[Federal Register: March 19, 2010 (Volume 75, Number 53)]
[Notices]
[Page 13282-13284]
[DOCID:fr19mr10-71]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2010-0008; FRL-8812-9]

Pesticide Products; Registration Applications

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: This notice announces receipt of applications to register new
uses for pesticide products containing currently registered active
ingredients, pursuant to the provisions of section 3(c) of the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is
publishing this Notice of such applications, pursuant to section
3(c)(4) of FIFRA.

DATES: Comments must be received on or before April 19, 2010.

ADDRESSES: Submit your comments, identified by the docket
identification (ID) number specified within the table below, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only
accepted during the Docket Facility's normal hours of operation (8:30
a.m. to 4 p.m., Monday through Friday, excluding legal holidays).
Special arrangements should be made for deliveries of boxed
information. The Docket Facility telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to the docket ID number
specified for the pesticide of interest as shown in the registration
application summaries. EPA's policy is that all comments received will
be included in the docket without change and may be made available on-
line at http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov,
your e-mail address will be automatically captured and included as part
of the comment that is placed in the docket and made available on the
Internet. If you submit an electronic comment, EPA recommends that you
include your name and other contact information in the body of your
comment and with any disk or CD-ROM you submit. If EPA cannot read your
comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index
available at http://www.regulations.gov. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the Internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available either in the

electronic docket at http://www.regulations.gov, or, if only available
in hard copy, at the OPP Regulatory Public Docket in Rm. S-4400, One
Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The
hours of operation of this Docket Facility are from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays. The Docket
Facility telephone number is<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: A contact person is listed at the end
of each registration application summary and may be contacted by
telephone or e-mail. The mailing address for each contact person listed
is: Registration Division (7505P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
Potentially affected entities may include, but are not limited to:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).
    This listing is not intended to be exhaustive, but rather provides
a guide for readers regarding entities likely to be affected by this
action. Other types of entities not listed in this unit could also be
affected. The North American Industrial Classification System (NAICS)
codes have been provided to assist you and others in determining
whether this action might apply to certain entities. If you have any
questions regarding the applicability of this action to a particular
entity, consult the person listed under FOR FURTHER INFORMATION
CONTACT.

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 e-mail. 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).
If you are commenting in a docket that addresses multiple products,
please indicate to which registration number(s) your comment applies.
    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.

II. Registration Applications

    EPA received applications as follows to register pesticide products
containing currently registered active ingredients pursuant to the
provisions of section 3(c) of FIFRA, and is publishing this Notice of
such applications pursuant to section 3(c)(4) of FIFRA. Notice of
receipt of these applications does not imply a decision by the Agency
on the applications.
    1. Registration Numbers: 100-739, 100-1262, 100-1278, 100-1312,
100-1313, 100-1317, Docket Number: EPA-HQ-OPP-2009-0162. Company name
and address: Syngenta Crop Protection, Inc., P.O. Box 18300,
Greensboro, NC 27419. Active ingredient: Difenoconazole. Proposed Uses:
Bulb vegetables, brassica (cole) leafy vegetables, cucurbit vegetables,
citrus fruits, grapes, tree nuts, pistachios Contact: Rose Mary Kearns,
(703) 305-5611<EMAIL_ADDRESS>    2. Registration Numbers/File Symbol: 100-936, 100-941, 100-RGAL,
Docket Number: EPA-HQ-OPP-2010-0041. Company name and address: Syngenta
Crop Protection, Inc., P.O. Box 18300, Greensboro, NC 27419. Active
ingredient: Thiamethoxam. Proposed Use: Peanut seed treatment. Contact:
Julie Chao,<PHONE_NUMBER><EMAIL_ADDRESS>    3. Registration Numbers: 100-1061, 100-1062. Docket Number: EPA-HQ-
OPP-2009-0920. Company name and address: Syngenta Crop Protection,
Inc., P.O. Box 18300, Greensboro, NC 27419. Active ingredient: Diquat
Dibromide. Proposed Use: Preharvest (desiccation broadcast) application
to Canola. Contact: Bethany Benbow,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    4. Registration Numbers: 264-645, 264-646, 264-829. Docket Number:
EPA-HQ-OPP-2010-0031. Company name and address: Bayer CropScience, P.O.
Box 12014, 2 T.W. Alexander Drive, Research Triangle Park, NC 27709.
Active ingredient: Glufosinate-ammonium. Proposed Uses: Citrus: lemon,
orange, grapefruit, lime, mandarin, tangerine, tangelo, calamondin,
kumquat, and pummelo; olives; pome fruits: Apple, Pear, Crabapple,
Loquat, Mayhaw, and Quince; and Stone Fruit: Apricot, Cherry, Peach,
Nectarine, and Plum. Contact: James M. Stone,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    5. Registration Numbers: 264-718, 264-719, 264-850. Docket Number:
EPA-HQ-OPP-2008-0262. Company name and address: Bayer CropScience, P.O.
Box 12014, 2T.W. Alexander Drive, Research Triangle Park, NC 27709.
Active ingredient: Spiromesifen. Proposed Uses: Cardoon, celery,
Chinese celery, celtuce, Florence fennel, rhubarb, Swiss chard (crop
subgroup 4B). Contact: Jennifer Gaines<PHONE_NUMBER>,
<EMAIL_ADDRESS>    6. Registration Numbers: 264-830, 264-831. Docket Number: EPA-HQ-
OPP-2009-0861. Company name and address: Bayer CropScience, P.O. Box
12014, 2T.W. Alexander Drive, Research Triangle Park, NC 27709. Active
ingredient: Spirodiclofen. Proposed Use: Aronia berry, highbush
blueberry, lowbush blueberry, buffalo currant, Chilean guava, black
currant, red currant, elderberry, European barberry, highbush
cranberry, edible honeysuckle, huckleberry, jostaberry, juneberry,
lingonberry, native currant, salai, and sea buckhorn (crop subgroup 13-
07B). Contact: Rita Kumar,<PHONE_NUMBER><EMAIL_ADDRESS>    7. Registration Number: 264-1025. Docket Number: EPA-HQ-OPP-2007-
0099. Company name and address:

