[Federal Register Volume 82, Number 37 (Monday, February 27, 2017)]
[Rules and Regulations]
[Pages 11797-11800]
[FR Doc No: 2017-03265]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2015-3984; Directorate Identifier 2015-NM-033-AD;
Amendment 39-18803; AD 2017-04-08]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are superseding Airworthiness Directive (AD) 2008-13-12 R1
for certain The Boeing Company Model 737-100, -200, -200C, -300, -400,
and -500 series airplanes. AD 2008-13-12 R1 required various repetitive
inspections for cracking of a certain splice of the fuselage, and other
specified and corrective actions if necessary; and provided for an
optional preventive modification, which terminated the repetitive
inspections. This new AD adds an inspection to determine if the
existing frame repair meets all specified requirements; a modification
of a certain splice, which terminates the repetitive inspections;
reduces certain inspection thresholds and repetitive intervals; and
adds post-repair/post-modification inspections. This AD was prompted by
reports of additional fatigue cracking of a certain splice of the
fuselage and one report of a severed frame, due to susceptibility to
widespread fatigue damage (WFD). We are issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective April 3, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of April 3,
2017.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes,

Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd.,
MC 110-SK57, Seal Beach, CA 90740; telephone<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com. You may view this referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, WA. For information on the availability of this
material at the FAA, call<PHONE_NUMBER>. It is also available on the
Internet at http://www.regulations.gov by searching for and locating
Docket No. FAA-2015-3984.

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-2015-
3984; 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 AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200
New Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Galib Abumeri, Aerospace Engineer,
Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification
Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone:
562-627-5324; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a supplemental notice of proposed rulemaking (SNPRM) to
amend 14 CFR part 39 to supersede AD 2008-13-12 R1, Amendment 39-15719
(73 FR 67383, November 14, 2008) (``AD 2008-13-12 R1''). AD 2008-13-12
R1 applied to certain The Boeing Company Model 737-100, -200, -200C, -
300, -400, and -500 series airplanes. The SNPRM published in the
Federal Register on November 14, 2016 (81 FR 79395). We preceded the
SNPRM with a notice of proposed rulemaking (NPRM) that published in the
Federal Register on October 9, 2015 (80 FR 61133). The NPRM proposed to
continue to require the actions of AD 2008-13-12 R1. The NPRM also
proposed to add, for certain airplanes, an inspection to determine if
the existing frame repair meets all specified requirements, and for
certain other airplanes, a new modification of the upper-frame-to-side-
frame splice, which would terminate the repetitive inspections. The
NPRM also proposed to reduce certain inspection thresholds and
repetitive intervals. The NPRM was prompted by reports of additional
fatigue cracking of the upper-frame-to-side-frame splice of the
fuselage, and one report of a severed frame. The SNPRM proposed to add
post-repair/post-modification inspections that were not included in the
NPRM. We are issuing this AD to detect and correct fatigue cracking of
the upper-frame-to-side-frame splice of the fuselage, which could
result in reduced structural integrity of the frame and adjacent lap
joint, causing increased loading in the fuselage skin, which will
accelerate skin crack growth and could result in decompression of the
airplane.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the comment received. The commenter,
Stephanie Reid, agreed that the airplanes should be inspected.

Conclusion

    We reviewed the relevant data, considered the comment received, and
determined that air safety and the public interest require adopting
this AD as proposed, except for minor editorial changes. We have
determined that these minor changes:
     Are consistent with the intent that was proposed in the
SNPRM for correcting the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the SNPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 737-53A1261, Revision 1,
dated January 30, 2015. The service information describes procedures
for various repetitive inspections for cracking of the upper-frame-to-
side-frame splice of the fuselage, a preventive modification to prevent
WFD, an inspection to determine if the existing frame repair meets all
specified requirements, and corrective actions. 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.

Costs of Compliance

    We estimate that this AD affects 391 airplanes of U.S. registry.
    We estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
             Action                     Labor cost          Parts cost     Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Retained inspections from AD     Between 18 and 38 work-              $0  Between $1,530 and  Between $598,230
 2008-13-12 R1.                   hours x $85 per hour,                    $3,230 per          and $1,262,930,
                                  depending on airplane                    inspection cycle.   per inspection
                                  configuration =                                              cycle.
                                  between $1,530 and
                                  $3,230 per inspection
                                  cycle.
New inspections................  213 work[dash]hours x                $0  $18,105 per         Up to $7,079,055,
                                  $85 per hour, $18,105                    inspection cycle.   per inspection
                                  per inspection cycle.                                        cycle.
New modification...............  256 work-hours x $85              (\1\)  $21,760...........  Up to $8,508,160.
                                  per hour = $21,760.
----------------------------------------------------------------------------------------------------------------
\1\ We currently have no specific cost estimates associated with the parts necessary for the modification.

    We have received no definitive data that would enable us to provide
a cost estimate for the on-condition actions specified in this AD.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, Section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701, ``General
requirements.'' Under that

section, Congress charges the FAA with promoting safe flight of civil
aircraft in air commerce by prescribing regulations for practices,
methods, and procedures the Administrator finds necessary for safety in
air commerce. This regulation is within the scope of that authority
because it addresses an unsafe condition that is likely to exist or
develop on products identified in this rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2008-13-12 R1, Amendment 39-15719 (73 FR 67383, November 14, 2008), and
adding the following new AD:

2017-04-08 The Boeing Company: Amendment 39-18803; Docket No. FAA-
2015-3984; Directorate Identifier 2015-NM-033-AD.

(a) Effective Date

    This AD is effective April 3, 2017.

(b) Affected ADs

    This AD replaces AD 2008-13-12 R1, Amendment 39-15719 (73 FR
67383, November 14, 2008) (``AD 2008-13-12 R1'').

(c) Applicability

    (1) This AD applies to The Boeing Company Model 737-100, -200, -
200C, -300, -400, and -500 series airplanes, certificated in any
category, as identified in Boeing Alert Service Bulletin 737-
53A1261, Revision 1, dated January 30, 2015.
    (2) Installation of Supplemental Type Certificate (STC)
ST01219SE (http://rgl.faa.gov/Regulatory_and_Guidance_Library/rgstc.nsf/0/BE866B732F6CF31086257B9700692796?OpenDocument&Highlight=st01219se)
does not affect the ability to accomplish the actions required by
this AD. Therefore, for airplanes on which STC ST01219SE is
installed, a ''change in product'' alternative method of compliance
(AMOC) approval request is not necessary to comply with the
requirements of 14 CFR 39.17.

