[Federal Register Volume 76, Number 45 (Tuesday, March 8, 2011)]
[Notices]
[Pages 12743-12744]
[FR Doc No: 2011-5146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0097]

Medical Device Reporting; Malfunction Reporting Frequency

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is clarifying that
device manufacturers and importers of all devices, including class I
and those class II devices that are not permanently implantable, life
supporting, or life sustaining, must continue to submit malfunction
reports in full compliance with FDA's Medical Device Reporting
regulation, pending future FDA notice under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments by May 9, 2011.

ADDRESSES: Submit electronic comments on this document to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Identify comments with the docket number
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Victoria Schmid, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 3236, Silver Spring, MD 20993-0002, 301-
796-6108.

I. Background

    Title II, section 227 of the Food and Drug Administration
Amendments Act of 2007 (FDAAA) (Public Law 110-85), amended section
519(a) of the FD&C Act (21 U.S.C. 360i(a)), relating to the reporting
of malfunctions to FDA under part 803 (21 CFR part 803). The
malfunction reporting requirements for class III devices and those
class II devices that are permanently implantable, life supporting, or
life sustaining were not altered by FDAAA. Under the amended section
519(a), device manufacturers and importers are to continue to submit
malfunction reports in accordance with part 803 for all class III
devices and for those class II devices that are permanently
implantable, life supporting, or life sustaining, unless the Secretary
of Health and Human Services (the Secretary) (and, by delegation, FDA)
grants an exemption, variance from, or an alternative to, a requirement
under such regulations under Sec.  803.19 (section 519(a)(1)(B)(i) of
the FD&C Act).
    However, FDAAA changed malfunction reporting requirements for class
I devices and those class II devices that are not permanently
implantable, life supporting, or life sustaining. Under section 519(a)
of the FD&C Act, as amended by FDAAA, the Secretary (and, by
delegation, FDA) is required to publish a notice in the Federal
Register or send a letter to the person who is the manufacturer or
importer of a class I device or a class II device that is not
permanently implantable, life

supporting, or life sustaining, if FDA finds that such a device should
be subject to part 803 in order to protect the public health (section
519(a)(1)(B)(i)(III) of the FD&C Act). If such class I or class II
devices are not the subject of an FDA notice or letter, the malfunction
reports for these devices are to be submitted in accordance with the
criteria established by the Secretary (and, by delegation, FDA), which
criteria shall require the reports to be in summary form and made on a
quarterly basis (section 519(a)(1)(B)(ii) of the FD&C Act).
    Under section 519(a) of the FD&C Act, as amended by FDAAA, there is
no change to the obligation for an importer to submit malfunction
reports to the manufacturer in accordance with part 803 for devices
that it imports into the United States (section 519(a)(1)(B)(iii) of
the FD&C Act).
    FDA intends to provide notice in the Federal Register that lists
the types of devices that should be subject to part 803 in order to
protect the public health, as required by section 519(a)(1)(B)(i)(III)
of the FD&C Act). In addition, FDA intends to, by rulemaking, establish
malfunction reporting criteria for devices subject to section
519(a)(1)(B)(ii) of the FD&C Act. In the interim, in the interest of
public health, FDA is publishing this notice under section
519(a)(1)(B)(i)(III), to clarify that, to the extent there is any
confusion as to current malfunction reporting requirements, all device
manufacturers and importers of class I and those class II devices that
are not permanently implantable, life supporting, or life sustaining,
must continue to report in full compliance with part 803, pending
further FDA notice under section 519(a)(1)(B)(i)(III), as to specific
devices or device types subject to part 803, and the establishment of
criteria in accordance with section 519(a)(1)(B)(ii). FDA considers it
necessary to subject all such devices to part 803 in the interim, in
order to protect the public health by ensuring that there is no gap in
malfunction reporting for any device.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed 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.

    Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5146 Filed 3-7-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: November 28, 2008 (Volume 73, Number 230)]
[Rules and Regulations]
[Page 72320-72323]
[DOCID:fr28no08-6]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0176; Directorate Identifier 2007-NM-228-AD;
Amendment 39-15748; AD 2008-24-08]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 737-600, -700, -700C, -800
and -900 Series Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
Boeing Model 737-600, -700, -700C, -800 and -900 series airplanes. This
AD requires an inspection of the escape slides for the forward and aft
entry and service doors to determine the part number and service
bulletin number stenciled on the escape slide girt, and modification of
the escape slide assemblies. This AD also requires concurrent
modification of the escape slide latch assemblies; concurrent
inspection of the escape slides to determine the part number and
service bulletin number stenciled on the escape slide girts, and
replacement of the trigger housing on the regulator valve with an
improved trigger housing if necessary; and concurrent replacement of
the rod in the pilot valve regulator with a new, improved rod; as
applicable. This AD results from reports that certain escape slides did
not automatically inflate when deployed or after the manual inflation
cable was pulled. We are issuing this AD to prevent failure of an
escape slide to inflate when deployed, which could result in the slide
being unusable during an emergency evacuation and consequent injury to
passengers or crewmembers.

