[Federal Register Volume 83, Number 175 (Monday, September 10, 2018)]
[Notices]
[Pages 45640-45642]
[FR Doc No: 2018-19612]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3272]

Identifying the Root Causes of Drug Shortages and Finding
Enduring Solutions; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public meeting entitled ``Identifying the Root Causes of
Drug Shortages and Finding Enduring Solutions.'' The purpose of the
meeting is to give stakeholders, including health care providers,
patients, manufacturers, wholesalers, pharmacists, pharmacy benefit
managers, veterinarians, public and private insurers, academic
researchers, and the public, the opportunity to provide input on the
underlying systemic causes of drug shortages, and make recommendations
for actions to prevent or mitigate drug shortages. Members of Congress
have asked the Agency to examine the root causes and drivers of these
shortages, and to recommend measures that will provide more enduring
solutions. To this end, the Commissioner has convened an inter-Agency
task force of senior Federal officials of FDA, the Centers for Medicare
& Medicaid Services, the Department of Veterans Affairs, and the
Department of Defense. After receiving input from stakeholders, the
task force intends to provide a report to Congress regarding the root
causes of drug shortages. The report will also include recommendations
regarding new authorities FDA or other Federal agencies could use to
help provide enduring solutions to shortages.

DATES: The public meeting will be held on November 27, 2018, from 8:30
a.m. to 4:30 p.m. Submit either electronic or written comments on this
public meeting by January 11, 2019. See the SUPPLEMENTARY INFORMATION
section for registration date and information.

ADDRESSES: The public meeting will be held at the Washington Marriott
at Metro Center, 775 12th St. NW, Washington, DC 20005. The hotel's
phone number is<PHONE_NUMBER>.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before January 11, 2019. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of January 11, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2018-N-3272 for ``Identifying the Root Causes of Drug Shortages and
Finding Enduring Solutions.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Michie Hunt, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire

Ave., Bldg. 51, Rm. 6153, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Drug shortages are among the greatest challenges health care
providers and patients face. These shortages can affect treatment
options and require practitioners to make difficult decisions that can
compromise care, such as rationing supplies or using less desirable,
but more readily available, alternative therapies. FDA has acted within
its statutory authority to prevent and mitigate drug shortages. By
working with industry and other parties, the Agency has helped to
steadily reduce the number of new shortages since a peak of 251 new
shortages occurred in 2011, as detailed in the Agency's ``Report on
Drug Shortages for Calendar Year 2017,'' which is available at https://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM610662.pdf.
    Despite this success in preventing or mitigating individual cases,
more can and must be done to better understand and address the
underlying systemic factors that are leading to shortages of medically
necessary drugs. Members of Congress have asked the Agency to examine
the root causes and drivers of these shortages, and to recommend
measures that will provide more enduring solutions. To this end, the
Commissioner has convened an inter-agency task force of senior federal
officials of FDA, the Centers for Medicare & Medicaid Services, the
Department of Veterans Affairs, and the Department of Defense. After
receiving input from stakeholders, the task force intends to provide a
report to Congress regarding the root causes of drug shortages. The
report will also include recommendations regarding new authorities FDA
or other federal agencies could use to help provide enduring solutions
to shortages.

II. Topics for Discussion at the Public Meeting

    We are soliciting input from stakeholders concerning the adverse
consequences of drug shortages, the underlying systemic causes and
drivers of these shortages, and the policies and strategies that may
help to prevent or mitigate them. We welcome any relevant information
that stakeholders wish to share, as all factors contributing to
shortages are matters of concern. We are particularly interested in
stakeholder input in the following areas:

A. Assessing the Adverse Consequences of Drug Shortages to Patients,
Health Care Providers, and the Drug Supply Chain

    1. Drug Shortages' Impact on Patients
    a. What clinical impacts have patients experienced: e.g., adverse
events, treatment delays, accelerated disease progression, or worsened
outcomes due to patients' to using less effective or less safe
alternatives?
    b. What economic impacts have patients affected by drug shortages
experienced?
    c. Do drug shortages affect patients disproportionately by
geographic region, age, disease or condition, socioeconomic status, or
other factors? Are there specific times of year or classes of drugs
that see episodic, more frequent or more severe shortages? If so, why
does this happen?
    2. Drug Shortages Impact on Health Care Providers
    a. What economic impacts (including increased inventory management
costs, substitution of more expensive drugs for drugs in shortage, and
increased liability from adverse events) have health care providers,
including veterinarians, experienced because of drug shortages?
    b. Do the adverse consequences of shortages affect providers
disproportionately by, for example, geographic region, clinical area,
or other characteristics?
    3. Drug Shortages' Impact on the Supply Chain
    a. What economic effects have shortages had on key links in the
drug supply chain: e.g., wholesalers, distributors, and pharmacies?
    b. Have certain links in the supply chain been disproportionately
affected by shortages? If so, which ones?
    4. Do available data accurately capture the differences among
shortages (e.g., their severity and duration) that may affect their
clinical and economic adverse consequences? If not, what additional
data would be needed to better capture these differences?

