[Federal Register Volume 81, Number 196 (Tuesday, October 11, 2016)]
[Notices]
[Pages 70122-70124]
[FR Doc No: 2016-24430]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1445]

Blood Glucose Monitoring Test Systems for Prescription Point-of-
Care Use; Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the guidance entitled ``Blood Glucose Monitoring
Test Systems for Prescription Point-of-Care Use.'' This document
describes studies and criteria that FDA recommends be used when
submitting premarket notifications (510(k)s) for blood glucose
monitoring systems (BGMSs) which are for prescription point-of-care use
in professional healthcare settings. FDA intends for this document to
serve as a guide for manufacturers in conducting appropriate
performance studies and preparing 510(k)s for these device types.

DATES: Submit either electronic or written comments on this guidance at
any time. General comments on Agency guidance documents are welcome at
any time.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public
submit, the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-D-1445 for ``Blood Glucose Monitoring Test Systems for
Prescription Point-of-Care Use; Guidance for Industry and Food and Drug
Administration Staff; Availability.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at http://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the

claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
    An electronic copy of the guidance document is available for
download from the Internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single copy of the guidance document to the Office of
the Center Director, Guidance and Policy Development, Center for
Devices and Radiological Health, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your request.

FOR FURTHER INFORMATION CONTACT: Leslie Landree, Center for Devices and
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 4623,
10903 New Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    This document describes studies and criteria that FDA recommends be
used when submitting 510(k)s for BGMSs which are for prescription
point-of-care use in professional settings. FDA intends for this
document to serve as a guide for manufacturers in conducting
appropriate performance studies and preparing 510(k)s for these device
types. This document is not meant to address self-monitoring blood
glucose test systems (SMBGs) for over-the-counter (OTC) home use by
lay-users. Elsewhere in this issue of the Federal Register, FDA is
announcing the availability of the guidance ``Self-Monitoring Blood
Glucose Test Systems for Over-the-Counter Use'' to address those device
types.
    Historically, FDA has not recommended different types of
information in 510(k)s for BGMSs used by healthcare professionals as
compared to SMBGs intended for home use by lay-users. However, it has
become increasingly clear that these different use settings have
distinct intended use populations with unique characteristics that can
impact device design specifications, and that manufacturers should take
these unique characteristics into account when designing their devices.
In order to distinguish between FDA recommendations for prescription-
use blood glucose meters, which are intended for use in point-of-care
professional healthcare settings, and SMBG devices intended for home
use for self-monitoring by lay-persons, the Agency is issuing two
separate guidances for (i) BGMSs intended for use in point-of-care
professional healthcare settings, and (ii) SMBGs intended for home use
for self-monitoring by lay-users. FDA believes that in making this
distinction, BGMSs can be better designed to meet the needs of their
intended use populations, thereby providing greater safety and
efficacy.
    Because BGMSs are used in professional healthcare settings, they
are more likely to be used on multiple patients. The Centers for
Medicare and Medicaid Services and Centers for Disease Control and
Prevention have expressed concern over the possibility that blood
glucose meters can transmit bloodborne pathogens if these devices are
contaminated with blood specimens and shared between users without
effective cleaning, disinfecting, and appropriate infection control
measures. This document describes certain design features and capacity
for cleaning and disinfection to prevent the spread of bloodborne
pathogens.
    In addition, concerns have been raised citing the inability of
currently cleared BGMSs to perform effectively in professional
healthcare settings because these devices have not been adequately
evaluated in some of the populations in which they are being used.
Patients in professional healthcare settings are often fundamentally
different than lay-users using these devices at home. Patients in
professional healthcare settings can be acutely ill and medically
fragile and are more likely to present physiological and pathological
factors that could interfere with glucose measurements relative to lay-
users. Errors in BGMSs accuracy can lead to incorrect insulin dosing,
which, when combined with other factors, can lead to increased episodes
of hypoglycemia. For hospitalized patients who may be seriously ill,
glucose meter inaccuracies could further increase risk to health. This
document describes studies that can be conducted to demonstrate BGMS
performance for devices intended to be used in diverse professional
healthcare settings on subjects in various states of health. While FDA
recommends that the information described in this guidance be included
in premarket submissions for BGMSs, submissions containing alternative
information may be sufficient if able to demonstrate substantial
equivalence to a legally marketed predicate device.
    In the Federal Register of January 7, 2014 (79 FR 830), the Agency
issued the draft guidance entitled ``Blood Glucose Monitoring Test
Systems for Prescription Point-of-Care Use''. In the Federal Register
of April 9, 2014 (79 FR 19622), the Agency announced that the deadline
for the comment period would be extended until May 7, 2014, to allow
for more public comments on this draft guidance document. FDA
considered the comments received on this draft guidance and FDA revised
the guidance as appropriate in response to the comments.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Blood Glucose Monitoring Test Systems for
Prescription Point-of-Care Use.'' It does not establish any rights for
any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the Internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance
documents are also available at http://www.regulations.gov. Persons
unable to download an electronic copy of ``Blood Glucose Monitoring
Test Systems for Prescription Point-of-Care

Use'' may send an email request to<EMAIL_ADDRESS>to receive
an electronic copy of the document. Please use the document number 1755
to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations and guidance. These collections of
information are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 807 subpart E have
been approved under OMB control number 0910-0120; the collections of
information in 21 CFR 801 and 21 CFR 809.10 have been approved under
OMB control number 0910-0485; the collections of information in 21 CFR
part 820 have been approved under OMB control number 0910-0073; the
collections of information in the guidance document ``Recommendations:
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver
Applications for Manufacturers of In Vitro Diagnostic Devices'' have
been approved under OMB control number 0910-0598; and the collections
of information in the guidance document ``Requests for Feedback on
Medical Device Submissions: The Pre-Submission Program and Meetings
with Food and Drug Administration Staff'' have been approved under OMB
control number 0910-0756.