DATES: This AD is effective January 2, 2009.
    The Director of the Federal Register approved the incorporation by
reference of certain publications listed in this AD as of January 2,
2009.
    The Director of the Federal Register previously approved the
incorporation by reference of Boeing Service Bulletin 737-25-1404,
dated May 25, 2000 on August 28, 2001 (66 FR 38361, July 24, 2001).

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; 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 (telephone<PHONE_NUMBER>) is the Document 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: Robert K. Hettman, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue, SW., Renton,
Washington 98057-3356; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain Boeing Model 737-600, -700, -700C, -800 and -900 series
airplanes. That NPRM was published in the Federal Register on February
15, 2008 (73 FR 8833). That NPRM proposed to require an inspection of
the escape slides for the forward and aft entry and service doors to
determine the part number and service bulletin number stenciled on the
escape slide girt, and modification of the escape slide assemblies.
That NPRM also proposed to require concurrent modification of the
escape slide latch assemblies; concurrent inspection of the escape
slides to determine the part number and service bulletin number
stenciled on the escape slide girts, and replacement of the trigger
housing on the regulator valve with an improved trigger housing if
necessary; and concurrent replacement of the rod in the pilot valve
regulator with a new, improved rod; as applicable.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the three commenters.

Support for the NPRM

    Boeing concurs with the contents of the proposed rule.

Requests To Refer to Additional Goodrich Service Bulletin

    Goodrich, and Air Transport Association (ATA) on behalf of one of
its members, American Airlines (AA), request that Boeing revise Boeing
Service Bulletin 737-25-1491, dated April 23, 2007 (cited in the NPRM
as the appropriate source of service information for accomplishing
certain actions specified in the NPRM), to include a reference to
Goodrich Service Bulletin 5A3307-25-339, Revision 2, dated March 31,
2004, as an alternative method of compliance (AMOC) to BFGoodrich
Service Bulletin 25-308, dated January 21, 2000 (cited in the NPRM as a
source of service information for accomplishing certain other actions
specified in the NPRM). ATA and AA note that this service bulletin
modifies the applicable slide to the latest standard offered by
Goodrich. AA and Goodrich suggest that if Boeing Service Bulletin 737-
25-1491, dated April 23, 2007, is not revised, the AD should state that
it does not apply to Goodrich part number (P/N) 5A3307-5 slides and
that Goodrich Service Bulletin 5A3307-25-339, Revision 2, dated March
31, 2004, be identified as an AMOC for the slide portion of the AD.
    We disagree with the request to revise the AD to refer to Goodrich
Service Bulletin 5A3307-25-339, Revision 2, dated March 31, 2004. There
are significant differences in the actions between BFGoodrich Service
Bulletin 25-308, dated January 21, 2000 and Goodrich Service Bulletin
5A3307-25-339, Revision 2, dated March 31, 2004. Therefore, any request
to use the procedures in Goodrich Service Bulletin 5A3307-25-339 is
best handled through the AMOC process. Under the provisions of
paragraph (k) of the AD, we will consider requests for approval of an
AMOC if sufficient data are submitted to substantiate that the change
would provide an acceptable level of safety. We have not changed the AD
in this regard.

Request To Revise Unsafe Condition

    Goodrich notes that paragraph (g)(1) of the NPRM addresses an
unsafe

condition (escape slide latch assembly) that is not mentioned in
paragraph (d), ``Unsafe Condition,'' of the NPRM. Goodrich requests
that we revise paragraph (d) to include a reference to the escape slide
latch assembly.
    We disagree with the request to revise the unsafe condition to
refer to the escape slide latch assembly. The unsafe condition
addressed by this AD (failure of an escape slide to inflate when
deployed) is addressed by the inspection and modification required by
paragraph (f) of this AD. However, the inspection and modification
cannot be done unless the applicable concurrent requirements addressed
by both paragraphs (g)(1) and (g)(2) of the AD are done before or
concurrently with the actions required by paragraph (f) of this AD.
Those concurrent requirements, in paragraph (g)(1) of this AD, are part
of addressing the unsafe condition only in that they enable
accomplishment of paragraph (f) of this AD. We have not changed the AD
in this regard.

Request To Include Alternative Rod Replacement

    Goodrich notes that paragraph (g)(3) of the NPRM specifies rod
replacement in the regulator valve in accordance with BFGoodrich
Service Bulletin 25-308, dated January 21, 2000, for slides with P/Ns
5A3307-1 and -3. Goodrich states that the combination rod/bushing/
trigger housing replacement in Goodrich Service Bulletin 5A3307-25-339,
Revision 2, dated March 31, 2004, provides an acceptable alternative
rod replacement. Goodrich recommends that we include this alternative
in the AD.
    We disagree with the request to revise the AD to refer to Goodrich
Service Bulletin 5A3307-25-339, Revision 2, dated March 31, 2004. As
stated previously, there are significant differences in the actions
between BF Goodrich Service Bulletin 25-308, dated January 21, 2000 and
Goodrich Service Bulletin 5A3307-25-339, Revision 2, dated March 31,
2004. Therefore, any request to use the procedures in Goodrich Service
Bulletin 5A3307-25-339 is best handled through the AMOC process. Under
the provisions of paragraph (k) of the AD, we will consider requests
for approval of an AMOC if sufficient data are submitted to
substantiate that the change would provide an acceptable level of
safety. We have not changed the AD in this regard.

