[Federal Register Volume 77, Number 223 (Monday, November 19, 2012)]
[Proposed Rules]
[Pages 69393-69399]
[FR Doc No: 2012-28015]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. FDA-2011-N-0090]
RIN 0910-AG31

Unique Device Identification System

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; amendment.

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SUMMARY: The Food and Drug Administration (FDA) is amending its July
10, 2012, proposed rule (77 FR 40736) to establish a unique device
identification system as required by recent amendments to the Federal
Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food
and Drug Administration Safety and Innovation Act (FDASIA) was signed
into law; section 614 of FDASIA amends the FD&C Act in ways that
require modification of the timeframe for implementation of the
proposed rule's requirements as they apply to devices that are
implantable, life-saving (life-supporting), or life-sustaining.

DATES: Submit either electronic or written comments on the amendment to
the Proposed Rule by December 19, 2012. See section VII for the
proposed effective dates of a final rule based on the amended proposed
rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2011-
N-0090 and/or RIN Number 0910-AG31, by any of the following methods.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (For paper or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency
name, Docket Number, and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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.

FOR FURTHER INFORMATION CONTACT: Jay Crowley, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On July 9, 2012, FDASIA was signed into law (Pub. L. 112-144). On
July 10, 2012, FDA published a proposed rule to establish a unique
device identification system, as required by section 519(f) of the FD&C
Act (21 U.S.C. 360i(f)). Section 614 of FDASIA amends section 519(f) of
the FD&C Act in ways that require modification of the timeframe for
implementation of the proposed rule's requirements as they apply to
devices that are implantable, life-saving (life-supporting), or life-
sustaining. This document explains how FDA is amending the July 10,
2012, proposed rule to meet the requirements of amended section 519(f)
of the FD&C Act.

II. Description of the Proposed Rule

A. FDA's July 10, 2012, Proposed Rule

    Our July 10, 2012, document provides a detailed description of the
proposed rule. The proposed rule includes unique device identifier
(UDI) labeling requirements (proposed for inclusion in 21 CFR part
801), requirements relating to issuing Agencies and submission of data
to the Global Unique Device Identification Database (GUDID) (proposed
new part 830), and conforming amendments to several existing FDA
regulations. FDA proposed a phased implementation of the rule's
requirements, with some requirements going into effect immediately
after publication of a final rule, and other requirements going into
effect 1 year, 3 years, 5 years, and 7 years after publication of a
final rule. This phased implementation is summarized in the July 10,
2012, proposed rule by Table 7--Effective Dates of UDI Regulatory
Requirements (77 FR 40736 at 40764).

B. Changes Required by the Enactment of FDASIA

    Section 614 of FDASIA amends section 519(f) of the FD&C Act, the
provision that requires FDA to establish a unique device identification
system. Prior to the enactment of FDASIA, section 519(f) of the FD&C
Act did not specify the date by which a proposed rule is required, did
not identify any particular devices as requiring expedited
implementation of UDI requirements, and did not specify timeframes for
publication of a final rule. The FDASIA amendments to section 519(f)
address each of those points. As amended by FDASIA, section

519(f) of the FD&C Act now requires that not later than December 31,
2012, the Secretary shall issue proposed regulations establishing a
unique device identification system for medical devices requiring the
label of devices to bear a unique identifier, unless the Secretary
requires an alternative placement or provides an exception for a
particular device or type of device. The unique identifier shall
adequately identify the device through distribution and use, and may
include information on the lot or serial number. Section 519(f) of the
FD&C Act also requires that the Secretary shall finalize the proposed
regulations not later than 6 months after the close of the comment
period and shall implement the final regulations with respect to
devices that are implantable, life-saving, and life sustaining not
later than 2 years after the regulations are finalized, taking into
account patient access to medical devices and therapies.
    The change that has prompted amendment of FDA's proposed rule is
the provision in the final sentence that requires ``final regulations
with respect to devices that are implantable, life-saving, and life
sustaining'' to be implemented within 2 years of finalization of the
rule. (We refer to ``life-saving'' devices as ``life-supporting,'' as
explained later in this document.). Thus we are amending our July 10,
2012, proposed rule by changing some of the proposed effective dates
for requirements applicable to implantable, life-supporting, and life-
sustaining devices, so that the requirements applicable to these
devices will be effective no later than 2 years from finalization of
the rule.
    Under our July 10, 2012, proposed rule, all class III devices and
all devices licensed under the Public Health Service Act (PHS Act) (42
U.S.C. 262) would be required to bear a UDI within 1 year of the date
we publish a final rule; thus, this effective date does not need to be
changed. Pursuant to amended section 519(f) of the FD&C Act, we are now
proposing to require all other implantable, life-supporting, and life-
sustaining devices (i.e., those that are not already subject to the 1-
year effective date) to bear a UDI within 2 years following the
publication of a final rule. (See proposed Sec.  801.20(b)(2) as
amended by this document.) Under our July 10, 2012, proposed rule, when
a device is required to be labeled with a UDI, proposed Sec.  830.300
would require the labeler of that device to submit information
concerning the device to the GUDID. Consequently, the labelers of all
implantable, life-supporting, and life-sustaining devices will be
required to submit data to the GUDID within 2 years of the date we
publish a final rule; see proposed Sec.  801.20(b)(1) and (b)(2) as
amended by this document.
    Proposed Sec.  801.50 would require direct marking of the UDI on
the device itself for implantable devices, devices intended to be used
more than once and that are intended to be sterilized before each use,
and stand-alone software. We are now amending the proposed rule so that
any such devices that fall into the categories specified by revised
section 519(f) of the FD&C Act--devices that are implantable, life
supporting, or life sustaining--would have to comply with Sec.  801.50,
establishing a system of unique device identification 2 years after
publication of a final rule. FDA believes that the only devices subject
to direct marking that fit within the device categories expressly
referred to in revised section 519(f) of the FD&C Act are implantable
devices and is assuming only implantable devices will be affected by
the revised implementation date for the direct marking requirement. We
welcome comments on whether any devices subject to the direct marking
requirement under proposed Sec.  801.50 other than implantable devices
fit within the device categories in amended section 519(f) of the FD&C
Act.
    FDA interprets ``life-saving'' in section 519(f) of the FD&C Act,
as amended by section 614 of FDASIA, to have the same meaning as
``life-supporting'' in other device provisions of the FD&C Act. Section
614 of FDASIA refers to devices that are ``implantable, life-saving,
and life-sustaining.'' The device provisions of the FD&C Act do not use
the term ``life-saving'' in any other instance, but in several
instances refer to devices that are ``implantable, life sustaining, or
life supporting.'' (See section 513(a) of the FD&C Act (21 U.S.C.
360c(a)) (definitions of class II and class III devices); section 519
(records and reports on devices, including adverse event reporting and
device tracking); section 522 of the FD&C Act (21 U.S.C. 360l)
(postmarket surveillance); and section 523 of the FD&C Act (21 U.S.C.
360m) (accredited persons).) In order for the language of our proposed
UDI rule to be consistent with existing FDA regulations and the other
provisions of the FD&C Act, in the amendments to the proposed
regulations we use the term ``life-supporting'' instead of ``life-
saving.'' FDA, the medical device industry, and the health care
community are already familiar with the term ``life-supporting'' as
applied to medical devices, which will facilitate FDA's implementation
of the amended proposed rule.
    A list of product codes for devices that FDA considers to be
implantable, life-saving, and life-sustaining for purposes of section
614 of FDASIA, amending section 519(f) of the FD&C Act, is available in
docket FDA-2011-N-0090 (Ref. 12).
    FDA is not extending the comment period of the proposed rule, which
closed on November 7, 2012. We do not believe that amending some of the
proposed effective dates for certain categories of devices necessitates
additional time to review the amended proposed rule and to submit
comments to FDA.