B. Identifying the Root Causes and Drivers of Drug Shortages

    1. What factors affect the likelihood, severity, and duration of
shortages? Are these factors mostly related to raw materials,
management, and resilience of production facilities, or other factors
such as contracting or market structure? Do they differ for various
drugs?
    2. What government policies and regulations may contribute to drug
shortages, and how could these be modified to prevent or limit impacts
of drug shortages?
    3. How do manufacturers contribute to drug availability or
shortages, including responses to shortages?
    a. What factors do generic and brand manufacturers consider when
making decisions about whether to seek approval for certain drugs, to
produce and market a drug for which they already hold an approved new
drug application or abbreviated new drug application, or to discontinue
marketing a drug? How do those decisions contribute (directly or
indirectly) to shortages?
    b. How do manufacturers monitor for situations that may result in a
drug shortage? Are there certain indicators that are monitored? If so,
are the potential triggers the same for all drugs, for example brand
and generic sterile injectable drugs?
    c. When manufacturers recognize a potential shortage, what options
do they have for averting one? How easy or difficult is it to implement
these options, and how costly is it to implement them? What is the
impact of government policy or regulation on these options?
    d. What factors play a role in manufacturers' decisions to make
capital investments to expand capacity or to modernize infrastructure?
    e. When manufacturers are remediating or upgrading a facility, how
can shortages related to production slowdowns and shutdowns be avoided?
    4. Drug supply is controlled through contracts among manufacturers,
distributors, and end users. What features of contracts used throughout
the supply chain contribute to drug availability and shortages,
including responses to shortages?
    a. What is the effect of duration and scope (how many and what
types of drug products are covered by each contract, and whether non-
drug products are bundled into the contract), on drug availability or
shortage?
    b. How commonly do these contracts include incentives such as
contingency clauses, performance requirements, failure-to-supply
clauses, or restrictions on limiting downstream price increases? How
large are these incentives currently? Are there institutional or
informational impediments limiting greater use of such incentives or
performance clauses?
    c. What are the implications of markups on inventory management
throughout the supply chain? How might these markups contribute to
shortages, and to response to shortages?
    d. How have the characteristics of contracts, and markups at
different points in the supply chain, changed over the past 15 years?

    e. What are the implications of these contracting provisions and
their changes for the probability, severity, and duration of drug
shortages?
    f. How much competition exists throughout the supply chain? Over
the past 15 years, have there been challenges to competition and if so,
what factors are responsible for these challenges? For example, has
consolidation in different parts of the supply chain created market
barriers to entry and reduced competition? If so, what effect has the
reduction in competition had on drug shortages?

C. Identifying Strategies for Preventing or Mitigating Drug Shortages

    1. What policies could the Federal Government adopt, and what
strategies could it implement, that would reduce the likelihood,
severity, and duration of shortages? Would additional authorities be
necessary or helpful? For example:
    a. Establish a list of ``essential medicines'' for use in
preventing and mitigating shortages. If such a list were established,
what should be the criteria for inclusion? And how should such a list
be maintained and administered?
    b. Provide financial incentives, such as tax credits or revised
reimbursement policies: e.g., to allow additional payments for drugs in
or at risk of shortage or to encourage investment to expand
manufacturing capacity or to modernize aging infrastructure, to enhance
process capability and variability control, or to prevent manufacturing
problems that affect product availability;
    c. Allow other entities (e.g., contract manufacturers) to fill gaps
in supply;
    d. Require risk management plans to help manufacturers prepare to
respond efficiently and effectively to potential shortages;
    e. Require the extension of expiration dates for drugs in shortage
or at risk of shortage, where scientifically justified;
    f. Revise trade policies and authorities: e.g., to allow federal
purchasers to buy imported drugs or raw materials to prevent or
mitigate a shortage;
    g. Heighten scrutiny of proposed mergers and acquisitions that
increase market concentration or the likelihood of shortages;
    h. Revise payment policies and authorities: e.g., that would be
coupled with a requirement to establish contingency plans for supplying
medicines that go into shortage; and
    i. Federal investment in production capacity for essential
medicines directly related to national security, emergency
preparedness, and defense.
    2. In designing new policies to prevent or mitigate shortages, how
can the Federal Government avoid creating perverse incentives or
negative cascading effects in the health care financing and delivery
system? For example, how might changes to government payment and
reimbursement affect the other sectors of the market?
    3. Are there lessons for the Federal Government, or practices that
it can emulate, from strategies used to prevent or mitigate shortages
in other commodity markets that face shortage issues?
    4. What challenges does the global nature of drug manufacturing and
marketing pose for efforts to prevent shortages in the U.S. market?
    5. As drug shortages are a national problem, what are the sources
of funding that can be applied to provide incentives to remedy the root
causes?

III. Participating in the Public Meeting

    Registration: To register for the public meeting, please visit the
following website: https://healthpolicy.duke.edu/events/drug-shortage-task-force. Please provide complete contact information for each
attendee, including name, title, affiliation, address, email, and
telephone. Registration is free and based on space availability, with
priority given to early registrants. Persons interested in attending
this public meeting must register by Wednesday, November 21, 2018,
midnight Eastern Time. There will be no onsite registration. Early
registration is recommended because seating is limited; therefore, FDA
may limit the number of participants from each organization.
Registrants will receive confirmation when they have been accepted. If
you are unable to attend the meeting in person, you can register to
view a live webcast of the meeting. The Duke-Margolis Center for Health
Policy will post on its website if registration closes before the day
of the public meeting.
    If you need special accommodations due to a disability, please
contact Sarah Supsiri at the Duke-Margolis Center for Health Policy
(phone:<PHONE_NUMBER>, email: [email protected]) no later than
November 20, 2018.
    Streaming webcast of the public workshop: This public workshop will
be webcast live. Persons interested in viewing the live webcast may
register ahead of the event by visiting https://healthpolicy.duke.edu/events/drug-shortage-task-force. The live webcast will also be
available at the website above on the day of the event without pre-
registration. Archived video footage will be available at the Duke-
Margolis website following the workshop.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm.
    Other Issues for Consideration: A 1-hour lunch break is scheduled,
but food will not be provided. There are multiple restaurants within
walking distance of the Washington Marriott at Metro Center, 775 12th
St. NW, Washington, DC 20005.
    All event materials will be provided to registered attendees via
email prior to the workshop and will be publicly available at the Duke-
Margolis Center for Health Policy website at https://healthpolicy.duke.edu/events/drug-shortage-task-force.