Bayer CropScience, P.O. Box 12014, 2 T.W. Alexander Drive, Research
Triangle Park, NC 27709. Active ingredient: Flubendiamide. Proposed
Use: Christmas trees. Contact: Carmen Rodia,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    8. Registration Numbers: 400-480, 400-503. Docket Number: EPA-HQ-
OPP-2009-0890. Company name and address: Chemtura Corporation, 199
Benning Road, Middlebury, CT 06749. Active ingredient: Bifenazate.
Proposed Uses: Sugar apple, cherimoya, atemoya, custard apple, ilama,
soursop, biriba, avocado, small vine climbing fruits except fuzzy
kiwifruit (crop subgroup 13-07F), low growing berries (crop subgroup
13-07G). Contact: Jennifer Gaines,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    9. Registration Numbers: 524-537, 524-549. Docket Number: EPA-HQ-
OPP-2009-0988. Company name and address: Monsanto Company, 1300 I St.,
NW., Suite 450 East, Washington, DC 20005. Active ingredient:
Glyphosate. Proposed Use: Roundup ready sweet corn. Contact: Erik
Kraft,<PHONE_NUMBER><EMAIL_ADDRESS>    10. Registration Numbers: 10163-264, 10163-265. Docket Number: EPA-
HQ-OPP-2008-0886. Company name and address: Gowan Company, P.O. Box
5569, Yuma, AZ 85366. Active ingredient: Formetanate Hydrochloride.
Proposed Use: Bulb onion sub group 3-07 A. Contact: Autumn Metzger,
(703) 305-5314<EMAIL_ADDRESS>    11. Registration Numbers: 66330-39, 66330-38. Docket Number: EPA-
HQ-OPP-2009-0812. Company name and address: Arysta LifeScience, North
Americal LLC, 15401 Weston Parkway, Suite 150, Cary, NC 27513. Active
ingredient: Acequinocyl. Proposed Uses: Field and greenhouse grown
fruiting vegetables (except cucurbits) eggplant, ground cherry
(physalis spp.), pepino, pepper (includes bell pepper, chili pepper,
cooking pepper, pimento, sweet pepper), tomatillo, tomato, okra, edible
podded beans, hops. Contact: Autumn Metzger,<PHONE_NUMBER>,
<EMAIL_ADDRESS>    12. File Symbols: 70585-O, 70585-RN. Docket Number: EPA-HQ-OPP-
2010-0042. Company name and address: Novartis Animal Health US, Inc.
3200 Northline Avenue, Greensboro, NC 27408. Active ingredient:
Thiamethoxam, (Z)-9-tricosene. Proposed Use: Fly control bait. Contact:
Julie Chao,<PHONE_NUMBER><EMAIL_ADDRESS>    13. Registration Numbers: 71512-2, 71512-3. Docket Number: EPA-HQ-
OPP-2009-0801. Company name and address: ISK Biosciences Corporation,
7470 Auburn Road, Suite A, Concord, OH 44077. Active ingredient:
Cyazofamid. Proposed Uses: Brassica Head and Stem Subgroup 5A, Brassica
Leafy Greens Subgroup 5B, Turnip Greens, Spinach and Hops. Contact:
Janet Whitehurst,<PHONE_NUMBER><EMAIL_ADDRESS>    14. Registration Number/File Symbol: 71512-11, 71512-RI. Docket
Number: EPA-HQ-OPP-2010-0043. Company name and address: ISK Biosciences
Corporation, 7470 Auburn Road, Suite A, Concord, OH 44077. Active
ingredient: Flazasulfuron. Proposed Uses: Grape, citrus, sugarcane,
Christmas trees, and industrial vegetation management. Contact: Hope
Johnson,<PHONE_NUMBER><EMAIL_ADDRESS>    15. File Symbol: 87243-R. Docket Number: EPA-HQ-OPP-2010-0051.
Company name and address: Arysta Lifescience America, Inc.; 1450
Broadway, 7th Floor; New York, NY 10018. Active ingredient: Amitraz.
Proposed Use: Insecticidal strip for use in bee hives to control mites
(varroatosis) on honeybees. Contact: Julie Chao,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
List of Subjects

    Environmental protection, Pesticides and pest.

    Dated: March 5, 2010.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

[FR Doc. 2010-5958 Filed 3-18-10; 8:45 am]
BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 148 (Thursday, August 1, 2013)]
[Proposed Rules]
[Pages 46532-46536]
[FR Doc No: 2013-18511]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0616; Directorate Identifier 2007-NM-353-AD]
RIN 2120-AA64

Airworthiness Directives; the Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of
comment period.

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SUMMARY: We are revising an earlier proposed airworthiness directive
(AD) for all The Boeing Company Model 767 airplanes. That NPRM proposed
to require repetitive operational tests of the engine fuel suction feed
of the fuel system, and other related testing if necessary. That NPRM
was prompted by reports of two in-service occurrences on Model 737-400
airplanes of total loss of boost pump pressure of the fuel feed system,
followed by loss of fuel system suction feed capability on one engine,
and in-flight shutdown of the engine. This action revises that NPRM by
proposing to revise the maintenance program to incorporate a revision
to the Airworthiness Limitations Section of the maintenance planning
data (MPD) document, and to remove airplanes from the applicability. We
are proposing this supplemental NPRM to detect and correct failure of
the engine fuel suction feed capability of the fuel system, which could
result in dual engine flameout, inability to restart the engines, and
consequent forced landing of the airplane. Since these actions impose
an additional burden over that proposed in the previous NPRM, we are
reopening the comment period to allow the public the chance to comment
on these proposed changes.

DATES: We must receive comments on this supplemental NPRM by September
16, 2013.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced service
information at the FAA, Transport Airplane Directorate, 1601 Lind
Avenue SW., Renton, Washington. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (phone:<PHONE_NUMBER>) is in the ADDRESSES
section. Comments will be available in the AD docket shortly after
receipt.

FOR FURTHER INFORMATION CONTACT: Sue Lucier, Aerospace Engineer,
Propulsion Branch, ANM-140S, 1601 Lind Avenue SW., Renton, Washington
98057-3352; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2008-0616;
Directorate Identifier 2007-NM-353-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this

proposed AD because of those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    We issued an NPRM to amend 14 CFR part 39 to include an AD that
would apply to all The Boeing Company Model 767 airplanes. That NPRM
published in the Federal Register on June 6, 2008 (73 FR 32252). That
NPRM proposed to require repetitive operational tests of the engine
fuel suction feed of the fuel system, and other related testing if
necessary, according to a method approved by the FAA.

Actions Since Previous NPRM (73 FR 32252, June 6, 2008) Was Issued

    Since we issued the previous NPRM (73 FR 32252, June 6, 2008), we
have received comments from operators indicating a high level of
difficulty performing the actions in the previous NPRM during
maintenance operations. It is standard practice for operators to revise
maintenance tasks to incorporate actions into their individual
maintenance manuals as part of the maintenance program. Based on these
comments, and a review of the previous NPRM, we determined a revision
to the procedures was necessary. In conjunction with Boeing we
developed an airworthiness limitation for the engine fuel suction feed
system to address this issue.

Relevant Service Information

    We reviewed Section 9, Airworthiness Limitations (AWLs) and
Certification Maintenance Requirements (CMRs), D622T001-9, Revision
October 2012 and Revision January 2013, of the Boeing 767 Maintenance
Planning Data (MPD) Document. Among other things, Section 9 describes
AWL No. 28-AWL-101, Engine Fuel Suction Feed Operational Test, of
Section E., AWLS--Fuel Systems, which provides procedures for
performing repetitive operational tests of the engine fuel suction feed
of the fuel system.

Comments

    We gave the public the opportunity to comment on the previous NPRM
(73 FR 32252, June 6, 2008). The following presents the comments
received on the previous NPRM and the FAA's response to each comment.

Request To Withdraw the Previous NPRM (73 FR 32252, June 6, 2008)

    ABX Air asked that we withdraw the previous NPRM (73 FR 32252, June
6, 2008). ABX stated that there have been no incidents recorded in the
NTSB or FAA databases for a Model 767 flameout due to the loss of fuel
system suction feed capability. ABX added that it does not believe the
subject unsafe condition is a critical safety concern.
    We do not agree with the request to withdraw the previous NPRM (73
FR 32252, June 6, 2008), because, together with the manufacturer, we
have evaluated this issue and determined it to be an important safety
concern. Although the fuel system on Model 767 airplanes differs from
the Model 737 with respect to the engine fuel feed system design,
service data of transport category airplanes indicates that multi-
engine flameouts have generally resulted from a common cause, such as
fuel mismanagement, crew action that inadvertently shut off the fuel
supply to the engines, exposure to common environmental conditions, or
engine deterioration on all engines of the same type. Successful in-
flight restart of the engines is dependent on adequate fuel being
supplied to the engines, solely through engine fuel suction feed.
Deterioration of the fuel plumbing system can lead to line (vacuum)
losses, reducing the engine fuel suction feed capability; therefore,
directed maintenance is necessary to ensure this system is functioning
correctly in order to maintain continued safe flight of the airplane.
We have not changed the supplemental NPRM in this regard.