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Unsafe Condition

    This AD was prompted by reports of additional fatigue cracking
of the upper-frame-to-side-frame splice of the fuselage, and one
report of a severed frame due to susceptibility to widespread
fatigue damage (WFD). We are issuing this AD to detect and correct
fatigue cracking of the upper-frame-to-side-frame splice of the
fuselage, which could result in reduced structural integrity of the
frame and adjacent lap joint, causing increased loading in the
fuselage skin, which will accelerate skin crack growth and could
result in decompression of the airplane.

(f) Compliance

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

(g) Repetitive Inspections and Corrective Actions for Certain Airplanes

    (1) For Groups 1 through 3, Configurations 1, 3, 4, and 5
airplanes; Group 7, Configurations 1, 3, 4, and 5 airplanes; Groups
4 through 6, Configurations 1, 3, 4, and 6 airplanes; and Groups 8
through 11, Configurations 1, 3, 4, and 6 airplanes; as identified
in Boeing Alert Service Bulletin 737-53A1261, Revision 1, dated
January 30, 2015: Do the actions specified in paragraphs (g)(1)(i)
and (g)(1)(ii) of this AD, and all applicable corrective actions, in
accordance with the Accomplishment Instructions of Boeing Alert
Service Bulletin 737-53A1261, Revision 1, dated January 30, 2015,
except as required by paragraph (i)(3) of this AD. Do all applicable
corrective actions before further flight.
    (i) At the applicable time specified in Tables 1, 2, 3, 5, 6,
and 8 of paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 737-53A1261, Revision 1, dated January 30, 2015, except as
required by paragraphs (i)(1) and (i)(2) of this AD: Do medium
frequency eddy current inspections for cracking of the upper-frame-
to-side-frame splice of the fuselage.
    (ii) Repeat the inspections specified in paragraph (g)(1)(i) of
this AD at the applicable time specified in Tables 1, 2, 3, 5, 6,
and 8 of paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 737-53A1261, Revision 1, dated January 30, 2015, until the
preventive modification required by paragraph (k) of this AD, or a
terminating action specified in paragraph (l) of this AD, has been
accomplished. The inspections are terminated for the repaired or
modified areas only.
    (2) For Groups 4 through 6, Configurations 2 and 5 airplanes;
and Groups 8 through 11, Configurations 2 and 5 airplanes; as
identified in Boeing Alert Service Bulletin 737-53A1261, Revision 1,
dated January 30, 2015: Do the actions specified in paragraphs
(g)(2)(i) and (g)(2)(ii) of this AD, and all applicable corrective
actions, in accordance with the Accomplishment Instructions of
Boeing Alert Service Bulletin 737-53A1261, Revision 1, dated January
30, 2015, except as required by paragraph (i)(3) of this AD. Do all
applicable corrective actions before further flight.
    (i) At the applicable time specified in Tables 4 and 7 of
paragraph 1.E., ``Compliance,'' of Boeing Alert Service Bulletin
737-53A1261, Revision 1, dated January 30, 2015, except as required
by paragraphs (i)(1) and (i)(2) of this AD: Do a detailed inspection
to determine if the existing frame repair meets all requirements
specified in Boeing Alert Service Bulletin 737-53A1261, Revision 1,
dated January 30, 2015, and for any frame repair that does meet all
requirements, do detailed and high frequency eddy current (HFEC)
inspections for cracking of the existing frame repairs.
    (ii) Repeat the inspections for cracking specified in paragraph
(g)(2)(i) of this AD at the applicable time specified in Tables 4
and 7 of paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 737-53A1261, Revision 1, dated January 30, 2015.

(h) Post-Repair and Post-Modification Actions for Certain Airplanes

    For Group 1, Configurations 2 and 6 airplanes; Group 2,
Configurations 2 and 6 airplanes; Group 3, Configurations 2 and 6
airplanes; and Group 7, Configurations 2 and 6 airplanes; as
identified in Boeing Alert Service Bulletin 737-53A1261, Revision 1,
dated January 30, 2015: Within 120 days after the effective date of
this AD, do post-repair and post-modification actions using a method
approved in accordance with the procedures specified in paragraph
(n) of this AD.

(i) Exceptions to Service Bulletin Specifications

    (1) Where Boeing Alert Service Bulletin 737-53A1261, Revision 1,
dated January 30, 2015, specifies a compliance time ``after the
Revision 1 date of this service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.
    (2) Where the ``Condition'' column of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1261,

Revision 1, dated January 30, 2015, specifies a condition based on
whether an airplane has or has not been inspected, this AD bases the
condition on whether an airplane has or has not been inspected as of
the effective date of this AD.
    (3) Where Boeing Alert Service Bulletin 737-53A1261, Revision 1,
dated January 30, 2015, specifies to contact Boeing for repair
instructions: Before further flight, repair using a method approved
in accordance with the procedures specified in paragraph (n) of this
AD.

(j) Post-Repair and Post-Modification Inspections

    For Groups 4 through 6, Configurations 1, 3, 4, 6, 7, 8, 9, and
10 airplanes; and Groups 8 through 11, Configurations 1, 3, 4, 6, 7,
8, 9, and 10 airplanes; as identified in Boeing Alert Service
Bulletin 737-53A1261, Revision 1, dated January 30, 2015: Except as
provided by paragraphs (i)(1) and (i)(2) of this AD, at the
applicable time specified in Tables 12 through 17 of paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 737-53A1261,
Revision 1, dated January 30, 2015; do the post-repair/post-
modification inspections, in accordance with the Accomplishment
Instructions of Boeing Alert Service Bulletin 737-53A1261, Revision
1, dated January 30, 2015, except as required by paragraph (i)(3) of
this AD. Do all applicable corrective actions before further flight.

(k) Preventive Modification for Certain Airplanes

    For Groups 4 through 6, Configurations 1, 3, 4, and 6 airplanes;
and Groups 8 through 11, Configurations 1, 3, 4, and 6 airplanes; as
identified in Boeing Alert Service Bulletin 737-53A1261, Revision 1,
dated January 30, 2015: Except as provided by paragraphs (i)(1) and
(i)(2) of this AD, at the applicable time specified in Tables 3, 5,
6, and 8 in paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 737-53A1261, Revision 1, dated January 30, 2015, do the
preventive modification, including HFEC inspections for cracking and
applicable corrective actions, in accordance with Part 4 of the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
53A1261, Revision 1, dated January 30, 2015, except as required by
paragraph (i)(3) of this AD. Do all applicable corrective actions
before further flight. Accomplishing the modification required by
this paragraph terminates the inspections required by paragraph
(g)(1) of this AD for the modified area only.