    Dated: October 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24430 Filed 10-7-16; 8:45 am]
 BILLING CODE 4164-01-P


  SEQ CHAPTER \h \r 1 	SUPPORTING STATEMENT FOR

	AN INFORMATION COLLECTION REQUEST (ICR)

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title of the Information Collection

	Application and Summary Report for an Emergency Exemption for
Pesticides

	OMB No.:  2070-0032 		EPA No.:  0596.08

	1(b)	Short Characterization/Abstract

	This Information Collection Request (ICR) is a renewal of an existing
ICR that is currently approved by OMB and is due to expire July 31,
2012.  Section 18 of the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) authorizes the Environmental Protection Agency (EPA) to
grant emergency exemptions to states and Federal agencies to allow an
unregistered use of a pesticide for a limited time if EPA determines
that emergency conditions exist.  A Section 18 action arises when
growers and others encounter a pest problem on a site for which there is
either no registered pesticide available, or for which there is a
registered pesticide that would be effective but is not yet approved for
use on that particular site.  Section 18 also allows EPA to grant
unregistered pesticide use exemptions for public health and quarantine
reasons.

Most requests for emergency exemptions are made by state lead
agricultural agencies, although agencies such as the United States
Departments of Agriculture (USDA), Defense (DOD) and Interior (USDI)
also request exemptions.  This process is generally initiated when
growers in particular regions identify an urgent, non-routine situation
which registered pesticides will not alleviate.  The growers contact
their state lead agency (usually a state’s department of agriculture)
and request that the state agency apply to EPA for a Section 18
emergency exemption for a particular use.  The state agency evaluates
the requests and submits requests to EPA for emergency exemptions they
believe are warranted.  The uses are requested for a limited period of
time to address the emergency situation only.

2.	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

This information collection allows the Agency to access needed data to
expeditiously make statutory determinations to grant or deny a section
18 request. Unexpected changes in climatic conditions, development of
pest resistance and/or importation of pests are some of the
unpredictable situations that could give rise to a section 18 emergency
exemption request.  In these situations there is an immediate need for a
pesticide for a use for which it is not registered and for which there
is insufficient time to obtain registration.

Requests for Section 18 emergency exemptions, i.e., the submission of
applications, are at the discretion of a state, U.S. territory, or
federal agency.  Should one of these entities apply for an emergency
exemption, EPA requests the information and data identified under
Section 4(b) “Information Requested” of this supporting statement.
If EPA determines that conditions exist which require an exemption and
the risks are acceptable, EPA typically approves the emergency exemption
request.  EPA will deny an exemption request if the pesticide use may
cause unreasonable adverse effects to human health or the environment,
or if emergency criteria are not met.  A state may withdraw an exemption
request at any point in the process.

	In unpredictable emergency situations when insufficient time for a
formal section 18 application and review process is available to address
the problem, a state agency may issue a crisis exemption which allows
for the immediate use of an unregistered pesticide for no longer than 15
days, unless an application for the specific exemption request has been
submitted to EPA.

	The state issuing the crisis exemption must coordinate the declaration
with EPA prior to releasing it to the users.  EPA performs a cursory
review of the use to ensure there are no concerns.  If any concerns are
noted, EPA confers with the state and under extreme cases may not allow
a crisis to be declared.  If the state follows up the crisis with, or
has already submitted, an emergency exemption request, the use may
continue under the crisis until EPA has made a decision on the request.
EPA must establish the appropriate time-limited tolerance(s) required by
the Federal Food, Drug and Cosmetic Act (FFDCA) for any pesticide uses
to commercial agricultural items under emergency exemptions, including
crisis exemptions.

	EPA receives an average of approximately 159 section 18 requests per
year.  Producers of minor crops are especially reliant on the emergency
exemption program.  Less frequently, emergency exemption applications
are submitted in order to combat pests which pose a threat to public
health.  Other pests of national importance include zebra mussels and
varroa mites. The

section 18 emergency exemption program is also supporting the stink bug
invasive species agricultural initiatives.

	On January 27, 2006, EPA published a final rule (71 FR 4495) revising
the regulations governing emergency exemptions.  EPA received
considerable stakeholder involvement and identified several
opportunities to streamline and improve the pesticide emergency
exemption process without compromising protection for human health and
the environment  The new section 18 rule became effective on March 28,
2006.  The final rule, 40 CFR part 166, contains two primary revisions
to the application, review and approval process for specific exemptions.

	Section 18 of FIFRA (see Attachment A) states in part that, "The
Administrator may, at [his/her] discretion, exempt any federal or state
agency from any provision of this Act if [s]he determines that emergency
conditions exist that require such exemption".  Under this provision,
EPA may temporarily authorize federal or state agencies to allow use of
pesticide products under emergency conditions.  Detailed regulations
regarding the procedures for emergency exemptions are contained in 40
CFR Part 166 (see Attachment B).

	Section 408 of the Federal Food, Drug, and Cosmetic Act (see Attachment
C) requires that EPA establish tolerances, or maximum legal limits for
all pesticide residues in food, including those resulting from Section
18 emergency uses.  Tolerances established for emergency exemptions are
time-limited to correspond to the use season or multiple use seasons.
Thus, data collected under this collection also allows the Agency
establish tolerances or tolerance exemptions for section 18 emergency
actions.  When the Agency establishes a tolerance, there must be a
finding that there is “reasonable certainty that no harm” will
result to human health from aggregate and cumulative exposure to the
pesticide, as required by the health-based standard. For section 18
actions, these Agency tolerance setting activities decisions must be
conducted in a timely manner, and their expiration dates, are
established by a final rulemaking published in the Federal Register.
The time-limited tolerances for pesticide emergency exemptions are
codified at 40 CFR 176, see Attachment D.

	2(b)	Practical Utility/Users of the Data

	EPA uses the information collected to carry out its statutory
responsibilities under FIFRA section 18.  This data collected allows EPA
to evaluate an application for a permit for the temporary use of a
pesticide product for an unregistered use and whether such use will
mitigate an emergency situation.  Generally, the data submitted must
support the Agency’s evaluation of whether: 1) an emergency exists; 2)
use of the pesticide under the exemption will be protective of human
health and the environments; and 3) the requested product’s
effectiveness in allaying the emergency. The application and follow-up
reporting is essential to weighing the emergency nature of the situation
as well as the effectiveness, risks of the treatment program, and
comparing the cost impacts based on the new tiered thresholds for
significant economic loss determination.

	NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	3(a)	Non duplication

	This information collection activity is unique and is administered by
EPA pursuant to FIFRA.  The possibility of duplication does not exist by
any other federal agency.

3(b)	Public Notice and Opportunity to Comment

	In preparing the renewal for this ICR, EPA published a notice in the
Federal Register (72 FR 30794) on June 4, 2007 which provided a 60-day
public notice and comment period on the draft ICR.  The Agency did not
receive any public comments on the draft renewal ICR.