Request To Incorporate CMR Task Into the Maintenance Program Instead of
Issuing an NPRM

    ABX, Japan Airlines International (JAL), and Qantas Airways Ltd.
asked that a CMR task be developed for incorporation into the
maintenance program instead of issuing an NPRM (73 FR 32252, June 6,
2008). The commenters stated that the maintenance program is already in
use by operators and the procedures are understood and followed. Qantas
added that the task associated with this action will generate an
administrative burden for operators, with no benefit.
    We do not agree with the requests to develop a CMR task. CMRs are
developed by the Certification Maintenance Coordination Committee
(CMCC) during the type certification process. The CMCC is made up of
manufacturer representatives (typically maintenance, design, and safety
engineering personnel), operator representatives designated by the
Industry Steering Committee chairperson, FAA Aircraft Certification
Office specialists, and the Maintenance Review Board (MRB) chairperson.
CMRs developed during this process become a part of the certification
basis of the airplane upon issuance of the type certificate. We do not
have a process for convening the CMCC outside of the type certification
process; based on this, the CMR is not an option for replacing this AD.
Therefore, if the airworthiness limitation items (ALIs) were not in the
maintenance program at the time of initial certification, an AD is
required to make the ALI task a required action. We have not changed
the supplemental NPRM in this regard.

Requests To Allow the Use of Later Revisions of the Maintenance
Documents

    Air New Zealand (ANZ), ABX, Continental Airlines (CAL), and Boeing
asked that we allow using later revisions of the referenced maintenance
documents, because those documents could be revised over time and would
require frequent requests for alternative methods of compliance
(AMOCs).
    We do not agree with the request. Allowing later revisions of
service documents in an AD is not allowed by the Office of the Federal
Register regulations for approving materials incorporated by reference.
We have made no change to the supplemental NPRM in this regard.

Request To Clarify Reason for the Unsafe Condition

    Boeing asked that we clarify the reason for the unsafe condition
identified in the previous NPRM (73 FR 32252, June 6, 2008). Boeing
asked that the AD include the results from a report of in-service
occurrences of loss of fuel system suction feed capability on one
engine, due to two in-service engine flameout events on a Model 737-400
airplane while operating on suction feed with undetected air leak
failures. Boeing stated that there are no known reports of any engine
flameout related to events on Model 767 airplanes. Boeing acknowledged
that undetected air leaks could exist and that this maintenance
procedure is a proactive measure to ensure engine flameout will not
occur during suction feed operation.
    We agree to clarify the unsafe condition. We have revised the
Summary section and paragraph (e) of this supplemental NPRM
accordingly.

Requests for Changes To Certain Maintenance Document References

    JAL, ANZ, and Boeing asked that we remove the airplane maintenance
manual (AMM) reference to Section 28-22-00 specified in paragraph (f)
of the previous NPRM (73 FR 32252, June 6, 2008). The commenters stated
that the AMM is covered in Boeing 767 Task Card 28-020-02, and noted
that having fewer references included lessens the chance of errors.
    We acknowledge and agree with the commenters concerns regarding the
maintenance documents referenced in the previous NPRM (73 FR 32253,
June 6, 2008). However, these maintenance documents are not FAA-
approved and we do not have the publication controls associated with
AD-related service documents. We do not agree with the requested
changes because we have decided to mandate an FAA-approved document
which should eliminate these concerns. We changed paragraph (f) of the
previous NPRM (paragraph (g) in this supplemental NPRM) to require
revising the maintenance program to incorporate new procedures into the
maintenance documents.

Requests To Extend Repetitive Test Intervals

    CAL and Air Canada asked that we extend the repetitive operational
test interval specified in paragraph (f) of the previous NPRM (73 FR
32252, June 6, 2008).
    CAL stated that a re-evaluation of the proposed repetitive interval
limit after doing the initial inspection should be done, since CAL's
service history has revealed no reported engine flameout events or
related operational discrepancies. CAL asked that the repetitive
interval be extended to a normal maintenance 2C-check or within 12,000
flight hours, whichever occurs first.
    Air Canada asked that the repetitive interval be extended to a
calendar time of 24 months. Air Canada does not understand the logic
behind a repetitive frequency of 7,500 flight hours.
    We do not agree with the requests that the repetitive intervals be
extended. In developing an appropriate compliance time for the actions
specified in paragraph (g) of this supplemental NPRM (paragraph (f) of
the previous NPRM (73 FR 32252, June 6, 2008)), we considered the
safety implications and normal maintenance schedules for the timely
accomplishment of the specified actions. We have determined that the
proposed compliance time will ensure an acceptable level of safety and
allow the actions to be done during scheduled maintenance intervals for
most affected operators. However, affected operators may request an
AMOC to request an extension of the repetitive operational test
interval under the provisions of paragraph (h) of this supplemental
NPRM by submitting data substantiating that the change would provide an
acceptable level of safety. We have not changed the supplemental NPRM
in this regard.

Request To Clarify That Engine Fuel Suction Feed Test Is Allowed in
Lieu of the Operational Test

    JAL asked that we clarify that the engine fuel suction feed test
procedure in the Boeing 767 Maintenance Planning Data (MPD) document is
an option for performing the operational test in the previous NPRM (73
FR 32252, June 6, 2008). JAL asked that we consider adding the pressure
leak check of the fuel lines and fittings procedure as an alternative
procedure to performing the operational test specified in Section 28-
22-00 of the Boeing 767 Aircraft Maintenance Manual (AMM).
    We agree to provide clarification. The pressure leak check is not
equivalent to the operational test (Task 28-22-00-710-802) since
certain fuel line seal details may function normally under positive
pressure, but fail to hold in-line vacuum when under fuel suction feed.
Additionally, a fuel suction feed test would be required after
reconnecting the fuel line to the manifold to verify final system
integrity. Therefore, we have not changed the supplemental NPRM in this
regard.

Request To Include Warning Information

    CAL suggested that the Boeing service manuals include a critical
design configuration control limitation (CDCCL) warning identification
statement to alert maintenance personnel of the importance of
regulatory compliance, as well as the configuration control
requirement. CAL did not include any justification for this request.
    We agree that a CDCCL warning statement would serve as direct
communication to maintenance personnel that there is an AD associated
with certain maintenance actions. New service information has been
added to this supplemental NPRM since issuance of the previous NPRM (73
FR 32252, June 6, 2008), which should eliminate the commenter's
concern. The airplane maintenance manual will be a ``referred to''
document within the AWL task, which gives operators flexibility in
developing maintenance programs based on equivalent procedures. We have
made no change to the supplemental NPRM in this regard.

Request To Include Corrective Action

    CAL asked that the related testing language specified in paragraph
(f) of the previous NPRM (73 FR 32252, June 6, 2008) be changed. CAL
stated that the language should specify correcting discrepancies before
further flight if the engine fails the operational test. CAL added that
the corrective actions should be done in accordance with the procedures
in the ``Right (Left) Engine Fails the Suction Feed Test'' procedure in
the Boeing 767 Fault Isolation Manual (FIM) 28-22-00/101.
    We acknowledge and agree with the commenters concern. However, as
stated previously, we are issuing this supplemental NPRM to revise the
maintenance program to incorporate a revision to the Airworthiness
Limitations Section of the MPD document to include the ``Engine Fuel
Suction Feed Operational Test'' procedure. Therefore, the language
identified by the commenter has been removed from this supplemental
NPRM. We have made no change to the supplemental NPRM in this regard.