    Dated: September 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-19612 Filed 9-7-18; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 115 (Thursday, June 14, 2018)]
[Rules and Regulations]
[Pages 27711-27713]
[FR Doc No: 2018-12809]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2017-0565; FRL-9977-75]

Extract of Swinglea glutinosa; Exemption From the Requirement of
a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for Extract of Swinglea glutinosa in or on all food
commodities when used in accordance with label directions and good
agricultural practices. Gowan Company LLC submitted a petition to EPA
under the Federal Food, Drug, and Cosmetic Act (FFDCA) requesting an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of Extract of Swinglea glutinosa under FFDCA.

DATES: This regulation is effective June 14, 2018. Objections and
requests for hearings must be received on or before August 13, 2018,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2017-0565, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through
Friday, excluding legal holidays. The telephone number for the Public
Reading Room is<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Robert McNally, Biopesticides and
Pollution Prevention Division (7511P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460-0001; main telephone number:<PHONE_NUMBER>; email address:
[email protected].

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.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file
an objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2017-0565 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
August 13, 2018. Addresses for mail and hand delivery of objections and
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2017-0565, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC
20460-0001.
     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html. Additional
instructions on commenting or visiting the docket, along with more
information about dockets generally, is available at http://www.epa.gov/dockets.

II. Background

    In the Federal Register of January 26, 2018 (83 FR 3658) (FRL-9971-
46), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide tolerance
petition (PP 6F8504) by Gowan Company LLC, P.O. Box 5569, Yuma, AZ
85366-5569. The petition requested that 40 CFR 180 be amended by
establishing an exemption from the

requirement of a tolerance for residues of the biochemical fungicide
Extract of Swinglea glutinosa in or on all food commodities. That
document referenced a summary of the petition prepared by the
petitioner, Gowan Company LLC, which is available in the docket via
http://www.regulations.gov. There were no comments received in response
to the notice of filing.

III. Final Rule

A. EPA's Safety Determination

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the exemption is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings but does not include
occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in
establishing or maintaining in effect an exemption from the requirement
of a tolerance, EPA must take into account the factors set forth in
FFDCA section 408(b)(2)(C), which require EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance or tolerance exemption and
to ``ensure that there is a reasonable certainty that no harm will
result to infants and children from aggregate exposure to the pesticide
chemical residue . . . .'' Additionally, FFDCA section 408(b)(2)(D)
requires that EPA consider ``available information concerning the
cumulative effects of [a particular pesticide's] . . . residues and
other substances that have a common mechanism of toxicity.'' FFDCA
section 408(b)(2)(C) provides that EPA shall apply an additional
tenfold (10X) margin of safety for infants and children in the case of
threshold effects to account for prenatal and postnatal toxicity and
the completeness of the database on toxicity and exposure unless EPA
determines based on reliable data that a different margin of safety
will be safe for infants and children. This additional margin of safety
is commonly referred to as the FQPA Safety Factor (SF). In applying
this provision, EPA either retains the default value of 10X, or uses a
different additional safety factor when reliable data available to EPA
support the choice of a different factor.
    EPA evaluated the available toxicity and exposure data on Extract
of Swinglea glutinosa and considered their validity, completeness, and
reliability, as well as the relationship of this information to human
risk. EPA also considered available information concerning the
variability of the sensitivities of major identifiable subgroups of
consumers, including infants and children.
    Extract of Swinglea glutinosa is extracted from the leaves of
Swinglea glutinosa. Commonly known as Tabog, the plant is found in
southeast Asian and South American countries and is also commercially
cultivated for ornamental purposes. As a pesticidal active ingredient,
Extract of Swinglea glutinosa is intended for use as a fungicide on
growing crops and ornamentals in agricultural, greenhouse, turf,
recreational, and commercial landscape use sites to control fungal
diseases such as powdery mildew and sour rot. The antifungal mode of
action (MOA) of Extract of Swinglea glutinosa is likely cell membrane
disruption, attributable to the terpene constituents in the essential
oil of the extract. This mode of action is similar to that observed in
other essential oils that are considered biopesticides, such as tea
tree oil, rosemary oil and thyme oil. The constituent compounds in
Extract of Swinglea glutinosa are ubiquitous in fruits and vegetables
and are regularly consumed by humans as part of a normal diet. The
constituent compounds are also biodegradable; and the active ingredient
is highly soluble in water and will degrade rapidly in aqueous
environments.
    Based on the data submitted in support of this petition and the
dietary risk assessment conducted by the Agency, EPA concludes that
there is a reasonable certainty of no harm from aggregate exposures to
Extract of Swinglea glutinosa, including the consumption of food
treated with this active ingredient in accordance with label directions
and good agricultural practices. EPA has made this determination
because available toxicology data indicate that the active ingredient
is not acutely toxic, subchronically toxic, mutagenic, or
developmentally toxic via repeat oral exposure. As such, the Agency has
not identified any endpoints of concern for Extract of Swinglea
glutinosa and has conducted a qualitative assessment of exposure. The
Agency has also determined that residues Extract of Swinglea glutinosa
in drinking water are not expected to be significant when products are
used according to label instructions. The active ingredient is applied
at low concentrations, is very soluble in water, and degrades rapidly
in aqueous solutions. Non-occupational exposures are not expected since
Extract of Swinglea glutinosa is only intended for commercial
agricultural and landscaping use. A full explanation of the data upon
which EPA relied and its dietary risk assessment based on those data
can be found within the April 10, 2018, document entitled ``Federal
Food, Drug, and Cosmetic Act (FFDCA) Considerations for Extract of
Swinglea glutinosa.'' This document, as well as other relevant
information, is available in the docket for this action as described
under ADDRESSES.
    Based upon its evaluation, EPA concludes that Extract of Swinglea
glutinosa is not toxic. No toxic endpoints were established for oral
toxicity, dermal toxicity or inhalation toxicity. Exposure to Extract
of Swinglea glutinosa via pesticidal use is not expected to exceed any
levels of concern. EPA also determined that retention of the Food
Quality Protection Act (FQPA) safety factor was not necessary due to
the lack of threshold effects.
    Therefore, EPA concludes that there is a reasonable certainty that
no harm will result to the U.S. population, including infants and
children, from aggregate exposure to residues of Extract of Swinglea
glutinosa. Therefore, EPA is establishing an exemption from the
requirement of a tolerance for residues of Extract of Swinglea
glutinosa when applied pre-harvest in accordance with label directions
and good agricultural practices.

B. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes due
to the lack of concern about safety for Extract of Swinglea glutinosa
at any exposure level.

IV. Statutory and Executive Order Reviews

    This action establishes a tolerance exemption under FFDCA section
408(d) in response to a petition submitted to EPA. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66

FR 28355, May 22, 2001) or Executive Order 13045, entitled ``Protection
of Children from Environmental Health Risks and Safety Risks'' (62 FR
19885, April 23, 1997); nor is it considered a regulatory action under
Executive Order 13771, entitled ``Reducing Regulations and Controlling
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not
contain any information collections subject to OMB approval under the
Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq., nor does it
require any special considerations under Executive Order 12898,
entitled ``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance
exemption in this action, do not require the issuance of a proposed
rule, the requirements of the Regulatory Flexibility Act (RFA) (5
U.S.C. 601 et seq.) do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes. As a result, this
action does not alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, EPA has determined that this
action will not have a substantial direct effect on States or tribal
governments, on the relationship between the national government and
the States or tribal governments, or on the distribution of power and
responsibilities among the various levels of government or between the
Federal Government and Indian tribes. Thus, EPA has determined that
Executive Order 13132, entitled ``Federalism'' (64 FR 43255, August 10,
1999), and Executive Order 13175, entitled ``Consultation and
Coordination with Indian Tribal Governments'' (65 FR 67249, November 9,
2000), do not apply to this action. In addition, this action does not
impose any enforceable duty or contain any unfunded mandate as
described under Title II of the Unfunded Mandates Reform Act (UMRA) (2
U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require EPA's consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act (NTTAA) (15 U.S.C. 272 note).

V. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: May 29, 2018.
Richard P. Keigwin, Jr.,
Director, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. Add Sec.  180.1356 to subpart D to read as follows:

Sec.  180.1356  Extract of Swinglea glutinosa; exemption from the
requirement of a tolerance.

    Residues of the biochemical pesticide Extract of Swinglea glutinosa
are exempt from the requirement of a tolerance in or on all food
commodities when applied pre-harvest in accordance with label
directions and good agricultural practices.

[FR Doc. 2018-12809 Filed 6-13-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 30 (Monday, February 14, 2022)]
[Rules and Regulations]
[Pages 8152-8158]
[FR Doc No: 2022-03144]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2022-0095; Project Identifier AD-2022-00054-T;
Amendment 39-21947; AD 2022-04-05]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
The Boeing Company Model 757 airplanes and Model 767 airplanes. This AD
was prompted by a determination that radio altimeters cannot be relied
upon to perform their intended function if they experience interference
from wireless broadband operations in the 3.7-3.98 GHz frequency band
(5G C-Band), and a recent determination that, during approach,
landings, and go-arounds, as a result of this interference, certain
airplane systems may not properly function, resulting in increased
flightcrew workload while on approach with the flight director,
autothrottle, or autopilot engaged. The FAA is issuing this AD to
address 5G C-Band interference that could result in increased
flightcrew workload and could lead to reduced ability of the flightcrew
to maintain safe flight and landing of the airplane. This AD requires
revising the limitations and operating procedures sections of the
existing airplane flight manual (AFM) to incorporate specific operating
procedures for landing distance calculations, instrument landing system
(ILS) approaches, non-precision approaches, speedbrake deployment,

and go-around and missed approaches, when in the presence of 5G C-Band
interference as identified by Notices to Air Missions (NOTAMs). The FAA
is issuing this AD to address the unsafe condition on these products.