C. How the Amendments Made by This Proposed Rule Will Affect the July
10, 2012, Proposed Rule

    These amendments affect only implantable, life-supporting, or life-
sustaining devices. With the exception of the change to the proposed
effective date for the direct marking requirement, these amendments do
not affect class III devices or devices licensed under the PHS Act
because such devices would have to bear a UDI within 1 year of
finalization under the July 10, 2012, proposed rule.
    We are updating Table 7--Effective Dates of UDI Regulatory
Requirements, of the July 10, 2012, proposed rule to reflect the
revisions provided by this document; we have also corrected two
citations within the table (citations to Sec.  830.320 should have
cited Sec.  830.300). Updated table 7 appears in this document in
section VI. Updated Proposed Effective Dates.
    New table 8 of this document summarizes the effects of the
amendments we are making to the July 10, 2012, proposed rule.

 Table 8--Effects of the Amendments to the July 10, 2012, Proposed Rule
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                                             Effect of amendments to
           Category of device                     proposed rule
------------------------------------------------------------------------
Class III implantable, life-supporting,  No effect with respect to
 and life-sustaining devices, and         proposed requirement for
 implantable, life-supporting, and life-  device to bear UDI on the
 sustaining devices licensed under the    label and device package or
 PHS Act.                                 proposed requirements for
                                          submission of data to the
                                          GUDID.

                                         Implantable devices would have
                                          to bear a UDI as a permanent
                                          marking on the device itself 1
                                          year earlier than first
                                          proposed.
Class II implantable, life-supporting,   Would have to bear a UDI on the
 and life-sustaining devices.             label and device package and
                                          submit data to the GUDID 1
                                          year earlier than first
                                          proposed.
                                         Implantable devices would have
                                          to bear a UDI as a permanent
                                          marking on the device itself 3
                                          years earlier than first
                                          proposed.
Class I implantable, life-supporting,    Would have to bear a UDI on the
 and life-sustaining devices, and         label and device package and
 implantable, life-supporting, and life-  submit data to the GUDID 3
 sustaining devices that have not been    years earlier than first
 classified into class I, II, or III.     proposed.
                                         Implantable devices would have
                                          to bear a UDI as a permanent
                                          marking on the device itself 5
                                          years earlier than first
                                          proposed.
------------------------------------------------------------------------

D. Request for Comments

    This amendment announces changes to the proposed rule required by
FDASIA. The comment period on the proposed rule closed on November 7,
2012. We request comments only on the changes discussed in this
amendment to the proposed rule and may decline to consider other
comments submitted to this docket.