(l) Terminating Action

    (1) For Groups 4 through 6, Configurations 1, 3, 4, and 6
airplanes; and Groups 8 through 11, Configurations 1, 3, 4, and 6
airplanes; as identified in Boeing Alert Service Bulletin 737-
53A1261, Revision 1, dated January 30, 2015: Accomplishing the
preventive modification, including HFEC inspections for cracking and
applicable corrective actions, in accordance with Part 4 of the
Accomplishment Instructions of Boeing Alert Service Bulletin 737-
53A1261, Revision 1, dated January 30, 2015, except as required by
paragraph (i)(3) of this AD, terminates the inspections required by
paragraph (g)(1) of this AD for the modified area only.
    (2) For Groups 4 through 6, Configurations 3 and 6 airplanes;
and Groups 8 through 11, Configurations 3 and 6 airplanes; as
identified in Boeing Alert Service Bulletin 737-53A1261, Revision 1,
dated January 30, 2015: Accomplishing the repair, including HFEC
inspections for cracking and applicable corrective actions, in
accordance with Part 3 of the Accomplishment Instructions of Boeing
Alert Service Bulletin 737-53A1261, Revision 1, dated January 30,
2015, except as required by paragraph (i)(3) of this AD, terminates
the repetitive inspections required by paragraph (g)(1) of this AD,
and the preventive modification required by paragraph (k) of this
AD, for the repaired area only.
    (3) Accomplishment of the repair or the preventive modification
specified in Boeing Message M-7200-02-1294, dated August 20, 2002,
before the effective date of this AD terminates the repetitive
inspections required by paragraph (g)(1) of this AD and the
preventive modification required by paragraph (k) of this AD for the
repaired or modified area only.

(m) Credit for Previous Actions

    (1) This paragraph provides credit for the inspections required
by paragraph (g) of this AD, if those inspections were performed
before the effective date of this AD using Boeing Alert Service
Bulletin 737-53A1261, dated January 19, 2006, which was incorporated
by reference in AD 2008-13-12, Amendment 39-15575 (73 FR 38905, July
8, 2008) (``AD 2008-13-12'').
    (2) This paragraph provides credit for the modification
specified in paragraphs (k) and (l)(1) of this AD, if the
modification was performed before the effective date of this AD
using Boeing Alert Service Bulletin 737-53A1261, dated January 19,
2006, which was incorporated by reference in AD 2008-13-12.
    (3) This paragraph provides credit for repairs specified in
paragraphs (l)(2) of this AD, if those repairs were performed before
the effective date of this AD using Boeing Alert Service Bulletin
737-53A1261, dated January 19, 2006, which was incorporated by
reference in AD 2008-13-12.

(n) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office
(ACO), 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 manager of the ACO, send it to the
attention of the person identified in paragraph (o)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) 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.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD if it is approved by the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that has been authorized by the Manager, Los Angeles ACO, to
make those findings. For a repair method to be approved, the repair
must meet the certification basis of the airplane, and the approval
must specifically refer to this AD.
    (4) AMOCs approved for AD 2008-13-12 and AD 2008-13-12 R1 are
approved as AMOCs for the corresponding provisions of paragraph (g)
of this AD.

(o) Related Information

    (1) For more information about this AD, contact Galib Abumeri,
Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles
Aircraft Certification Office (ACO), 3960 Paramount Boulevard,
Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>    (2) Service information identified in this AD that is not
incorporated by reference is available at the addresses specified in
paragraphs (p)(3) and (p)(4) of this AD.

(p) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 737-53A1261, Revision 1, dated
January 30, 2015.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740;
telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on February 1, 2017.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-03265 Filed 2-24-17; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 169 (Thursday, August 30, 2018)]
[Notices]
[Pages 44273-44274]
[FR Doc No: 2018-18775]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1041]

Development of a Shared System Risk Evaluation and Mitigation
Strategy; Draft Guidance for Industry; Availability; Reopening of the
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notice of availability for
``Development of a Shared System Risk Evaluation and Mitigation
Strategy; Draft Guidance for Industry,'' published in the Federal
Register of June 1, 2018. The Agency has received a request for an
extension of the comment period for the draft guidance.

DATES: FDA is reopening the comment period on the notice of
availability published June 1, 2018 (83 FR 25468). Submit either
electronic or written comments on the draft guidance by September 13,
2018 to ensure that the Agency considers your comment on this draft
guidance before it begins work on the final version of the guidance.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted,

such as medical information, your or anyone else's Social Security
number, or confidential business information, such as a manufacturing
process. Please note that if you include your name, contact
information, or other information that identifies you in the body of
your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-D-1041 for ``Development of a Shared System Risk Evaluation
and Mitigation Strategy; Draft Guidance for Industry.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lubna Merchant, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4418, Silver Spring, MD 20993-0002, 301-
796-5162, email: [email protected]; or Stephen Ripley, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 1, 2018 (83 FR 25468), FDA
published a notice of availability with a 60-day comment period to
request comments on the draft guidance for industry entitled
``Development of a Shared System Risk Evaluation and Mitigation
Strategy.''
    The Agency has received a request for an extension of the comment
period for the draft guidance. FDA has considered the request and is
reopening the comment period for the draft guidance until September 13,
2018. The Agency believes that a 14-day reopening of the comment period
allows adequate time for interested persons to submit comments to
ensure that the Agency can consider the comments on this draft guidance
before it begins work on the final version of the guidance.

II. Electronic Access

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

    Dated: August 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-18775 Filed 8-29-18; 8:45 am]
BILLING CODE 4164-01-P


SUPPORTING STATEMENT FOR EPA INFORMATION COLLECTION REQUEST NUMBER 1189.16 " CONDITIONAL EXCLUSION FOR USED CATHODE RAY TUBES "

March 29, 2004 TABLE OF CONTENTS 1. IDENTIFICATION OF THE INFORMATION COLLECTION . . . . . . . . . . . . . . . . . . 1 1( a) Title and Number of the Information Collection . . . . . . . . . . . . . . . . . . . . . . . . . 1 1( b) Short Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 2. NEED FOR AND USE OF THE COLLECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2( a) Need and Authority for the Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 2( b) Practical Utility and Users of the Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( a) Nonduplication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( b) Public Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( c) Consultations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( d) Effects of Less Frequent Collection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 3( e) General Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3( f) Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 3( g) Sensitive Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4. THE RESPONDENTS AND THE INFORMATION REQUESTED . . . . . . . . . . . . . . . 4 4( a) Respondents and SIC/ NAICS Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 4( b) Information Requested . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT . . . . . . . . . . . . . . . . . . . 9 5( a) Agency Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 5( b) Collection Methodology and Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5( c) Small Entity Flexibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 5( d) Collection Schedule . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 6. ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION . . . . . . 12 6( a) Estimating Respondent Burden Hours . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6( b) Estimating Respondent Costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6( c) Estimating Agency Hour and Cost Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 6( d) Estimating the Respondent Universe and Total Hour and Cost Burden . . . . . . . 13 6( e) Bottom Line Hour and Cost Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 6( f) Reasons for Change In Burden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 6( g) Public Burden Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 1 1. IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title and Number of the Information Collection This Information Collection Request ( ICR) is entitled " Conditional Exclusion for Used Cathode Ray Tubes," EPA ICR Number 1189.16.