FAA's Determination

    We are proposing this supplemental NPRM because we evaluated all
the relevant information and determined the unsafe condition described
previously is likely to exist or develop in other products of the same
type design. Certain changes described above expand the scope of the
previous NPRM (73 FR 32252, June 6, 2008). As a result, we have
determined that it is necessary to reopen the comment period to provide
additional opportunity for the public to comment on this supplemental
NPRM.

Proposed Requirements of the Supplemental NPRM

    This supplemental NPRM revises the previous NPRM (73 FR 32252, June
6, 2008) by proposing to remove the actions in paragraph (f) of the
previous NPRM and replace with a revision to the maintenance program to
incorporate procedures for the Engine Fuel Suction Feed Operational
Test Airworthiness Limitations Section of the MPD document, and to
remove airplanes from the applicability.
    This AD requires revisions to certain operator maintenance
documents to include new actions (e.g., inspections) and/or CDCCLs.
Compliance with these actions and/or CDCCLs is required by 14 CFR
91.403(c). For airplanes that have been previously modified, altered,
or repaired in the areas addressed by this

AD, the operator may not be able to accomplish the actions described in
the revisions. In this situation, to comply with 14 CFR 91.403(c), the
operator must request approval for an alternative method of compliance
according to paragraph (i)(1) of this AD. The request should include a
description of changes to the required actions that will ensure the
continued operational safety of the airplane.

Costs of Compliance

    We estimate that this proposed AD affects 406 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Revise airworthiness limitations....  1 work-hour x $85 per                $0              $85          $34,510
                                       hour = $85.
----------------------------------------------------------------------------------------------------------------

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2008-0616; Directorate Identifier
2007-NM-353-AD.

(a) Comments Due Date

    We must receive comments by September 16, 2013.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 767-200, -300, -
300F, and -400ER series airplanes, certificated in any category,
that have received a certificate of airworthiness or foreign export
before November 2, 2012.

    Note 1 to paragraph (c) of this AD: November 2, 2012, is the
original publication date of Section 9, Airworthiness Limitations
(AWLs) and Certification Maintenance Requirements (CMRs), D622T001-
9, Revision October 2012, of the Boeing 767 Maintenance Planning
Data (MPD) Document, or Revision January 2013 of the Boeing 767
Maintenance Planning Data (MPD) Document; including Airworthiness
Limitations (AWLS)--Fuel Systems of Airworthiness Limitation (AWL)
No. 28-AWL-101, Engine Fuel Suction Feed Operational Test.

(d) Subject

    Joint Aircraft System Component (JASC)/Air Transport Association
(ATA) of America Code 2800, Aircraft Fuel System.

(e) Unsafe Condition

    This AD results from reports of two in-service occurrences on
Model 737-400 airplanes of total loss of boost pump pressure of the
fuel feed system, followed by loss of fuel system suction feed
capability on one engine, and in-flight shutdown of the engine. We
are issuing this AD to detect and correct failure of the engine fuel
suction feed capability of the fuel system, which could result in
dual engine flameout, inability to restart the engines, and
consequent forced landing of the airplane.

(f) Compliance

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

(g) Maintenance Program Revision

    Within 90 days after the effective date of this AD: Revise the
maintenance program to incorporate AWL No. 28-AWL-101, Engine Fuel
Suction Feed Operational Test, of Section E., AWLS--Fuel Systems of
Section 9, AWLs and CMRs, D622T001-9, Revision October 2012 or
Revision January 2013, of the Boeing 767 MPD Document.

(h) No Alternative Actions, Intervals, and/or Critical Design
Configuration Control Limitations (CDCCLs)

    After accomplishing the revision required by paragraph (g) of
this AD, no alternative actions (e.g., tests), intervals, or CDCCLs
may be used unless the actions, intervals, or CDCCLs are approved as
an alternative method of compliance (AMOC) in accordance with the
procedures specified in paragraph (i) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle 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 the Related Information
section 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.

(j) Related Information

    (1) For more information about this AD, contact Sue Lucier,
Aerospace Engineer, Propulsion Branch, ANM-140S, 1601 Lind Avenue
SW., Renton, Washington 98057-3352; phone:<PHONE_NUMBER>; fax: 425-
917-6590; email<EMAIL_ADDRESS>    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Data & Services Management,
P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-
5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may review copies of the referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, Washington. For information on the
availability of this material at the FAA, call<PHONE_NUMBER>.

    Issued in Renton, Washington, on July 21, 2013.
Stephen P. Boyd,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2013-18511 Filed 7-31-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45820-45825]
[FR Doc No: 2011-19331]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0528]

Food Safety Modernization Act Domestic and Foreign Facility
Reinspections, Recall, and Importer Reinspection User Fee Rates for
Fiscal Year 2012

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2012 fee rates for certain domestic and foreign
facility reinspections, failure to comply with a recall order, and
importer reinspections that are mandated in the Federal Food, Drug, and
Cosmetic Act (the FD&C Act), amended by the FDA Food Safety
Modernization Act (FSMA). These fees are effective on October 1, 2011,
and will remain in effect through September 30, 2012. Invoices for
these fees for FY 2012 will be issued using the fee schedule
established in this document. FDA is accepting comments to this
document and intends to consider such comments in implementing these
user fees in FY 2013.

DATES: Submit either electronic or written comments by October 31,
2011.

ADDRESSES: Submit electronic comments 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.

FOR FURTHER INFORMATION CONTACT: Amy Waltrip, 12420 Parklawn Dr., Rm.
2012, Rockville, MD 20857,<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FSMA (Pub. L. 111-353), section 743 of the FD&C Act (21 U.S.C.
379j-31), establishes three different kinds of fees. The fees are
assessed for the costs of the following activities: (1) Certain
domestic and foreign facility reinspections (section 743(a)(1)(A)), (2)
failure to comply with a recall order under section 423 or 412(f) of
the FD&C Act (section 743(a)(1)(B)), and (3) certain importer
reinspections (section 743(a)(1)(D)).
    Fees for each of these activities are to be established to capture
100 percent of the costs of each activity for each year (sections
743(b)(2)(A), (B), and (D) of the FD&C Act), and must be made available
solely to pay for the costs of each activity for which the fee was
incurred (section 743(b)(3) of the FD&C Act.
    These fees are effective on October 1, 2011, and will remain in
effect through September 30, 2012. FDA is accepting comments to this
document and intends to consider such comments, as well as experience
and additional data gained in implementing these user fees in FY 2012,
in implementing these user fees in FY 2013.

II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2012

    FDA is required to estimate 100 percent of its cost for each
activity and assess fees for FY 2012. In each year, the costs of salary
(or personnel compensation) and benefits for FDA employees account for
between 50 and 60 percent of the funds available to, and used by, FDA.
Almost all of the remaining funds (or the operating funds) available to
FDA are used to support FDA employees for paying rent, travel, utility,
information technology, and other operating costs.