III. Legal Authority for the Proposed Rule

    Section 226 of the Food and Drug Administration Amendments Act
(Pub. L. 110-85) (2007), amended the FD&C Act by adding a new section
519(f). This section provides for FDA to issue regulations establishing
a unique device identification system for medical devices. In addition,
section 510(e) of the FD&C Act (21 U.S.C. 360(e)) authorizes FDA to
issue regulations to ``prescribe a uniform system for identification of
devices'' and to require persons to ``list such devices in accordance
with such system.'' Therefore, FDA is issuing the provisions of this
proposed rule that would establish a unique device identification
system under sections 510(e), 519(f), and 701(a) (21 U.S.C. 371(a)) of
the FD&C Act (which provides FDA the authority to issue regulations for
the efficient enforcement of the FD&C Act).
    Devices for which there has been a failure or refusal to furnish
any material or information required by or under section 519 of the
FD&C Act respecting the device are misbranded under section 502(t)(2)
of the FD&C Act (21 U.S.C. 352(t)(2)). The failure or refusal to
furnish any material or information required by or under section 519 of
the FD&C Act is a prohibited act under section 301(q)(1)(B) of the FD&C
Act (21 U.S.C. 331(q)(1)(B)).
    Section 701(a) of the FD&C Act gives FDA the authority to issue
regulations for the efficient enforcement of the FD&C Act. By requiring
a UDI to appear on the label of devices, and by establishing the GUDID,
the proposed rule is designed to improve the accuracy and precision of
adverse event reporting, as required by section 519(a) and (b) of the
FD&C Act, which will enable FDA to more quickly and precisely identify
device problems, such as safety and/or effectiveness concerns. Once a
problem is identified, whether through improved reporting or otherwise,
the presence of the UDI on the device label, packaging, in certain
cases directly marked on the device itself, and in the GUDID will
enable FDA to more efficiently and effectively respond, and protect the
public health by addressing the problem using one or more of the
regulatory tools that Congress has provided for this purpose, such as
notification or mandatory recall under section 518 of the FD&C Act (21
U.S.C. 360h), tracking under section 519(e) of the FD&C Act, ensuring
the adequacy of a voluntary recall with the assistance of reports of
corrections and removals as required by section 519(g) of the FD&C Act,
or seizing a device that is adulterated under section 501 of the FD&C
Act (21 U.S.C. 351) and/or misbranded under section 502 of the FD&C
Act. Thus, these provisions of the proposed rule are issued under the
authority of these sections in addition to the broad authority of
section 519(f) of the FD&C Act.
    Section 510(j) of the FD&C Act requires listing information to be
accompanied by, at minimum, the label, package insert, and a
representative sampling of any other labeling for the device (see
section 510(j)(1)(B)(ii)). For certain categories of devices, all
labeling must be submitted (see section 510(j)(1)(A) and (j)(1)(B)(i)
of the FD&C Act). We expect most of the information that would be
required to be submitted to the GUDID (see proposed Sec.  830.310), is
information that appears on the device label or in the package insert,
and is included in the information that is required to be submitted to
FDA by section 510(j) of the FD&C Act.
    The provisions of the proposed rule that would require UDIs to be
included in various records and reports, allow the use of UDIs to
identify devices subject to reports of corrections and removals and
records of corrections of removals that are not required to be reported
to FDA, and require reporting of UDIs in periodic reports for class III
devices, are issued under the authority of sections 519 and 701(a) of
the FD&C Act.
    The provisions of the proposed rule that would amend the Quality
System Regulation by requiring examination of the accuracy of the UDI
as part of the scope of the labeling inspection, that the device
history record include any UDI or universal product code (UPC), that
complaint records include any UDI or UPC, and that the service report
include an UDI or UPC, are issued under sections 520(f) (21 U.S.C.
360j(f)) and 701(a) of the FD&C Act.
    The provisions of the proposed rule that would require the
inclusion of UDIs on reports regarding tracked devices is authorized by
sections 519(e) and 701(a) of the FD&C Act.
    The provision of the proposed rule that would require that
postmarket surveillance plans submitted to FDA include the device
identifier of the devices involved is issued under sections 522 (21
U.S.C. 360l), and 701(a) of the FD&C Act.
    Finally, the changes in proposed effective dates for devices that
are implantable, life-saving, and life sustaining, are pursuant to the
changes to section 519(f) of the FD&C Act made by section 614 of
FDASIA.

IV. Analysis of Impacts

    Our July 10, 2012, document summarizes the analysis of impacts of
the proposed rule. The full analysis of impacts and findings that are
presented in Preliminary Regulatory Impact Analysis (RIA) of the
proposed rule remain unchanged (Ref. 10 of the July 10, 2012, proposed
rule). However, we are amending our summary of costs to include the
FDASIA requirement to

incorporate the revised implementation date of 2 years for devices that
are implantable, life-supporting, and life-sustaining. The July 10,
2012, RIA and the Addendum to the RIA (new Ref. 13) are available at
http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/ucm309815.htm.
    We lack sufficient information to estimate the number of
establishments that label life-supporting and life-sustaining devices
and would be affected by the FDASIA requirement. Therefore, for this
amended cost summary, we make a simplifying assumption that labelers of
all class II devices would comply with the UDI requirements in year 2
instead of year 3 as initially specified under the proposed rule.
Because the modified timeframe would advance the implementation date to
directly mark implantable, life-supporting, and life-sustaining
devices, we assume that labelers of class III devices that are implants
would comply with the direct marking requirements in year 2 instead of
year 3 as initially specified under the proposed rule. The effect of
these simplifying assumptions might be to overstate the annualized
costs for some labelers of class II devices that are not considered
life-supporting or life-sustaining devices, and to underestimate the
annualized costs for some labelers of class I devices that are
considered life-supporting or life-sustaining devices.
    The amended summary of the total costs of the proposed rule for all
sectors is presented in the updated table 3 of this document. The total
present value of domestic costs for all affected sectors would be about
$554.8 million over 10 years with a 7 percent discount rate and $625.4
million at 3 percent. The total annualized costs over 10 years would be
$73.8 million at 7 percent and $71.1 million at 3 percent. The total
increase in annualized costs to domestic labelers compared to the
proposed rule is about $5.4 million at 7 percent over 10 years.