Request To Revise Costs of Compliance

    ATA on behalf of AA states that the Costs of Compliance provided by
the NPRM do not accurately reflect the true costs associated with the
proposed modification. The commenters state that accomplishment of the
minimum required service bulletins would accrue approximately $800 per
airplane in material for modification of the slide in accordance with
BFGoodrich Service Bulletin 25-308, dated January 21, 2000, and $200 in
labor for verification of incorporation of the new latch assembly.
    We infer that the commenters would like us to revise the Costs of
Compliance section of the NPRM. We disagree. We based our cost estimate
of $516 per airplane for parts for the modification of the slide in
accordance with BFGoodrich Service Bulletin 25-308, dated January 21,
2000, on information from the manufacturer. The commenters did not
supply additional information to use as a basis for changing the Costs
of Compliance section. Therefore, we do not find it necessary to change
the AD in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD as proposed.

Costs of Compliance

    We estimate that this AD affects 480 airplanes of U.S. registry. We
also estimate that it takes about 1 work-hour per product to comply
with the inspection. The average labor rate is $80 per work-hour. Based
on these figures, we estimate the cost of this AD to U.S. operators to
be $38,400 or $80 per product.
    The following table provides the estimated costs, at an average
labor rate of $80 per work-hour, for U.S. operators to comply with the
concurrent actions, if applicable.

                                           Estimated Concurrent Costs
----------------------------------------------------------------------------------------------------------------
                                                                     Cost per
                 Action                   Work hours     Parts       airplane              Fleet cost
----------------------------------------------------------------------------------------------------------------
Concurrent actions specified in Boeing             2       $1,424       $1,584  Up to $760,320.
 Service Bulletin 737-25-1404.
Concurrent actions specified in Boeing             3        1,740        1,980  Up to $950,400.
 Special Attention Service Bulletin 737-
 25-1475.
Concurrent actions specified in                    3          516          756  Up to $362,880.
 BFGoodrich Service Bulletin 25-308.
----------------------------------------------------------------------------------------------------------------

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

    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), and
    (3) 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

0
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 adding the following new AD:

2008-24-08 Boeing: Amendment 39-15748. Docket No. FAA-2008-0176;
Directorate Identifier 2007-NM-228-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective January 2,
2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to Boeing Model 737-600, -700, -700C, -800
and -900 series airplanes, certificated in any category, as
identified in Boeing Service Bulletin 737-25-1491, dated April 23,
2007.

Unsafe Condition

    (d) This AD results from reports that certain escape slides did
not inflate when deployed or after the manual inflation cable was
pulled. We are issuing this AD to prevent failure of an escape slide
to inflate when deployed, which could result in the slide being
unusable during an emergency evacuation and consequent injury to
passengers or crewmembers.

Compliance

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

Inspection and Modification

    (f) Within 36 months after the effective date of this AD,
inspect the escape slides for the forward and aft entry and service
doors to determine the Goodrich part number (P/N) and service
bulletin number stenciled on the escape slide girts, and modify the
escape slide assemblies, in accordance with the Accomplishment
Instructions of Boeing Service Bulletin 737-25-1491, dated April 23,
2007.

    Note 1: Boeing Service Bulletin 737-25-1491, dated April 23,
2007, refers to Goodrich Service Bulletin 25-338, Revision 1, dated
March 31, 2004, as an additional source of service information for
modifying the escape slide assemblies.

Concurrent Requirements

    (g) Prior to or concurrently with accomplishing the actions
required by paragraph (f) of this AD, do the applicable actions
specified in paragraphs (g)(1), (g)(2), and (g)(3) of this AD.
    (1) For Model 737-600, -700, and -800 series airplanes
identified in Boeing Service Bulletin 737-25-1404, dated May 25,
2000, equipped with any escape slide having P/N 5A3307-1, P/N
5A3307-3, P/N 5A3086-3, or P/N 5A3088-3: Modify the escape slide
latch assembly in accordance with Boeing Service Bulletin 737-25-
1404, dated May 25, 2000, as required by paragraph (a) of AD 2001-
15-01; or Boeing Service Bulletin 737-25-1404, Revision 1, dated
April 18, 2002.
    (2) For Model 737-600, -700, -700C, -800 and -900 series
airplanes equipped with any escape slide having P/N 5A3086-3 or P/N
5A3088-3: Inspect the four escape slides to determine the part
number and service bulletin number stenciled on the escape slide
girts, and replace the trigger housing on the regulator valve with
an improved trigger housing if BFGoodrich Service Bulletin 5A3086/
5A3088-25-302 is not stenciled on the girt, in accordance with the
Accomplishment Instructions of Boeing Special Attention Service
Bulletin 737-25-1475, dated November 26, 2002. For airplanes
identified as Group 2 in Boeing Special Attention Service Bulletin
737-25-1475, dated November 26, 2002, a records review may be done
in lieu of the inspection to determine the part number.

    Note 2: Boeing Special Attention Service Bulletin 737-25-1475,
dated November 26, 2002, refers to Goodrich Service Bulletin 5A3086/
5A3088-25-336, dated June 17, 2002, as an additional source of
service information for replacing the trigger housing on the
regulator valve with a new, improved trigger housing.

