[Federal Register Volume 88, Number 34 (Tuesday, February 21, 2023)]
[Notices]
[Pages 10525-10526]
[FR Doc No: 2023-03521]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-P-2438]

Determination That ASACOL HD (Mesalamine) Delayed-Release Tablet,
800 Milligrams, Was Not Withdrawn From Sale for Reasons of Safety or
Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) has
determined that ASACOL HD (Mesalamine) Delayed-Release Tablet, 800
milligrams (mg), was not withdrawn from sale for reasons of safety or
effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Donna Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved, and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all approved drugs. FDA publishes this list as part of the ``Approved
Drug Products With Therapeutic Equivalence Evaluations,'' which is
known generally as the ``Orange Book.'' Under FDA regulations, drugs
are removed from the list if the Agency withdraws or suspends approval
of the drug's NDA or ANDA for reasons of safety or effectiveness or if
FDA determines that the listed drug was withdrawn from sale for reasons
of safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 mg, is the
subject of NDA 021830, held by Allergan Pharmaceuticals International
Ltd., and initially approved on May 29, 2008. ASACOL HD is indicated
for the treatment of moderately active ulcerative colitis in adults.
    In a letter dated May 13, 2022, Allergan Pharmaceuticals
International Ltd. notified FDA that ASACOL HD (Mesalamine) Delayed-
Release Tablet, 800 mg, was being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book.
    Aurobindo Pharma USA, Inc., submitted a citizen petition dated
October 4, 2022 (Docket No. FDA-2022-P-2438), under 21 CFR 10.30,
requesting that the Agency determine whether ASACOL HD (Mesalamine)
Delayed-Release Tablet, 800 mg, was withdrawn from sale for reasons of
safety or effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that ASACOL HD (Mesalamine) Delayed-Release Tablet,
800 mg, was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
ASACOL HD (Mesalamine) Delayed-Release Tablet, 800 mg, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of ASACOL HD (Mesalamine)
Delayed-Release Tablet, 800 mg, from sale. We have also independently
evaluated relevant literature and data for possible postmarketing
adverse events. We have found no information that would indicate that
this drug product was withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list ASACOL HD
(Mesalamine) Delayed-Release Tablet, 800 mg, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: February 15, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03521 Filed 2-17-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: September 22, 2006 (Volume 71, Number 184)]
[Notices]
[Page 55533-55535]
[DOCID:fr22se06-160]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-54459; File No. SR-NASDAQ-2006-035]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing and Order Granting Accelerated Approval of Proposed
Rule Change To Amend Existing Rules for Portfolio Depository Receipts,
Index Fund Shares, and Index-Linked Securities

September 15, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 14, 2006, The NASDAQ Stock Market LLC (``Nasdaq'') filed
with the Securities and Exchange Commission (``Commission'') the
proposed rule change as described in Items I, II, and III below, which
Items have been prepared by Nasdaq. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons and to approve the proposed rule change on an accelerated
basis.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to amend its existing rules for portfolio
depository receipts, index fund shares, and index-linked securities to
provide that an eligible index may be calculated following a
methodology weighting components based on one or more of the following:
Sales, cash flow, book value, and dividends.
    The text of the proposed rule change is below. Proposed new
language is italicized; there are no proposed deletions.\3\
---------------------------------------------------------------------------

    \3\ Changes are marked to the rule text that appears in the
electronic manual of Nasdaq found at http://www.complinet.com/nasdaq
.

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* * * * *
4420. Quantitative Listing Criteria
    (a)-(h) No Change.
(i) Portfolio Depository Receipts
    (1)-(2) No Change.
    (3)(A) No Change.
    (3)(B) Index Methodology and Calculation
    (i) The index underlying a series of Portfolio Depository Receipts
will be calculated based on [either] the market capitalization,
modified market capitalization, price, equal-dollar or modified equal-
dollar weighting or a methodology weighting components of the index
based on any, some or all of the following: Sales, cash flow, book
value and dividends;
    (3)(B)(ii)-(iii) No Change.
    (3)(C)-(E) No Change.
    (4)-(7) No Change.
(j) Index Fund Shares
    (1)-(2) No Change.
    (3)(A) No Change.
    (3)(B) Index Methodology and Calculation
    (i) The index underlying a series of Index Fund Shares will be
calculated based on [either] the market capitalization, modified market
capitalization, price, equal-dollar or modified equal-dollar weighting
or a

methodology weighting components of the index based on any, some or all
of the following: Sales, cash flow, book value and dividends;
    (3)(B)(ii)-(iii) No Change.
    (3)(C)-(E) No Change.
    (4)-(7) No Change.
    (k)-(l) No Change.
(m) Index-Linked Securities
    (1)-(6) No Change.
    (7) No Change.
    (7)(i)-(ii) No Change.
    (iii) Each index will be calculated based on a capitalization,
modified capitalization, price, equal-dollar or modified equal-dollar
weighting or a methodology weighting components of the index based on
any, some or all of the following: Sales, cash flow, book value and
dividends;
    (7)(iv)-(ix) No Change.
    (8)-(10) No Change.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item III below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    According to Nasdaq, the purpose of this proposed rule change is to
amend Nasdaq's existing generic listing standards pursuant to Rule 19b-
4(e) of the Act \4\ for portfolio depository receipts, index fund
shares \5\ and index-linked securities to provide that an eligible
index may be calculated following a methodology weighting components
based on one or more of the following: Sales, cash flow, book value and
dividends. This methodology is also referred to as the fundamentals
weighting methodology.
---------------------------------------------------------------------------

    \4\ 17 CFR 240.19b-4(e).
    \5\ Portfolio depository receipts and index fund shares are
registered investment companies under the Investment Company Act of
1940 and are referred to in this filing as exchange traded funds
(``ETFs'').
---------------------------------------------------------------------------

    Nasdaq currently has generic listing standards (within the meaning
of Rule 19b-4(e) of the Act \6\), which permit the listing and trading
of various qualifying ETFs and index linked notes (``ILNs'') subject to
the procedures contained in Rule 19b-4(e). The existence of a generic
listing standard allows qualifying ETFs and ILNs to list or trade
without the need to file a rule change for each security under Rule
19b-4 of the Act.\7\ By amending its generic listing standards pursuant
to Rule 19b-4(e), Nasdaq intends to reduce the time frame for listing
portfolio depository receipts, index fund shares and index-linked
securities that rely on an index utilizing a fundamentals weighting
methodology and thereby reduce the burdens on issuers and other market
participants.
---------------------------------------------------------------------------

    \6\ 17 CFR 240.19b-4(e).
    \7\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The current rules already provide that eligible indexes may be
calculated based on either the market capitalization, modified market
capitalization, price, equal-dollar or modified equal-dollar weighting
methodology. The proposed rule change will specify one additional
methodology. The fundamentals weighting methodology allows the
weighting of the individual components of the index based on any, some
or all of the following: sales, cash flow, book value, and
dividends.\8\
---------------------------------------------------------------------------

    \8\ In each instance, the index methodology will set forth the
means of calculating sales, cash flow, book value, and dividends.
---------------------------------------------------------------------------