                 Updated Table 3--Summary of the Estimated Regulatory Costs of the Proposed Rule
                                               [2010 dollars] 1 2
----------------------------------------------------------------------------------------------------------------
                                     Total present value of cost over 10    Total annualized costs over 10 years
                                             years  ($ million)                         ($ million)
         Affected sectors         ------------------------------------------------------------------------------
                                        3 Percent           7 Percent           3 Percent          7 Percent
----------------------------------------------------------------------------------------------------------------
Domestic Labelers................  $608.3............  $540.2............  $69.2.............  $71.9.
Issuing Agencies.................  $1.0..............  $0.9..............  $0.1..............  $0.1.
FDA..............................  $16.1.............  $13.7.............  $1.8..............  $1.8.
Imports..........................  Not quantified....  Not quantified....  Not quantified....  Not quantified.
                                  ------------------------------------------------------------------------------
    Total Domestic Cost of the     $625.4............  $554.8............  $71.1.............  $73.8.
     Proposed Rule.
----------------------------------------------------------------------------------------------------------------
\1\ Present value and annualized costs calculated at the beginning of the period.
\2\ Domestic costs for labelers are revised to reflect FDASIA requirement that labelers of affected devices
  comply in year 2. However, FDA's revised estimate assumes that all class II devices would comply in year 2.

    Updated table 1 (and identical updated table 4 of the proposed
rule) presents the Regulatory Information Service Center (RISC) and
Office of Information and Regulatory Affairs (OIRA) Combined
Information System (ROCIS) accounting information under the assumption
that labelers of all class II devices would comply with the UDI
requirements in year 2 and that all labelers of class II implantable
devices would comply with the direct marking requirements in year 2.

[GRAPHIC] [TIFF OMITTED] TP19NO12.001

V. Information Collection Requirements

    The updates made by this proposed rule do not affect the estimate
we previously provided regarding our July 10, 2012, proposed rule.
    In accordance with section 3507(d) of the PRA (44 U.S.C. 3501 et
seq.), the information collection or recordkeeping requirements
included in this proposed rule have been submitted for approval to OMB.
A copy of the supporting statement for this information collection is
available on the Internet at http://www.reginfo.gov/public/do/PRAMain
(OMB Number 0910-0720) and is posted to the docket at http://www.regulations.gov, in docket FDA-2011-N-0090 (Ref. 11 of the proposed
rule).

VI. Environmental Impact

    FDA has determined under 21 CFR 25.30(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VII. Updated Proposed Effective Dates

    FDA updates Table 7--Effective Dates of UDI Regulatory
Requirements, in our July 10, 2012, proposed rule as follows.

                         Updated Table 7--Effective Dates of UDI Regulatory Requirements
----------------------------------------------------------------------------------------------------------------
                 Effective date                                            Requirement
----------------------------------------------------------------------------------------------------------------
Immediately upon publication of a final rule...  Requests for an exception or alternative to UDI labeling
                                                  requirements may be submitted pursuant to Sec.   801.35.
                                                 Sec.  Sec.   830.100-830.130 (subpart C of part 830, concerning
                                                  accreditation of issuing Agencies) and Sec.   830.10
                                                  (incorporation by reference of certain standards) go into
                                                  effect. This will allow applications for accreditation as an
                                                  issuing Agency to be submitted to FDA immediately.
One year after publication of a final rule.....  Dates on medical device labels must be formatted as required by
                                                  Sec.   801.18.
                                                 The label and package of class III medical devices and devices
                                                  licensed under the PHS Act must bear a UDI. Sec.
                                                  801.20(b)(1).
                                                 Data for class III devices and devices licensed under the PHS
                                                  Act that are required to be labeled with a UDI must be
                                                  submitted to the GUDID data base. Sec.   830.300.
Two years after publication of a final rule....  The label and package of implantable, life-supporting, and life-
                                                  sustaining devices that are not class III devices or licensed
                                                  under the PHS Act must bear a UDI. Sec.   801.20(b)(2).
                                                 Data for implantable, life-supporting, and life-sustaining
                                                  devices that are not class III devices or licensed under the
                                                  PHS Act and that are required to be labeled with a UDI, must
                                                  be submitted to the GUDID data base. Sec.   830.300.
                                                 All implantable devices required to be labeled with a UDI must
                                                  bear a UDI as a permanent marking on the device itself. Sec.
                                                  801.50.
Three years after publication of a final rule..  Class III devices required to be labeled with a UDI must bear a
                                                  UDI as a permanent marking on the device itself if the device
                                                  is (1) a device intended to be used more than once and
                                                  intended to be sterilized before each use, or (2) stand-alone
                                                  software regulated as a medical device. Sec.   801.50.
                                                 The label and package of class II medical devices must bear a
                                                  UDI. Sec.   801.20(b)(3).
                                                 Data for class II devices that are required to be labeled with
                                                  a UDI, must be submitted to the GUDID data base. Sec.
                                                  830.300.
Five years after publication of a final rule...  Class II devices required to be labeled with a UDI must bear a
                                                  UDI as a permanent marking on the device itself if the device
                                                  is (1) a device intended to be used more than once and
                                                  intended to be sterilized before each use, or (2) stand-alone
                                                  software regulated as a medical device. Sec.   801.50.
                                                 The label and package of class I medical devices and devices
                                                  that have not been classified into class I, class II, or class
                                                  III must bear a UDI. Sec.   801.20(b)(4), (5).
                                                 Data for class I devices and devices that have not been
                                                  classified into class I, class II, or class III that are
                                                  required to be labeled with a UDI must be submitted to the
                                                  GUDID data base. Sec.   830.300.
Seven years after publication of a final rule..  Class I devices and devices that have not been classified into
                                                  class I, class II, or class III required to be labeled with a
                                                  UDI must a bear UDI as a permanent marking on the device
                                                  itself if the device is (1) a device intended to be used more
                                                  than once and intended to be sterilized before each use, or
                                                  (2) stand-alone software regulated as a medical device. Sec.
                                                  801.50.
90 days after publication of a final rule......  All other provisions go into effect, although some will have no
                                                  practical effect until other provisions listed in this table
                                                  go into effect.
----------------------------------------------------------------------------------------------------------------

VIII. Federalism

    FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
have substantial direct effects 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.
Accordingly, the Agency tentatively concludes that the proposed rule
does not contain policies that have federalism implications as defined
in the Executive order and, consequently, a federalism summary impact
statement is not required.