A. Estimating the Full Cost Per Direct Work Hour in FY 2010

    In general, the starting point for estimating the full cost per
direct work hour is to estimate the cost of a full-time-equivalent
(FTE) or paid staff year for the relevant activity. This is most
reasonably done by dividing the total funds allocated to the elements
of FDA primarily responsible for carrying out the activities for which
fees are being collected by the total FTEs allocated to those
activities, using information from the most recent FY for which data
are available. For the purposes of the FSMA fee provisions, primary
responsibility for the activities for which fees will be collected
rests with FDA's Office of Regulatory Affairs (ORA), which carries out
inspection and other field-based activities on behalf of FDA's product
centers, including the Center for Food Safety and Applied Nutrition
(CFSAN) and the Center for Veterinary Medicine (CVM), which have FSMA
implementation responsibilities. Thus, as the starting point for
estimating the full cost per direct work hour, FDA will use the total
funds allocated to ORA for CFSAN and CVM related field activities. The
most recent FY with available data is FY 2010. In that year, FDA
obligated a total of $626,095,116 for the Office of Regulatory Affairs
(ORA) in carrying out work related to programs of the CFSAN and CVM,
excluding the costs of foreign inspection travel. These are the staff
primarily conducting the work related to the reinspection and recall
activities

for which fees would be charged. The obligated total amount paid for
salary, benefits, and operating costs of 2,701 FTEs or paid staff years
utilized by ORA in FY 2010, but exclude the cost of foreign inspection
travel. Dividing $626,095,116 by 2,701 FTEs, results in an average cost
of $231,801 per paid staff year, excluding the costs of foreign
inspection travel.
    Not all of the FTEs required to support the activities for which
fees will be collected are conducting direct work such as inspecting or
reinspecting facilities, examining imports, or monitoring recalls. Data
collected over a number of years and used consistently in other FDA
user fee programs (e.g., under the Prescription Drug User Fee Act
(PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA))
show that every seven FTEs who perform direct FDA work require three
indirect and supporting FTEs. These indirect and supporting FTEs
function in budget, facility, human resource, information technology,
planning, security, administrative support, legislative liaison, legal
counsel, program management, and other essential program areas. On
average, two of these indirect and supporting FTEs are located in ORA
or the FDA center where the direct work is being conducted, and one of
them is located in the Office of the Commissioner. To get the fully
supported cost of an FTE, FDA needs to multiply the average cost of an
FTE by 1.43, to take into account the indirect and supporting
functions. The 1.43 factor is derived by dividing the 10 fully
supported FTEs by 7 direct FTEs. In FY 2010, the average cost of an FTE
was $231,801. Multiplying this amount by 1.43 results in an average
fully supported cost of $331,476 per FTE, excluding the cost of foreign
inspection travel.
    To calculate an hourly rate, FDA must divide the average fully
supported cost of $331,476 per FTE by the average number of supported
direct FDA work hours. See table 1.

      Table 1--Supported Direct FDA Work Hours in a Paid Staff Year
------------------------------------------------------------------------

------------------------------------------------------------------------
Total number of hours in a paid staff year..............           2,080
Less:
  10 paid holidays......................................              80
  20 days of annual leave...............................             160
  10 days of sick leave.................................              80
  10 days of training...................................              80
  2 hours of meetings per week..........................              80
Net Supported Direct FDA Work Hours Available for                  1,600
 Assignments............................................
------------------------------------------------------------------------

    Dividing the average fully supported cost of an FTE in FY 2010
($331,476) by the total number of supported direct work hours available
for assignment (1,600) results in an average fully supported cost of
$207 (rounded to the nearest dollar), excluding foreign inspection
travel costs, per supported direct work hour in FY 2010--the last FY
for which data are available.

B. Adjusting FY 2010 Costs for Inflation to Estimate FY 2012 Costs

    To adjust the hourly rate for FY 2012, FDA must estimate cost of
inflation in each year for FY 2011 and FY 2012. FDA uses the method
prescribed for estimating inflationary costs under the PDUFA provisions
of the FD&C Act (section 736(c)(1) (21 U.S.C. 379h(c)(1))), the only
provision the FD&C Act that provides a method for estimating future
inflationary costs. The inflationary adjustment specified in these
provisions, since FY 2008, is the greater of the following amounts: (1)
The total percentage change that occurred in the Consumer Price Index
(CPI) (all items; U.S. city average) during the 12-month period ending
June 30 preceding the FY for which fees are being set; (2) the total
percentage pay change for the previous FY for Federal employees
stationed in the Washington, DC metropolitan area; or (3) the average
annual change in cost, per FDA FTE, of all personnel compensation and
benefits paid per FTE over the previous five of the most recent six
FYs. PDUFA IV provides for this adjustment to be cumulative and
compounded annually after FY 2008 (see section 736(c)(1)).
    For FY 2012, the first factor is the CPI increase for the 12-month
period ending in June 2011. The CPI for June 2011 was 225.722 and the
CPI for June 2010 was 217.965. (These CPI figures are available on the
Bureau of Labor Statistics Web site at http://data.bls.gov/cgi-bin/surveymost?bls by checking the first box under ``Price Indexes'' and
then clicking ``Retrieve Data'' at the bottom of the page. FDA has
verified the Web site addresses throughout this document, but is not
responsible for any subsequent changes to the Web sites after this
document publishes in the Federal Register.) The CPI for June 2011 is
3.559 percent higher than the CPI for the previous 12-month period.
    The second factor for the FY 2012 inflationary increase is the
increase in pay for the previous FY (FY 2011 in this case) for Federal
employees stationed in the Washington, DC metropolitan area. (This
figure is published by the Office of Personnel Management, and can be
found on the Web site at http://www.opm.gov/oca/11tables/html/dcb.asp
above the salary table. For FY 2011, the inflationary increase was 0.00
percent.
    For FY 2012, the third factor is the average change in FDA's cost
for compensation and benefits per FTE over the previous five of the
most recent six FYs (FY 2006 through FY 2010). The data on total
compensation and benefits paid and numbers of FTEs paid, from which the
average cost per FTE can be derived, are published in FDA's
Justification of Estimates for Appropriations Committees. Table 2 of
this document summarizes the actual costs and FTE data for the
specified FYs, and provides the percent changes from the previous FYs
and the average percent change over the previous five of the most
recent six FYs, which is 3.72 percent.

                                  Table 2--FDA Personnel Compensation and Benefits (PC&B) Each Year and Percent Change
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Average
                                           FY 2005          FY 2006          FY 2007          FY 2008          FY 2009          FY 2010       for latest
                                                                                5 years
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total PC&B...........................   $1,077,604,000   $1,114,704,000   $1,144,369,000   $1,215,627,000   $1,464,445,000   $1,634,108,000  ...........
Total FTE............................            9,910            9,698            9,569            9,811           11,413           12,526  ...........
PC&B per FTE.........................         $108,739         $114,942         $119,591         $123,905         $128,314         $130,457  ...........
% Change from Previous Year..........            5.75%            5.70%            4.05%            3.61%            3.56%            1.67%        3.72%
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Taking all three factors into consideration, the inflationary
increase for FY 2012 is 3.72 percent. The average percent change over
the previous five of the most recent six FYs is 3.72 percent which is
greater than the CPI change