	3(c)	Consultations

	Consultation and/or dialogue between states and the Agency during the
submission and review of an application are frequent and ongoing.
Questions or consultations pertaining to a particular submission are
addressed in meetings or telephone conversations with the applicant and
do not necessarily occur at specified intervals.  In addition to
communications regarding specific exemption requests, Agency staff
participates in stakeholder training workshops with state pesticide
regulatory representatives.  These communications permit an exchange of
problems and questions on the program in general and other relevant
issues.  For example, OPP staff members conducted a series of training
workshops at headquarters and several regional locations for
stakeholders.  Consultations responses will be posted during the second
comment period. See Attachment E.

	3(d)	Effects of Less Frequent Collection

	As discussed above, there is no collection schedule for this
information collection activity, per se.  State and federal agencies
initiate the information collection activity when they prepare an
emergency exemption application for submission to EPA.  State and
federal agencies determine the frequency in which to pursue an emergency
exemption request with EPA.  EPA does not solicit or request the
exemption application.

3(e) 	General Guidelines

	EPA requires the states to maintain records of the first food use of a
pesticide under an emergency exemption for two years following the date
of expiration.  Generally, an applicant for an emergency exemption is
not required to maintain data beyond the date that the summary report
has been received by the Agency.  Therefore, the OMB guidelines codified
in 5 CFR 1320.6 indicate that data, other than health, medical, or tax
records, need not be retained for more than three years and will not be
exceeded in this program.

	3(f) 	Confidentiality

	Although the EPA urges the submitter to minimize the amount of claimed
Confidential Business Information (CBI), certain limited all data and/or
information brought to the Agency in conjunction with this rule may be
claimed as trade secret, or commercial or financial information and will
be protected from disclosure by the EPA under FIFRA section 10 and the
associated regulation as contained in 40 CFR Part 2, Subpart B.  In
general, EPA works to make information relative to section 18 decisions
and supporting data easily available to the public (e.g. web site
postings of program information, and public distribution of decision
documents).  Growers and industry stakeholders need to be made aware of
section 18 exemptions.  Thus, as a rule, claims of confidentiality are
not made on emergency exemption applications.  On certain rare
occasions, the manufacturer of the requested producer may have product
formulation information that is necessary to protect CBI.

When trade secret information or Confidential Business Information is
provided to the Agency, such information is protected from disclosure
under FIFRA Section 10, as amended and EPA's confidentiality regulation,
Title 40 CFR, Subpart B.  Data submitted to the Agency are handled
strictly in accordance with the FIFRA CBI Security Manual.  This manual
contains instructions relative to all contact with confidential
documents, including responsibility of EPA employees; physical security
measures; CBI materials within EPA, such as CBI typing procedures
(documents typed internally or on contract); and division internal
procedures.  The manual dictates that: (1) all CBI must be marked or
flagged as such , (2) all CBI must be kept in secure, double-locked
areas, and (3) all CBI for destruction must be cleared by a document
control officer and placed in the Office of Prevention, Pesticides and
Toxic Substances paper shredder.

3(g) 	Sensitive Questions

	No information of a sensitive or private nature is requested in
conjunction with this collection activity.  Further, this information
collection activity complies with the provisions of the Privacy Act of
1974 and OMB circular A-108.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)	Respondents/NAICS Codes

	Respondents affected by the collection activities under this ICR are
federal and state agencies which regulate pesticides or pesticide
products.  The North American Industrial Classification System (NAICS)
code assigned to the states and federal government agencies responding
to this information is 9241, The Administration of Environmental Quality
Programs subsector groups of government establishments primarily engaged
in the administration of environmental quality. Section 2(aa) of FIFRA
defines State to include any of the 50 States, the District of Columbia,
the Commonwealth of Puerto Rico, the United States Virgin Islands, Guam,
the Trust Territory of the Pacific Islands, and American Samoa.

4(b)	Information Requested

	To apply for an exemption, an application must be submitted in writing
by the head of a federal or state agency, the Governor of the state
involved, or their official designee.  If a designee has been delegated
authority to request exemptions, written authorization of such
delegation must accompany the request or be on file with the EPA.

	Applications for specific, quarantine, or public health exemptions must
contain the following information:

Identity of contact person(s)	Name and telephone number of one or more
qualified experts who may be contacted if questions arise concerning the
application.

Description of the pesticide	Description of pesticide(s) proposed for
the use under the exemption.

For a federally registered pesticide:

registration number and name of pesticide product (if a specific product
is requested), or formulation(s) requested (if a specific product is not
desired), and

copy of any additional labeling proposed for the emergency exemption.

For an unregistered pesticide product, copy of:

EPA Form No. 8570-4 Confidential Statement of Formula (or reference to
one already submitted to the Agency), and

Complete labeling to be used in connection with proposed use.

Description of the proposed use	Application must identify all of the
following:

sites to be treated, including locations within the state,

method of application,

rate of application of active ingredient and product,

total acreage or other appropriate unit proposed to be treated,

total amount of pesticide proposed to be used (active ingredient and
product), and

all applicable restrictions and requirements concerning proposed use and
qualifications of applicators using the pesticide.

Alternative methods of control	Detailed explanation of why the
pesticide(s), currently registered for the particular use proposed in
the application, is not available in adequate supplies and/or effective
to the degree needed to control the emergency.  If the applicant states
that an available registered pesticide is ineffective for the given
situation, the statement must be supported by field data that
demonstrate this, or if such data are unavailable, statements by
qualified agricultural experts, extension personnel, university
personnel or other persons similarly qualified in the field of pest
control.  In addition, a detailed explanation must be provided of why
alternative practices, if available, either would not provide adequate
control or would not be economically or environmentally feasible.

Effectiveness of proposed use	Application must contain data, discussion
of field trials, and other evidence that provide the basis for the
conclusion that the proposed pesticide treatment will be effective in
dealing with the emergency.

Discussion of residues for food uses	If proposed use is expected to
result in residues of the pesticide in or on food or feed, application
must list the food likely to contain such residues and must contain an
estimate of the maximum amount of the residue likely to result from the
proposed use, together with the information on which such estimates are
based.

Discussion of risk information	Potential risks to human health,
endangered species, beneficial organisms, and the environment expected
to result from the proposed use, together with references to data and
other supporting information.