IX. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

X. References

    We have not removed any references listed in the July 10, 2012,
proposed rule. We are adding new references 12 and 13 to account for
the additional costs attributable to the FDASIA amendment of section
519(f) of the FD&C Act, specifically the requirement that FDA must
implement the regulation with respect to devices that are implantable,
life-supporting, and life-sustaining not later than 2 years after we
publish a final rule.
    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.
    12. List of medical devices, by product code, that FDA considers to
be implantable, life-saving, and life-sustaining for purposes of
section 614 of FDASIA, amending section 519(f) of the FD&C Act,
November 2012.
    13. Addendum to the Preliminary Regulatory Impact Analysis of the
Proposed Rule to Require a Unique Device Identification System, Docket
No. FDA-2011-N-0090.

List of Subjects in 21 CFR Part 801

    Labeling, Medical devices, Reporting and recordkeeping
requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321 et seq., as amended) and under authority delegated to the
Commissioner of Food and Drugs, it is proposed that 21 CFR part 801, as
proposed to be amended in the Federal Register of July 10, 2012 (77 FR
40736), be further amended as follows:

PART 801--LABELING

    1. The authority citation for part 801 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

Subpart B--[Amended]

    2. Revise Sec.  801.20(b) to read as follows:

Sec.  801.20  Label to bear a unique device identifier (UDI).

* * * * *
    (b) Effective dates. The requirements of paragraph (a) of this
section become effective:
    (1) If the device is a class III medical device or is a device
licensed under section 351 of the Public Health Service Act, as
amended, 5 U.S.C. 262, [A DATE WILL BE ADDED THAT IS 1 YEAR AFTER DATE
OF PUBLICATION OF THE FINAL RULE IN THE Federal Register];
    (2) If the device is an implantable, life-supporting, or life-
sustaining device, and is not a class III device or a device licensed
under section 351 of the Public Health Service Act, as amended, 5
U.S.C. 262, [A DATE WILL BE ADDED THAT IS 2 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
    (3) If the device is a class II medical device not covered by
paragraph (2), [A DATE WILL BE ADDED THAT IS 3 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
    (4) If the device is a class I medical device not covered by
paragraph (2), [A DATE WILL BE ADDED THAT IS 5 YEARS AFTER DATE OF
PUBLICATION OF THE FINAL RULE IN THE Federal Register];
    (5) If the device is not classified into class I, II, or III, [A
DATE WILL BE ADDED THAT IS 5 YEARS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE Federal Register].
* * * * *
    3. Revise Sec.  801.50(d) to read as follows:

Sec.  801.50  Devices that must be directly marked with a unique device
identifier.

* * * * *
    (d) Effective dates. The requirements of this section apply to a
device that is an implantable, life-supporting, or life-sustaining
device [A DATE WILL BE ADDED THAT IS 2 YEARS AFTER DATE OF PUBLICATION
OF THE FINAL RULE IN THE Federal Register], and to any other device 2
years after the date that applies to the device under Sec.  801.20(b).
* * * * *

    Dated: November 14, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28015 Filed 11-16-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 88, Number 14 (Monday, January 23, 2023)]
[Proposed Rules]
[Pages 3933-3935]
[FR Doc No: 2023-01079]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2022-1741; Airspace Docket No. 22-ASO-29]
RIN 2120-AA66

Proposed Amendment of Class E Airspace; Andrews, NC

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to amend Class E airspace extending
upward from 700 feet above the surface for Western Carolina Regional
Airport, Andrews, NC, as a new Area Navigation Global Positioning
System (RNAV GPS) approach has been designed for this airport. This
action would also update the airport's name and geographic coordinates.
Murphy Medical Center would also be removed from the descriptor, as all
instrument approaches into the hospital have been canceled. Controlled
airspace is necessary for the safety and management of instrument
flight rules (IFR) operations in the area.

DATES: Comments must be received on or before March 9, 2023.

ADDRESSES: Send comments on this proposal to: the U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify Docket
No. FAA-2022-1741; Airspace Docket No. 22-ASO-29 at the beginning of
your comments. You may also submit comments through the internet at
www.regulations.gov.
    FAA Order JO 7400.11G Airspace Designations and Reporting Points
and subsequent amendments can be viewed online at www.faa.gov/air_traffic/publications/. For further information, contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; Telephone: (202) 267-
8783.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in

Title 49 of the United States Code. Subtitle I, Section 106 describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the
FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority,
as it would amend airspace in Andrews, NC, to support IFR operations in
the area.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments as they
may desire. Comments that provide a factual basis supporting the views
and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2022-1741 and Airspace Docket No. 22-ASO-29) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2022-1347; Airspace Docket No. 22-ASO-29.'' The postcard
will be dated/time-stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal in this document may be changed in light of the comments
received. All comments submitted will be available for examination in
the public docket before and after the comment closing date. A report
summarizing each substantive public contact with FAA personnel
concerned with this rulemaking will be filed in the docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at
www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received, and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except on federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except for federal holidays at the
office of the Eastern Service Center, Federal Aviation Administration,
Room 350,1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order JO 7400.11G, Airspace
Designations and Reporting Points, dated August 19, 2022, and effective
September 15, 2022. FAA Order JO 7400.11G is publicly available as
listed in the ADDRESSES section of this document. FAA Order JO 7400.11G
lists Class A, B, C, D, and E airspace areas, air traffic service
routes, and reporting points.

