
                         Accelerated Aging of        (Reapproved 2008).
                         Ultra-High Molecular
                         Weight Polyethylene after
                         Gamma Irradiation in Air.
8-226.................  Standard Specification for  ASTM F603--12.
                         High-Purity Dense
                         Aluminum Oxide for
                         Medical Application.
------------------------------------------------------------------------
                       E. OB-GYN/Gastroenterology
------------------------------------------------------------------------
9-75..................  Optics and Optical          ISO 8600-3 First
                         instruments--Medical        edition 1997-07-01.
                         endoscopes and endoscopic
                         accessories--Part 3:
                         Determination of field of
                         view and direction of
                         view of endoscopes with
                         optics.
9-76..................  Water for haemodialysis     ISO 13959 Second
                         and related therapies.      edition 2009-04-15.
9-77..................  Guidance for the            ISO 23500 First
                         preparation and quality     edition 2011-05-15.
                         management of fluids for
                         haemodialysis and related
                         therapies.
9-78..................  Quality of dialysis fluid   ISO 11663 First
                         for haemodialysis and       edition 2009-04-15.
                         related therapies.
------------------------------------------------------------------------
                              F. Ophthalmic
------------------------------------------------------------------------
10-73.................  American National Standard  ANSI Z80.21-2010.
                         for Ophthalmics--
                         Instruments--General-
                         Purpose Clinical Visual
                         Acuity Charts.
10-74.................  Ophthalmic instruments--    ISO 10940 Second
                         Fundus cameras.             edition 2009-08-01.
------------------------------------------------------------------------
                              G. Orthopedic
------------------------------------------------------------------------
11-237................  Implants for surgery--      ISO 7206-6 First
                         Partial and total hip       edition 1992-03-l5.
                         joint prostheses--Part 6:
                         Determination of
                         endurance properties of
                         head and neck region of
                         stemmed femoral
                         components.
11-238................  Standard Specification for  ASTM F 2033-12.
                         Total Hip Joint
                         Prosthesis and Hip
                         Endoprosthesis Bearing
                         Surfaces Made of
                         Metallic, Ceramic, and
                         Polymeric Materials.
11-239................  Standard Test Methods for   ASTM F2345-03
                         Determination of Static     (Reapproved 2008).
                         and Cyclic Fatigue
                         Strength of Ceramic
                         Modular Femoral Heads.
11-240................  Standard Specification and  ASTM F382-99
                         Test Method for Metallic    (Reapproved 2008).
                         Bone Plates.
11-241................  Standard Specification and  ASTM F543-07
                         Test Methods for Metallic   [euro]\1\.
                         Medical Bone Screws.
11-242................  Standard Specification for  ASTM F1839-08
                         Rigid Polyurethane Foam     [euro]\2\.
                         for Use as a Standard
                         Material for Testing
                         Orthopaedic Devices and
                         Instruments.
11-243................  Standard Test Methods for   ASTM F2346-05
                         Static and Dynamic          (Reapproved 2011).
                         Characterization of
                         Spinal Artificial Discs.
------------------------------------------------------------------------
                              H. Radiology
------------------------------------------------------------------------
12-249................  Photobiological safety of   IEC 62471 First
                         lamps and lamp systems.     edition 2006-07.
------------------------------------------------------------------------
                         I. Software/Informatics
------------------------------------------------------------------------
13-31.................  Specimen Labels: Content    CLSI AUTO12-A.
                         and Location, Fonts, and
                         Label Orientation;
                         Approved Standard.
13-32.................  Medical device software--   ANSI/AAMI/IEC
                         Software life cycle         62304:2006.
                         processes.
------------------------------------------------------------------------
                              J. Sterility
------------------------------------------------------------------------
14-361................  Sterilization of health     ISO 14160 Second
                         care products--Liquid       edition 2011-07-01.
                         chemical sterilizing
                         agents for single-use
                         medical devices utilizing
                         animal tissues and their
                         derivatives--Requirements
                         for characterization,
                         development, validation
                         and routine control of a
                         sterilization process for
                         medical devices.
------------------------------------------------------------------------
 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 minor revisions described in this notice into the database and,
upon publication in the Federal Register, this recognition of consensus
standards will be effective. FDA will announce additional modifications
and minor revisions to the list of recognized consensus standards, as
needed, in the Federal Register once a year, or more often, if
necessary.

V. Recommendation of Standards for Recognition by FDA

    Any person may recommend consensus standards as candidates for
recognition under the new provision of section 514 of the FD&C Act by
submitting such recommendations, with reasons for the recommendation,
to the contact person (see FOR FURTHER INFORMATION CONTACT). To be
properly considered, such recommendations should contain, at a minimum,
the following information: (1) Title of the standard; (2) any reference
number and date; (3) name and address of the national or international
standards development organization; (4) a proposed list of devices for
which a declaration of conformity to this standard should routinely
apply; and (5) a brief identification of the testing or performance or
other characteristics of

the device(s) that would be addressed by a declaration of conformity.

VI. Electronic Access

    You may obtain a copy of ``Guidance on the Recognition and Use of
Consensus Standards'' by using the Internet. CDRH maintains a site on
the Internet for easy access to information including text, graphics,
and files that you may download to a personal computer with access to
the Internet. Updated on a regular basis, the CDRH home page includes
the guidance as well as the current list of recognized standards and
other standards-related documents. After publication in the Federal
Register, this notice announcing ``Modification to the List of
Recognized Standards, Recognition List Number: 029'' will be available
on the CDRH home page. You may access the CDRH home page at http://www.fda.gov/MedicalDevices.
    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.
    This Federal Register document on modifications in FDA's
recognition of consensus standards is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Standards/ucm123792.htm

VII. Submission of Comments and Effective Date

    Interested persons may submit to the contact person (see FOR
FURTHER INFORMATION CONTACT) either electronic or written comments
regarding this document. It is no longer necessary to send two copies
of mailed comments. 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: 029. These modifications to the list of
recognized standards are effective upon publication of this notice in
the Federal Register.

    Dated: August 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20323 Filed 8-17-12; 8:45 am]
BILLING CODE 4160-01-P