DATES: This AD is effective February 14, 2022.
    The FAA must receive comments on this AD by March 31, 2022.

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 https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2022-0095; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this final rule, any
comments received, and other information. The street address for the
Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: For Model 757 airplanes, contact
Jeffrey Palmer, Aerospace Engineer, Systems and Equipment Section, FAA,
Los Angeles ACO Branch, 3960 Paramount Boulevard, Lakewood, CA 90712-
4137; phone:<PHONE_NUMBER>; email: [email protected]. For Model
767 airplanes, contact Dean Thompson, Senior Aerospace Engineer,
Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South
216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].

SUPPLEMENTARY INFORMATION:

Background

    In March 2020, the United States Federal Communications Commission
(FCC) adopted final rules authorizing flexible use of the 3.7-3.98 GHz
band for next generation services, including 5G and other advanced
spectrum-based services.\1\ Pursuant to these rules, C-Band wireless
broadband deployment was permitted to occur in phases with the
opportunity for operations in the lower 0.1 GHz of the band (3.7-3.8
GHz) in certain markets beginning on January 19, 2022. This AD refers
to ``5G C-Band'' interference, but wireless broadband technologies,
other than 5G, may use the same frequency band.\2\ These other uses of
the same frequency band are within the scope of this AD since they
would introduce the same risk of radio altimeter interference as 5G C-
Band.
---------------------------------------------------------------------------

    \1\ The FCC's rules did not make C-Band wireless broadband
available in Alaska, Hawaii, and the U.S. Territories.
    \2\ The regulatory text of the AD uses the term ``5G C-Band''
which, for purposes of this AD, has the same meaning as ``5G'', ``C-
Band'' and ``3.7-3.98 GHz.''
---------------------------------------------------------------------------

    The radio altimeter is an important aircraft instrument, and its
intended function is to provide direct height-above-terrain/water
information to a variety of aircraft systems. Commercial aviation radio
altimeters operate in the 4.2-4.4 GHz band, which is separated by 0.22
GHz from the C-Band telecommunication systems in the 3.7-3.98 GHz band.
The radio altimeter is more precise than a barometric altimeter and for
that reason is used where aircraft height over the ground needs to be
precisely measured, such as autoland, manual landings, or other low
altitude operations. The receiver on the radio altimeter is typically
highly accurate, however it may deliver erroneous results in the
presence of out-of-band radio frequency emissions from other frequency
bands. The radio altimeter must detect faint signals reflected off the
ground to measure altitude, in a manner similar to radar. Out-of-band
signals could significantly degrade radio altimeter functions during
critical phases of flight, if the altimeter is unable to sufficiently
reject those signals.
    The FAA issued AD 2021-23-12, Amendment 39-21810 (86 FR 69984,
December 9, 2021) (AD 2021-23-12) to address the effect of 5G C-Band
interference on all transport and commuter category airplanes equipped
with a radio (also known as radar) altimeter. AD 2021-23-12 requires
revising the limitations section of the existing AFM to incorporate
limitations prohibiting certain operations, which require radio
altimeter data to land in low visibility conditions, when in the
presence of 5G C-Band interference as identified by NOTAM. The FAA
issued AD 2021-23-12 because radio altimeter anomalies that are
undetected by the automation or pilot, particularly close to the ground
(e.g., landing flare), could lead to loss of continued safe flight and
landing.
    Since the FAA issued AD 2021-23-12, Boeing has continued to
evaluate potential 5G C-Band interference on aircraft systems that rely
on radio altimeter inputs. Boeing issued Boeing Multi Operator Message
MOM-MOM-22-0022-01B(R2), dated February 1, 2022; Boeing Flight Crew
Operations Manual Bulletin TBC-67 R1, ``Radio Altimeter Anomalies due
to 5G C-Band Wireless Broadband Interference in the United States,''
dated February 1, 2022; Boeing Flight Crew Operations Manual Bulletin
TBCC-72 R1, ``Radio Altimeter Anomalies due to 5G C-Band Wireless
Broadband Interference in the United States,'' dated February 1, 2022;
Boeing Flight Crew Operations Manual Bulletin TBC-86 R1, ``Radio
Altimeter Anomalies due to 5G C-Band Wireless Broadband Interference in
the United States,'' dated February 1, 2022; and Boeing Flight Crew
Operations Manual Bulletin TBC4-33 R1, ``Radio Altimeter Anomalies due
to 5G C-Band Wireless Broadband Interference in the United States,''
dated February 1, 2022; for Model 757 and 767 airplanes.
    Based on Boeing's data, the FAA identified an additional hazard
presented by 5G C-Band interference on The Boeing Company Model 757 and
767 airplanes. The FAA determined anomalies due to 5G C-Band
interference may affect multiple other airplane systems using radio
altimeter data, regardless of the approach type or weather. These
anomalies may not be evident until very low altitudes. Impacted systems
include, but are not limited to, autopilot flight director system;
autothrottle system; flight controls; flight instruments; traffic alert
and collision avoidance system (TCAS); ground proximity warning system
(GPWS); and configuration warnings.
    In the event of 5G C-Band interference, landing performance and
flightcrew workload can be adversely impacted. This may have multiple
effects, including:
     Autopilot Flight Director System: NO AUTOLAND Autopilot
Status Annunciation may be shown; autopilot may not engage; autopilot
disconnect may occur when LAND 2 or LAND 3 status is shown; the flight
directors may provide erroneous guidance during ILS approaches;
autoland runway alignment may not occur or may activate earlier or
later than expected; autoland flare may not occur, however, FLARE mode
can be erroneously annunciated on the FMA (flight mode annunciation);
or go-around mode may not be available.
     Autothrottle System: Autothrottle can remain in SPD
(speed) mode and may advance to maintain speed during flare instead of
reducing the thrust to