The Proposal

    The FAA proposes an amendment to 14 CFR part 71 to amend Class E
airspace extending upward from 700 feet above the surface for Carolina
Regional Airport (formerly Andrews-Murphy Airport), Andrews, NC, as a
new RNAV GPS approach has been designed for this airport. The 6.5-mile
radius would remain, but extensions to the northeast and the southwest
would be created. This action would also update the airport's name and
geographic coordinates. Also, the descriptor header would be updated to
Andrews, NC (formerly Andrews-Murphy, NC). Additionally, Murphy Medical
Center would be removed from the descriptor, as all instrument
approaches into the hospital have been canceled.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order JO 7400.11G, dated August 19, 2022, and effective September
15, 2022, which is incorporated by reference in 14 CFR 71.1. The Class
E airspace designations listed in this document will be published
subsequently in FAA Order JO 7400.11.
    FAA Order JO 7400.11, Airspace Designations and Reporting Points,
is published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures,'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order JO 7400.11G, Airspace Designations and Reporting
Points, dated August 19, 2022, and effective September 15, 2022, is
amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO NC E5 Andrews, NC [Amended]

Western Carolina Regional Airport, NC
    (Lat. 35[deg]11'43'' N, long. 83[deg]51'47'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of the Western Carolina Regional Airport
and within 1.5 miles on each side of the 257[deg] bearing from the
airport, extending from the 6.5-mile radius to 13.5-miles southwest
of the airport, and within 1-mile each side of the 077[deg] bearing
from the airport, extending from the 6.5-mile radius to 11-miles
northeast of the airport.

    Issued in College Park, Georgia, on January 11, 2023.
Andreese C. Davis,
Manager, Airspace & Procedures Team South, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2023-01079 Filed 1-20-23; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 74 (Tuesday, April 17, 2018)]
[Proposed Rules]
[Pages 16792-16794]
[FR Doc No: 2018-07636]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0271; Product Identifier 2017-NM-111-AD]
RIN 2120-AA64

Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly
Known as Saab AB, Saab Aerosystems) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to supersede Airworthiness Directive (AD) 2016-13-
06, which applies to certain Saab AB, Saab Aeronautics Model 340A
(SAAB/SF340A) and SAAB 340B airplanes. AD 2016-13-06 requires a
revision of the applicable airplane flight manual (AFM), repetitive
inspections of the horizontal stabilizer de-icing boots, and applicable
corrective actions. Since we issued AD 2016-13-06, the manufacturer has
developed an improved de-icing boot. This proposed AD would continue to
require a revision of the applicable AFM, repetitive inspections of the
horizontal stabilizer de-icing boots, and applicable corrective
actions. This proposed AD would also require replacement of single
stitched de-icing boots with improved double stitched boots, and re-
identification of the modified horizontal stabilizer leading edge. We
are proposing this AD to address the unsafe condition on these
products.

DATES: We must receive comments on this proposed AD by June 1, 2018.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For service information identified in this NPRM, contact Saab AB,
Saab Aeronautics, SE-581 88, Link[ouml]ping, Sweden; telephone: +46 13
18 5591; fax: +46 13 18 4874; email: [email protected];
internet: http://www.saabgroup.com. You may view this referenced
service information at the FAA, Transport Standards Branch, 2200 South
216th St., Des Moines, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0271; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Operations office (telephone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Shahram Daneshmandi, Aerospace
Engineer, International Section, Transport Standards Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2018-0271;
Product Identifier 2017-NM-111-AD'' at the beginning of your comments.
We specifically invite comments on the overall regulatory, economic,
environmental, and energy aspects of this proposed AD. We will consider
all comments received by the closing date and may amend this proposed
AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued AD 2016-13-06, Amendment 39-18570 (81 FR 41432, June 27,
2016) (``AD 2016-13-06''), for certain Saab AB, Saab Aeronautics Model
340A (SAAB/SF340A) and SAAB 340B airplanes. AD 2016-13-06 was prompted
by reports of ruptured horizontal stabilizer de-icing boots. AD 2016-
13-06 requires a revision of the applicable AFM, repetitive inspections
of the horizontal stabilizer de-icing boots, and applicable corrective
actions. We issued AD 2016-13-06 to detect and correct damage of the
de-icing boot; such damage could lead to a ruptured boot, severe
vibrations, and possible reduced control of the airplane.
    Since we issued AD 2016-13-06, the manufacturer has developed an
improved de-icing boot, reinforced through double stitch lines.
    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA AD
2017-0144, dated August 9, 2017 (referred to after this as the
Mandatory Continuing Airworthiness Information, or ``the MCAI''), to
correct an unsafe condition for certain Saab AB, Saab Aeronautics Model
340A (SAAB/SF340A) and SAAB 340B airplanes. The MCAI states:

    Several occurrences were reported of rupture of the horizontal
stabilizer de-icing boot in flight. In some of the reported events,
the de-icing boot had formed a large open scoop.
    This condition, if not detected and corrected, could lead to
complete loss of the de-icing function within its associated zone
and severe vibrations, possibly resulting in reduced control of the
aeroplane.
    To address this potential unsafe condition, Saab AB, Aeronautics
(hereafter referred to as ``Saab'' in this [EASA] AD) issued Alert
Operations Bulletin (AOB) No. 12 and AOB No. 23 as temporary
measures, recommending to select Flaps 0 for landing in the event of
a suspected rupture of the de-icing boot on the horizontal
stabilizer. In addition, Saab issued SB [Service Bulletin] 340-30-
094 providing instructions for inspection of de-icing boots.