during the 12-month period ending June 30 preceding the FY for which
fees are being set (3.559 percent), and the increase in pay for the
previous FY (FY 2011 in this case) for Federal employees stationed in
the Washington, DC metropolitan area (0.00 percent). Therefore, the
average percent change in PC&B cost per FTE (3.72 percent) becomes the
inflation adjustment for the fee revenue for FY 2012.
    The inflationary adjustment for FY 2011 under the same provisions
in section 736(c)(1) of the FD&C Act was 4.53 percent--the average
percent change over the previous five of the most recent six FYs (FY
2005 through FY 2009). This 4.53 percent is greater than the CPI
increase during the 12-month period ending June 30 preceding the FY for
which fees were being set on June 30, 2010 (1.053 percent), and the
increase in pay for FY 2010 for Federal employees stationed in
Washington, DC (2.42 percent).
    Section 736(c)(1) of the FD&C Act requires the inflationary
adjustment to be cumulative and compounded. This factor for FY 2012
(3.72 percent) is compounded by adding 1 and then multiplying by 1 plus
the inflationary adjustment factor for FY 2011 (4.53 percent), to
account for the 2 years of inflationary adjustments since FY 2010. The
result of this multiplication (1.0372 times 1.0453) becomes the
inflationary adjustment for FY 2012, which is 1.0842, or an increase of
8.42 percent over FY 2010 costs.
    Increasing FY 2010 average fully supported cost per supported
direct FDA work hour of $207 (excluding foreign inspection travel
costs) by 8.42 percent yields an inflationary adjusted cost of $224 per
a supported direct work hour in FY 2012, excluding foreign inspection
travel costs. This is the unit cost that FDA will use in billing the
reinspection and the recall activities for FY 2012 if no foreign travel
is required for the activity.
    In FY 2010, ORA spent a total of $1,010,900 on a total of 91
foreign inspection trips related to FDA's food and veterinary medicine
programs, which averaged a total of $11,109 per foreign inspection
trip. These trips averaged 3 weeks (or 120 paid hours) per trip.
Dividing $11,109 per trip by 120 hours per trip results in a total and
an additional cost of $93 per paid hour spent for foreign inspection
travel costs in FY 2010. To adjust $93 for inflationary increases in FY
2011 and FY 2012, FDA must multiply it by the same inflation factor
mentioned previously in this document (1.0842) which results in an
estimated cost of $101 dollars per paid hour in addition to $224 for a
total of $335 per paid hour ($224 plus $101) for each direct hour of
work requiring foreign inspection travel. These are the rates that FDA
will use in charging fees in FY 2012 when foreign travel is required.

                 Table 3--FSMA Fee Schedule for FY 2012
------------------------------------------------------------------------
                                                              Fee rates
                        Fee category                         for FY 2012
------------------------------------------------------------------------
Hourly rate if no foreign travel is required...............         $224
Hourly rate if foreign travel is required..................          335
------------------------------------------------------------------------

    Congress directed FDA to publish, within 180 days of enactment of
FSMA, a proposed set of guidelines in consideration of the burden of
fee amounts on small business (section 743(b)(2)(B)(iii) of the FD&C
Act). Such consideration may include reduced fee amounts for small
businesses. FDA believes it is important to gather additional
information before publishing such guidelines. Therefore, the Agency is
publishing a separate document in this issue of the Federal Register
requesting public input to help the Agency understand what factors
should be taken into account when drafting the proposed guidelines. The
Agency intends to consider the comments received and then publish for
comment a proposed set of guidelines on the considerations of the
burden of fee amounts on small business. Any adjustment to the fee
schedule for small business must be done through notice and comment
rulemaking (see section 743(b)(2)(B)(iii)). Thus, there will be no
separate small business fees published for FY 2012 (table 3 of this
document) and the published fees in this document will apply to all
businesses in FY 2012.
    FDA recognizes, however, that for some small businesses the full
cost recovery of FDA reinspection or recall oversight could impose
severe economic hardship, and there may be unique circumstances in
which some relief would be appropriate. Thus, during FY 2012, FDA will
consider waiving in limited cases some or all of an invoiced fee based
on a severe economic hardship, the nature and extent of the underlying
violation, and other relevant factors.

III. Fees for Reinspections of Domestic or Foreign Facilities Under
Section 743(a)(1)(A)

A. What will cause this fee to be assessed?

    The fee will be assessed for a reinspection conducted under section
704 of the FD&C Act to determine whether corrective actions have been
implemented and are effective and compliance has been achieved to the
Secretary of Health and Human Services' (the Secretary) (and, by
delegation, FDA's) satisfaction at a facility that manufactures,
processes, packs or holds food \1\ for consumption necessitated as a
result of a previous inspection (also conducted under section 704) of
this facility which had a final classification of Official Action
Indicated (OAI) conducted by or on behalf of FDA, when FDA determined
the non-compliance was materially related to food safety requirements
of the FD&C Act. FDA considers such non-compliance to include non-
compliance with a statutory or regulatory requirement under section 402
of the FD&C Act (21 U.S.C. 342) and section 403(w) of the FD&C Act (21
U.S.C. 343(w)). However, FDA does not consider non-compliance that is
materially related to a food safety requirement to include
circumstances where the non-compliance is of a technical nature and not
food safety related (e.g., failure to comply with a food standard or
incorrect font size on a food label). Determining when non-compliance,
other than under section 402 and 403(w) of the FD&C Act, is materially
related to food safety may depend on the facts of a particular
situation. FDA may consider issuing guidance to provide additional
information about the circumstances under which FDA would consider when
non-compliance is materially related to a food safety requirement.
---------------------------------------------------------------------------

    \1\ The term ``food'' for purposes of this document has the same
meaning as such term in section 201(f) of the FD&C Act (21 U.S.C.
321(f)).
---------------------------------------------------------------------------

    Under section 743(a)(1)(A) of the FD&C Act, FDA shall assess and
collect fees from ``the responsible party for each domestic facility
(as defined in section 415(b) (21 U.S.C. 350d)) and the United States
agent for each foreign facility subject to a reinspection'' to cover
reinspection-related costs.
    Section 743(a)(2)(A)(i) of the FD&C Act defines the term
``reinspection'' with respect to domestic facilities as ``1 or more
inspections conducted under section 704 subsequent to an inspection
conducted under such provision which identified non-compliance
materially related to a food safety requirement of th[e] Act,
specifically to determine whether compliance has been achieved to the
Secretary's satisfaction.''
    The FD&C Act does not contain a definition of ``reinspection''
specific to foreign facilities. In order to give meaning to the
language in section

743(a)(1)(A) of the FD&C Act to collect fees from the United States
agent of a foreign facility subject to a reinspection, the Agency is
using the following definition, of ``reinspection,'' for purposes of
assessing and collecting fees under section 743(a)(1)(A) of the FD&C
Act, with respect to a foreign facility: ``1 or more inspections
conducted by officers or employees duly designated by the Secretary
subsequent to such an inspection which identified non-compliance
materially related to a food safety requirement of the FD&C Act,
specifically to determine whether compliance has been achieved to the
Secretary's (and, by delegation, FDA's) satisfaction.''
    This definition allows FDA to fulfill the mandate to assess and
collect fees from the United States agent of a foreign facility in the
event that an inspection reveals non-compliance materially-related to a
food safety requirement causing one or more subsequent inspections to
determine whether compliance has been achieved to the Secretary's (and,
by delegation, FDA's) satisfaction. By requiring the initial inspection
to be conducted by officers or employees duly designated by the
Secretary, the definition ensures that a foreign facility would be
subject to fees only in the event that FDA, or an entity designated to
act on its behalf, has made the requisite identification at an initial
inspection of non-compliance materially related to a food-safety
requirement of the FD&C Act. The definition of ``reinspection-related
costs,'' as defined in section 743(a)(2)(B) of the FD&C Act, relates to
both a domestic facility reinspection and a foreign facility
reinspection, as described in section 743(a)1)(A) of the FD&C Act.