    (3) For Model 737-600, -700, -700C, -800 and -900 series
airplanes equipped with any escape slide having P/N 5A3307-1, P/N
5A3086-3, or P/N 5A3088-3; or P/N 5A3307-3 and BFGoodrich Service
Bulletin 5A3307-25-309 stenciled on the girt: Replace the rod in the
pilot valve regulator with a new, improved rod in accordance with
BFGoodrich Service Bulletin 25-308, dated January 21, 2000.

Terminating Action for AD 2001-15-01

    (h) For Model 737-600, -700, and -800 series airplanes
identified in Boeing Special Attention Service Bulletin 737-25-1403,
dated May 4, 2000: Accomplishing the replacement of the regulator
piston plug in the vespel piston with a new piston plug,
installation of a new insolate pad on the valise, and removal of the
trigger housing cover, in accordance with Goodrich Service Bulletin
25-338, Revision 1, dated March 31, 2004, terminates the
modification specified in Boeing Special Attention Service Bulletin
737-25-1403, dated May 4, 2000, as required by paragraph (a) of AD
2001-15-01. All other applicable actions required by paragraph (a)
of AD 2001-15-01 must be fully complied with.
    (i) For Model 737-600, -700, and -800 series airplanes:
Installation of a cover assembly on the trigger housing of the
inflation cylinder on the escape slides in accordance with Boeing
Special Attention Service Bulletin 737-25-1403, Revision 1, dated
November 29, 2001, terminates the corresponding action required by
paragraph (a) of AD 2001-15-01. All other applicable actions
required by paragraph (a) of AD 2001-15-01 must be fully complied
with.
    (j) For Model 737-600, -700, and -800 series airplanes:
Modification of the escape slide latch assembly in accordance with
Boeing Service Bulletin 737-25-1404, Revision 1, dated April 18,
2002, terminates the corresponding action required by paragraph (a)
of AD 2001-15-01. All other applicable actions required by paragraph
(a) of AD 2001-15-01 must be fully complied with.

Alternative Methods of Compliance (AMOCs)

    (k)(1) The Manager, Seattle Aircraft Certification Office, FAA,
ATTN: Robert K. Hettman, Aerospace Engineer, Cabin Safety and
Environmental Systems Branch, ANM-150S, 1601 Lind Avenue, SW.,
Renton, Washington 98057-3356; telephone<PHONE_NUMBER>, fax (425)
917-6590; has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Material Incorporated by Reference

    (l) You must use the applicable service information contained in
Table 1 of this AD to do the actions required by this AD, unless the
AD specifies otherwise. If you accomplish the terminating actions
for AD 2001-15-01 specified in this AD, you must use the applicable
service information contained in Table 2 of this AD, unless the AD
specifies otherwise.

                   Table 1--Material Incorporated by Reference for Actions Required in This AD
----------------------------------------------------------------------------------------------------------------
             Service Bulletin                        Revision                              Date
----------------------------------------------------------------------------------------------------------------
Boeing Service Bulletin 737-25-1404......  Original....................  May 25, 2000.
Boeing Service Bulletin 737-25-1404......  1...........................  April 18, 2002.
Boeing Service Bulletin 737-25-1491......  Original....................  April 23, 2007.

Boeing Special Attention Service Bulletin  Original....................  November 26, 2002.
 737-25-1475.
BFGoodrich Service Bulletin 25-308.......  Original....................  January 21, 2000.
----------------------------------------------------------------------------------------------------------------

           Table 2--Material Incorporated by Reference for the Optional Terminating Action in This AD
----------------------------------------------------------------------------------------------------------------
             Service Bulletin                        Revision                              Date
----------------------------------------------------------------------------------------------------------------
Boeing Service Bulletin 737-25-1404......  1...........................  April 18, 2002.
Boeing Special Attention Service Bulletin  1...........................  November 29, 2001.
 737-25-1403.
Goodrich Service Bulletin 25-338.........  1...........................  March 31, 2004.
----------------------------------------------------------------------------------------------------------------

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in
Table 3 of this AD under 5 U.S.C. 552(a) and 1 CFR part 51.

                                 Table 3--New Material Incorporated by Reference
----------------------------------------------------------------------------------------------------------------
             Service Bulletin                        Revision                              Date
----------------------------------------------------------------------------------------------------------------
Boeing Service Bulletin 737-25-1404......  1...........................  April 18, 2002.
Boeing Service Bulletin 737-25-1491......  Original....................  April 23, 2007.
Boeing Special Attention Service Bulletin  Original....................  November 26, 2002.
 737-25-1475.
Goodrich Service Bulletin 25-308.........  Original....................  January 21, 2000.
----------------------------------------------------------------------------------------------------------------

    (2) The Director of the Federal Register previously approved the
incorporation by reference of Boeing Service Bulletin 737-25-1404,
dated May 25, 2000, on August 28, 2001 (66 FR 38361, July 24, 2001).
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207; telephone<PHONE_NUMBER>; fax<PHONE_NUMBER>; e-mail
<EMAIL_ADDRESS>Internet https://www.myboeingfleet.com.
    (4) You may review copies of the service information that is
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or 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/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on November 16, 2008.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
 [FR Doc. E8-27926 Filed 11-26-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 78, Number 54 (Wednesday, March 20, 2013)]
[Notices]
[Pages 17201-17204]
[FR Doc No: 2013-06406]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2013-0152; FRL-9381-3]