IDLE; or autothrottle may retard to idle prematurely in the flare.
     Flight Controls: Automatic speedbrake deployment may not
occur after touchdown (for Model 757 and 767 models with Yaw Damper
Stabilizer Trim module (YSM)); or SPEEDBRAKES EXT Caution message may
not be available.
     Flight Instruments: The RA (radio altimeter) indication
may not be shown; the RADIO minimums indications (flashing or turning
amber) may not be shown or may be erroneous; the rising runway symbol
may not be shown; the localizer deviation alert amber scale and
flashing pointer may not be shown (deviation indications are still
available); or the glideslope deviation alert amber scale and flashing
pointer may not be shown (deviation indications are still available).
     TCAS: TCAS alerts may not be available (TCAS alerts that
do occur will be valid); or TCAS inhibits for resolution advisories may
be erroneous.
     GPWS: GPWS alerts may not be available or may be erroneous
(although look-ahead terrain alerting remains available); radio
altimeter-based altitude and minimums aural callouts during approach
may not be available or erroneous; or windshear detection systems
(predictive and reactive) may be inoperative.
     Configuration Warnings: Erroneous landing gear
configuration warning may occur.
     Considerations for Dispatch: For Model 757 and 767
airplanes with YSM, adjust operational (time of arrival) landing
distance for manual speedbrakes. For airplanes without YSM, no impacts
on dispatch landing performance calculations.
     Other simultaneous flight deck effects associated with the
5G C-Band interference could increase pilot workload.
    These effects may cause erroneous indications and annunciations, as
well as conflicting information, being provided to the flightcrew
during a critical phase of flight. This could lead to reduced ability
of the flightcrew to maintain safe flight and landing of the airplane,
and is an unsafe condition.
    To address this unsafe condition, this AD mandates procedures for
operators to incorporate specific operating procedures for landing
distance calculations, ILS approaches, non-precision approaches,
speedbrake deployment, and go-around and missed approaches, when in the
presence of 5G C-Band interference as identified by NOTAMs.
    The FAA notes that for those airplanes equipped with YSM, the 5G
interference to the radio altimeter creates an error to the YSM which
causes the speedbrakes to not automatically deploy on landing; the
flightcrew must manually deploy the speedbrakes when this occurs.
Further, the additional landing distance calculation is required due to
the differences in manual deployment versus automatic deployment during
landing.
    Finally, the FAA notes that AD 2021-23-12 remains in effect and
thus prohibits certain ILS approaches. Thus, this AD addresses
procedures applicable only to those ILS approaches not prohibited by AD
2021-23-12.
    The FAA is issuing this AD to address the unsafe condition on these
products.

FAA's Determination

    The FAA is issuing this AD because the agency has determined the
unsafe condition described previously is likely to exist or develop in
other products of the same type design.

AD Requirements

    This AD requires revising the limitations and operating procedures
sections of the existing AFM to incorporate specific operating
procedures for landing distance calculations, ILS approaches, non-
precision approaches, speedbrake deployment, and go-around and missed
approaches, when in the presence of 5G C-Band interference as
identified by NOTAMs.

Compliance With AFM Revisions

    Section 91.9 prohibits any person from operating a civil aircraft
without complying with the operating limitations specified in the AFM.
FAA regulations also require operators to furnish pilots with any
changes to the AFM (14 CFR 121.137) and pilots in command to be
familiar with the AFM (14 CFR 91.505).

Interim Action

    The FAA considers this AD to be an interim action. If final action
is later identified, the FAA might consider further rulemaking.

Justification for Immediate Adoption and Determination of the Effective
Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies forgoing notice and comment prior to adoption of this rule
because the FAA determined that radio altimeters cannot be relied upon
to perform their intended function if they experience interference from
wireless broadband operations in the 5G C-Band, and a determination
that, during approach, landings, and go-arounds, as a result of this
interference, certain airplane systems may not properly function,
resulting in increased flightcrew workload while on approach with the
flight director, autothrottle, or autopilot engaged. This increased
flightcrew workload could lead to reduced ability of the flightcrew to
maintain safe flight and landing of the airplane. The urgency is based
on the hazard presented by 5G C-Band interference, and on C-Band
wireless broadband deployment, which began in phases with operations on
January 19, 2022. Accordingly, notice and opportunity for prior public
comment are impracticable and contrary to the public interest pursuant
to 5 U.S.C. 553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forgo notice and
comment.

Comments Invited

    The FAA invites you to send any written data, views, or arguments
about this final rule. Send your comments to an address listed under
ADDRESSES. Include Docket No. FAA-2022-0095 and Project Identifier AD-
2022-00054-T at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any

personal information you provide. The agency will also post a report
summarizing each substantive verbal contact received about this final
rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI for Model 757 airplanes
should be sent to Jeffrey Palmer, Aerospace Engineer, Systems and
Equipment Section, FAA, Los Angeles ACO Branch, 3960 Paramount
Boulevard, Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; email:
[email protected]. Submissions containing CBI for Model 767
airplanes should be sent to Dean Thompson, Senior Aerospace Engineer,
Systems and Equipment Section, FAA, Seattle ACO Branch, 2200 South
216th St., Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected]. Any commentary that the FAA receives that is
not specifically designated as CBI will be placed in the public docket
for this rulemaking.