1( b) Short Characterization Section 3001 of the Resource Conservation and Recovery Act of 1976 ( RCRA), as amended, requires the U. S. Environmental Protection Agency ( EPA) to identify substances that must be managed as hazardous waste during treatment, storage, or disposal. Under this authority, EPA has established four hazardous waste characteristics ( i. e., toxicity, reactivity, ignitability, and corrosivity), and has listed specific wastes that must be managed as hazardous. Waste cathode ray tube ( CRT) glass often is hazardous because it exhibits the characteristic of toxicity by exceeding the regulatory level for lead. As a result, many CRTs are subject to controls under RCRA hazardous waste regulations.

To encourage greater reuse, recycling, and better management of this growing waste stream, EPA is amending the RCRA hazardous waste regulations by establishing a conditional exclusion for used CRTs. Under the conditional exclusion, used CRTs and glass removed from CRTs sent for recycling are excluded from the definition of solid waste, if they meet specified conditions.

In Sections 1 through 5 of this ICR, EPA presents a comprehensive description of the new information collection requirements resulting from the conditional exclusion for used CRTs. In Section 6, EPA estimates the total annual hour and cost burden to respondents associated with these new information collection requirements. In addition, EPA estimates in Section 6( d) the total annual hour and cost savings to generators and subsequent waste handlers for no longer complying with existing RCRA information collection requirements in managing their excluded CRTs.

In the following paragraphs, EPA briefly describes the new information collection requirements contained in the final rule.

( 1) Labels Under 40 CFR 261.39( a)( 2), generators of used CRTs destined for recycling must label or mark clearly each container in which used, broken CRTs are contained with one of the following phrases: " Used cathode ray tube( s)  contains leaded glass" or " Used cathode ray tube( s)  contains leaded glass from televisions or computers." Generators also must label each container with the words: " Do not mix with other glass materials." 2 ( 2) Export Notification for Used CRTs Destined for Recycling Under 40 CFR 261.39( a)( 5), exporters of used, broken CRTs must provide written notification to EPA of an intended export before the CRTs are scheduled to leave the U. S. Upon request by EPA, the exporter must furnish to EPA any additional information that a receiving country requests in order to respond to a notification. Exporters must keep copies of notifications and consents for a period of three years following receipt of the consent.

Under 40 CFR 261.40, exporters of used, intact CRTs destined for recycling must meet the conditions of section 261.39( a)( 5).

( 3) Export Notification for Used CRTs Destined for Reuse Under 40 CFR 261.41, exporters of used, intact CRTs for reuse must send a one time notification to EPA. In addition, they must keep copies of normal business records ( e. g., contracts) demonstrating that each shipment of exported CRTs will be reused. This documentation must be retained for a period of at least three years from the date the CRTs were exported.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need and Authority for the Collection EPA is establishing a conditional exclusion from the definition of solid waste for used CRTs and glass removed from CRTs sent for recycling under the authority of Sections 2002( a), 3001, 3002, 3004, and 3006 of RCRA, as amended. EPA believes the information collection requirements covered in this ICR are needed to ensure that the excluded CRTs are properly managed, and to facilitate enforcement of the regulations.

In particular, the labeling requirement is necessary to alert anyone handling the containers with the used, broken CRTs of what is enclosed in the container so that proper handling ( or inspection) may occur. The notification requirements are necessary to assist the Agency in identifying and tracking exporters of used CRTs.

2( b) Practical Utility and Users of the Data EPA will use the collected information to ensure that excluded CRTs are being managed in a protective manner. Information marked on CRT containers will assist generators, processors, and transporters ensure proper handling during storage and shipment. Notifications submitted to EPA will aid the Agency in identifying and tracking exporters of used CRTs. In addition, information kept in facility records will help exporters of used CRTs demonstrate, and on site inspectors ensure, that the excluded CRTs are being properly managed. 3 3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Nonduplication Most of the information required by the regulations covered in this ICR is not available from any source but the respondents. Therefore, this information does not duplicate other Federal program requirements. In addition, the regulations relieve generators and subsequent handlers of used CRTs from some of RCRA's information collection requirements, as specified.

3( b) Public Notice In compliance with the Paperwork Reduction Act of 1995, EPA issued a public notice in the Federal Register on June 12, 2002 ( 67 FR 40508). The public comment period extended through August 12, 2002. EPA reviewed public comments received in response to the notice and has addressed comments received, as appropriate.

3( c) Consultations For over two years, EPA worked on a collaborative basis with the Computers and Electronics Sector of the Common Sense Initiative ( CSI) Council in developing the CRT standards. This workgroup consisted of representatives of environmental groups, industry trade associations, CRT glass manufacturers, CRT glass recyclers, electronics Original Equipment Manufacturers ( OEMs), academic experts, States ( California, Massachusetts, Minnesota, and New Jersey), EPA, and expert consultants in the environmental, legal/ regulatory, worker health and safety, and environmental justice issues. Recommendations provided by this workgroup were considered in establishing the information collection requirements under the final rule.

In addition, a proposed ICR was published in conjunction with the proposed rule and the public, including potential respondents, had the opportunity to provide comment and input on the assumptions and cost estimates provided in the proposed ICR. Any information provided to EPA, or OMB, in response to the proposed ICR and/ or the Economics Background Document developed for the proposed rule was reviewed by the Agency in developing this ICR for the final rule.

3( d) Effects of Less Frequent Collection EPA has carefully considered the information collection burden imposed upon the regulated community by the final rule. EPA is confident that those activities required of respondents are necessary, and to the extent possible, the Agency has attempted to minimize the burden imposed. EPA believes strongly that, if the minimum information collection requirements of the final rule are not met, neither the respondents ( e. g., generators, processors, exporters) nor 4 EPA can ensure that excluded CRTs are being properly managed, and do not pose a serious threat to human health and the environment.

3( e) General Guidelines This ICR adheres to the guidelines stated in the Paperwork Reduction Act of 1995, OMB's implementing regulations, EPA's ICR Handbook, and other applicable OMB guidance.

3( f) Confidentiality Section 3007( b) of RCRA; 40 CFR part 2, subpart B; and 40 CFR 260.2 contain provisions for confidentiality. If a business asserts a claim of confidentiality covering any of the information collection requirements covered in this ICR, EPA must and will treat the information in accordance with the regulations cited above. EPA also will assure that this information collection complies with the Privacy Act of 1974 and OMB Circular 108.