Pesticide Chemicals; Registration Review; Draft Human Health and
Ecological Risk Assessments; Notice of Availability

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces the availability of EPA's draft human
health and ecological risk assessments for the registration review of
ancymidol, fosthiazate, lactofen, polybutene resins, quizalofop, and
soap salts and opens a public comment period on these documents.
Registration review is EPA's periodic review of pesticide registrations
to ensure that each pesticide continues to satisfy the statutory
standard for registration, that is, the pesticide can perform its
intended function without unreasonable adverse effects on human health
or the environment. As part of the registration review process, the
Agency has completed draft risk assessments for each of the subject
chemicals and is making them available for public comment. After
reviewing comments received during the public comment period, EPA will
issue a revised risk assessment, if appropriate, explain any changes to
the draft risk assessment, and respond to comments and may request
public input on risk mitigation. Through

this program, EPA is ensuring that each pesticide's registration is
based on current scientific and other knowledge, including its effects
on human health and the environment.

DATES: Comments must be received on or before May 20, 2013.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number for the specific pesticide of interest
provided in Table 1. in Unit III.A., by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: For information about a particular
pesticide included in this document, contact the Chemical Review
Manager identified in Table 1. in Unit III.A. for the pesticide of
interest.
    For general questions on the registration review program, contact:
Jane Robbins, Pesticide Re-evaluation Division (7508P), Office of
Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW., Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>;
fax number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

 A. Does this action apply to me?

    This action is directed to the public in general, and may be of
interest to a wide range of stakeholders including environmental, human
health, farm worker, and agricultural advocates; the chemical industry;
pesticide users; and members of the public interested in the sale,
distribution, or use of pesticides. Since others also may be
interested, the Agency has not attempted to describe all the specific
entities that may be affected by this action. If you have any questions
regarding the applicability of this action to a particular entity,
consult the Chemical Review Manager identified in Table 1. in Unit
III.A. for the pesticide of interest.

B. What should I consider as I prepare my comments for EPA?

    1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
    2. Tips for preparing your comments. When submitting comments,
remember to:
    i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
    ii. Follow directions. The Agency may ask you to respond to
specific questions or organize comments by referencing a Code of
Federal Regulations (CFR) part or section number.
    iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
    iv. Describe any assumptions and provide any technical information
and/or data that you used.
    v. If you estimate potential costs or burdens, explain how you
arrived at your estimate in sufficient detail to allow for it to be
reproduced.
    vi. Provide specific examples to illustrate your concerns and
suggest alternatives.
    vii. Explain your views as clearly as possible, avoiding the use of
profanity or personal threats.
    viii. Make sure to submit your comments by the comment period
deadline identified.
    3. Environmental justice. EPA seeks to achieve environmental
justice, the fair treatment and meaningful involvement of any group,
including minority and/or low income populations, in the development,
implementation, and enforcement of environmental laws, regulations, and
policies. To help address potential environmental justice issues, the
Agency seeks information on any groups or segments of the population
who, as a result of their location, cultural practices, or other
factors, may have atypical or disproportionately high and adverse human
health impacts and/or environmental effects from exposure to the
pesticides discussed in this document, compared to the general
population.

II. Authority

    EPA is conducting its registration review of the pesticides
identified in this document pursuant to section 3(g) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Procedural
Regulations for Registration Review at 40 CFR part 155, subpart C.
Section 3(g) of FIFRA provides, among other things, that the
registrations of pesticides are to be reviewed every 15 years. Under
FIFRA, a pesticide product may be registered or remain registered only
if it meets the statutory standard for registration given in FIFRA
section 3(c)(5). When used in accordance with widespread and commonly
recognized practice, the pesticide product must perform its intended
function without unreasonable adverse effects on the environment; that
is, without any unreasonable risk to man or the environment, or a human
dietary risk from residues that result from the use of a pesticide in
or on food.

III. Registration Reviews

 A. What action is the Agency taking?

    As directed by FIFRA section 3(g), EPA is reviewing the pesticide
registrations for ancymidol, fosthiazate, lactofen, polybutene resins,
quizalofop, and soap salts to ensure that they continue to satisfy the
FIFRA standard for registration--that is, that these pesticides can
still be used without unreasonable adverse effects on human health or
the environment.
    At this stage in the registration review process, consistent with
the proposed notice, published in the Federal Register issue of August
17, 2012 (77 FR 49792) (FRL-9356-5), jointly developed with the U.S.
Department of Agriculture, the National Marine Fisheries Service, and
the U.S. Fish and Wildlife Service (``the Services'') to enhance
opportunities for stakeholder input during pesticide registration
reviews and endangered species consultations, draft environmental risk
assessments include a screening-level evaluation of the potential risks
to federally listed endangered and threatened species (hereafter
referred to as ``listed species''). EPA intends to complete a refined
assessment of potential risks to individual listed