    ``Sales'' refers to the total of reported operating revenues less
various adjustments to gross sales, such as returns, discounts,
allowances, excise taxes, insurance charges, sales taxes, and value
added taxes. In calculating the sales value, an index provider may opt
to average the company's applicable figures for several prior years
(e.g., five prior years as reflected in the company's Annual Report on
Form 10-K).
    ``Cash Flow'' refers to operating income plus depreciation. For
example, a manufacturer typically reports its operating income as its
net sales plus other operating income minus the cost of goods sold and
selling, general and administrative expenses. Depreciation expense for
a manufacturer typically includes the depreciation that is directly
related to or associated with tangible fixed assets and includes
amortization of fixed assets that are part of plant, property and
equipment, such as leased assets, leasehold improvements, and internal
use software. For example, for a manufacturer depreciation expense
excludes amortization of intangible assets. For banks, financial
companies, and REITs, operating income refers to their total operating
revenue minus total operating expenses. For REITs, depreciation expense
includes depreciation relating to real estate property and includes
corporate fixed asset depreciation if not separated from property
depreciation. In calculating cash flow, an index provider may opt to
average the company's applicable figures for several prior years (e.g.,
five prior years as reflected in the company's Annual Report on Form
10-K).
    ``Book Value'' refers to a company's book value at the index review
date. In accordance with accounting principles, book value generally
means total common equity, which is derived from adding share capital
and additional paid-in capital to retained earnings. In calculating
book value, an index provider may opt to average the company's
applicable figures for several prior years (e.g., five prior years as
reflected in the company's Annual Report on Form 10-K).
    ``Dividends'' refers to total dividend distributions, including
both special and regular dividends paid in cash. Generally, the total
dividend amount that is declared to all classes of common shareholders
includes regular cash, as well as special cash dividends, and excludes
returns of capital and in-specie dividends. In calculating dividends,
an index provider may opt to average the company's applicable figures
for several prior years (e.g., five prior years as reflected in the
company's Annual Report on Form 10-K).
    Nasdaq believes that the fundamentals weighting methodology is a
transparent methodology that provides investors with an alternative to
capitalization weighted index methodologies. Nasdaq believes that by
amending its generic listing standards to provide for this new index
calculation methodology, it is providing investors with more investment
choices and thereby increasing competition in the marketplace. Nasdaq
notes that products based on indexes using this methodology are already
subject to the other requirements of the generic listing standards
pursuant to Rule 19b-4(e).\9\ Therefore, Nasdaq requests accelerated
approval in order to avoid unnecessary delay in the listing of
otherwise eligible securities linked to fundamentals weighted indexes.
---------------------------------------------------------------------------

    \9\ 17 CFR 240.19b-4(e).
---------------------------------------------------------------------------

2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
the provisions of Section 6 of the Act,\10\ in general and with Section
6(b)(5) of the Act,\11\ in particular, in that it is designed

to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, remove impediments to a free
and open market and a national market system, and, in general, to
protect investors and the public interest. Nasdaq believes that the
proposed rule change should facilitate the listing and trading of
portfolio depository receipts, index fund shares, and index-linked
securities that rely on an index utilizing a fundamentals weighting
methodology and should thereby reduce the burdens on issuers and other
market participants.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    Written comments were neither solicited nor received.

III. Solicitation of Comments

    Interested persons are invited to submit written data, views and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASDAQ-2006-035 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-NASDAQ-2006-035. This
file number should be included on the subject line if e-mail is used.
To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml.
) Copies of the submission, all subsequent amendments,

all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for inspection
and copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of the Nasdaq. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASDAQ-2006-035 and should be submitted on or before
October 13, 2006.

IV. Commission's Findings and Order Granting Accelerated Approval of
the Proposed Rule Change

    After careful review, the Commission finds that the proposed rule
change is consistent with the requirements of the Act and the rules and
regulations thereunder applicable to a national securities
exchange.\12\ In particular, the Commission finds that the proposed
rule change is consistent with Section 6(b)(5) of the Act,\13\ which
requires, among other things, that the rules of a national securities
exchange be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism for a free and open market and
a national market system, and, in general, to protect investors and the
public interest.
---------------------------------------------------------------------------

    \12\ In approving this rule change, the Commission notes that it
has considered the proposed rule's impact on efficiency,
competition, and capital formation. See 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

    The proposed rule change amends Nasdaq's existing generic listing
standards pursuant to Rule 19b-4(e) \14\ for portfolio depository
receipts, index fund shares, and index-linked securities to provide
that an eligible index may be calculated following the ``fundamentals
weighting'' or ``fundamental index'' methodology. This index
calculation methodology weights components based on one or more of the
following: sales, cash flow, book value, and dividends.\15\
---------------------------------------------------------------------------

    \14\ 17 CFR 240.19b-4(e).
    \15\ According to Nasdaq, in each instance, the index
methodology will set forth the means of calculating sales, cash
flow, book value, and dividends and thus will be transparent.
---------------------------------------------------------------------------

    Including this index calculation methodology in Nasdaq's generic
listing standards will provide investors with more investment choices
by offering an alternative to the other index methodologies, such as
capitalization-weighted ones. The Commission notes that the indexes
that would be based on the fundamentals weighting methodology will
already be subject to the requirements of the generic listing standards
pursuant to Rule 19b-4(e) of the Act,\16\ including trading volume and
liquidity requirements. In addition, by amending its generic listing
standards pursuant to Rule 19b-4(e) of the Act,\17\ Nasdaq should
reduce the time frame for listing portfolio depository receipts, index
fund shares, and index-linked securities that rely on an index
utilizing a fundamentals weighting methodology. The proposed rule
change should therefore facilitate the listing and trading of such
securities and thereby reduce the burdens on issuers and other market
participants.
---------------------------------------------------------------------------

    \16\ 17 CFR 240.19b-4(e).
    \17\ Id.
---------------------------------------------------------------------------

    The Exchange has requested accelerated approval of the proposed
rule change. The Commission finds good cause for approving the proposed
rule change prior to the 30th day after the date of publication of the
notice of filing in the Federal Register. The Commission believes the
proposed rule change should provide investors with an alternative to
the current index calculation methodologies. In addition, the proposed
rule change should reduce the burden on issuers and market participants
to list and trade portfolio depository receipts, index fund shares, and
index-linked securities based on the fundamentals weighting
methodology. Therefore, the Commission finds good cause, consistent
with Section 19(b)(2) of the Act,\18\ to approve the proposed rule
change on an accelerated basis.
---------------------------------------------------------------------------

    \18\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

V. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\19\ that the proposed rule change (SR-NASDAQ-2006-035) is approved
on an accelerated basis.
---------------------------------------------------------------------------

    \19\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\20\
---------------------------------------------------------------------------

    \20\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jill M. Peterson,
Assistant Secretary.
[FR Doc. 06-8043 Filed 9-21-06; 8:45 am]

BILLING CODE 8010-01-P


Page 1 of 7 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES 01 JUN 2006 MEMORANDUM SUBJECT: Cypermethrin. Health Effects Division ( HED) Phase 4 Response to Phase 3 Comments on the Cypermethrin Preliminary Reregistration Eligibility Decision ( RED) and Supporting Memos. PC Code 109702; DP Barcodes D293402 & D293403.