3( g) Sensitive Questions No questions of a sensitive nature are included in any of the information collection requirements.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents and SIC/ NAICS Codes The following is a list of Standard Industrial Classification ( SIC) codes and corresponding North American Industry Classification System ( NAICS) codes associated with industries most likely affected by the information collection requirements covered in this ICR.

Industry SIC Code NAICS Code AGRICULTURE Agricultural crop production 01 111 Agricultural livestock production 02 112 Agricultural services 07 115, 311, 541, 561, 812 Forestry 08 111, 113, 115 Fishing, hunting, trapping 09 111, 112, 114 MINING Metal mining 10 212, 213 Coal mining 12 212, 213 Oil & gas extraction 13 211, 213 Non metallic minerals, except fuels 14 212, 213 5 Industry SIC Code NAICS Code CONSTRUCTION General contractors 15 233 235 Heavy construction 16 233 235 Special trade contractors 17 233 235 MANUFACTURING Food & kindred products 20 111, 311, 312 Tobacco products 21 312 Textile mill products 22 313 315 Apparel & other textile products 23 313 315, 336, 339 Lumber & wood products 24 113, 321, 333 Furniture & fixtures 25 336, 337, 339 Paper & allied products 26 322, 326 Printing & publishing 27 323, 511, 512 Chemicals & allied products 28 211, 311, 325, 331 Petroleum and coal products 29 324 Rubber & miscellaneous plastics products 30 316, 325, 326, 337, 339 Leather & leather products 31 315, 316, 321 Stone, clay, and glass products 32 212, 327 Primary metal industries 33 331 Fabricated metal products 34 332, 337, 339 Industrial machinery & equipment 35 331 335, 339 Electronic & other electronic equipment 36 332 336, 512 Transportation equipment 37 332, 333, 336, 488, 541, 811 Instrument & related products 38 322, 325, 333, 334, 339 Miscellaneous manufacturing 39 325, 336, 339, 488 TRANSPORTATION Local & inter urban passenger transit 41 485, 487 Trucking & warehousing 42 493, 484, 488, 492, 531 U. S. postal service 43 491 Water transportation 44 483, 487, 488, 532 Transportation by air 45 481, 488, 492, 561, 621 Pipelines, except natural gases 46 486 Transportation services 47 488, 532, 561, 722 Communication 48 513 Electronic, gas, & sanitary services 49 221, 488, 562 6 Industry SIC Code NAICS Code WHOLESALE TRADE Wholesale trade durable goods 50 421, 441 444, 446, 453 Wholesale trade nondurable goods 51 312, 313, 422, 444, 451, 454 Bldg. materials & garden supplies 52 444, 453 RETAIL TRADE General merchandise store 53 452 Food stores 54 311, 445, 447, 722 Auto dealers & service station 55 441, 447, 452 Apparel & accessory stores 56 315, 448 Furniture & home furnishing stores 57 337, 442, 451 Eating & drinking places 58 722 Miscellaneous retail 59 339, 443, 445, 446, 448, 451, 453, 454, 522, 722 FINANCE, INSURANCE, AND REAL ESTATE Depository institution 60 521, 522 Nondepository institution 61 522, 523 Security & commodity brokers 62 523, 525, 533, 551, 813 Insurance carriers 63 523 525 Insurance agents, brokers, & services 64 523 525 Real estate 65 233, 531, 711, 812 Holding & other investment offices 67 523, 525, 533, 551, 813 SERVICES Hotels & other lodging places 70 721 Personal services 72 512, 532, 561, 611, 811, 812 Business services 73 234, 313, 314, 323, 325, 334, 421, 443, 491, 511, 512, 514, 522, 532, 541, 561, 562, 711, 811, 812 Auto repair, services, & parking 75 326, 488, 532, 811, 812 Misc. repair services 76 115, 235, 335, 442, 443, 451, 488, 561, 562, 711, 811 Motion picture 78 334, 421, 512, 514, 532, 541, 561, 711 Amusement & recreation services 79 487, 532, 561, 611, 711, 712, 713 Health services 80 339, 541, 621 Legal services 81 541 Educational services 82 514, 611 Social services 83 623, 624, 813, 922 Museums, botanical, zoological gardens 84 712 Membership organization 86 561, 813, 912 7 Industry SIC Code NAICS Code Engineering & management service 87 233, 234, 541, 561, 611 Private household services 88 81 Services 89 512, 541, 711 4( b) Information Requested ( 1) Labels Under 40 CFR 261.39( a)( 2), generators of used, broken CRTs destined for recycling must label or mark clearly each container in which the CRTs are contained.

( i) Data Items:

° Label or mark with the phrase: " Used cathode ray tube( s)  contains leaded glass" or " Used cathode ray tube( s)  contains leaded glass from televisions or computers."

° Label or mark with the words: " Do not mix with other glass materials."

( ii) Respondent Activity:

° Label or mark clearly each container, as specified.

( 2) Export Notification for Used CRTs Destined for Recycling Under 40 CFR 261.39( a)( 5), exporters of used, broken CRTs must provide written notification to EPA of an intended export before the CRTs are scheduled to leave the U. S. Upon request by EPA, the exporter must furnish to EPA any additional information that a receiving country requests in order to respond to a notification. Exporters must keep copies of notifications and consents for a period of three years following receipt of the consent.

Under 40 CFR 261.40, exporters of used, intact CRTs destined for recycling must meet the conditions of section 261.39( a)( 5).

( i) Data Items:

° Notification of intent to export that includes the following information:

 Name, mailing address, telephone number, and EPA ID number ( if any) of the exporter; 8  The estimated frequency or rate at which CRTs are to be exported and the period of time over which they are to be exported;

 The estimated total quantity of CRTs specified in kilograms;

 All points of entry to and departure from each foreign country through which the CRTs will pass;

 A description of the means by which each shipment of the CRTs will be transported ( e. g., air, highway, rail, water);

 Name and address of the recycler;

 A description of the manner in which the CRTs will be recycled in the receiving country;

 The name of any transit country through which the CRTs will be sent and a description of the approximate length of time the CRTs will remain in such country; and  Signature of the exporter.

° On the front of the envelope used to submit the written notification, the words: " Attention: Notification of Intent to Export."

° Additional information that a receiving country requests in order to respond to a notification.

° Receiving/ transit country's written consent to the receipt of the CRTs.

° Notification of receiving/ transit country's objection to the receipt of the CRTs, if applicable.

° Notification of receiving/ transit country's withdrawal of a prior consent to the receipt of CRTs, if applicable.

( ii) Respondent Activities:

° Prepare and submit written notification.

° Prepare and submit additional information that a receiving country requests in order to respond to a notification. 9 ° Keep copies of notifications and consents.