Coordination with other affected state or federal agencies.	If the
proposed pesticide use is likely to be of concern to other federal or
state agencies, application must indicate that such agencies have been
contacted prior to submission of the application, and any comments
received from such agencies must be submitted to EPA.

Notification of registrant or basic manufacturer.	Statement that the
registrants of all pesticide products proposed for use or, if
appropriate, the basic manufacturer, support the request for a specific,
quarantine, or public health exemption.

Description of proposed enforcement program.	Explanation of the
authority of the applicant or related state or federal agency for
ensuring that use of the pesticide under the proposed exemption would
comply with any special requirements imposed by EPA and a description of
the program and procedures for assuring such compliance.

Progress toward registration.

	Prior to submitting an application for a repeat specific or public
health exemption, the federal or state agency must contact the
registrant regarding the progress being made toward registration of the
proposed use and include this information in the section 18 application.
 This information must also include a summary of study deficiencies and
data gaps, and registrant's timetable for completing requirements for
registration.

In addition, the following information must be provided:

For a specific exemption	All of the following, as appropriate, must be
provided concerning the nature of the emergency:

scientific and common name of the pest or pest complex;

events that brought about the emergency condition;

anticipated risks to endangered or threatened species, beneficial
organisms, or the environment that would be remediated by the proposed
use of the pesticide; and

anticipated significant economic loss that would occur without the use
of the requested registered pesticide, together with data and other
supporting information, that addresses the historical net and gross
revenues for the site, the estimated net and gross revenues for the site
without use of the proposed pesticide, and the estimated net and gross
revenues for the site with use of the proposed pesticide.

For a quarantine exemption	A quarantine exemption may be authorized in
an emergency condition to control the introduction or spread of any pest
new to and therefore known to be widely prevalent or distributed within
and throughout the United States and its territories.  The application
for the quarantine exemption must include the following information:

scientific and common name of the pest or pest complex;

origin of the introduced pest and the means of its introduction and
spread into the area, if known.

economic impact of controlling versus not controlling the pest via the
proposed pesticide treatment.

For a public health exemption	Scientific and common name of pest or pest
complex; if the pest is a vector, a description of the disease it is
expected to transmit; and

magnitude of the health problems that are expected to occur without the
pesticide use; and availability of medical treatment for the health
problem.

For a crisis exemption, only the following information must be provided:
The state or federal agency issuing the crisis exemption must coordinate
any crisis declaration in advance with EPA prior to initiating the use.
  The notice must include:

name of active ingredient authorized for the crisis use, including the
common name and the Chemical Abstracts Service (CAS) number;

crop or site on which the pesticide is to be used;

use pattern (method, number, and rate of applications);

dates that applications started or will begin and end;

an estimate of the level or residues of the pesticide expected to result
from use under the crisis exemption (for food crops); and

discussion of the emergency situation and any other pertinent
information available at the time, including why time was insufficient
to request a specific or quarantine exemption, and intentions with
respect to requesting a specific exemption for this use.

4(c)	Data Items, Including Record keeping requirements

	EPA Form No. 8570-4, Confidential Statement of Formula, (Attachment F)
is the single form associated with either application for, or summary
reports on, an emergency exemption. To comply with the reporting and
record keeping requirements for specific, quarantine, and public health
exemptions, the exemption holder must provide the following data items
to EPA:

Unexpected adverse effects information		Any unexpected adverse effects
resulting from the use of a pesticide under a  crisis, specific,
quarantine, or public health exemption must be reported immediately to
the Agency.

Final reports	A report summarizing the results of pesticide use under a
specific, quarantine, and public health exemption must be submitted to
EPA within six months of the expiration of the exemption unless
otherwise specified by the Agency.  The information in this report must
include the following:

total acreage, amount of commodity or other unit treated and the total
quantity of the pesticide used;

discussion of the effectiveness of the pesticide in dealing with the
emergency condition;

description of any unexpected adverse effects that resulted from the use
of the pesticide under the exemption;

results of any monitoring required and/or carried out under the
exemption;

any enforcement actions taken in connection with the exemption;

method(s) of disposition of food crops, if required to be destroyed; and

any other information requested by the Administrator.

Records	Records for all treatments involving the first food use of a
pesticide will be maintained by the state or federal agency for which an
emergency exemption was granted for a minimum of two years following the
date of expiration of the exemption.  On request by EPA, these records
must be made available to the Administrator.  Records must include the
following;

locations where the pesticide was applied;

dates of application (range); and

total quantity of the pesticide used.

	4(d)	Applicant Activities

	To obtain a permit to use an unregistered pesticide product under
emergency conditions, an applicant must petition EPA in writing and
provide information addressing the data items listed above and commit to
the submission of the summary report on the action taken to meet the
emergency Section 18 Emergency Exemption applications are submitted to
the Risk Integration Minor Use, and Emergency Response Branch (Mail Code
7505P), Registration Division, Office of Pesticide Programs, U.S.
Environmental Protection Agency, 1200 Pennsylvania Avenue., N.W.,
Washington, D.C., 20460.

	In order to participate in the program, the applicant must:

Read germane FIFRA requirements and CFR regulations.

Process, compile, and review the requested data for accuracy and
appropriateness.

Generate application correspondence and follow-up summary report.

Store, file or maintain the information.

5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

	5(a)	Agency Activities

	On October 25, 2000, EPA published a Final Rule in the Federal Register
(65 FR 64125) entitled “Time-Limited Tolerances for Pesticide
Emergency Exemptions.”  This rule, which became effective on November
24, 2000, set into place a process to ensure timely decisions on any
tolerance-related issue in response to a request for an emergency
exemption for a pesticide to be used on food or feed.  Under this rule,
time-limited tolerance petitions related to FIFRA Section 18 are
evaluated on a case-by-case basis to determine if adequate reliable data
are available to make the required safety finding mandated under FFDCA
Section 408 and FQPA.

	Applications for emergency exemptions are submitted by U.S. states and
territories, and federal agencies at their discretion.  These
applications are received by the Office of Pesticide Programs (OPP),
Registration Division, Risk Integration, Minor Use, and Emergency
Response Branch, where they are reviewed for completeness.  The
application package is routed to scientists and economists within OPP to
determine whether the proposed emergency exemption is warranted, that
there is “reasonable certainty of no harm” to human health resulting
from aggregate and cumulative exposure, and that it presents no undue
hazard to humans or the environment.  Once the determinations are made,
the applicant is notified in writing.  The tolerance is published in the
Federal Register.

