[Federal Register: November 15, 2007 (Volume 72, Number 220)]
[Notices]
[Page 64265-64266]
[DOCID:fr15no07-113]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-56767; File No. SR-NYSEArca-2007-87]

Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing
of a Proposed Rule Change, and Amendments No. 1 and No. 2 Thereto, To
Amend Listing Fees for Structured Products

November 7, 2007.
    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 August 16, 2007, NYSE Arca, Inc. (``NYSE Arca'' or ``Exchange'')
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 substantially prepared by the Exchange. On October 30,
2007, the Exchange filed Amendment No. 1 to the proposed rule change.
On November 7, 2007, the Exchange filed Amendment No. 2 to the proposed
rule change. The Commission is publishing this notice to solicit
comments on the proposed rule change, as amended, from interested
persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange, through its wholly-owned subsidiary NYSE Arca
Equities, Inc. (``NYSE Arca Equities''), proposes to amend its Schedule
of Fees and Charges (``Fee Schedule'') to revise the listing fees
applicable to structured products listed on NYSE Arca, LLC (``NYSE Arca
Marketplace''), the equities facility of NYSE Arca Equities. The
proposed revisions would apply retroactively as of October 3, 2007. The
text of the proposed rule change is available at the Commission's
Public Reference Room, at the Exchange, and at http://www.nyse.com.

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

    In its filing with the Commission, the Exchange 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 IV below. The Exchange 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
a. Listing Fee Schedule
    NYSE Arca has determined to revise the listing fees specifically
applicable to Structured Products \3\ in order to harmonize its fees
with the New York Stock Exchange LLC's fees. The proposed revisions
would apply as of October 3, 2007.
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    \3\ For purposes of this proposal, Structured Products include
securities qualified for listing and trading on NYSE Arca under the
following NYSE Arca Equities Rules: Rule 5.2(j)(1) (Other
Securities), 5.2(j)(2) (Equity Linked Notes), Rule 5.2(j)(4) (Index-
Linked Exchangeable Notes), Rule 5.2(j)(6) (Equity Index-Linked
Securities, Commodity-Linked Securities and Currency-Linked
Securities) and Rule 8.3 (Currency and Index Warrants), as these
rules may be amended from time to time.
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    NYSE Arca currently assesses a one-time Listing Fee of $20,000 for
each Structured Product that is listed pursuant to an initial public
offering (``IPO'') or an initial listing. Each time the issuer lists
additional shares for the same Structured Product pursuant to a
subsequent IPO, the issuer is charged a $1,000 fee. If an issuer lists
a Structured Product that is already listed on another Marketplace or
quoted on an inter-dealer Quotation System, the issuer is subject to a
$5,000 fee per such product. In addition, if an issuer lists additional
Structured Products that were already listed on another marketplace or
quoted on an inter-dealer quotation system, the issuer is subject to
the following fees:

------------------------------------------------------------------------
                                                                Fee per
                Number of  structured products                  product
------------------------------------------------------------------------
2-10.........................................................     $1,000
11-100.......................................................        500
100+.........................................................        100
------------------------------------------------------------------------

    The revised fee schedule would clarify the types of products
defined as ``Structured Products'' and replace the current fee schedule
with a fee schedule based on the total of shares outstanding. The
revised fee schedule provides a fee cap of $45,000 per issue. The new
fee schedule is as follows:

------------------------------------------------------------------------
                      Shares outstanding                          Fee
------------------------------------------------------------------------
Up to 1 million..............................................     $5,000
1+ to 2 million..............................................     10,000
2+ to 3 million..............................................     15,000
3+ to 4 million..............................................     20,000
4+ to 5 million..............................................     25,000
5+ to 6 million..............................................     30,000
6+ to 7 million..............................................     30,000
7+ to 8 million..............................................     30,000
8+ to 9 million..............................................     30,000
9+ to 10 million.............................................     32,500
10+ to 15 million............................................     37,500
in excess of 15 million......................................     45,000
------------------------------------------------------------------------

    As set forth in the revised fee schedule for Structured Products,
the fees will apply each time an issuer lists a Structured Product as
well as subsequent listings of additional shares of the same Structured
Product. The Exchange will treat each series of a Structured Product as
a separate issue.
b. Annual Fee Schedule
    NYSE Arca currently assesses Annual Fees based on the total number
of Structured Products per issuer. The Annual Fee for one Structured
Product listed is $5,000. For each additional Structured Product listed
by the same issuer the following fees apply:

------------------------------------------------------------------------
                                                                Fee per
                Number of  structured products                  product
------------------------------------------------------------------------
2 through 10.................................................     $1,000
11 through 100...............................................        500
101+.........................................................        100
------------------------------------------------------------------------

    NYSE Arca proposes revised Annual Fees for Structured Products
based on total shares outstanding for each issue, as follows:

------------------------------------------------------------------------
                      Shares outstanding                          Fee
------------------------------------------------------------------------
Up to 6 million..............................................    $10,000
6+ to 7 million..............................................     12,000
7+ to 8 million..............................................     14,000
8+ to 9 million..............................................     16,000
9+ to 10 million.............................................     18,000
10+ to 15 million............................................     20,000
15+ to 25 million............................................     25,000