( 3) Export Notification for Used CRTs Destined for Reuse Under 40 CFR 261.41, exporters of used, intact CRTs for reuse must send a one time notification to EPA. In addition, they must keep copies of normal business records ( e. g., contracts) demonstrating that each shipment of exported CRTs will be reused. This documentation must be retained for a period of at least three years from the date the CRTs were exported.

( i) Data Items:

° Notification that includes the following information:

 A statement that the notifier plans to export used, intact CRTs for reuse;

 Notifier's name, address, and EPA ID number ( if applicable); and  Contact person's name and phone number.

° Normal business records ( e. g., contracts) demonstrating that each shipment of exported CRTs will be reused.

( ii) Respondent Activities:

° Prepare and submit a one time notification.

° Keep copies of normal business records ( e. g., contracts) demonstrating that each shipment of exported CRTs will be reused.

5. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT The following section discusses how EPA or the implementing agency will collect and manage the information received from respondents. This section also includes a discussion of how EPA has taken steps to ensure that the information collections are not overly burdensome on small entities. 10 5( a) Agency Activities ( 1) Labels There are no Agency activities associated with the labeling requirements under 40 CFR 261.39( a)( 2).

( 2) Export Notification for Used CRTs Destined for Recycling Agency activities associated with the conditional exclusion for used CRTs exported for recycling include:

° Receive and review notification submitted by an exporter of used CRTs to determine whether or not the notification is complete. A notification is complete when EPA determines that it satisfies the requirements of 40 CFR 261.39( a)( 5)( i).

° Solicit, from exporter, additional information requested by the receiving country.

° Provide, in conjunction with the Department of State, the complete notification to the receiving country.

° Forward the receiving/ transit country's written consent to the receipt of the used CRTs to the exporter.

° Prepare and send written notification to the exporter if the receiving/ transit country objects to the receipt of the used CRTs or withdraws a prior consent.

° Keep copies of notifications, consents, and other related documents.

( 3) Export Notification for Used CRTs Destined for Reuse Agency activities associated with the conditional exclusion for used CRTs exported for reuse include:

° Receive and review notification submitted by exporter of used CRTs.

° Keep copy of notification. 11 5( b) Collection Methodology and Management In collecting and analyzing the information submitted under 40 CFR 261.39( a)( 5), 261.40, and 261.41, EPA will use equipment such as personal computers and applicable database software, where appropriate. EPA will ensure the accuracy and completeness of the collected information by reviewing each submittal.

5( c) Small Entity Flexibility In establishing the conditional exclusion for used CRTs, EPA considered the reporting and recordkeeping burden for small businesses. In addition, the conditional exclusion is a regulatory relief initiative that should reduce hour and cost burden for generators and subsequent handlers of excluded CRTs, but should particularly benefit small entities.

5( d) Collection Schedule ( 1) Labels Generators of used, broken CRTs destined for recycling must label or mark clearly each container in which the CRTs are contained, as specified. EPA believes that each container should be labeled or marked to ensure proper management and handling.

( 2) Export Notification for Used CRTs Destined for Recycling Exporters of used CRTs destined for recycling must provide written notification to EPA of an intended export before the CRTs are scheduled to leave the U. S. A complete notification must be submitted 60 days before the initial shipment is intended to be shipped off site. This notification may cover export activities extending over a 12 month or lesser period. In addition, upon request by EPA, exporters must furnish to EPA any additional information that a receiving country requests in order to respond to a notification.

( 3) Export Notification for Used CRTs Destined for Reuse Exporters of used CRTs destined for reuse must send a one time notification to EPA. In addition, they must keep, at the facility, copies of normal business records ( e. g., contracts) demonstrating that each shipment of exported CRTs will be reused. 12 6. ESTIMATING THE HOUR AND COST BURDEN OF THE COLLECTION 6( a) Estimating Respondent Burden Hours In Exhibit 1, EPA estimates the respondent hourly burden associated with the new information collection requirements covered in this ICR. Exhibit 1 includes burden hours ( total and by labor type) per respondent, as well as the overall burden hours for all respondents.

6( b) Estimating Respondent Costs EPA estimates the annual respondent costs associated with the new information collection requirements in Exhibit 1. These costs are based on the cost of labor, capital, and operation and maintenance ( O& M).

( 1) Labor Costs For purposes of this analysis, EPA estimates an average hourly respondent labor cost ( including fringe and overhead) of $ 126.19 for legal staff, $ 120.15 for managerial staff, $ 65.94 for technical staff, $ 30.08 for workman staff, and $ 47.05 for clerical staff. These hourly labor costs were obtained from the economics background document developed for this rulemaking.

Using the total burden hours discussed in Section 6( a) and the hourly wage rates outlined in this section, Exhibit 1 illustrates the labor costs associated with the new information collection requirements covered in this ICR.

( 2) Capital Costs Capital costs usually include any produced physical good needed to provide the needed information, such as machinery, computers, and other equipment. EPA does not anticipate that respondents will incur capital costs in carrying out the information collection requirements covered in this ICR.

( 3) Operation & Maintenance Costs O& M costs are those costs associated with an information collection requirement incurred continually over the life of the ICR. They are defined by the Paperwork Reduction Act of 1995 as " the recurring dollar amount of costs associated with O& M or purchasing services." For this ICR, O& M costs include mailing costs ($ 0.37 for postage and $ 0.01 for a standard size envelope). These O& M costs are shown in Exhibit 1. 13 1 The universe estimates and assumptions in this ICR are based on the economics background document developed for this rulemaking. 6( c) Estimating Agency Hour and Cost Burden EPA estimates the Agency hour and cost burden associated with the new information collection requirements covered in this ICR in Exhibit 2. As shown in the exhibit, EPA estimates an average hourly labor cost of $ 66.26 for legal staff ( GS 15, Step 1), $ 47.66 for managerial staff ( GS 13, Step 1), $ 33.44 for technical staff ( GS 11, Step 1), and $ 20.34 for clerical staff ( GS 06, Step 1). To derive these hourly estimates, EPA referred to the General Schedule ( GS) Salary Table 2004. This publication summarizes the unloaded ( base) hourly rate for various labor categories in the Federal Government. EPA then applied the standard government overhead factor of 1.6 to the unloaded rate to derive these loaded hourly rates.

6( d) Estimating the Respondent Universe and Total Hour and Cost Burden In this section, EPA first describes the respondent universe affected by the new information collection requirements covered in this ICR. EPA then estimates the annual incremental burden to respondents under the final rule and the annual burden savings to respondents for no longer managing their excluded CRTs under existing RCRA information collection requirements.

( 1) Respondent Universe Table 1 presents the annual number of respondents subject to the new information collection requirements covered in this ICR. 1 It shows that EPA expects 3,775 facilities to generate and/ or manage used CRTs each year. Of these 3,775 facilities, 3,482 are original users, 288 are collectors, and five are processors.