species, as needed. The refined listed species assessments will be
based on the recommendations of the National Research Council (NRC),
which has been tasked with providing advice on ecological risk
assessment tools and scientific approaches in developing listed species
risk assessments that are compliant with both FIFRA and the Endangered
Species Act (ESA). EPA anticipates that the NRC report, expected in
Spring 2013, will provide recommendations to ensure scientific
soundness and maximize the utility of risk assessment refinements for
listed species. Additional information can be found at the following
Web site: http://www8.nationalacademies.org/cp/projectview.aspx?key=49396. Useful refinements to the listed species
assessments are expected to include, but not be limited to, the
following:
     More detailed, species-specific ecological and biological
data.
     More detailed and accurate information on chemical use
patterns.
     Sub-county level spatial proximity data depicting the co-
occurrence of potential effects areas and listed species and any
designated critical habitat.
    In the event that a draft risk assessment shows risks of concern to
human health or the environment for a specific chemical, EPA reserves
the right to initiate mitigation at this stage of registration review.
This effort to mitigate a chemical's risks early in the registration
review process is consistent with the Agency's approach for
registration review. Where risks are identified early in the
registration review process and opportunities for early mitigation
exist, the Agency may pursue those opportunities as they arise, rather
then waiting for completion of a chemical's registration review in
order to mitigate risks. The public comment period for the draft risk
assessments allows members of the public to provide comments and
suggestions for revising the draft risk assessments and for reducing
risks.
    Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity,
through this notice of availability, for interested parties to provide
comments and input concerning the Agency's draft human health and
ecological risk assessments for ancymidol, fosthiazate, lactofen,
polybutene resins, quizalofop, and soap salts. Such comments and input
could address, among other things, the Agency's risk assessment
methodologies and assumptions, as applied in these draft risk
assessments.
    The Agency will consider all comments received during the public
comment period and make changes, as appropriate, to the draft human
health and ecological risk assessments. EPA will then issue revised
risk assessments, if appropriate, and explain any changes to the draft
risk assessments, and respond to comments. In the Federal Register
notice announcing the availability of the revised risk assessments, if
any of the revised risk assessments indicate risks of concern, the
Agency may provide a comment period for the public to submit
suggestions for mitigating the risks identified in those revised risk
assessments. At present, EPA is releasing registration review draft
risk assessments for the pesticide cases identified in the following
table and further described in this unit.

           Table 1--Registration Review Draft Risk Assessments
------------------------------------------------------------------------
                                                      Chemical review
 Registration review case name   Pesticide docket    manager, telephone
            and No.               identification       No., and email
                                       No.                address
------------------------------------------------------------------------
Ancymidol, Case No. 3017......  EPA-HQ-OPP-2011-0  Christina Scheltema,
                                 482.<PHONE_NUMBER>,
<EMAIL_ADDRESS>Fosthiazate, Case No. 7604....  EPA-HQ-OPP-2009-0  Khue Nguyen, (703)
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Lactofen, Case No. 7210.......  EPA-HQ-OPP-2005-0  Kelly Ballard, (703)
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Polybutene resins, Case No.     EPA-HQ-OPP-2009-0  Joel Wolf, (703) 347-
 4076.                           649.               0228,
<EMAIL_ADDRESS>Quizalofop, Case No. 7215.....  EPA-HQ-OPP-2007-1  Khue Nguyen, (703)
<PHONE_NUMBER>,
<EMAIL_ADDRESS>Soap salts, Case No. 4083.....  EPA-HQ-OPP-2008-0  Monica Wait, (703)
<PHONE_NUMBER>,
<EMAIL_ADDRESS>------------------------------------------------------------------------

     Ancymidol. The registration review docket for ancymidol
(EPA-HQ-OPP-2011-0482) opened in the Federal Register issue of June 29,
2011 (76 FR 38166) (FRL-8877-4). Ancymidol is a plant growth regulator
that acts by inhibiting giberillin biosynthesis, resulting in plants
with more compact growth. Ancymidol is registered for use only on
container grown greenhouse and nursery ornamentals. It is used only on
plants grown for commercial production and has no food, feed, or
residential uses. The Final Work Plan for ancymidol described numerous
data requirements for registration review, and a registration review
timeline that included the issuance of a data call-in. However, EPA has
revisited the timeline and data requirements for registration review
and determined that a data call-in is not necessary for ancymidol. The
Agency has conducted qualitative environmental and human health risk
assessments for ancymidol based on the available information and on
limited use of this pesticide active ingredient.
     Fosthiazate. The registration review docket for
fosthiazate (EPA-HQ-OPP-2009-0267) opened in the Federal Register issue
of June 24, 2009 (74 FR 30077) (FRL-8422-4). Fosthiazate is an
organophosphate nematicide and insecticide that is currently registered
for use on tomatoes. The Agency has conducted a human health risk
assessment for both dietary (food and drinking water) and occupational
exposure pathways. The Agency has also conducted a quantitative
ecological risk assessment, which includes a screening-level listed
species assessment. EPA acknowledges that further refinements to the
listed species assessment will be completed in future revisions and
requests public comment on specific areas that will reduce the
uncertainties associated with the characterization of risk to listed
species identified in the current assessment.
     Lactofen. The registration review docket for lactofen
(EPA-HQ-OPP-2005-0287) opened in the Federal Register issue of February
2, 2007 (72 FR 5050) (FRL-8113-1). Lactofen is a light dependent
peroxidizing herbicide (LDPH), and is registered for use on conifer
seedlings, cotton, kenaf, peanuts, and soybean, with local
registrations on fruiting vegetables, okra, snap beans, and
strawberries. For lactofen, the Agency has conducted an occupational
handler exposure risk assessment for the application of lactofen on
conifer seedlings, snap beans, soybeans, and strawberries. The Agency
has also conducted an ecological risk assessment, which includes a
screening-level listed species assessment. EPA acknowledges that
further refinements to the listed species assessment will be completed
in future revisions and requests public comment