From: William H. Donovan, Ph. D., Chemist John Doherty, Ph. D., Toxicologist Seyed Tadayon, Chemist Reregistration Branch 3 Health Effects Division [ 7509P]

Through: Danette Drew, Branch Senior Scientist Reregistration Branch 3 Health Effects Division [ 7509P]

To: Dirk Helder, Chemical Review Manager Reregistration Branch 2 Special Review and Reregistration Division [ 7508P]

FMC Corporation has provided Phase 3 comments on the cypermethrin preliminary RED and supporting memos in a submission dated 03 MAR 2006 ( MRID 46775902). In partial response to these comments, HED has updated the following memos: 1) Occupational and residential exposure memo for cypermethrin ( see D293417, S. Tadayon, 05 APR 2006). 2) Human health risk assessment for cypermethrin ( see D293416, W. Donovan et al., 06 APR 2006). Page 2 of 7 Most of the issues raised by FMC Corporation have been resolved. Thus, rather than issue a point by point response to each comment, below we address the remaining issues where agreement has not yet been reached, or where new data have been submitted. For convenience, we have organized the following discussion by document number referred to in the FMC submission.

Document 1. Cypermethrin HED Chemistry Chapter of the Reregistration Eligibility Decision ( RED): Summary of Product and Residue Chemistry Data. DP Barcode D289422. 09 SEP 2003.

A. OPPTS 830.1750 Certified Limits FMC Statement: FMC will address this issue during a later phase of the RED.

HED Response: This deficiency remains unresolved.

B. OPPTS 830.7050 UV/ Visible absorption FMC Statement: Submission of MRID 46775906, " Zeta Cypermethrin and its Degradates: UV VIS Absorption Spectra", Thomas Class, PTRL Europe Study: P661G, 25 MAR 2003 HED Response: HED concurs that the UV/ Vis study for zeta cypermethrin may be translated to cover the requirement for cypermethrin. The study shows one absorption maximum at 278 nm. This deficiency is now resolved.

C. OPPTS 830.1800 Enforcement Analytical Method FMC Statement: Submission of MRID, " Cypermethrin Technical ( 52/ 48; JCPG): Analysis and Certification of Product Ingredients", Mark Halfon, 02 FEB 2006.

HED Response: This study is currently under review by SRRD/ PRB.

Document 2. Cypermethrin: Phase 2 HED Risk Assessment for the Reregistration Eligibility Decision ( RED). D293415, 16 NOV 2005.

FMC Statement: Requests update on review of zeta cypermethrin DNT study.

HED Response: This review has not been finalized yet but results in the removal of the 10X database uncertainty factor. A copy can be forwarded to FMC upon review completion. Page 3 of 7 FMC Statement: Drinking Water Exposure. The drinking water paragraph is somewhat misleading. Cypermethrin should not persist in water as it would quickly partition into the sediment. The levels of cypermethrin modeled in water are severe overestimates based on the physical/ chemical properties of cypermethrin.

HED Response: HED concurs that the water modeling approach produces conservative estimates of cypermethrin levels in drinking water. However, as this standard approach results in risk levels below our level of concern, further refinement of these values is not warranted.

FMC Statement: In response to an identified data gap, FMC has submitted the following crop field trial data for cotton gin byproducts: MRID 46775904, " Magnitude and Decline Pattern of the Residues of Cypermethrin in/ on Cotton Treated with Six Applications of Ammo 2.5 EC Insecticide", John R. Arabinick, Study No. 191COT04R1, Report No. P 3806. 134 pages. 23 FEB 2006.

HED Response: This study has been summarized in the following data evaluation record ( DER): 46775904. der. It was determined that this study is scientifically acceptable to satisfy the requirements of OPPTS 860.1500 for cotton gin byproducts. The tolerance spreadsheet calculator recommends a tolerance level of 11 ppm for this commodity, based on the submitted field trial results ( see Attachment 1). As HED is not aware of any compelling reason to depart from the tolerance spreadsheet recommendation, 11 ppm is the appropriate tolerance level for cotton gin byproducts.

FMC Statement: In response to an identified data gap, FMC has submitted the following waiver request: MRID 46775903, " Rationale to Waive the Storage Stability Study of Cypermethrin in Cottonseed Processed Commodities", Audrey W. Chen, Report No. P 3821. 9 pages. 14 FEB 2006. The FMC data waiver request points out that cypermethrin and zeta cypermethrin storage stability studies have been conducted on several diverse crops and processed commodities. As none of these studies have demonstrated stability problems with these chemicals in any matrix studied, it is unlikely that there would be stability problems in cottonseed oil.

HED Response: HED concurs that the existing storage stability studies for cypermethrin and zeta cypermethrin are adequate to support the storage interval for processed cotton commodities. Thus, HED approves this data waiver request.

Document 3. Cypermethrin and Zeta Cypermethrin: Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision Document. D289426, 15 OCT 2004.

HED has addressed the FMC's comments and concerns in the following updated version of the above memo: Page 4 of 7 Cypermethrin and Zeta Cypermethrin: Revised Occupational and Residential Exposure Assessment for the Reregistration Eligibility Decision Document. D293417, 05 APR 2006.

Document 4. Cypermethrin: Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision Document. D289429, 11 JUL 2003.

FMC Statement: FMC requested that the following changes be made: A. Section 2.0, page 9: change footnote to acknowledge submission of zeta cypermethrin DNT study. B. Section 6.2, page 30: Add a new paragraph summarizing the results of the DNT study and its impact on the safety factors utilized in the risk assessment document.

HED Response: An update to the cypermethrin toxicology chapter including the requested changes is being prepared and can be forwarded to FMC Corporation upon completion.

Document 5. Cypermethrin. HED Response to Error Only Registrant Comments on the Cypermethrin Preliminary RED and Supporting Documents, D298690, 05 MAR 2004.

FMC Statement: FMC requested that a sentence be added stating that a developmental neurotoxicity ( DNT) study with zeta cypermethrin has been submitted and is currently under review.

HED Response: HED will not make the requested change since the results of the review of the DNT study are discussed in other documents and because the present memo supercedes Document 5.

Document 6. Review of Cypermethrin Incident Reports. D293143, 26 AUG 2003.

FMC Statement: FMC requested that the most recent data be included in the cypermethrin incident report, and provided this information as collected by an emergency hotline for FMC Corporation.

HED Response: HED requests a short summary from FMC on the scope of their contract incident report generation service, PROSAR. We would also need a description of the denominators for the data given by FMC in percentages, the area of geographic coverage, and a copy of the data collection protocols used by the call center run by PROSAR. Without this information, we do not know if the data are comparable to PCC. Reporting by PROSAR to a State PCC does not insure data are uploaded to the national AAPCC reporting system that has very strict data reporting requirements. Low numbers can be a true reflection of the current situation, or a function of under reporting. A comparison of protocols will assist in answering this question. Page 5 of 7 Appendix 1. Tolerance Spreadsheet Calculator Results for Cypermethrin/ Cotton Gin Byproducts Field Trials.