    Consequently, EASA issued AD 2015-0129 [which corresponds to FAA
AD 2016-13-06] to require amendment of the applicable Aircraft
Flight Manual (AFM), repetitive inspections of the horizontal
stabilizer de-icing boots and, depending on findings, accomplishment
of applicable corrective action(s).
    Since that [EASA] AD was issued, Saab developed an improved de-
icing boot, reinforced through double stitch lines, and issued SB
340-30-095 providing instructions for boot replacement.
    For the reason described above, this [EASA] AD retains the
requirements of EASA AD 2015-0129, which is superseded, and requires
replacement of single stitched de-icing boots, installed on the
left-hand (LH) and right-hand (RH) horizontal stabilizer, with
improved double stitched boots, and re-identification of the
modified horizontal stabilizer leading edge.

    You may examine the MCAI in the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0271.

Related Service Information Under 1 CFR Part 51

    Saab AB, Saab Aeronautics has issued the following service
information.
     Service Bulletin 340-30-094, dated March 27, 2015. This
service information describes procedures for repetitive detailed
inspections of the de-icing boots installed on the horizontal
stabilizers, and repair and replacement of damaged de-icing boots.
     Service Bulletin 340-30-095, dated April 3, 2017. This
service information describes procedures for replacement of single
stitched de-icing boots with improved double stitched boots, and re-
identification of the modified horizontal stabilizer leading edge.
    Saab AB, Saab Aeronautics has also issued the following AFMs, which
describe performance limitations and general data. These AFMs are
distinct since they apply to different airplane models in different
configurations.
     AFM 340A 001, Revision 57, dated March 27, 2015.
     AFM 340B 001, Revision 35, dated March 27, 2015.
     AFM 340B 010, Revision 28, dated March 27, 2015.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of these
same type designs.

Costs of Compliance

    We estimate that this proposed AD affects 51 airplanes of U.S.
registry.
    The actions required by AD 2016-13-06, and retained in this
proposed AD take about 6 work-hours per product, at an average labor
rate of $85 per work-hour. Based on these figures, the estimated cost
of the actions that are required by AD 2016-13-06 is $510 per product.
    In addition, we estimate that any necessary follow-on actions
required by AD 2016-13-06, and retained in this proposed AD take about
6 work-hours and require parts costing $9,500, for a cost of $10,010
per product. We have no way of determining the number of aircraft that
might need these actions.
    We also estimate that it would take about 6 work-hours per product
to comply with the basic requirements of this proposed AD. The average
labor rate is $85 per work-hour. Required parts would cost about
$13,500 per product. Based on these figures, we estimate the cost of
this proposed AD on U.S. operators to be $714,510, or $14,010 per
product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes to
the Director of the System Oversight Division.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2016-13-06, Amendment 39-18570 (81 FR 41432, June 27, 2016), and adding
the following new AD:

Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab
Aerosystems): Docket No. FAA-2018-0271; Product Identifier 2017-NM-
111-AD.

(a) Comments Due Date

    We must receive comments by June 1, 2018.

(b) Affected ADs

    This AD replaces AD 2016-13-06, Amendment 39-18570 (81 FR 41432,
June 27, 2016) (``AD 2016-13-06'').

(c) Applicability

    This AD applies to Saab AB, Saab Aeronautics (formerly known as
Saab AB, Saab Aerosystems) airplanes, certificated in any category,
identified in paragraphs (c)(1) and (c)(2), of this AD.
    (1) Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A)
airplanes, serial numbers 004 through 138 inclusive, if Saab
modification 1462 has been embodied in production, or Saab Service
Bulletin 340-55-008 has been embodied in service, except those that
have also embodied Saab modification 1793 in production, or Saab
Service Bulletin 340-55-010 in service; and serial numbers 139
through 159 inclusive.
    (2) Saab AB, Saab Aeronautics Model SAAB 340B airplanes, serial
numbers 160 through 459 inclusive.

(d) Subject

    Air Transport Association (ATA) of America Code 30, Ice and rain
protection.

(e) Reason

    This AD was prompted by reports of ruptured horizontal
stabilizer de-icing boots. We are issuing this AD to detect and
correct ruptured horizontal stabilizer de-icing boots, which could
lead to complete loss of the de-icing function within its associated
zone and severe vibrations, possibly resulting in reduced control of
the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Retained Revision of the Airplane Flight Manual (AFM), With No
Changes

    This paragraph restates the requirements of paragraph (g) of AD
2016-13-06, with no changes. Within 30 days after August 1, 2016
(the effective date of AD 2016-13-06), revise the ``Abnormal
Procedures'' section of the applicable Saab 340 AFM to incorporate
the revision specified in paragraphs (g)(1) through (g)(3) of this
AD.
    (1) For Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A)
airplanes, revise AFM 340A 001 by incorporating Revision 57, dated
March 27, 2015.
    (2) For Saab AB, Saab Aeronautics Model SAAB 340B airplanes,
revise AFM 340B 001 by incorporating Revision 35, dated March 27,
2015.
    (3) For Saab AB, Saab Aeronautics Model SAAB 340B airplanes with
extended wing tips, revise AFM 340B 010 by incorporating Revision
28, dated March 27, 2015.

(h) Retained Inspection/Replacement, With No Changes

    This paragraph restates the requirements of paragraph (h) of AD
2016-13-06, with no changes. Within 400 flight hours or 6 months,
whichever occurs first after August 1, 2016 (the effective date of
AD 2016-13-06), do a detailed inspection for damage of the
horizontal stabilizer de-icing boots, and existing repairs of
horizontal stabilizer de-icing boots, in accordance with the
Accomplishment Instructions of Saab Service Bulletin 340-30-094,
dated March 27, 2015. Repeat the inspection thereafter at intervals
not to exceed 400 flight hours. If, during any inspection required
by this paragraph, any damage or existing repair outside the limits
specified in Saab Service Bulletin 340-30-094, dated March 27, 2015,
is found, before further flight, repair or replace the horizontal
stabilizer de-icing boots, in accordance with the Accomplishment
Instructions of Saab Service Bulletin 340-30-094, dated March 27,
2015. Repair or replacement on an airplane of the horizontal
stabilizer de-icing boots, as required by this paragraph, does not
constitute terminating action for the repetitive inspections
required by this paragraph for that airplane.