on specific areas that will reduce the uncertainties associated with
the characterization of risk to listed species identified in the
current assessment.
     Polybutene resins. The registration review docket for
polybutene resins (EPA-HQ-OPP-2009-0649) opened in the Federal Register
issue of June 23, 2010 (75 FR 35810) (FRL-8832-3). Polybutene is a
sticky polymer registered for use as a bird and small mammal repellent.
It is used to prevent house sparrows, pigeons, and starlings from
roosting inside and outside of buildings, as well as to prevent beavers
from attacking trees and shrubs. There are no food/feed uses and, it is
exempt from a tolerance requirement when used as a sticker agent in
packaging of insect control products used on food crops. Polybutene is
approved by the Food and Drug Administration (FDA) as an indirect food
additive and is used as an ingredient in cosmetic products that are
applied directly to the skin such as sun block or moisturizer, and that
may be incidentally ingested, such as lipstick. EPA has conducted a
qualitative assessment for both human health and environmental fate and
ecological risks.
     Quizalofop. The registration review docket for
quizalofop ethyl and quizalofop-p-ethyl (EPA-HQ-OPP-2007-1089) opened
in the Federal Register issue of December 19, 2007 (72 FR 71893) (FRL-
8342-9). Quizalofop ethyl is a 50/50 racemic mixture of R-and S-
enantiomers; quizalofop-p-ethyl is the purified R-enantiomer which is
pesticidally active. Quizalofop-p-ethyl is registered for use to
control weeds in food crops (including barley, beans, lentil, peas,
sorghum, soybean, and sugar beets), non-food crops grown for seed
(including alfalfa, carrots, garlic, onion, radish, and spinach), and
non-cropland (including rights-of-way and fencerows). Quizalofop-p-
ethyl is not registered for residential use. The Agency has conducted a
human health assessment for both dietary (food and drinking water) and
occupational exposure pathways. The Agency has conducted a quantitative
ecological risk assessment, including a listed species assessment, for
quizalofop. EPA acknowledges that further refinements to the listed
species assessment may be completed in future revisions and requests
public comment on specific areas that will reduce the uncertainties
associated with the characterization of risk to listed species
identified in the current assessment.
     Soap salts. The registration review docket for soap salts
(EPA-HQ-OPP-2008-0519) opened in the Federal Register issue of
September 15, 2008 (73 FR 53244) (FRL-8381-3). The case consists of
three active ingredients, the ammonium, potassium, and sodium salts of
fatty acids, which are registered for use as acaricides, algaecides,
herbicides, and insecticides on food and non-food crops in various
settings, chiefly residential and agricultural. Ammonium and sodium
soap salts are also used as animal repellents. Because the Agency has
not identified any toxicological endpoints for human health risk
assessment and because current product labels are adequate to protect
for potential eye and skin irritation, a qualitative human health risk
assessment was conducted for soap salts. The Agency has conducted a
quantitative ecological risk assessment, which includes a screening-
level listed species assessment. EPA acknowledges that further
refinements to the listed species assessment will be completed in
future revisions and requests public comment on specific areas that
will reduce the uncertainties associated with the characterization of
risk to listed species identified in the current assessment.

    1. Other related information. Additional information on
ancymidol, fosthiazate, lactofen, polybutene resins, quizalofop, and
soap salts is available on the chemical pages for these pesticides
in Chemical Search, http://www.epa.gov/pesticides/chemicalsearch,
and in each chemical's individual docket listed in Table 1. in Unit
III.A. Information on the Agency's registration review program and
its implementing regulation is available at http://www.epa.gov/oppsrrd1/registration_review.
    2. Information submission requirements. Anyone may submit data
or information in response to this document. To be considered during
a pesticide's registration review, the submitted data or information
must meet the following requirements:
     To ensure that EPA will consider data or information
submitted, interested persons must submit the data or information
during the comment period. The Agency may, at its discretion,
consider data or information submitted at a later date.
     The data or information submitted must be presented in
a legible and useable form. For example, an English translation must
accompany any material that is not in English and a written
transcript must accompany any information submitted as an
audiographic or videographic record. Written material may be
submitted in paper or electronic form.
     Submitters must clearly identify the source of any
submitted data or information.
     Submitters may request the Agency to reconsider data or
information that the Agency rejected in a previous review. However,
submitters must explain why they believe the Agency should
reconsider the data or information in the pesticide's registration
review.
    As provided in 40 CFR 155.58, the registration review docket for
each pesticide case will remain publicly accessible through the
duration of the registration review process; that is, until all
actions required in the final decision on the registration review
case have been completed.