25+ to 50 million............................................     42,000
in excess of 50 million......................................     55,000
------------------------------------------------------------------------

    The Annual Fees for Structured Products are billed each calendar
quarter and are apportioned based on the number of shares outstanding
for an issue at the end of the preceding quarter. While the Exchange
imposes a maximum total fee of $250,000 paid by an issuer each year,
this maximum fee does not apply to Structured Products.
2. Statutory Basis
    NYSE Arca believes that the proposal is consistent with Section
6(b) of the Act \4\ in general, and Section 6(b)(4) of the Act \5\ in
particular, in that it provides for the equitable allocation of
reasonable dues, fees and other charges among its issuers and other
persons using its facilities.
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    \4\ 15 U.S.C. 78f (b).
    \5\ 15 U.S.C. 78f (b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose 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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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-NYSEArca-2007-87 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-NYSEArca-2007-87. 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 Commissionwill 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, 100 F Street,
NE., Washington, DC 20549, on official business days between the hours
of 10 a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of the Exchange. 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-NYSEArca-2007-87 and should
be submitted on or before December 6, 2007.
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    \6\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\6\
Florence E. Harmon,
Deputy Secretary.
[FR Doc. E7-22295 Filed 11-14-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26775-26776]
[FR Doc No: 2012-10901]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4061-DR; Docket ID FEMA-2012-0002]

West Virginia; Amendment No. 1 to Notice of a Major Disaster
Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for the State of West Virginia (FEMA-4061-DR), dated March 22, 2012,
and related determinations.

DATES: Effective Date: March 31, 2012.

FOR FURTHER INFORMATION CONTACT: Peggy Miller, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW.,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice is hereby given that the incident
period for this disaster is closed effective March 31, 2012.

(The following Catalog of Federal Domestic Assistance Numbers (CFDA)
are to be used for reporting and drawing funds: 97.030,

Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households in Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.)

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2012-10901 Filed 5-4-12; 8:45 am]
BILLING CODE 9111-23-P


register their containers in inventory by November 15, 2023. The report
must contain the name and address of the company; contact information
for the owner of the company; inventory of regulated substance owned by
the company as of December 31, 2020, December 31, 2021, and December
31, 2022; for each container of regulated substance still in the
company's possession, the amount and name of the regulated substance in
the container, any unique identification number assigned to the
container, whether the regulated substance was acquired from a domestic
supplier, though import, or through reclamation, and the date the
regulated substance was acquired, imported, or reclaimed; and a
certification from the owner of the company or other responsible
officer that the regulated substance in his/her/their possession was
acquired consistent with the laws of the United States.

Sec.  84.25   Required processes to import regulated substances as
feedstocks or for destruction.

    (a)(1) Petition to import regulated substances for use in a process
resulting in transformation or destruction. A person must petition the
relevant Agency official for the import of each individual shipment of
a regulated substance imported for use in a process resulting in
transformation or destruction in order to not expend allowances. A
petition is required at least 30 working days before the shipment is to
leave the foreign port of export, and must contain the following
information:
    (i) Name, commodity code, and quantity in kilograms of each
regulated substance to be imported;
    (ii) Name and address of the importer, the importer ID number, and
the contact person's name, email address, and phone number;
    (iii) Name and address of the consignee and the contact person's
name, email address, and phone number;
    (iv) Source country;
    (v) The U.S. port of entry for the import, the expected date of
import, and the vessel transporting the material. If at the time of
submitting the petition the importer does not know this information,
and the importer receives a non-objection notice for the individual
shipment in the petition, the importer is required to notify the
relevant Agency official of this information prior to the entry of the
individual shipment into the United States;
    (vi) Name, address, contact person, email address, and phone number
of the responsible party at the facility where the regulated substance
will be used in a process resulting in the substance's transformation
or destruction;
    (2) Review of petition to import for use in a process resulting in
transformation or destruction. (i) The relevant Agency official will
initiate a review of the information submitted under paragraph (a)(1)
of this section and take action within 30 working days to issue either
an objection notice or a non-objection notice for the individual
shipment to the person who submitted the petition.
    (ii) The relevant Agency official may issue an objection notice to
a petition for the following reasons:
    (A) If the relevant Agency official determines that the information
is insufficient, that is, if the petition lacks or appears to lack any
of the information