	The Agency conducts the following activities when responding to an
emergency exemption application under FIFRA section 18:

Route the application/report to appropriate scientists and economists
for review.

Review information submitted for scientific accuracy.

Perform a biological, ecological, and economic analysis and a
multi-disciplinary risk assessment of the requested use and then forward
a regulatory recommendation on the proposed exemption along with a draft
notification to EPA management.

Make the FQPA finding of “reasonable certainty of no harm” to human
health resulting from aggregate and cumulative exposure. Establish a
time-limited tolerance if required.

Conduct an assessment of the progress toward registration for the
requested use.

OPP Director (or designee) makes final decision.

Notify applicant of decision.

Prepare and publish Federal Register Notice (for applicable food use
requests).

Record electronic data in Agency's data system and internet cite.

	5(b) 	Collection Methodology and Management

	When applications for emergency exemptions are received by EPA, they
are jacketed and filed by the name of the state, territory or federal
agency, by the date, and by the number of the submission for that
entity.  The application is tracked in EPA’s data system as an active
pending request through the determination process, and subsequent
receipt of the summary report, after which the exemption becomes a
historical file and the regulatory action is closed.

	5(c) 	Small Entity Flexibility

	No flexibility for small entities exists under this information
collection activity.  Section 18 of FIFRA applies directly only to
State, territorial, and federal government agencies; it does not apply
to other entities.  States are not “small entities” as defined by
the Regulatory Flexibility Act.

	5(d)	Collection Schedule

	There is no collection schedule associated with this information
collection activity, per se.  This information collection activity is
initiated by the States or by certain federal agencies when they
determine that they are confronted with an emergency situation and
subsequently submit an emergency exemption application to EPA under
FIFRA Section 18.

ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	The total annual response burden associated with submitting an
application for Emergency Exemption (Section 18) is estimated to be
49,500 burden hours per year at a cost of $2,472,770 indexed to 2006
dollars for the next three years.  The number of applications received
by EPA has decreased from an average of 494 per year for the years 2004
- 2006 to an average of about 159 per year for the years ranging from
2008 - 2010.  The important trends seen in the applications received in
the past three years are:

the successful transition of a high number of minor crop section 18
programs to full registrations and tolerances under section 3 labels;

there are continuing pest management challenges that are national in
scope that trigger emergency exemption requests (e.g. the use of
potassium salt of hop beta acids and fenpyroximate in beehives to
control varroa mite; expanding reliance on section 18 programs to plan
for and respond to agricultural species threats - such as invasive stink
bugs and quarantine exemptions to control invasive mussel species.

The Agency expects that some of these factors will persist and projects
that it will process an average of 159 applications annually for the
next three years.

	6(b)	Estimating Respondent Costs

Agency economists revised the estimated wages, benefits and overhead for
all labor categories for affected industries, state government, and EPA
employees based on publicly available data from the US Bureau of Labor
Statistics. The formulas used to estimate the labor rates and formulas
used to derive the fully loaded rates and overhead costs for this ICR
are listed in Attachment G.

	Methodology:	The methodology uses data on each sector and labor type
for an Unloaded wage rate (hourly wage rate), and calculates the Loaded
wage rate (unloaded wage rate + benefits), and the Fully loaded wage
rate (loaded wage rate + overhead).  Fully loaded wage rates are used to
calculate respondent costs.

	Unloaded Wage Rate:  Wages are estimated for labor types (management,
technical, and clerical) within applicable sectors. The Agency uses
average wage data for the relevant sectors available in the National
Industry-Specific Occupational Employment and Wage Estimates from the
Bureau of Labor Statistics (BLS) at   HYPERLINK
"http://www.bls.gov/oes/current/oes_nat.htm"
http://www.bls.gov/oes/current/oes_nat.htm .

	Sectors: The specific North American Industry Classification System
(NAICS) code and website for each sector is included in that sector’s
wage rate table.  Within each sector, the wage data are provided by
Standard Occupational Classification (SOC).  The SOC system is used by
Federal statistical agencies to classify workers into occupational
categories for the purpose of collecting, calculating, or disseminating
data (see   HYPERLINK "http://www.bls.gov/oes/current/oes_stru.htm"
http://www.bls.gov/oes/current/oes_stru.htm ).

	Loaded Wage Rate: Unless stated otherwise, all benefits represent 43%
of unloaded wage rates, based on benefits for all civilian non-farm
workers, from   HYPERLINK "http://www.bls.gov/news.release/ecec.t01.htm"
 http://www.bls.gov/news.release/ecec.t01.htm . However, if other
sectors are listed for which 43% is not applicable; the applicable
percentage will be stated.

	Fully Loaded Wage Rate: We multiply the loaded wage rate by 50% (EPA
guidelines 20-70%) to get overhead costs.

	For Section 18 emergency exemption requests, the state government is
the applicant and the only respondent.  Labor rates for the applicant
are based on NAICS 999200, State Government.  To derive the labor rates
for Section 18 applicants, EPA estimated the wages for the management,
technical, and clerical activities using the methodology described
above.  The fully loaded wage rates used to calculate the state
respondent costs for this ICR are estimated at $82.63, $57.68, and
$39.20 per hour, which are the state government wage rates for
managerial, technical, and clerical labor hours, respectively.  Table 1
shows the total burden hours for each respondent collection activity by
labor category and the total costs of each activity based on the wage
rates.  For example, the total cost for the state applicant to “Read
FIFRA and FQPA requirements and CFR regulations” is $561, calculated
as 4 hours of managerial labor at $82.63 per hour plus 4 hours of
technical labor at $57.68 per hour.  In total, the burden hours for
completing a Section 18 application are estimated at 99 hours, 4
managerial hours, 93 technical hours, and 2 clerical hours.  Using this
burden estimate and the fully loaded wage rates for state governments,
the Agency estimated the applicant labor costs to be approximately
$5,774 per response.  Table 1. FIFRA §18 – Applicant (State
Government) Burden Hours and Cost Estimates per Emergency Exemption
Request

COLLECTION ACTIVITY	Burden per application (hours) 1	Total

	Managerial

$82.63/hr	Technical

$57.68/hr	Clerical

$39.20/hr	Hours	Costs ($)

Read FIFRA and FQPA requirements and CFR regulations	4	4	0	8	$       561

Process, compile, and review the requested data for accuracy and
appropriateness	0	74	0	74	$    4,269

Generate application correspondence and follow-up summary report	0	15	0
15	$       865

Store/maintain/submit information	0	0	2	2	$         78

Totals 	4	93	2	99	$    5,774

1 Hourly wages rates are fully loaded wage rates based on NAICS 999200
– State Government, from U.S. Dept. of Labor, Bureau of Labor
Statistics, May 2010. See Attachment H for wage calculations.