EPA Cypermethrin Cotton GBYP 13 14 days 0.60 lb/ A Residues LN( Residues) Zscores 7.500 2.01 0.54 6.510 1.87  0.31 6.820 1.92 0.10 6.510 1.87  0.10 8.840 2.18 1.64 5.700 1.74  0.79 6.180 1.82  0.54 5.530 1.71  1.11 4.730 1.55  1.64 8.320 2.12 1.11 8.280 2.11 0.79 7.100 1.96 0.31 Page 6 of 7 Regulator: EPA Chemical: Cypermethrin Crop: Cotton GBYP PHI: 13 14 days App. Rate: 0.60 lb/ A Submitter:

n: 12 min: 4.73 max: 8.84 median; 6.67 average: 6.84 95th Percentile 99th Percentile 99.9th Percentile 9.0 10 11 EU Method I Normal ( 11) ( 12) ()

10 11 12 EU Method I Log Normal ( 12) ( 14) () 17 EU Method II Distributio n Free 11 California Method µ + 3  UPLMedian95 th 50 Approximate Shapiro Francia Normality Test Statistic 0.9786 p value > 0.05 : Do not reject lognormality assumption Page 7 of 7 Lognormal Probability Plot 99.9 99 98 95 90 80 70 50 30 20 10 5 2 1 0.1 9.0000 4.5000 y = 0.1933x + 1.9066 R 2 = 0.9786 Percentiles Concentrations EPA Cypermethrin Cotton GBYP 13 14 days 0.60 lb/ A


[Federal Register Volume 81, Number 96 (Wednesday, May 18, 2016)]
[Rules and Regulations]
[Pages 31171-31172]
[FR Doc No: 2016-11713]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0406]

Drawbridge Operation Regulation; Lake Champlain, North Hero
Island, VT

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the US2 Bridge across Lake Champlain
(The Gut), mile 91.8, between North Hero and South Hero Island,
Vermont. This deviation is necessary to allow the bridge owner to
perform mechanical and electrical repairs at the bridge.

DATES: This deviation is effective without actual notice from May 18,
2016 to 8 a.m. on June 15, 2016. For the purposes of enforcement,
actual notice will be used from 8 a.m. on May 15, 2016, until May 18,
2016.

ADDRESSES: The docket for this deviation, USCG-2016-0406, is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Jim Rousseau; Project Officer, First
Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:  The US2 Bridge across Lake Champlain, at
North Hero Island, Vermont, has a vertical clearance in the closed
position of 18 feet at mean high water. The existing bridge operating
regulations are found at 33 CFR 117.993(b).
    The subject waterway is typically transited by seasonal,
recreational vessels of various sizes. Several marina facilities are in
the area of the bridge with local vessels requesting bridge openings
several times a week.
    The bridge owner, Vermont Agency of Transportation, requested a
temporary deviation from the normal operating schedule to facilitate
mechanical and electrical repairs at the bridge. In response to the
request, the Coast Guard's First District has approved a deviation from
8 a.m. on May 15, 2016 until 8 a.m. June 15, 2016.
    During the time of this temporary deviation, the US2 Bridge shall
open on signal on the hour, but it will not open on the half hour. Also
during the time of this temporary deviation, the US2 Bridge will be
open by use of an auxiliary drive system not designed for high-speed
openings, which means the bridge will open more slowly than it does
under normal operations.
    Vessels that are able to pass under the bridge in the closed
position may do so at anytime. The bridge will be able to open for
emergencies, and there is an alternate route for vessels to pass to the
north under the Alburg Passage US2 fixed bridge, which has a vertical
clearance of 26 feet at mean high water.
    The Coast Guard will inform the users of the waterways through our
Local Notice and Broadcast to Mariners of the change in operating
schedule for the bridge so that vessel operations can arrange their
transits to minimize any impact caused by the temporary deviation.

    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the effective
period of this temporary deviation. This deviation from the operating
regulations is authorized under 33 CFR 117.35.

    Dated: May 13, 2016,
C.J. Bisignano,
Supervisory Bridge Management Specialist, First Coast Guard District.
[FR Doc. 2016-11713 Filed 5-17-16; 8:45 am]
 BILLING CODE 9110-04-P


Pesticides in Streams: Summary Statistics; Preliminary Results from Cycle I of the National Water Quality Assessment Program ( NAWQA), 1992 2001 PROVISIONAL DATA  SUBJECT TO REVISION Jeffrey D. Martin, jdmartin@ usgs. gov ; Charles G. Crawford, cgcrawfo@ usgs. gov ; and Steven J. Larson, sjlarson@ usgs. gov February 19, 2003 INTRODUCTION As part of the National Water Quality Assessment Program ( NAWQA), 76 pesticides and 7 pesticide degradation products were analyzed in surface water samples collected for one or more years during 1992 to 2001 at 162 sites in 49 of the nation's most important river basins ( NAWQA study units). Previous studies have analyzed data collected early in the period ( Gilliom and others, 1999; Larson and others, 1999; U. S. Geological Survey, 1999b). This report provides a preliminary analysis of the entire data set. These data on pesticides in U. S. rivers and streams are the most extensive ever collected for such a wide range of pesticides and locations. The 76 herbicides, insecticides, and fungicides targeted in the study account for approximately 75 percent of the total amount ( by weight) of pesticides used for agriculture in the United States and a substantial portion of urban and suburban use ( U. S. Geological Survey, 1999a). The purpose of this summary is to estimate ( 1) the annual frequency of pesticide detection and ( 2) selected percentiles of the annual distribution of pesticide concentrations in streams sampled for the NAWQA Program during 1992 2001. Estimates of the annual frequency of pesticide detection and percentiles of the annual distribution of pesticide concentrations for NAWQA surface water sampling sites are summarized by land use category to provide estimates of pesticide concentrations in streams draining agricultural, urban, undeveloped, and mixed land uses.

SUMMARY OF METHODS The following sections provide a brief description of the methods used to select sites and samples and to calculate summary statistics. A more detailed discussion of methods is available ( see Expanded Methods). Sample collection and processing: Surface water sampling sites in each Study Unit were selected in accordance with the NAWQA national design strategy ( Gilliom and others, 1995). Surface water sites were classified into four land use groups on the basis of two national land use data sets and information on point sources and other influences on water quality provided by Study Units ( D. K. Mueller, Nutrient National Synthesis, U. S. Geological Survey, written commun., October 2, 2002). Pesticide samples generally were collected for one year at each site using a combination of fixed interval and extreme flow sampling ( Gilliom and others, 1995, p. 16). Two to four samples generally were collected each month during seasonal periods of high pesticide use and runoff and one to two samples were collected each month during other periods. Streamflow weighted, depth and width integrated water samples were collected using standard USGS methods ( Shelton, 1994, p. 14 17). All sample collection and processing equipment that came in contact with the pesticide sample was constructed of Teflon, glass, aluminum, or stainless steel. Equipment was cleaned with a dilute solution of phosphate free detergent and rinsed with deionized water and pesticide grade methanol. Water samples were filtered using pre combusted glass fiber filters with a nominal 0.7