List of Subjects

    Environmental protection, Ancymidol, Fosthiazate, Lactofen,
Pesticides and pests, Polybutene resins, Quizalofop, Soap salts.

    Dated: March 12, 2013.
Richard P. Keigwin, Jr.,
Director, Pesticide Re-evaluation Division, Office of Pesticide
Programs.
[FR Doc. 2013-06406 Filed 3-19-13; 8:45 am]
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[Federal Register: March 19, 2007 (Volume 72, Number 52)]
[Notices]
[Page 12796-12797]
[DOCID:fr19mr07-60]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2006-0740; FRL-8288-9]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Information Requirements for
Importation of Nonconforming Vehicles (Renewal); EPA ICR No. 0010.11,
OMB Control No. 2060-0095

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (PRA)(44 U.S.C.
3501 et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR, which is abstracted below, describes the
nature of the information collection and its estimated burden and cost.

DATES: Additional comments may be submitted on or before April 18,
2007.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2006-0740, to (1) EPA online using http://www.regulations.gov (our preferred

method), or by mail to: EPA Docket Center, Environmental Protection
Agency, Air and Radiation Docket, Mailcode 6102T, 1200 Pennsylvania
Ave., NW., Washington, DC 20460, and (2) OMB by mail to: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Lynn Sohacki, Compliance and
Innovative Strategies Division, Office of Transportation and Air
Quality, Environmental Protection Agency, 2000 Traverwood, Ann Arbor,
Michigan 48105; telephone number:<PHONE_NUMBER>; fax number: 734-214-
4869; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On September 14, 2006 (71 FR 54280), EPA sought comments on
this ICR pursuant to 5 CFR 1320.8(d). EPA received no comments during
the comment period. Any additional comments on this ICR should be
submitted to EPA and OMB within 30 days of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2006-0740, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air Docket in the EPA

Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave.,
NW., Washington, DC. The EPA/DC Public Reading Room is open from 8 a.m.
to 4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at
http://www.regulations.gov, to submit or view public comments, access the

index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA receives

them and without change, unless the comment contains copyrighted
material, CBI, or other information whose public disclosure is
restricted by statute. For further information about the electronic
docket, go to http://www.regulations.gov.

    Title: Information Requirements for Importation of Nonconforming
Vehicles (Renewal).
    ICR numbers: EPA ICR No. 0010.11, OMB Control No. 2060-0095.
    ICR Status: This ICR is scheduled to expire on March 31, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An 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. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: Importers into the U.S. of light duty vehicles, light
duty trucks, and on road motorcycles, or the corresponding engines, are
required to report and keep records regarding the imports. The
collection of this information is mandatory to insure compliance with
Federal emissions requirements. Joint EPA and U.S. Customs Service
regulations at 40 CFR 85.1501 et seq., 19 CFR part 1273, and 19 CFR
part 1774, promulgated under the authority of Clean Air Act sections
203 and 208, give authority for the collection of this information. The
information is used by program personnel to ensure that all federal
emissions requirements are met, and by state regulatory agencies,
businesses, and individuals to verify whether vehicles are in
compliance. Any information submitted to the Agency for which a claim
of confidentiality is made is safeguarded according to policies set
forth in title 40, chapter 1, part 2, subpart B--Confidentiality of
Business Information (see 40 CFR part 2), and the public is not
permitted access to information containing personal or organizational
identifiers.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 0.83
hours per response. 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 which have subsequently changed; 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.
    Respondents/Affected Entities: Importers (including Independent
Commercial Importers) of light duty vehicles or engines, light duty
trucks or engines, and highway motorcycles or engines.
    Estimated Number of Respondents: 12,005.
    Frequency of Response: On occasion.
    Estimated Total Annual Hour Burden: 10,216.

    Estimated Total Annual Cost Burden: $1,169,545, including $736,000
in annualized capital costs, $1,780 in O&M costs, and $431,765 in labor
costs.
    Changes in the Estimates: There is a decrease of 5,584 hours in the
total estimated burden currently identified in the OMB Inventory of
Approved ICR Burdens. This decrease is due to use of revised estimates,
based on actual counts, of the number of import forms submitted. There
is a decrease in O&M costs of $1,264,220 and an increase in annualized
capital costs of $736,000. These changes are due to the following: (1)
The labor burden of recordkeeping has been adjusted and costed for the
first time. These replace an O&M cost per form in the prior estimate.
(2) The number of EPA Form 3520-8s has been increased from 200 to 352.
The number of EPA Form 3520-1s has been reduced from 20,000 to 12,000
based on a better estimate due to the availability of a logged
database. (The prior renewal listed 13,000 respondents filing 11,200
responses.) (3) The testing cost is modified to distinguish the
different testing requirements for the two different classes of ICIs.
(4) An O&M and a capital cost are assigned to the testing requirement,
consistent with other certification ICRs, namely the EPA ICR 0783
series and (5) This testing O&M cost replaces a $660,000 O&M expense
that was in the prior renewal.

    Dated: March 12, 2007.
Oscar Morales,
Director, Collection Strategies Division.
[FR Doc. E7-4929 Filed 3-16-07; 8:45 am]

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