Table 1 Annual Number of Respondents Subject to the New Information Collection Requirements Covered in this ICR Type of Respondent Number of Respondents Original Users 3,482 Collectors 288 Processors 5 Total 3,775 14 2 The universe estimates and assumptions in this ICR are based on the economics background document developed for this rulemaking. Table 2 presents the annual number of exporters of used CRTs, as well as the annual number of export shipments. 2 It shows that EPA expects 29 facilities ( i. e., 15 + 14 = 29) to export a total of 500 shipments of used CRTs ( i. e., 256 + 244 = 500) each year. Of these 500 shipments, 256 will be destined for recycling and 244 will be destined for reuse.

Table 2 Annual Number of Exporters and Export Shipments of Used CRTs Subject to the New Information Collection Requirements Covered in this ICR Type of CRT Number of Exporters Number of Export Shipments Used CRTs destined for Recycling 15 256 Used CRTs destined for Reuse 14 244 ( 2) Total Hour and Cost Burden ( a) Hour and Cost Burden under the Final Rule Based on the universe data presented in Tables 1 and 2, EPA estimated the respondent burden associated with all of the new information collection requirements covered in this ICR in Exhibit 1. A discussion of the assumptions used in developing these burden estimates follows.

( a1) Reading the Regulations EPA estimates that 3,775 respondents will be subject to the new information collection requirements covered in this ICR. EPA assumes that all these respondents will read the regulations once during the three year life of the ICR. In estimating the annual respondent hour and cost burden over the three year period covered by this ICR, EPA annualized the hour and cost burden of this one time activity by dividing the number of respondents by three. Thus, EPA estimates that 1,258 respondents ( i. e., 3,775 respondents / 3 years), on average, will read the regulations each year.

( a2) Labels Under 40 CFR 261.39( a)( 2), generators of used, broken CRTs destined for recycling must label or mark clearly each container ( e. g., " gaylord" box) in which used, broken CRTs are contained, as specified. EPA estimates that, each year, respondents will use 32,423 containers. EPA assumes that these respondents will mark each of these containers by writing the specified words on them. EPA also assumes that each container will be used only once. 15 ( a3) Export Notification for Used CRTs Destined for Recycling Under 40 CFR 261.39( a)( 5), exporters of used CRTs must notify EPA of the intended shipment before the CRTs are scheduled to leave the U. S. The notification may cover export activities extending over a 12 month or lesser period. In addition, upon EPA's request, exporters must furnish any additional information that a receiving country requests in order to respond to a notification.

EPA estimates that, each year, 256 shipments of used CRTs will be exported for recycling. EPA expects that these exporters will notify the Agency of their intent to export the used CRTs. In addition, the Agency estimates that approximately 26 exporters will furnish additional information.

( a4) Export Notification for Used CRTs Destined for Reuse Under 40 CFR 261.41, exporters of used CRTs destined for reuse must send a one time notification to EPA. In addition, they must keep copies of normal business records ( e. g., contracts) demonstrating that each shipment of exported CRTs will be reused.

EPA estimates that, each year, 14 respondents will export used CRTs for reuse. EPA assumes that all these respondents will notify the Agency once during the three year life of the ICR. In estimating the annual respondent hour and cost burden over the three year period covered by this ICR, EPA annualized the hour and cost burden of this one time activity by dividing the number of respondents by three. Thus, EPA estimates that 5 respondents ( i. e., 14 respondents / 3 years), on average, will submit the one time notification each year.

The total number of responses under the reporting and recordkeeping requirements for CRTs exported for recycling and reuse described in paragraphs ( a)( 3) and ( a)( 4) is 557.

( b) Hour and Cost Burden under Existing Information Collection Requirements In addition to estimating the incremental burden from the new information collection requirements, EPA also estimated the hour and cost savings to generators and subsequent handlers for no longer complying with existing RCRA information collection requirements in managing excluded CRTs. These costs are presented in Exhibit 3, broken out by the existing EPA ICRs affected by the final rule.

In developing Exhibit 3, EPA reviewed each of the affected ICRs to identify the existing information collection activities that will be undertaken by generators and handlers of used CRTs, calculated the associated hour and cost burden, and presented the totals in the exhibit. Following are the affected ICRs, along with a description of relevant capital and O& M costs: 16 ° Manifest ICR ( EPA ICR Number 801): there are no capital costs; O& M costs are associated with sending and returning copies of the manifest forms;

° Generator Standards ICR ( EPA ICR Number 820): there are no capital or O& M costs;

° Biennial Report ICR ( EPA ICR Number 976): there are no capital costs; O& M costs are associated with submitting report to State or EPA Regional Office and maintaining copies of Site Identification, Waste Generation and Management ( GM), and Waste Received from Off Site ( WR) Forms; and C Land Disposal Restrictions ICR ( EPA ICR Number 1442): there are no capital costs; O& M costs are associated with transmittal and recordkeeping of one time LDR notifications and certifications.

6( e) Bottom Line Hour and Cost Burden ( 1) Respondent Tally EPA presents the total annual respondent hour and cost burden for the new information collection requirements associated with the final rule in Exhibit 1. In Exhibit 3, EPA tallies respondents' incremental burden under the rule and their burden savings for no longer complying with existing RCRA information collection requirements, in order to derive net impacts.

Exhibit 3 shows that the burden under the final rule is estimated to be 5,419 hours and $ 269,099 annually. EPA estimates that the burden savings under existing program requirements will be 22,725 hours and $ 1,147,133 per year. Thus, the net burden savings under the rule is estimated to be 17,306 hours and $ 878,034 per year. The three year bottom line net burden is estimated to be 51,918 hours and $ 2.63 million.

( 2) Agency Tally Exhibit 2 summarizes the total annual Agency hour and cost burden associated with all the requirements covered in this ICR. As shown in the exhibit, EPA estimates the annual Agency burden to be 371 hours, at an annual cost of $ 11,173. The bottom line burden to the Agency over three years is 1,113 hours, at a cost of $ 33,519. 17 6( f) Reasons for Change In Burden EPA believes the labeling requirement is necessary to alert anyone handling the containers with the used, broken CRTs of what is enclosed in the container so that proper handling ( or inspection) may occur. EPA also believes the notification requirements are necessary to assist the Agency in identifying and tracking exporters of used CRTs. As shown in the exhibits, EPA estimates that the labeling and notification requirements will impose a minor burden on generators of excluded CRTs. This burden is greatly offset by the savings that generators and subsequent handlers will see in no longer managing their excluded CRTs under existing information collection requirements.