2 Totals may not sum due to rounding.

Each year, there are approximately 159 Section 18 requests from states.
At 99 hours per request, the total annual burden to state government
applicants of filing Section 18 applications is approximately 15,740
hours.  Table 2 shows the calculations for total annual costs.  The
total management, technical, and clerical hours are multiplied times the
annual number of requests and by the fully loaded wage rates to get
total annual respondent costs of $917,993 for filing Section 18
applications (See Table 2).

Table 2. FIFRA §18 – Total Annual Applicant (State Government) Burden
Hours and Cost Estimates

Labor Category	Total Burden Hours per Request	Number of applications
Total Annual Hours	Labor Rate ($/hr)	Costs ($)

Managerial	4	159	636	$82.63	$        52,551

Technical	93	159	14,787	$57.68	$      852,975

Clerical	2	159	318	$39.20	$        12,466

Totals 	99	159	15,741	---	$      917,993

	6(c)	Estimating Agency Burden and Cost

	 The estimated cost to the federal government of the Section 18
Emergency Exemption was calculated by using the method described above
for this revision.  The TAIS data displayed in Table 6 indicate that the
estimated number of Agency FTE’s dedicated to Section 18 emergency
exemption activities is approximately 0.7 managerial FTEs, 6.3 technical
FTEs, and 0.5 clerical FTEs, for total of 7.6 FTEs allocated to
emergency exemption activities.

Table 6. Distribution of Agency FTEs Supporting Section 18 Activities

FTE Type	AD	BEAD	BPPD	EFED	HED	RD	PRD	OPP Total1

Managerial	0.0	0.2	0.0	0.0	0.0	0.5	0.0	0.7

Technical	0.1	1.4	0.1	0.3	0.1	4.3	0.0	6.3

Clerical	0.0	0.1	0.0	0.0	0.0	0.3	0.0	0.5

Totals	0.1	1.7	0.1	0.4	0.1	5.1	0.0	7.6

1 OPP Total is rounded up to the next FTE.

	Using total burden hours of 2,080 per FTE, the total annual Agency
burden hours for Section 18 activities are approximately15,751 per year,
averaged over the years 2008-2010.  Table 7 shows the breakdown of these
burden hours into managerial, technical, and clerical and the
calculations for deriving total Agency cost.  Multiplying the 2010 fully
loaded hourly wage rates for managerial, technical, and clerical hours
by the respective burden hours in each category, the annual cost total
annual Agency cost of the Section 18 program is approximately $1.17
million.

Table 7. OPP Hours by employment class, hourly wage rate, and total
costs

FTE Type	FTEs (rounded)	Hours / FTE	Total burden hours	Fully loaded wage
rates ($/hr) 1	Annual per FTE cost	Total Cost

Managerial	0.7	2,080 	1,522	$ 120	$ 249,285	$    182,415

Technical	6.3	2,080	13,158	$  72	$ 148,881	$    941,849

Clerical	0.5	2,080	1,071	$  43	$   89,875	$     46,274

OPP totals	7.6

15,751

	$ 1,170,538

1 See Attachment H for data sources and calculations of fully loaded
wage rates.

		6(d)	Bottom Line Burden Hours and Cost Tables

Table 10. FIFRA §18 - Total Burden and Cost Estimates for Applications
and Summary Report for Emergency Exemption

	Previous Estimates	Current Estimates

	Hours	Costs	Hours	Costs

Respondents (state governments)	49,500	$   2,472,770	15,741	$
917,993

Agency 	54,000	$   3,637,575	15,751	$   1,170,538

Total	103,500	$6,110,345	31,492	$ 2,088,530

		6(e)	Reasons for Change in Burden

	There is no change in the estimated respondent burden hours per
application for this information collection activity from the former
ICR. The fully loaded hourly wage rates were updated which caused a
slight increase in the respondent burden cost per application.  However,
the total annual respondent burden cost has decreased due to a change in
the average number of Section 18s requested per year from 494 to 159.
For the next renewal cycle the Agency projects it will receive
approximately 159 Section 18 applications each year over the next three
years.  The Agency believes that respondents will experience some burden
reduction over the next three years due to the streamlined
recertification process for Section 18 applications discussed in Section
2 of this document.  For example, during the 2010 use season, EPA
identified 97 exemptions that were eligible for the less data-intensive
application process through the recertification program.  Further, in
2010, the Agency made registration decisions for 36 use determinations
which negated the need for additional applications to be submitted for
those same uses.  Although EPA expects the streamlined recertification
process will result in some burden reduction, there is insufficient
information available to the Agency at this time to fully assess the
impact of these changes.

		6(f)	Burden Statement

	The annual respondent burden for collection of information associated
with the rule is estimated to average 99 hours per application.
According to the Paperwork Reduction Act, “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.  For this collection, it is the time reading the regulations,
planning the necessary data collection activities, conducting tests,
analyzing data, generating reports and completing other required
paperwork, and storing, filing, and maintaining the data.  The 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 number for this information collection
appears at the beginning and the end of this document.  In addition OMB
control numbers for EPA’s regulations, after initial display in the
final rule, are listed in 40 CFR part 9.

The Agency has established a public docket for this ICR under Docket ID
No. EPA-HQ-OPP-2007-0320, which is available for online viewing at
www.regulations.gov, or in person viewing at the OPP Regulatory Public
Docket in Rm. S-4400, One Potomac Yard (South Building), 2777 S. Crystal
Drive, Arlington, VA.  This docket facility is open from 8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays.  The docket
telephone number is<PHONE_NUMBER>.  You may submit comments regarding
the Agency's need for this information, the accuracy of the provided
burden estimates and any suggested methods for minimizing respondent
burden, including the use of automated collection techniques.