(i) New Requirement of This AD: Modification

    Within 18 months after the effective date of this AD, modify the
airplane by replacing the single stitched de-icing boots installed
on the left-hand (LH) and right-hand (RH) horizontal stabilizers
with double stitched de-icing boots and re-identify the LH and RH
horizontal stabilizer leading edge, in accordance with the
Accomplishment Instructions of Saab Service Bulletin 340-30-095,
dated April 3, 2017.

(j) Terminating Action

    Modification of the airplane as required by paragraph (i) of
this AD, constitutes terminating action for the repetitive
inspections required by paragraph (h) of this AD, for that airplane.

(k) Other FAA AD Provisions

    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Section, Transport Standards Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the International Section, send it to the attention of
the person identified in paragraph (l)(2) of this AD. Information
may be emailed to: [email protected]. Before using any
approved AMOC, notify your appropriate principal inspector, or
lacking a principal inspector, the manager of the local flight
standards district office/certificate holding district office.
    (2) Contacting the Manufacturer: As of the effective date of
this AD, for any requirement in this AD to obtain corrective actions
from a manufacturer, the action must be accomplished using a method
approved by the Manager, International Section, Transport Standards
Branch, FAA; or the European Aviation Safety Agency (EASA); or Saab
AB, Saab Aeronautics EASA Design Organization Approval (DOA). If
approved by the DOA, the approval must include the DOA-authorized
signature.

(l) Related Information

    (1) Refer to Mandatory Continuing Airworthiness Information
(MCAI) EASA AD 2017-0144, dated August 9, 2017, for related
information. This MCAI may be found in the AD docket on the internet
at http://www.regulations.gov by searching for and locating Docket
No. FAA-2018-0271.
    (2) For more information about this AD, contact Shahram
Daneshmandi, Aerospace Engineer, International Section, Transport
Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax:<PHONE_NUMBER>.
    (3) For service information identified in this AD, contact Saab
AB, Saab Aeronautics, SE-581 88, Link[ouml]ping, Sweden; telephone:
+46 13 18 5591; fax: +46 13 18 4874; email:
[email protected]; internet: http://www.saabgroup.com. You may view this service information at the FAA,
Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA,
call<PHONE_NUMBER>.

    Issued in Des Moines, Washington, on March 30, 2018.
Chris Spangenberg,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2018-07636 Filed 4-16-18; 8:45 am]
 BILLING CODE 4910-13-P


IMPORTANT NOTE TO USER:

This OMB form has been recreated in WP6.0 by OPPTS staff. The margins and lines are NOT block protected, so you must fill the form with caution, paying attention to any shifting of the existing text. The following tips should make this a simple task:

 Fill in the spaces by using the type over command. Otherwise you'll have to delete a space for each letter you add.

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If you have any problems or questions, please call your RID Desk Officer @ 260 2706. PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request U. S. Environmental Protection Agency, Office of Water, Office of Science and Technology 2. OMB control number b. x None a _ 2040_ __ __ __

3. Type of information collection ( check one) a. X New collection b. G Revision of a currently approved collection c. G Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title: Information Collection Request for the National Listing of Advisories 8. Agency form number( s) ( If applicable) 1959.01 9. Keywords: Public Health, Water Pollution Control 10. Abstract: EPA believes there is a need to improve the overall quality and availability of public information about the health risks associated with the consumption of chemically contaminated fish and shellfish, which includes but is not limited to, water quality standards, monitoring and assessment activities, and the issuance of fish advisories. State, territorial, and tribal health departments or environmental agencies share responsibility for these activities. Consequently, EPA's Office of Water will conduct an annual fish advisory survey. The survey will be sent to environmental health officials in state, territorial, and tribal agencies. The survey will obtain and verify information on the waterbodies currently under advisory, the location of the waterbodies, waterbody type, fish species cited in the advisory, the pollutant cited in the advisory, the type of advisory issued including the population of concern, and the residue data used to assess the need to issue the advisory. In addition, the survey will obtain information on the agency and persons responsible for maintaining and issuing advisories in freshwater lakes and rivers, and estuarine and coastal marine waters nationwide. The survey also obtains information on the monitoring design used, the risk assessment methodology employed, and risk communication practices used. Responses to the survey ( either on paper or electronically via the Internet) are required to assess public health risks of consuming locally caught fish and shellfish and to determine what steps EPA should take next, if any. Completion of the questionnaire is voluntary.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. Business or other for profit e. X Federal Government c. Not for profit institutions f. P State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. X Voluntary b. G Required to obtain or retain benefits c. G Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 92 b. Total annual responses 92 1. Percentage of these responses collected electronically 90 % c. Total hours requested 3,565 d. Current OMB inventory 0 e. Difference 3,565 f. Explanation of difference 1. Program Change 3,565 2. Adjustment 0 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs $ 0 b. Total annual costs ( O& M) $ 1 c. Total annualized cost requested $ 1 d. Current OMB inventory $ 0 e. Difference $ 1 f. Explanation of difference 1. Program change $ 1 2. Adjustment $ 0 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. X_ Program planning or management b P Program evaluation f. _ X_ Research c. __ General purpose statistics g. __ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. Q Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. X Annually 7. Q Biannually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Jeffrey Bigler Phone: 202 260 1305 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( I) Why the information is being collected' ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( I) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( I) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( I) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95