6( g) Public Burden Statement The public reporting burden associated with the new requirements is estimated to range between 3.40 and 4.10 hours per respondent per year. This burden includes time for preparing and submitting export notifications, and providing additional notification information upon EPA's request. The public recordkeeping burden associated with the new requirements is estimated to range between 3.60 and 3.70 hours per respondent per year. This burden includes time for reading the regulations, labeling containers of used CRTs, and keeping copies of CRT documentation, as specified.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. RCRA 2004 0010, which is available for public viewing at the RCRA Docket in the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the RCRA Docket is ( 202) 566 0270. An electronic version of the public docket is available through EPA Dockets ( EDOCKET) at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information 18 and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. RCRA 2004 0010. 19 EXHIBIT 1 Hours and Costs per Respondent Legal Managerial Technical Workman Clerical INFORMATION COLLECTION ACTIVITY $ 126.19/ Hr $ 120.15/ Hr $ 65.94/ Hr $ 30.08/ Hr $ 47.05/ Hr Read the regulations 0.00 0.50 0.50 0.00 0.00 1.00 $ 93.05 $ 0.00 $ 0.00 1,258 1,258 $ 117,057 Label or mark clearly each container, as specified 0.00 0.00 0.00 0.10 0.00 0.10 $ 3.01 $ 0.00 $ 0.00 32,423 3,242 $ 97,593 Prepare and submit written notification 0.00 0.10 1.80 0.00 1.50 3.40 $ 201.28 $ 0.00 $ 0.38 256 870 $ 51,625 Prepare and submit additional information that a receiving country requests in order to respond to a notification 0.00 0.10 0.50 0.00 0.10 0.70 $ 49.69 $ 0.00 $ 0.38 26 18 $ 1,302 Keep copies of notifications and consents 0.00 0.00 0.00 0.00 0.10 0.10 $ 4.71 $ 0.00 $ 0.00 256 26 $ 1,206 Subtotal 0.00 varies varies varies varies varies varies varies varies varies 914 $ 54,133 Prepare and submit a one time notification 0.00 0.10 0.50 0.00 0.10 0.70 $ 49.69 $ 0.00 $ 0.38 5 4 $ 250 Keep copies of normal business records ( e. g., contracts)

demonstrating that each shipment of exported CRTs will be reused 0.00 0.00 0.00 0.00 0.10 0.10 $ 4.71 $ 0.00 $ 0.00 14 1 $ 66 Subtotal 0.00 varies varies varies varies varies varies varies varies varies 5 $ 316 TOTAL 0.00 varies varies varies varies varies varies varies varies varies 5,419 $ 269,099 CONDITIONAL EXCLUSION FOR USED CATHODE RAY TUBES Total Hours and Costs Labels Number of Respondents or Containers Total Hours/

Year Total Cost/

Year Respon.

Hours/

Year Labor Cost/

Year Capital/

Startup Cost ESTIMATED ANNUAL RESPONDENT HOUR AND COST BURDEN Reading the Regulations O& M Cost Export Notification for Used CRTs Destined for Reuse Export Notification for Used CRTs Destined for Recycling 20 EXHIBIT 2 Hours and Costs per Respondent Legal Managerial Technical Clerical INFORMATION COLLECTION ACTIVITY $ 66.256/ Hr $ 47.664/ Hr $ 33.44/ Hr $ 20.336/ Hr Receive and review notification submitted by an exporter of used CRTs to determine whether or not the notification is complete 0.00 0.00 1.00 0.00 1.00 $ 33.44 $ 0.00 $ 0.00 256 256 $ 8,561 Solicit, from exporter, additional information requested by the receiving country 0.00 0.00 0.50 0.10 0.60 $ 18.75 $ 0.00 $ 0.38 26 16 $ 497 Provide, in conjunction with the Department of State, the complete notification to the receiving country 0.00 0.00 0.00 0.16 0.16 $ 3.25 $ 0.00 $ 0.38 256 41 $ 929 Forward the receiving/ transit country's written consent to the receipt of the used CRTs to the exporter 0.00 0.00 0.00 0.16 0.16 $ 3.25 $ 0.00 $ 0.38 0 0 $ 0 Prepare and send written notification to the exporter if the receiving/ transit country objects to the receipt of the used CRTs or withdraws a prior consent 0.00 0.00 0.50 0.10 0.60 $ 18.75 $ 0.00 $ 0.38 0 0 $ 0 Keep copies of notifications, consents, and other related documents 0.00 0.00 0.00 0.10 0.10 $ 2.03 $ 0.00 $ 0.00 538 54 $ 1,092 Subtotal 0.00 varies varies varies varies varies varies varies varies 367 $ 11,079 Receive and review notification submitted by exporter of used CRTs 0.00 0.00 0.50 0.00 0.50 $ 16.72 $ 0.00 $ 0.00 5 3 $ 84 Keep copy of notification 0.00 0.00 0.00 0.10 0.10 $ 2.03 $ 0.00 $ 0.00 5 1 $ 10 Subtotal 0.00 0.00 0.50 0.10 0.60 $ 18.75 $ 0.00 $ 0.00 5 4 $ 94 TOTAL 0.00 varies varies varies varies varies varies varies varies 371 $ 11,173 Export Notification for Used CRTs Destined for Reuse Total Hours and Costs Agency Hours/

Year Labor Cost/

Year Capital/

Startup Cost O& M Cost Number of Agency Activities Total Hours/

Year ESTIMATED ANNUAL AGENCY HOUR AND COST BURDEN Total Cost/

Year CONDITIONAL EXCLUSION FOR USED CATHODE RAY TUBES Export Notification for Used CRTs Destined for Recycling 21 EXHIBIT 3 ESTIMATED ANNUAL RESPONDENT HOUR AND COST BURDEN SUMMARY a ( INCLUDING SAVINGS IN PAPERWORK BURDEN IN EXISTING ICRs)

CRT Recycling [ ADD #] 5,419 $ 268,990 $ 0 $ 109 $ 269,099 Manifest 801 ( 17,022) ($ 786,241) $ 0 ($ 7,216) ($ 793,457)

Generator Standards 820 ( 3,421) ($ 285,894) $ 0 ($ 43) ($ 285,937)

Biennial Report 976 ( 2,074) ($ 59,706) $ 0 ($ 278) ($ 59,986)

Land Disposal Restrictions 1442 ( 208) ($ 7,579) $ 0 ($ 174) ($ 7,753)

Subtotal N/ A ( 22,725) ($ 1,139,420) $ 0 ($ 7,711) ($ 1,147,133)

TOTAL N/ A ( 17,306) ($ 870,430) $ 0 ($ 7,602) ($ 878,034)

a Exhibit contains rounding error.

Existing Paperwork Requirements Capital Cost/ Year O& M Cost/ Year Total Cost/ Year New Paperwork Requirements ICR Name ICR Number Hours/ Year Labor Cost/ Year