Regulatory Flexibility Act

    The requirements of the Regulatory Flexibility Act (RFA) do not
apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt
a rule without prior notice and comment. Because the FAA has determined
that it has good cause to adopt this rule without notice and comment,
RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 1,138 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
AFM revision..........................  1 work-hour x $85 per                 $0             $85         $96,730
                                         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.
    The FAA is 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, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

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:

2022-04-05 The Boeing Company: Amendment 39-21947; Docket No. FAA-
2022-0095; Project Identifier AD-2022-00054-T.

(a) Effective Date

    This airworthiness directive (AD) is effective February 14,
2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company airplanes identified
in paragraphs (c)(1) and (2) of this AD, certificated in any
category.
    (1) Model 757-200, -200PF, -200CB, and -300 series airplanes.
    (2) Model 767-200, -300, -300F, -400ER, and -2C series
airplanes.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Unsafe Condition

    This AD was prompted by a determination that radio altimeters
cannot be relied upon to perform their intended function if they
experience interference from wireless broadband operations in the
3.7-3.98 GHz frequency band (5G C-Band), and a determination that,
during approach, landings, and go-arounds, as a result of this
interference, certain airplane systems may not properly function,
resulting in increased flightcrew workload while on approach with
the flight director, autothrottle, or autopilot engaged. The FAA is
issuing this AD to address 5G C-Band interference that could result
in increased flightcrew workload and could lead to reduced ability
of the flightcrew to maintain safe flight and landing of the
airplane.

(f) Compliance

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

(g) Airplane Flight Manual (AFM) Revision

    (1) Within 2 days after the effective date of this AD: Revise
the Limitations Section of the existing AFM to include the
information specified in figure 1 to paragraph (g)(1) of

this AD. This may be done by inserting a copy of figure 1 to
paragraph (g)(1) of this AD into the Limitations Section of the
existing AFM.
BILLING CODE 4910-13-P
[GRAPHIC] [TIFF OMITTED] TR14FE22.012

    (2) Within 2 days after the effective date of this AD: Revise
the Operating Procedures Section of the existing AFM to include the
information specified in figure 2 to paragraph (g)(2) of this AD.
This may be done by inserting a copy of figure 2 to paragraph (g)(2)
of this AD into the Operating Procedures Section of the existing
AFM.

[GRAPHIC] [TIFF OMITTED] TR14FE22.013

BILLING CODE 4910-13-C
    Note 1 to paragraph (g)(2): Guidance for accomplishing the
actions required by paragraph (g)(2) of this AD can be found in
Boeing Multi Operator Message MOM-MOM-22-0022-01B(R2), dated
February 1, 2022; Boeing Flight Crew Operations Manual Bulletin TBC-
67 R1, ``Radio Altimeter Anomalies due to 5G C-Band Wireless
Broadband Interference in the United States,'' dated February 1,
2022; Boeing Flight Crew Operations Manual Bulletin TBCC-72 R1,
``Radio Altimeter Anomalies due to 5G C-Band Wireless Broadband
Interference in the United States,'' dated February 1, 2022; Boeing
Flight Crew Operations Manual Bulletin TBC-86 R1, ``Radio Altimeter
Anomalies due to 5G C-Band Wireless Broadband Interference in the
United States,'' dated February 1, 2022; and Boeing Flight Crew
Operations Manual Bulletin TBC4-33 R1, ``Radio Altimeter Anomalies
due to 5G C-Band Wireless Broadband Interference in the United
States,'' dated February 1, 2022.

(h) Alternative Methods of Compliance (AMOCs)

    (1) For Model 757 airplanes: The Manager, Los Angeles ACO
Branch, FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
responsible Flight Standards Office, as appropriate. If sending
information directly to the manager of the certification office,
send it to the attention of the person identified in paragraph
(i)(1) of this AD. Information may be emailed to: [email protected]. For Model 767 airplanes: The Manager, Seattle ACO
Branch, FAA, has the authority to approve AMOCs for this AD, if
requested using the procedures found in 14 CFR 39.19. In accordance
with 14 CFR 39.19, send your request to your principal inspector or
responsible Flight Standards Office, as appropriate. If sending
information directly to the manager of the certification office,
send it to the attention of the person identified in paragraph
(i)(2) of this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
    (3) AMOCs approved for AD 2021-23-12, Amendment 39-21810 (86 FR
69984, December 9, 2021) providing relief for specific radio
altimeter installations are approved as AMOCs for the provisions of
this AD.