µ m pore diameter to remove suspended particulate matter. Collection and processing methods are described by Shelton ( 1994). Analytical methods: Water samples were analyzed for pesticides at the National Water Quality Laboratory ( NWQL) of the USGS in Colorado. Data from two analytical methods are described in this summary and both use solid phase extraction to remove pesticides from water samples. Additional information on analytical performance, pesticide use, and water quality criteria for these pesticides is provided in U. S. Geological Survey ( 1999a). The GC/ MS method was the primary analytical method used by all Study Units. The GC/ MS method provides analyses of 47 pesticides or degradation products by gas chromatography/ mass spectrometry and selected ion monitoring ( Zaugg and others, 1995). The pesticide acetochlor was added to the GC/ MS method in June 1994 ( Lindley and others, 1996). The HPLC method was used extensively by Study Units that began investigations in 1991 and 1994. The HPLC method provides analyses of 36 additional pesticides or degradation products by high performance liquid chromatography and photodiode array detection ( Werner and others, 1996). A third analytical method, developed to replace the HPLC method, was used extensively by Study Units that began investigations in 1997. Unfortunately, many of the water samples analyzed by this method exceeded the holding times for the method and none of the data from this analytical method are used in this national summary. Reporting levels for the analytical methods have changed through time. A reporting level is the " less than" concentration used to indicate a nondetection of a pesticide ( for example: < 0.005 µ g/ L). For this summary, the maximum reporting levels routinely used by NWQL for water years 1992 to 2001 are given in Tables 1 4. Low level detections of pesticides by these methods are not censored at the reporting limit. All detections ( pesticides conclusively identified by retention time and spectral characteristics) are quantified. Data analysis: A one year period of pesticide data was selected for each site to describe an annual distribution of pesticide concentrations. Sites with few samples or significant gaps between samples were excluded from the national summary. The size of the drainage area, the length of the pesticide use and runoff season, and the seasonal frequency of sample collection were important variables in the selection of sites and samples. The maximum gap allowed between samples was longer for large streams than for small streams and was longer during periods when pesticide concentrations were expected to be lower and less variable. In general, the selected one year period was the year with the most samples and did not coincide with the start of a water year or calendar year, but with the initiation of sampling ( often in spring). Annual detection frequencies and annual percentiles of concentration for land use categories were computed from the one year time series of concentrations for all sites in the land use category. These statistics were calculated by weighting, by site, each concentration in the time series by the amount of time it was used to represent the pesticide concentration in that stream. Sample weights for sites in the land use category were pooled and normalized by the number of sites in the pooled data set. The use of " time weighted" values reduces the bias in estimates of annual detection frequencies and percentiles of concentration that is introduced by an increased sampling frequency during the high use pesticide season.

RESULTS Statistical summaries of pesticide detections and concentrations by land use are provided in Tables 1 4. Summaries for agricultural land use are provided in Table 1, for mixed land use in Table 2, for undeveloped land use in Table 3, and for urban land use in Table 4. Table 5 identifies the sites used for the statistical summaries of pesticide detections and concentrations. NOTES FOR USING TABLES: 1. Frequency of detection: Detection frequencies indicate how often a compound was detected in samples. Four detection frequencies are provided in Tables 1 4: " All" detections, detections at concentrations > 0.01 µ g/ L, detections at concentrations > 0.1 µ g/ L, and detections at concentrations > 1 µ g/ L. ( The symbol ">" means " greater than or equal to.") The values for " All" detections provide the percentage of detections for a given compound, but should not be directly compared among compounds because reporting levels ( detection capabilities) varied among compounds. Because reporting levels varied, detection frequencies were calculated using three common detection thresholds ( 0.01, 0.1, and 1 µ g/ L). The use of these detection thresholds facilitates comparisons among compounds by censoring detections to a common reference concentration. Adjustments of this type are essential in order to answer questions like " is compound x detected more often than compound y?" For most pesticides analyzed by GC/ MS, the lowest appropriate detection threshold for comparisons among compounds is 0.01 µ g/ L. Several compounds ( azinphos methyl for example) have maximum reporting levels that exceed the 0.01 µ g/ L threshold. In these cases, the detection frequency is preceded by a ">" symbol to indicate that the true percentage of samples with concentrations greater than the threshold probably is greater than or equal to that reported in the table. For most pesticides analyzed by HPLC, the lowest appropriate detection threshold for comparisons among compounds is 0.1 µ g/ L. Nonetheless, several compounds have maximum reporting levels that exceeded the threshold. In these cases, the detection frequencies may underestimate the true percentage of samples with concentrations greater than the threshold and detection frequencies are preceded with a ">" symbol. Nearly all of the pesticides can be compared at the 1 µ g/ L threshold. Use of this threshold censors the majority of the pesticide detections, but allows comparisons among pesticides measured at high concentrations. Detections in water samples were time weighted and the pooled detection frequency was calculated across all sites in a land use. As a consequence, the frequency of detection may be interpreted as an estimate of the percentage of time that pesticides are detected at NAWQA sites in that particular land use. For example, 52 surface water sites in areas of agricultural land use had sufficient monitoring data to estimate an annual distribution of concentrations of acetochlor ( Table 1). Acetochlor was detected 31.44 percent of the year at NAWQA sites draining agricultural land use and was detected 23.41 percent of the year at concentrations greater than or equal to 0.01 µ g/ L. 2. Percentiles of concentration: Annual time weighted concentrations measured for each pesticide are summarized using percentiles. The 25th, 50th, 75th, 90th, and 95th percentiles of concentration by land use category are provided in Tables 1 4. Percentiles provide information about the magnitude and duration of concentrations at selected points in the cumulative frequency distribution of the ranked, time weighted concentrations. For example, concentrations of acetochlor at NAWQA sites draining agricultural land use were less than 0.005 µ g/ L for 25 percent of the year, less than 0.005 µ g/ L for 50 percent of the year, less than or equal to 0.009 µ g/ L for 75 percent of the year, less than or equal to 0.052 µ g/ L for 90 percent of the year, and less than or equal to 0.165 µ g/ L for 95 percent of the year ( Table 1). If percentiles are not censored ( reported as less than a specified concentration for example, < 0.005 µ g/ L), the percentiles also may be interpreted as the percentage of the year where concentrations were greater than a given concentration. For example, concentrations of acetochlor at NAWQA sites draining agricultural land use were greater than or equal to 0.009 µ g/ L for 25 percent of the year, greater than or equal to 0.052 µ g/ L for 10 percent of the year, and greater than or equal to 0.165 µ g/ L for 5 percent of the year ( Table 1). Tables 1 4 include a column for " Maximum." The concentrations in this column are the maximum measured concentrations in the pooled annual data sets for each land use category. Concentrations greater than the value reported as maximum may have been measured at sites but are not reported because they were not measured during the oneyear periods selected to describe the annual distribution of concentrations. In addition, the probability is low that a water sample was collected at the time of the annual maximum concentration for any pesticide. Consequently, the maximum concentrations reported in Tables 1 4 should be interpreted as a lower bound for the true maximum concentrations. 3. Estimated concentrations: All pesticides denoted with "( E)" have more biased and/ or variable analytical performance than the other pesticides in the method. Information on analytical performance is provided in the method reports ( Zaugg and others, 1995; Werner and others, 1996) and is summarized for the period 1992 96 in Martin ( 1999). Individual concentrations that exceed the calibration curve of the analytical method are marked with an " E" to indicate that the uncertainty in these concentrations is greater than for concentrations within the calibration range. TABLES OF SUMMARY STATISTICS FOR PESTICIDES IN STREAMS: Table 1. For agricultural stream sites. Table 2. For mixed land use. Table 3. For undeveloped land use. Table 4. For urban land use. Table 5. List of stream sites used for statistics in Tables 1 4.