Submit your comments, referencing Docket ID No. EPA-HQ-OPP-2007-0320 and
OMB Control No. 2070-0032, to (1) EPA online using www.regulations.gov
(our preferred method), or by mail to: Public Information and Records
Integrity Branch (PIRIB), Mail Code: 7502P, Office of Pesticide Programs
(OPP), Environmental Protection Agency, 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.

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachments to the supporting statement are available in the public
docket established for this ICR under docket identification number
EPA-HQ-OPP-2007-0737.  These attachments are available for online
viewing at   HYPERLINK "http://www.regulations.gov_"
www.regulations.gov  or otherwise accessed as described in section 6(f)
of the supporting statement.

Attachment A:	7 U.S.C. 136p  - Section 18 of the Federal Insecticide,
Fungicide, and Rodenticide Act. Also available at online at the US House
of Representatives’  HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t05t08+17
57+0++%28%29%20%20AND%20%28%287%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC%
20w%2F10%20%28136p%29%29%3ACITE%20%20%20%20%20%20%20%20%20" US Code
website

Attachment B:	40 CFR Part 166 - Exemption of Federal and State Agencies
for Use of Pesticides under Emergency Conditions. Also available online
at the National Archives and Records Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=fa8e6a03533d54
0884422a4c93e3ff11&rgn=div5&view=text&node=40:<IP_ADDRESS>.16&idno=40"
Electronic CFR Website

Attachment C:	21 U.S.C 346a - Tolerances and exemptions for pesticide
chemical residues, FFDCA section 408. Also available at online at the US
House of Representatives’  HYPERLINK
"http://uscode.house.gov/uscode-cgi/fastweb.exe?getdoc+uscview+t21t25+14
9+1++%28%29%20%20AND%20%28%2821%29%20ADJ%20USC%29%3ACITE%20AND%20%28USC%
20w%2F10%20%28346a%29%29%3ACITE%20%20%20%20%20%20%20%20%20" US Code
website

Attachment D:	40 CFR Part 176 - Time-Limited Tolerances for Pesticide
Emergency Exemptions. Also available online at the National Archives and
Records Administration’s  HYPERLINK
"http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=fa8e6a03533d54
0884422a4c93e3ff11&rgn=div5&view=text&node=40:<IP_ADDRESS>.25&idno=40"
Electronic CFR Website

Attachment E:	Reserved

Attachment F:	EPA Form No. 8570-4 - Confidential Statement of Formula.
Also available online at   HYPERLINK
http://www.epa.gov/opprd001/forms/8570-4.pdf
http://www.epa.gov/opprd001/forms/8570-4.pdf

Attachment G:	State Government and EPA Labor Wage Formulas

Attachment H:	Display Related to OMB Control #2070-0032 -Listings of
Related Regulations in 40 CFR 9.1

November 8, 2011

November 8, 2011

 PAGE

Page   PAGE  16  of   啎偍䝁卅†ㄔᔶ഍഍഍

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[Federal Register Volume 83, Number 227 (Monday, November 26, 2018)]
[Notices]
[Page 60540]
[FR Doc No: 2018-25686]

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SECURITIES AND EXCHANGE COMMISSION

Proposed Collection; Comment Request

Upon Written Request Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE, Washington, DC
20549-2736.

Extension:
    Form T-1, SEC File No. 270-121, OMB Control No. 3235-0110.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.), the Securities and Exchange
Commission (``Commission'') is soliciting comments on the collection of
information summarized below. The Commission plans to submit this
existing collection of information to the Office of Management and
Budget for extension and approval.
    Form T-1 (17 CFR 269.1) is a statement of eligibility and
qualification under the Trust Indenture Act of 1939 (15 U.S.C. 77aaa et
seq.) of a corporation designated to act as a trustee under an
indenture. The information is used to determine whether the corporation
is qualified to serve as a trustee. Form T-1 takes approximately 15
hours per response to prepare and is filed by approximately 2
respondents. We estimate that 25% of the 15 hours (4 hours per
response) is prepared by the company for a total reporting burden of 8
hours (4 hours per response x 2 responses).
    Written comments are invited on: (a) Whether this proposed
collection of information is necessary for the performance of the
functions of the agency, including whether the information will have
practical utility; (b) the accuracy of the agency's estimate of the
burden imposed by the collection of information; (c) ways to enhance
the quality, utility, and clarity of the information collected; and (d)
ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques or other forms of information technology. Consideration will
be given to comments and suggestions submitted in writing within 60
days of this publication.
    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 control number.
    Please direct your written comment to Charles Riddle, Acting
Director/Chief Information Officer, Securities and Exchange Commission,
c/o Candace Kenner, 100 F Street NE, Washington, DC 20549 or send an
email to: [email protected].

    Dated: November 20, 2018.
Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2018-25686 Filed 11-23-18; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 82, Number 98 (Tuesday, May 23, 2017)]
[Rules and Regulations]
[Pages 23509-23512]
[FR Doc No: 2017-10257]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2016-9394; Directorate Identifier 2016-NM-162-AD;
Amendment 39-18872; AD 2017-09-10]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all The
Boeing Company Model 747-400, 747-400D, and 747-400F airplanes. This AD
was prompted by a report of a crack in the left wing front spar web,
found following a fuel leak. This AD requires repetitive inspections
for cracking of the front spar web, and repairs if necessary. We are
issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective June 27, 2017.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of June 27,
2017.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. You may view this referenced service information
at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW.,
Renton, WA. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>. It is also available on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9394.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-
9394; or in person at the Docket Management Facility between 9 a.m. and
5 p.m., Monday through Friday, except Federal holidays. The AD docket
contains this AD, the regulatory evaluation, any comments received, and
other information. The address for the Docket Office (phone: 800-647-
5527) is Docket Management Facility, U.S. Department of Transportation,
Docket

Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Bill Ashforth, Aerospace Engineer,
Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office
(ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-
6432; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to all The Boeing Company
Model 747-400, 747-400D, and 747-400F airplanes. The NPRM published in
the Federal Register on December 2, 2016 (81 FR 86977) (``the NPRM'').
The NPRM was prompted by a report indicating that a fuel leak in one
airplane led to the discovery of a 13.4-inch crack in the left wing
front spar web inboard of pylon number 2 between front spar station
inboard (FSSI) 655.75 and FSSI 660. The NPRM proposed to require
repetitive detailed, ultrasonic, and high frequency eddy current
inspections for cracking of the front spar web between FSSI 628 and
FSSI 713, and repairs if necessary. We are issuing this AD to detect
and correct cracking in the front spar web, which could lead to fuel
leaks and a consequent fire.