(i) Related Information

    (1) For more information about this AD for Model 757 airplanes,
contact Jeffrey W. Palmer, Aerospace Engineer, Systems and Equipment
Section, FAA, Los Angeles ACO Branch, 3960 Paramount Boulevard,
Lakewood, CA 90712-4137; phone:<PHONE_NUMBER>; email:
[email protected].
    (2) For more information about this AD for Model 767 airplanes,
contact Dean Thompson, Senior Aerospace Engineer, Systems and
Equipment Section, FAA, Seattle ACO Branch, 2200 South 216th St.,

Des Moines, WA 98198; phone and fax:<PHONE_NUMBER>; email:
[email protected].
    (3) For service information identified in this AD that is not
incorporated by reference, contact Boeing Commercial Airplanes,
Attention: Contractual & Data Services (C&DS), 2600 Westminster
Blvd., MC 110 SK57, Seal Beach, CA 90740-5600; telephone 562-797-
1717; internet https://www.myboeingfleet.com.

(j) Material Incorporated by Reference

    None.

    Issued on February 7, 2022.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2022-03144 Filed 2-10-22; 11:15 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 99 (Wednesday, May 22, 2019)]
[Notices]
[Pages 23563-23564]
[FR Doc No: 2019-10706]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2018-0663; FRL-9990-75-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Performance-Based Measurement System for
Fuels (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Performance-Based Measurement
System for Fuels (EPA ICR Number 2459.03, OMB Control Number 2060-0692)
to the Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. This is a proposed
extension of the ICR, which is currently approved through May 31, 2019.
Public comments were previously requested via the Federal Register on
November 5, 2018 during a 60-day comment period. This notice allows for
an additional 30 days for public comments. A fuller description of the
ICR is given below, including its estimated burden and cost to the
public. An agency may not conduct or sponsor and a person is not
required to respond to a collection of information unless it displays a
currently valid OMB control number.

DATES: Comments must be submitted on or before June 21, 2019.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2018-0663, to (1) EPA online using www.regulations.gov (our preferred
method), by email to<EMAIL_ADDRESS>or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: James W. Caldwell, Compliance
Division, Office of Transportation and Air Quality, 6405A,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: EPA regulations at 40 CFR part 80 set standards for
certain parameters of gasoline and diesel fuel, such as sulfur content,
to control harmful vehicle emissions and protect emission controls.
Refiners and importers are required to test for these parameters and
report the results to EPA. The regulations at 40 CFR part 80.47,
80.584, and 80.585 (1) identify acceptable test methods for some of the
regulated parameters, (2) specify criteria for precision, accuracy, and
quality control for the test methods used to measure the regulated
parameters (certain test methods in use prior to October 28, 2013 are
exempt from some of the criteria), and (3) establish procedures by
which a test laboratory can demonstrate that an alternative test method
meets the criteria and is thus ``qualified'' for use. This program for
the qualification of test methods is known as the Performance-Based
Measurement System (PBMS). Test laboratories are required to generate
certain records to demonstrate compliance with PBMS program
requirements. This ICR covers the recordkeeping and reporting
requirements for PBMS records. There are no required forms. Example
formats for certain records are at: https://www.epa.gov/fuels-registration-reporting-and-compliance-help/compliance-performance-based-measurement-system.
    Form Numbers: None.
    Respondents/affected entities: Laboratories that test gasoline and
diesel fuel.
    Respondent's obligation to respond: Mandatory.
    Estimated number of respondents: 1,015 (total).
    Frequency of response: On occasion, periodically (varies with test
method).
    Total estimated burden: 26,696 hours (per year). Burden is defined
at 5 CFR 1320.03(b).

    Total estimated cost: $2,460,454 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in Estimates: There is an increase of 17,198 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This increase is due to an incorrect estimate of 52
laboratories for the current approval while the actual number should
have been near 1,000.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2019-10706 Filed 5-21-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: December 1, 2010 (Volume 75, Number 230)]
[Notices]
[Page 74702-74703]
[DOCID:fr01de10-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13837-000]

City of Whittier; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

November 23, 2010.
    On September 1, 2010, and supplemented on November 9, 2010, the
City of Whittier filed an application for a preliminary permit,
pursuant to section 4(f) of the Federal Power Act (FPA), proposing to
study the feasibility of the Whittier Creek Hydroelectric Project
(Whittier Creek project) to be located on Whittier Creek, in the
Valdez-Cordova Borough, Alaska. The sole purpose of a preliminary
permit, if issued, is to grant the permit holder priority to file a
license application during the permit term. A preliminary permit does
not authorize the permit holder to perform any land-disturbing
activities or otherwise enter upon lands or waters owned by others
without the owners' express permission.
    The proposed project will consist of the following: (1) An
approximately 100-foot-long, 20-foot-high reinforced concrete dam; (2)
a 0.5-acre reservoir with a storage capacity of 10 acre-feet; (3) a
2,280-foot-long, 0.83-foot-diameter high density polyethylene penstock;
(4) a 30-foot-long, 25-foot-wide powerhouse containing a 250-kilowatt
turbine/generator unit; (5) a 100-foot-long, 5-foot-diameter steel
tailrace; (6) an approximately 1,000-foot-long transmission line with
an anticipated voltage between 4 kilovolts (kV) and 69 kV, connecting
the proposed powerhouse to an existing switchyard; and (7) appurtenant
facilities. The estimated annual generation of the Whittier Creek
project would be 1,750 megawatt-hours.
    Applicant Contact: Ed Barrett, City of Whittier, Alaska, P.O. Box
608, Whittier, AK 99693; phone:<PHONE_NUMBER>.
    FERC Contact: Jennifer Harper,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-
filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of the
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number

(P-13837-000) in the docket number field to access the document. For
assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-30159 Filed 11-30-10; 8:45 am]
BILLING CODE 6717-01-P