REFERENCES Gilliom, R. J., Alley, W. M., and Gurtz, M. E., 1995, Design of the National Water Quality Assessment Program: Occurrence and distribution of water quality conditions: U. S. Geological Survey Circular 1112, 33 p. Available at: http:// water. usgs. gov/ pubs/ circ/ circ1112/ Gilliom, R. J., Barbash, J. E., Kolpin, D. W., and Larson, S. J., 1999, Testing water quality for pesticide pollution: Environmental Science & Technology, v. 33, no. 7, p. 164A 169A. Available at: http:// pubs. acs. org/ hotartcl/ est/ 99/ apr/ test. html Larson, S. J., Gilliom, R. J., and Capel, P. D., 1999, Pesticides in streams of the United States Initial results from the National Water Quality Assessment Program U. S. Geological Survey Water Resources Investigations Report 98 4222, 92 p. Available at: http:// ca. water. usgs. gov/ pnsp/ rep/ wrir984222/ Lindley, C. E., Stewart, J. T., and Sandstrom, M. W., 1996, Determination of low concentrations of acetochlor in water by automated solid phase extraction and gas chromatography with mass selective detection: Journal of the AOAC International, v. 79, no. 4, p. 962 966. Martin, J. D., 1999, Quality of pesticide data for environmental water samples collected for the National Water Quality Assessment Program, 1992 96, and examples of the use of quality control information in water quality assessments: U. S. Geological Survey, accessed January 10, 2003 at: http:// ca. water. usgs. gov/ pnsp/ rep/ qcsummary/ Shelton, L. R., 1994, Field guide for collecting and processing stream water samples for the National Water Quality Assessment Program: U. S. Geological Survey Open File Report 94 455, 42 p. Available at: http:// ca. water. usgs. gov/ pnsp/ pest. rep/ sw t. html U. S. Geological Survey, 1999a, Pesticides analyzed in NAWQA samples Use, chemical analyses, and water quality criteria: U. S. Geological Survey, accessed January 10, 2003 at: http:// ca. water. usgs. gov/ pnsp/ anstrat/ _____, 1999b, The quality of our Nation's waters Nutrients and pesticides: U. S. Geological Survey Circular 1225, 82 p. Available at: http:// water. usgs. gov/ pubs/ circ/ circ1225/ Werner, S. L., Burkhardt, M. R., and DeRusseau, S. N., 1996, Methods of analysis by the U. S. Geological Survey National Water Quality Laboratory Determination of pesticides in water by Carbopak B solid phase extraction and high performance liquid chromatography: U. S. Geological Survey Open File Report 96 216, 42 p. Available at: http:// wwwnwql. cr. usgs. gov/ Public/ pubs/ OFR96 216/ OFR96 216. html Zaugg, S. D., Sandstrom, M. W., Smith, S. G., and Fehlberg, K. M., 1995, Methods of analysis by the U. S. Geological Survey National Water Quality Laboratory Determination of pesticides in water by C 18 solid phase extraction and capillary column gas chromatography/ mass spectrometry with selected ion monitoring: U. S. Geological Survey Open File Report 95 181, 49 p. Available at: http:// wwwnwql. cr. usgs. gov/ Public/ pubs/ OFR95 181/ OFR95 181. html


[Federal Register Volume 85, Number 191 (Thursday, October 1, 2020)]
[Proposed Rules]
[Pages 61889-61892]
[FR Doc No: 2020-21543]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0854; Project Identifier MCAI-2020-01067-T]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: The FAA proposes to supersede Airworthiness Directive (AD)
2020-01-10, which applies to certain Airbus SAS Model A350-941
airplanes. AD 2020-01-10 requires installing flight control and
guidance system (FCGS) software (SW) X11 Standard (STD). Since the FAA
issued AD 2020-01-10, Airbus has developed a modification that forces
the air generation system (AGS) ram air outlet doors to be flush in
cases of total engine flameout or loss of the main electrical supply.
Because of this additional modification, certain airplanes that were
excluded from the applicability of AD 2020-01-10 are included in the
applicability of this proposed AD. This proposed AD would retain the
requirements of AD 2020-01-10, require modifying the electrical power
supply of the AGS ram air outlet door actuators, and expand the
applicability by adding airplanes, as specified in a European Union
Aviation Safety Agency (EASA) AD, which will be incorporated by
reference. The FAA is proposing this AD to address the unsafe condition
on these products.

DATES: The FAA must receive comments on this proposed AD by November
16, 2020.

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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For the material identified in this proposed AD that will be
incorporated by reference (IBR), contact the EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this IBR
material on the EASA website at https://ad.easa.europa.eu. You may view
this IBR material at the FAA, Airworthiness Products Section,
Operational Safety Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call 206-
231-3195. It is also available in the AD docket on the internet at
https://www.regulations.gov by searching for and locating Docket No.
FAA-2020-0854.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
0854; 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 NPRM, any comments received, and other information. The street
address for Docket Operations is listed above. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    The FAA invites you to participate in this rulemaking by submitting
written comments, data, or views about this proposal. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time. Send your
comments to an address listed under the ADDRESSES section. Include
``Docket No. FAA-2020-0854; Project Identifier

MCAI-2020-01067-T'' at the beginning of your 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, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this proposed rulemaking. Before acting on this
proposal, the FAA will consider all comments received by the closing
date for comments. The FAA will consider comments filed after the
comment period has closed if it is possible to do so without incurring
expense or delay. The FAA may change this NPRM because of those
comments.

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 NPRM 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 NPRM, 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 NPRM. Submissions containing CBI should be sent to the
person identified in the FOR FURTHER INFORMATION CONTACT section. Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Discussion

    The FAA issued AD 2020-01-10, Amendment 39-19816 (85 FR 6747,
February 6, 2020) (``AD 2020-01-10''), which applies to certain Airbus
SAS Model A350-941 airplanes. AD 2020-01-10 requires installing FCGS SW
X11 STD. The FAA issued AD 2020-01-10 to address ram air turbine (RAT)
performance that may be below the expected (certificated) level when
the landing gear is extended. This condition, if not corrected, could
lead to partial or total loss of RAT electrical power generation when
the RAT is deployed in an emergency situation, possibly resulting in
reduced control of the airplane.

Actions Since AD 2020-01-10 Was Issued

    Since the FAA issued AD 2020-01-10, Airbus has developed a
modification that forces the AGS ram air outlet doors to be flush in
cases of total engine flameout or loss of the main electrical supply.
Because of this additional modification, certain airplanes that were
excluded from the applicability of AD 2020-01-10 are included in the
applicability of this proposed AD.
    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0167, dated July 27, 2020
(``EASA AD 2020-0167'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus A350-941 airplanes. EASA AD 2020-0167
supersedes EASA AD 2019-0203 (which corresponds to FAA AD 2020-01-10).
    This proposed AD was prompted by a determination through testing
that RAT performance may be below the expected (certificated) level
when the landing gear is extended, and by the development of a
modification that forces the AGS ram air outlet doors to be flush in
cases of total engine flameout or loss of the main electrical supply.
The FAA is proposing this AD to address RAT performance that may be
below the expected (certificated) level when the landing gear is
extended, which could lead to partial or total loss of RAT electrical
power generation when the RAT is deployed in an emergency situation,
possibly resulting in reduced control of the airplane. See the MCAI for
additional background information.