Comments

    We gave the public the opportunity to participate in developing
this AD. The following presents the comments received on the NPRM and
the FAA's response to each comment.

Support for the NPRM

    Boeing and commenter Melanie Smith stated that they support the
NPRM.

Request To Update the Labor Costs

    British Airways (BA), Cargolux Airlines (CLX), and KLM Royal Dutch
Airlines (KLM) all stated that the actual work-hours required to do the
mandated inspections are higher than the estimate listed in the NPRM.
They estimated the inspections actually take between 137 and 159 work-
hours, not the 55 work-hours stated in the NPRM.
    We agree that the estimated work-hours should be increased. When
issuing a service bulletin, Boeing estimates work-hours under expected
conditions. As operators implement the service bulletin, they may find
the actual work-hours are higher or lower than estimated. We have
updated the Costs of Compliance section of this AD to reflect a
conservative estimate of 159 work-hours per inspection cycle.

Request To Change the Initial and Repetitive Compliance Times

    BA, CLX, and KLM all requested that we change the initial and/or
repetitive compliance times to align with scheduled maintenance checks.
BA proposed to do time-limited alternative inspections in the most
critical web locations and to defer the majority of the web inspections
to coincide with longer planned maintenance checks. CLX requested that
we change the initial compliance time from 6 months to 24 months, and
that we change the repetitive inspection interval from 1,200 flight
cycles to 2,000 flight cycles. KLM requested that we extend the
repetitive inspection intervals for Model 747 freighters from 1,200
flight cycles to 1,800 flight cycles. Each of the commenters noted that
the actual work-hours are higher than estimated in the NPRM, and the
inspections would require additional downtime and costs if not done at
the same time as regularly scheduled maintenance. None of the
commenters provided engineering analyses to support their proposed
extended compliance times.
    We disagree with the requests. In developing an appropriate
compliance time for this action, we considered the urgency associated
with the subject unsafe condition and the practical aspect of
accomplishing the required modification within a period of time that
corresponds to the normal scheduled maintenance for most affected
operators. Boeing is aware of the discrepancy in work-hours and is
developing a request for a global alternative method of compliance
(AMOC) to provide operators an alternative for both the areas of
inspection and the compliance times. In addition, operators have the
option of proposing an adjustment to the compliance times, supported by
appropriate engineering analyses, in accordance with the provisions of
paragraph (j) of this AD. We have not changed this final rule regarding
this issue.

Conclusion

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

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 747-57A2357, dated
September 12, 2016. The service information describes procedures for
repetitive detailed, ultrasonic, and high frequency eddy current
inspections, and repairs of cracking of the front spar web between FSSI
628 and FSSI 713. This service information is reasonably available
because the interested parties have access to it through their normal
course of business or by the means identified in the ADDRESSES section.

Costs of Compliance

    We estimate that this AD affects 137 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost on U.S.
              Action                    Labor cost        Parts cost      Cost per product        operators
----------------------------------------------------------------------------------------------------------------
Inspections......................  159 work-hours x                 $0  $13,515 per          $1,851,555 per
                                    $85 per hour =                       inspection cycle.    inspection cycle.
                                    $13,515 per
                                    inspection cycle.
----------------------------------------------------------------------------------------------------------------

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

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

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

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2017-09-10 The Boeing Company: Amendment 39-18872; Docket No. FAA-
2016-9394; Directorate Identifier 2016-NM-162-AD.

(a) Effective Date

    This AD is effective June 27, 2017.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 747-400, 747-
400D, and 747-400F airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 57, Wings.

(e) Unsafe Condition

    This AD was prompted by a report of a 13.4-inch crack in the
left wing front spar web inboard of pylon number 2 between front
spar station inboard (FSSI) 655.75 and FSSI 660, found following a
fuel leak. We are issuing this AD to detect and correct cracking in
the front spar web, which could lead to fuel leaks and a consequent
fire.

(f) Compliance

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

(g) Repetitive Detailed, Ultrasonic, and High Frequency Eddy Current
Inspections

    At the applicable time specified in paragraph 1.E.,
``Compliance,'' of Boeing Alert Service Bulletin 747-57A2357, dated
September 12, 2016, except as provided by paragraph (i) of this AD,
do detailed, ultrasonic, and high frequency eddy current inspections
for any cracking in the front spar web, in accordance with the
Accomplishment Instructions of Boeing Alert Service Bulletin 747-
57A2357, dated September 12, 2016. Repeat the inspections thereafter
at the applicable time specified in paragraph 1.E., ``Compliance,''
of Boeing Alert Service Bulletin 747-57A2357, dated September 12,
2016.

(h) Repair of Any Cracking

    If any crack is found during any inspection required by
paragraph (g) of this AD, before further flight, repair using a
method approved in accordance with the procedures specified in
paragraph (j) of this AD. Thereafter, repeat the inspections
specified in paragraph (g) of this AD at all unrepaired areas.

(i) Service Information Exceptions

    Where paragraph 1.E., ``Compliance,'' of Boeing Alert Service
Bulletin 747-57A2357, dated September 12, 2016, specifies a
compliance time ``after the original date of this service
bulletin,'' this AD requires compliance within the specified
compliance time after the effective date of this AD.

(j) 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 paragraph (k) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO, to make those findings. To be approved, the
repair method, modification deviation, or alteration deviation must
meet the certification basis of the airplane, and the approval must
specifically refer to this AD.
    (4) Except as required by paragraph (i) of this AD: For service
information that contains steps that are labeled as Required for
Compliance (RC), the provisions of paragraphs (j)(4)(i) and
(j)(4)(ii) of this AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled as RC may be deviated from using accepted
methods in accordance with the operator's maintenance or inspection
program without obtaining approval of an AMOC, provided the RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(k) Related Information

    For more information about this AD, contact Bill Ashforth,
Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft
Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Boeing Alert Service Bulletin 747-57A2357, dated September
12, 2016.
    (ii) Reserved.
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; Internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For
information on the availability of this material at the FAA, call
425-227-1221.

    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Renton, Washington, on April 27, 2017.
Paul Bernado,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2017-10257 Filed 5-22-17; 8:45 am]
BILLING CODE 4910-13-P