B. Who will be responsible for paying this fee?

    The FD&C Act states that this fee is to be paid by the responsible
party for each domestic facility (as defined in section 415(b) of the
FD&C Act) and by the United States agent for each foreign facility
(section 743(a)(1)(A) of the FD&C Act). This is the party to whom FDA
will send the invoice for any fees that are assessed under this
section.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on such
reinspections, including time spent conducting the physical
surveillance and/or compliance reinspection at the facility, or
whatever components of such an inspection are deemed necessary, making
preparations and arrangements for the reinspection, traveling to and
from the facility, preparing any reports, analyzing any samples or
examining any labels if required, and performing other activities as
part of the OAI reinspection until the facility is again determined to
be in compliance. The direct hours spent on each such reinspection will
be billed at the appropriate hourly rate shown in table 3 of this
document.

IV. Fees for Non-Compliance With a Recall Order Under Section
743(a)(1)(B)

A. What will cause this fee to be assessed?

    The fee will be assessed for not complying with a recall order
under section 423(d) or 412(f) of the FD&C Act to cover food recall
activities associated with such order performed by the Secretary (and
by delegation, FDA) (section 743(a)(1)(B) of the FD&C Act).
Noncompliance may include the following: (1) Not initiating a recall as
ordered by FDA; (2) not conducting the recall in the manner specified
by FDA in the recall order; or (3) not providing FDA with requested
information regarding the recall, as ordered by FDA.

B. Who will be responsible for paying this fee?

    Section 743(a)(1)(B) of the FD&C Act states that the fee is to be
paid by the responsible party for a domestic facility (as defined in
section 415(b) of the FD&C Act and an importer who does not comply with
a recall order under section 423 or under section 412(f) of the FD&C
Act. In other words, the party paying the fee would be the party that
received the recall order.

C. How much will this fee be?

    The fee is based on the number of direct hours spent on taking
action in response to the firm's failure to comply with a recall order.
Types of activities could include conducting recall audit checks,
reviewing periodic status reports, analyzing the status reports and the
results of the audit checks, conducting inspections, traveling to and
from locations, and monitoring product disposition. The direct hours
spent on each such recall will be billed at the appropriate hourly rate
shown in table 3 of this document.

V. Fees for Import Reinspection/Reexamination Under Section
743(a)(1)(D)

A. What will cause this fee to be assessed?

    Under section 743(a)(2)(A)(ii) of the FD&C Act, for a fee to be
assessed, there must be two sets of examinations. First, there must be
an examination conducted under section 801 of the FD&C Act (21 U.S.C.
381), which must identify noncompliance materially related to a food
safety requirement of the FD&C Act.
    Second, subsequent to the first examination, there must be 1 or
more additional examinations conducted under section 801. These
additional examinations must be conducted specifically to determine
whether compliance has been achieved to the Secretary's (and, by
delegation, FDA's) satisfaction. Moreover, per section 743(a)(1)(D) of
the FD&C Act, an importer subject to a reinspection will be assessed a
fee to cover reinspection-related costs.
    FDA has determined that at least the following four specific
situations will cause a fee to be assessed:
1. Reconditioning of Imported Food
    FDA reviews food that is imported or offered for import to
determine admissibility into the United States (see, e.g., section
801(a) of the FD&C Act). Food is subject to refusal of admission if,
among other reasons, (a) it appears to be adulterated or misbranded, or
(b) if it is a dietary supplement subject to section 761 of the FD&C
Act (21 U.S.C. 379aa-1), FDA has credible evidence or information
indicating that the responsible person has not complied with a
requirement of that section or has not allowed access to records
described in that section. When FDA initiates a refusal of admission,
often referred to as detaining the product, notice is given to the
owner or consignee. If the detention is based on one of the reasons
just described, the owner or consignee of the food may request
permission to recondition the food under section 801(b) of the FD&C
Act. When the basis is that the food appears to be adulterated or
misbranded, the request can be to bring the food into compliance by
relabeling or other action, such as heat treatment, or to render it
other than a food, drug, device, or cosmetic. When the basis relates to
section 761 (serious adverse event reporting for dietary supplements),
the request can be for the responsible person, as defined in section
761, to take action to ensure that the responsible person is in
compliance with section 761.
    A request for reconditioning is made after FDA has determined that
the food is subject to refusal of admission under section 801(a) of the
FD&C Act. For the purpose of section 743 of the FD&C Act, FDA considers
its review of information for the purpose of determining whether an
article of food is admissible to be ``an examination conducted under
section 801.'' If that review leads FDA to determine that the food is
subject to