Explanation of Retained Requirements

    Although this proposed AD does not explicitly restate the
requirements of AD 2020-01-10, this proposed AD would retain all of the
requirements of AD 2020-01-10. Those requirements are referenced in
EASA AD 2020-0167, which, in turn, is referenced in paragraph (g) of
this proposed AD.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0167 describes procedures for installing FCGS SW X11
STD and for modifying the electrical power supply of the AGS ram air
outlet door actuators. This material 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.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is proposing this AD because the FAA
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified
in EASA AD 2020-0167 described previously, as incorporated by
reference, except for any differences identified as exceptions in the
regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0167
will be incorporated by reference in the FAA final rule. This proposed
AD would, therefore, require compliance with EASA AD 2020-0167 in its
entirety, through that incorporation, except for any differences
identified as exceptions in the regulatory text of this proposed AD.
Using common terms that are the same as the heading of a particular
section in the EASA AD does not mean that operators need comply only
with that section. For example, where the AD requirement refers to
``all required actions and compliance times,'' compliance with this AD
requirement is not limited to the section titled ``Required Action(s)
and Compliance Time(s)'' in the EASA AD. Service information specified
in EASA AD 2020-0167 that is required for compliance with EASA AD 2020-
0167 will be available on the internet at https://www.regulations.gov
by searching for and locating Docket No. FAA-2020-0854 after the FAA
final rule is published.

Costs of Compliance

    The FAA estimates that this proposed AD affects 13 airplanes of
U.S. registry. The FAA estimates the following costs to comply with
this proposed AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Retained actions from AD 2020-01-10...  8 work-hours x $85 per            $4,650          $5,330         $69,290
                                         hour = $680.
New proposed actions..................  8 work-hours x $85 per             1,950           2,630          34,190
                                         hour = $680.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this
proposed AD may be covered under warranty, thereby reducing the cost
impact on affected individuals. The FAA does not control warranty
coverage for affected individuals. As a result, the FAA has included
all known costs in the cost estimate.

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

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

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by removing Airworthiness Directive (AD)
2020-01-10, Amendment 39-19816 (85 FR 6747, February 6, 2020), and
adding the following new AD:

Airbus SAS: Docket No. FAA-2020-0854; Project Identifier MCAI-2020-
01067-T.

(a) Comments Due Date

    The FAA must receive comments by November 16, 2020.

(b) Affected ADs

    This AD replaces AD 2020-01-10, Amendment 39-19816 (85 FR 6747,
February 6, 2020) (``AD 2020-01-10'').

(c) Applicability

    This AD applies to Airbus SAS Model A350-941 airplanes,
certificated in any category, as identified in European Union
Aviation Safety Agency (EASA) AD 2020-0167, dated July 27, 2020
(``EASA AD 2020-0167'').

(d) Subject

    Air Transport Association (ATA) of America Code 21, Air
Conditioning; and 42, Flight Control and Guidance System.

(e) Reason

    This AD was prompted by a determination through testing that ram
air turbine (RAT) performance may be below the expected
(certificated) level when the landing gear is extended, and by the
development of a modification that forces the air generation system
(AGS) ram air outlet doors to be flush in cases of total engine
flameout or loss of the main electrical supply. The FAA is issuing
this AD to address RAT performance that may be below the expected
(certificated) level when the landing gear is extended, which could
lead to partial or total loss of RAT electrical power generation
when the RAT is deployed in an emergency situation, possibly
resulting in reduced control of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, EASA AD 2020-0167.

(h) Exceptions to EASA AD 2020-0167

    (1) Where EASA AD 2020-0167 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Where EASA AD 2020-0167 refers to September 3, 2019 (the
effective date of EASA AD 2019-0203), this AD requires using March
12, 2020 (the effective date of AD 2020-01-10).
    (3) The ``Remarks'' section of EASA AD 2020-0167 does not apply
to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation 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 local Flight
Standards District Office, as appropriate. If sending information
directly to the Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (j)(2) of this AD. Information may be emailed to<EMAIL_ADDRESS>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.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section,

International Validation Branch, FAA; or EASA; or Airbus SAS's EASA
Design Organization Approval (DOA). If approved by the DOA, the
approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): For any service information
referenced in EASA AD 2020-0167 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
procedures and tests must be done to comply with this AD; any
procedures or tests that are not identified as RC are recommended.
Those procedures and tests that are not identified 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 procedures and tests identified as
RC can be done and the airplane can be put back in an airworthy
condition. Any substitutions or changes to procedures or tests
identified as RC require approval of an AMOC.

(j) Related Information

    (1) For information about EASA AD 2020-0167, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
8999 000; email<EMAIL_ADDRESS>internet www.easa.europa.eu. You
may find this EASA AD on the EASA website at https://ad.easa.europa.eu. You may view this material at the FAA,
Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability
of this material at the FAA, call<PHONE_NUMBER>. This material may be
found in the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-
2020-0854.
    (2) For more information about this AD, contact Kathleen
Arrigotti, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
    Issued on September 23, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-21543 Filed 9-30-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29199-29200]
[FR Doc No: 2019-13231]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL19-38-000]

City and County of San Francisco v. Pacific Gas and Electric
Company; Notice of New Comment Date

    On January 28, 2019, City and County of San Francisco (San
Francisco or Complainant) filed a formal complaint (Complaint) against
Pacific Gas and Electric Company (PG&E) pursuant to sections 206, 306,
and 309 of the

Federal Power Act \1\ and Rule 206 of the Federal Energy Regulatory
Commission's (Commission) Rules of Practice and Procedure,\2\ alleging
that PG&E has violated its open-access Wholesale Distribution Tariff
(WDT) and that it is implementing its WDT in a manner that is unjust,
unreasonable, and unduly discriminatory. The Complaint was noticed with
a comment date of February 19, 2019.
---------------------------------------------------------------------------

    \1\ 16 U.S.C. 824e, 825e, and 825h.
    \2\ 18 CFR 385.206.
---------------------------------------------------------------------------

    On February 19, 2019, PG&E filed a notice in this proceeding
stating that it filed a petition under Chapter 11 of the Bankruptcy
Code in the United States Bankruptcy Court for the Northern District of
California, and thus the automatic stay provision of section 362 of the
Bankruptcy Code applied to stay the instant proceeding. Subsequently,
on May 30, 2019, PG&E filed an answer to the Complaint (Answer). PG&E
notes in its Answer that on May 15, 2019, the Honorable Dennis Montali,
the judge presiding over PG&E's bankruptcy proceeding, ruled that San
Francisco ``could continue to prosecute this Complaint and FERC could
continue to hear it.'' \3\
---------------------------------------------------------------------------

    \3\ Answer at n.4.
---------------------------------------------------------------------------

    Upon consideration, to provide other interested persons with an
opportunity to move to intervene in this proceeding and comment on the
Complaint, the comment date is hereby extended to and including June
27, 2019.

    Dated: June 17, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-13231 Filed 6-20-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 202 (Friday, October 20, 2023)]
[Notices]
[Pages 72557-72558]
[FR Doc No: 2023-23155]

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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Hazardous Materials: Notice of Actions on Special Permits

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of actions on special permit applications.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations, notice is hereby given
that the Office of Hazardous Materials Safety has received the
application described herein.

DATES: Comments must be received on or before November 20, 2023.

ADDRESSES: Record Center, Pipeline and Hazardous Materials Safety
Administration, U.S. Department of Transportation, Washington, DC
20590.
    Comments should refer to the application number and be submitted in
triplicate. If confirmation of receipt of comments is desired, include
a self-addressed stamped postcard showing the special permit number.

FOR FURTHER INFORMATION CONTACT: Donald Burger, Chief, Office of
Hazardous Materials Safety General Approvals and Permits Branch,
Pipeline and Hazardous Materials Safety Administration, U.S. Department
of Transportation, East Building, PHH-13, 1200 New Jersey Avenue
Southeast, Washington, DC 20590-0001,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Copies of the applications are available for
inspection in the Records Center, East Building, PHH-13, 1200 New
Jersey Avenue Southeast, Washington, DC.
    This notice of receipt of applications for special permit is
published in accordance with part 107 of the Federal hazardous
materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).