refusal of admission under section 801(a), FDA considers that to mean
that its examination ``identified noncompliance'' for the purpose of
section 743. This examination could involve, for example, a laboratory
analysis of physical samples of the product or a review of the
product's label. It could also involve reviewing other information FDA
obtains, such as reviewing sample results from a reliable third party,
relevant epidemiological evidence, or the results from an FDA or third
party inspection of a facility where the food was processed. A
detention without physical examination could also be based on
information contained in an import alert.
    When food is on an import alert, it typically means that FDA has
concluded there is sufficient evidence or other information to detain
without physical examination of future shipments of the imported food
(e.g., that future shipments appear to be adulterated or misbranded)
and they are subject to refusal unless the owner or consignee shows the
product is compliant (e.g., through third-party laboratory analysis).
FDA considers situations where FDA's review of information leads it to
conclude that food should be placed on an import alert for detention
without physical examination to be ``an examination conducted under
section 801 [that] identified noncompliance'' for the purposes of
section 743. FDA's Regulatory Procedures Manual (RPM), Chap. 9,
discusses the types of reviews FDA conducts, and the types of
information it reviews, in determining whether to detain a product or
to place a product on an import alert.
    For a fee to be assessed under section 743, FDA's determination
that the food is subject to refusal of admission must be on a basis
materially related to food safety requirements (see section III.A of
this document for a discussion about ``materially related to food
safety requirements'').
    If FDA authorizes a request for reconditioning, the reconditioning
operations are carried out under the supervision of either FDA or U.S.
Customs and Border Protection (CBP) (section 801(b) of the FD&C Act; 21
CFR 1.96(a)). FDA considers the review and approval of the request, as
well as this supervision to be ``1 or more examinations conducted under
section 801 * * * specifically to determine whether compliance has been
achieved'' to FDA's satisfaction.
2. Importer Seeking Admission of an Article That Has Been Detained
    If FDA has determined that an article of food is subject to refusal
of admission under section 801(a) of the FD&C Act, FDA gives notice of
this to the owner or consignee, who then has an opportunity to
introduce evidence regarding the admissibility of the food (section
801(a) of the FD&C Act; 21 CFR 1.94(a)). As discussed previously in
this document, where FDA has reviewed information for the purpose of
admissibility and determined that the food is subject to refusal of
admission under section 801, FDA considers that it has conducted ``an
examination conducted under section 801 [that] identified
noncompliance.'' This includes situations where FDA's review determines
that food should be placed on an import alert for detention without
physical examination.
    If the owner or consignee chooses to submit evidence regarding
admissibility, FDA reviews the information to determine whether--
despite the appearance that the product is adulterated, misbranded, or
otherwise subject to refusal of admission--the food is compliant and
admissible into the United States. The evidence the owner or consignee
submits varies. Depending on the circumstances, it could include, for
example, the results of laboratory analyses of samples conducted on the
owner/consignee's behalf to show the product is not contaminated. FDA
considers its review of the evidence submitted to be ``1 or more
examinations conducted under section 801 * * * specifically to
determine whether compliance has been achieved'' to FDA's satisfaction.
    Not all situations where the owner/consignee provides information
or evidence to demonstrate compliance will result in the assessment of
a fee. An example is if a food, not subject to an Import Alert, is
detained based on an appearance of adulteration or misbranding, but
information is presented that demonstrates that the food is not
adulterated or misbranded. FDA considers such a situation to be one in
which a fee is not assessed.
    A fee may or may not be assessed under certain circumstances
related to food that is detained based on an import alert for detention
without physical examination covering food from a particular geographic
region or country. FDA may place a region or country on an import alert
if there appears to be an ongoing problem or condition in that region
or country such that it causes the appearance of a violation for future
shipments of imported articles originating there. If food from a region
or country is subject to an import alert and is subsequently detained
based on the overarching import alert, the owner or consignee may seek
admission by providing evidence that the problem or conditions
regarding the food it is importing have been resolved. Alternatively,
the owner or consignee may provide evidence that the problems or
conditions that led to the alert, even if widespread in the region or
country, did not apply to its food and, thus, it did not need to
resolve any compliance-related issues. FDA considers the latter
situation to be one in which a fee is not assessed. A fee may be
assessed, however, when FDA reviews compliance information specific to
the food being imported or specific to a particular processor in
determining whether to issue a region- or country-wide import alert. An
example is a situation where FDA analyzed samples of food from
Processor A and found it to be contaminated, the food is later placed
on a region- or country-wide import alert, and the owner or consignee
is now importing or offering for import food from Processor A. If the
owner or consignee seeks admission of the food by providing third party
laboratory analyses to show the food is not contaminated, FDA's review
of this information would be ``1 or more examinations conducted under
section 801 * * * specifically to determine whether compliance has been
achieved'' to FDA's satisfaction.
3. Entity Requesting Removal From an Import Alert for Detention Without
Physical Examination
    Once placed on import alert, food imported from a particular firm,
region, or country may remain in this status until FDA has sufficient
evidence or other information, such as information that removes the
appearance of the violation that led to the initial placement on import
alert. Depending on the situation that led to the import alert, FDA's
RPM Chapter 9 or the import alert itself may explain the types of
information that should be provided.
    As discussed previously in this document, where FDA has reviewed
information and determined that food should be placed on an import
alert for detention without physical examination, it considers that it
has conducted 1 or more examinations conducted under section 801 that
identified noncompliance.
    Where an entity requests removal of food from an import alert and
provides supporting information, FDA considers its review of this
information, along with any other related examination it undertakes in
considering the request, to be ``1 or more examinations conducted under
section 801 * * * specifically to determine whether compliance has been
achieved'' to FDA's satisfaction.

    As discussed in section V.A.2 of this document, some requests for
removal from region- or country-wide import alerts will not lead to the
assessment of a fee. Fees would only be assessed in situations where,
in issuing the alert, FDA reviewed compliance information specific to a
particular person or entity sufficiently related to the request for
removal. An example of such a situation is where FDA analyzed samples
of food from Processor A and found it to be contaminated, the food is
then placed on a region- or country-wide import alert, and FDA receives
a request to remove food from Processor A from the import alert.
4. Destruction of Food That Has Been Refused Admission
    If a product is refused admission under section 801(a) of the FD&C
Act, it must be exported within 90 days of the document of refusal or
it is subject to destruction by CBP (section 801(a) of the FD&C Act).
In practice, when a product is destroyed, destruction is often
conducted by the owner or consignee under the supervision of FDA or
CBP. Where FDA conducts a review and/or approves a destruction proposal
and such supervision of destruction occurs, FDA considers this to be
``1 or more examinations conducted under section 801 * * * specifically
to determine whether compliance has been achieved'' to FDA's
satisfaction.

B. Who will be responsible for paying this fee?

    The importer that is subject to the additional examinations that
are described in section V.A of this document is responsible for paying
the fee, according to section 743(a)(1)(D) of the FD&C Act.
1. Reconditioning of Imported Food
    For reconditioning, the entity that is responsible for the
reconditioning is responsible for paying the fee. The request for
reconditioning can only be made by the owner or consignee of the food
(21 CFR 1.95). If ownership changes, the new owner will be responsible
for the reconditioning if that new owner executes a bond and obtains a
new authorization (21 CFR 1.96(d)).
2. Importer Seeking Admission of an Article That Has Been Detained
    The entity that introduces evidence regarding admissibility is
responsible for paying this fee. This is the owner or consignee of the
food that is being imported or offered for import. (Section 801(a) of
the FD&C Act; 21 CFR 1.83(b) and 1.94(a).)
3. Entity Requesting Removal From an Import Alert for Detention Without
Physical Examination.
    FDA considers the entity that requests removal of the food from the
import alert to be the importer subject to the examination and, thus,
responsible for paying this fee.
4. Destruction of Food That Has Been Refused Admission
    FDA considers the entity that destroys the product under FDA or CBP
supervision to be the importer subject to the examination and, thus,
responsible for paying this fee.

C. How much will this fee be?

    The fee is to cover all expenses incurred in connection with
arranging, conducting, and evaluating the results of the one or more
additional examinations that are described in section V.A of this
document.
    For reconditioning, section 801(c) of the FD&C Act directs the
owner or consignee to pay all expenses in connection with the
supervision of reconditioning with respect to food and certain other
FDA-regulated products. Those parties have been paying these expenses,
but FDA did not have authority to retain those fees. FDA considers the
enactment of section 743 of the FD&C Act to mean that, for food, FDA is
now authorized to assess and retain these fees, but only with respect
to the reconditioning of food and only if the other conditions of
section 743 are met. If a fee is authorized under section 743 for a
particular article of food, FDA considers this to mean it cannot
collect a fee related to reconditioning that article under section
801(c).
    For destruction, section 801(c) of the FD&C Act also directs the
owner or consignee to pay all expenses in connection with the
destruction of food and certain other FDA-regulated products under
section 801(a). However, neither FDA nor CBP have had the authority to
retain those fees. FDA considers the enactment of section 743 of the
FD&C Act to mean that, for food, FDA is now authorized to assess and
retain these fees, but only with respect to the destruction of food and
only if the other conditions of section 743 are met. If a fee is
authorized under section 743 for a particular article of food, FDA
considers this to mean it cannot collect a fee related to destruction
of that article under section 801(c) of the FD&C Act.
    The direct hours spent on each such import reinspections will be
billed at the appropriate hourly rate shown in table 3 of this
document.

VI. How must the fees be paid?

    An invoice will be sent to the responsible party for paying the fee
after FDA completes the work on which the invoice is based. Payment
must be made within 30 days of the invoice date in U.S. currency by
check, bank draft, or U.S. postal money order payable to the order of
the Food and Drug Administration. Detailed payment information will be
included with the invoice when it is issued.

VII. What are the consequences of not paying these user fees?

    Under section 743(e)(2) of the FD&C Act, any fee that is not paid
within 30 days after it is due shall be treated as a claim of the
United States Government subject to provisions of subchapter II of
chapter 37 of title 31, United States Code.

VIII. 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: July 26, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19331 Filed 7-29-11; 8:45 am]
BILLING CODE 4160-01-P