    Issued in Washington, DC, on October 12, 2023.
Donald P. Burger,
Chief, General Approvals and Permits Branch.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature of the special permits
       Application No.                Applicant           Regulation(s) affected              thereof
----------------------------------------------------------------------------------------------------------------
                                          Special Permits Data--Granted
----------------------------------------------------------------------------------------------------------------
11818-M.....................  Lockheed Martin            172.301(f), 172.101(j),   To modify the special permit
                               Corporation.               172.101(j)(1),            to authorize an additional
                                                          173.304a(a)(2).           hazardous material.
12783-M.....................  Cool Renewal, LLC........  173.304a(a)(1),           To modify the special permit
                                                          173.306(a).               to authorize the
                                                                                transportation in commerce
                                                                                of small units of certain
                                                                                compressed gas, intended for
                                                                                medical use as limited
                                                                                quantities.
14992-M.....................  VIP Transport, Inc.......  173.196(a), 173.196(b),   To modify the special permit
                                                          173.199, 178.609.         to authorize smaller inner
                                                                                packagings.
16318-M.....................  Technical Chemical         173.304(d), 173.167(a),   To modify the special permit
                               Company.                   173.302(a), 173.306(i).   to authorize additional
                                                                                hazardous materials and
                                                                                transportation of the
                                                                                hazardous materials as
                                                                                limited quantities.
20681-M.....................  Proserv UK Ltd...........  172.301(c),               To modify the special permit
                                                          173.302(a)(1),            to authorize additional
                                                          173.304(a).               cylinder coatings.
20936-M.....................  Co2 Exchange LLC.........  171.2(k), 172.200,        To modify the special permit
                                                          172.300, 172.700(a),      to authorize cylinders to be
                                                          172.400, 172.500.         packaged within an outer
                                                                                fiberboard box with or
                                                                                without a dispensing
                                                                                machine.
20998-M.....................  Daicel Safety Systems      173.301(a)(1),            To modify the special permit
                               Americas, Inc.             173.302(a)(1),            to remove the requirement
                                                          178.65(c)(3).             that a flattening test be
                                                                                conducted, authorize
                                                                                alternative marking, and
                                                                                authorize a pressure relief
                                                                                device designed to an
                                                                                alternative standard.
21297-M.....................  Luxfer Canada Limited....  173.301(i), 178.75......  To modify the special permit
                                                                                to authorize mounting of a
                                                                                cylinder within a structural
                                                                                frame during transportation.
21469-N.....................  Romeo Systems, Inc.......  172.101(j)..............  To authorize the
                                                                                transportation in commerce
                                                                                of lithium batteries
                                                                                exceeding 35 kg by cargo-
                                                                                only aircraft.
21580-N.....................  Arkema Inc...............  173.301, 173.302........  To authorize the
                                                                                transportation in commerce
                                                                                of Boron Trifluoride (BF3)
                                                                                in a non-DOT specification
                                                                                cylinder.
21584-N.....................  National Air Cargo Group,  172.204(c)(3),            To authorize the
                               Inc.                       172.101(j),               transportation in commerce
                                                          173.27(b)(2),             by cargo-only aircraft of
                                                          173.27(b)(3),             Class 1 explosives which are
                                                          175.30(a)(1).             forbidden or exceed the
                                                                                quantities authorized in
                                                                                172.101 Column 9B.
21599-N.....................  Lanxess Corporation......  178.274(b)(1)...........  To authorize the manufacture,
                                                                                mark, sale, and use of non-
                                                                                specification ``T20'' UN
                                                                                portable tanks conforming to
                                                                                all requirements of a UN
                                                                                portable tank, except as
                                                                                specified herein.

21629-N.....................  Space Bd Inc.............  172.101(j),               To authorize the
                                                          173.185(a)(1),            transportation in commerce
                                                          173.185(e)(7).            of prototype and low
                                                                                production lithium ion
                                                                                batteries including those
                                                                                contained in or packed with
                                                                                equipment.
21631-N.....................  Arkema Inc...............  173.173(b)(1)...........  To authorize the one-way
                                                                                transportation in commerce
                                                                                of 532 non-DOT specification
                                                                                1A1 metal drums containing
                                                                                resin solution.
21646-N.....................  Delta Air Lines, Inc.....  175.10, 175.75..........  To authorize the
                                                                                transportation in commerce
                                                                                of certain Division 2.2
                                                                                materials that have been
                                                                                loaded in an alternative
                                                                                manner.
----------------------------------------------------------------------------------------------------------------
                                          Special Permits Data--Denied
----------------------------------------------------------------------------------------------------------------
9998-M......................  Accumulators, Inc........  173.302(a)..............  To modify the special permit
                                                                                to authorize additional
                                                                                accumulators.
21163-M.....................  United Initiators, Inc...  178.345-10(b)(1)........  To modify the special permit
                                                                                to authorize additional
                                                                                hazardous materials.
21232-N.....................  Scandinavian Airlines      175.75(c)...............  To authorize the
                               System Denmark-Norway-                               transportation in commerce
                               Sweden.                                              of aviation fuel contained
                                                                                in a fuel tank by passenger-
                                                                                carrying aircraft in
                                                                                quantities that exceed the
                                                                                limitation for materials
                                                                                loaded in an inaccessible
                                                                                manner.
21404-N.....................  Adair Investments Inc....  173.219(c)(4),            To authorize the
                                                          173.21(f)(3)(i),          transportation of lithium
                                                          199.9(a)(1).              batteries, brake cleaners,
                                                                                starting fluid, and
                                                                                carborator cleaners.
21524-N.....................  Tea Technologies Inc.....  180.205(c), 180.205(f),   To authorize the
                                                          180.205(g).               transportation in commerce
                                                                                of composite tubes that have
                                                                                been requalified using modal
                                                                                acoustic emission (MAE) in
                                                                                lieu of volumetric and
                                                                                internal visual examination.
21573-N.....................  Sharpsville Container      178.274(j)(3),            To authorize the
                               Corporation.               178.274(j)(4).            transportation in commerce
                                                                                of portable tanks containing
                                                                                certain hazardous materials
                                                                                where the tank has not been
                                                                                leakage tested in accordance
                                                                                with 49 CFR 178.274(j).
21587-N.....................  Textron Aviation Defense   173.220(f)..............  To authorize the
                               LLC.                                                 transportation in commerce
                                                                                of an aircraft fuselage and
                                                                                canopy.
----------------------------------------------------------------------------------------------------------------
                                         Special Permits Data--Withdrawn
----------------------------------------------------------------------------------------------------------------
14152-M.....................  Entegris, Inc............  173.27(f)...............  To modify the special permit
                                                                                to authorize an additional
                                                                                hazardous material.
21579-N.....................  KULR Technology            173.6(a)(1), 173.6(d)...  To authorize the manufacture,
                               Corporation.                                         mark, sale, and use of
                                                                                packaging for the purpose of
                                                                                transporting lithium
                                                                                batteries as Materials of
                                                                                Trade in excess of the
                                                                                package weight limitations
                                                                                and vehicle aggregate weight
                                                                                limitations.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2023-23155 Filed 10-19-23; 8:45 am]
BILLING CODE P