required under paragraph (a)(1) of this section or other information
that may be requested during the review of the petition necessary to
verify that the regulated substance is for use in a process resulting
in transformation or destruction;
    (B) If the relevant Agency official determines that any portion of
the petition contains false or misleading information, or the official
has information from other U.S. or foreign government agencies
indicating that the petition contains false or misleading information.
    (iii) Within 10 working days after receipt of an objection notice
with the basis being ``insufficient information,'' the importer may re-
petition the relevant Agency official. If no re-petition is taken by
the tenth working day after the date on the objection notice, the
objection shall become final. Only one re-petition will be accepted for
any petition received by EPA.
    (iv) Any information contained in the re-petition which is
inconsistent with the original petition must be identified and a
description of the reason for the inconsistency must accompany the re-
petition.
    (v) In cases where the relevant Agency official does not object to
the petition, the official will issue a non-objection notice.
    (vi) If, following EPA's issuance of a non-objection notice, new
information is brought to EPA's attention which shows that the non-
objection notice was issued based on false information, then EPA has
the right to:
    (A) Revoke the non-objection notice;
    (B) Pursue all means to ensure that the regulated substance is not
imported into the United States; and
    (C) Take appropriate enforcement actions including but not limited
to seizing regulated substances that have already been imported into
the United States and revoking or withholding allowances.
    (3) Timing. An individual shipment authorized through a non-
objection notice must be used in the process resulting in its
transformation or destruction within sixty days of import.
    (4) Quantity. An individual shipment authorized through a non-
objection notice may not exceed the quantity (in MTEVe) of the
regulated substance stated in the non-objection notice.
    (b)(1) Petition to import used regulated substances for disposal by
destruction. A person must petition the relevant Agency official for
the import of each individual shipment of a used regulated substance
imported for purposes of destruction in order to not expend allowances.
A petition is required at least 30 working days before the shipment is
to leave the foreign port of export, and contain the following
information:
    (i) Name, commodity code, and quantity in kilograms of each
regulated substance to be imported;
    (ii) Name and address of the importer, the importer ID number, and
the contact person's name, email address, and phone number;
    (iii) Name and address of the consignee and the contact person's
name, email address, and phone number;
    (iv) Name and address of any intermediary who will hold regulated
substances imported for destruction, and the contact person's name,
email address, and phone number;
    (v) Source country;
    (vi) An English translation, if needed, of the export license (or
application for an export license) from the appropriate government
agency in the country of export;
    (vii) The U.S. port of entry for the import, the expected date of
import, and the vessel transporting the material. If at the time of
submitting the petition the importer does not know this information,
and the importer receives a non-objection notice for the individual
shipment in the petition, the importer is required to notify the
relevant Agency official of this information prior to the entry of the
individual shipment into the United States; and
    (viii) Name, address, contact person, email address, and phone
number of the responsible party at the destruction facility.
    (2) Review of petition to import for destruction. (i) The relevant
Agency official will initiate a review of the information submitted
under paragraph (b)(1) of this section and take action within 30
working days to issue either an objection notice or a non-objection
notice for the individual shipment to the person who submitted the
petition.
    (ii) The relevant Agency official may issue an objection notice to
a petition for the following reasons:
    (A) If the official determines that the information is
insufficient, that is, if the petition lacks or appears to lack any of
the information required under paragraph (b)(1) of this section or
other information that may be requested during the review of the
petition necessary to verify that the regulated substance is used;
    (B) If the official determines that any portion of the petition
contains false or misleading information, or the official has
information from other U.S. or foreign government agencies indicating
that the petition contains false or misleading information;
    (C) If allowing the import of the used regulated substance would
run counter to government restrictions from either the country of
recovery or export regarding regulated substances;
    (D) If destruction capacity is installed or is being installed for
that specific regulated substance in the country of recovery or country
of export and the capacity is funded in full or in part through the
Multilateral Fund to the Montreal Protocol.
    (iii) Within 10 working days after receipt of an objection notice
with the basis being ``insufficient information,'' the importer may re-
petition the official. If no re-petition is taken by the tenth working
day after the date on the objection notice, the objection shall become
final. Only one re-petition will be accepted for any petition received
by EPA.
    (iv) Any information contained in the re-petition which is
inconsistent with the original petition must be identified and a
description of the reason for the inconsistency must accompany the re-
petition.
    (v) In cases where the relevant Agency official does not object to
the petition, the official will issue a non-objection notice.
    (vi) If, following EPA's issuance of a non-objection notice, new
information is brought to EPA's attention which shows that the non-
objection notice was issued based on false information, then EPA has
the right to:
    (A) Revoke the non-objection notice;
    (B) Pursue all means to ensure that the regulated substance is not
imported into the United States; and
    (C) Take appropriate enforcement actions including but not limited
to seizing regulated substances that have already been imported into
the United States and revoking or withholding allowances.
    (3) Timing. An individual shipment authorized through a non-
objection notice must be destroyed within sixty days of import.
    (4) Quantity. An individual shipment authorized through a non-
objection notice may not exceed the quantity (in MTEVe) of the
regulated substance stated in the non-objection notice.
    (5) Proof of destruction. For each individual shipment of a used
regulated substance imported with the intent to destroy that substance
for which EPA issues a non-objection notice, an importer must submit to
the Administrator records indicating that the substance has been
destroyed within 45 days after destruction of the regulated
substance(s).

    (6) Recordkeeping. The person receiving the non-objection notice
from the relevant Agency official for a petition to import used
regulated substances must maintain the following records for five
years:
    (i) A copy of the petition;
    (ii) The EPA non-objection notice;
    (iii) The bill of lading for the import;
    (iv) The U.S. Customs entry number; and
    (v) Records indicating that the substance has been destroyed.

Sec.  84.27   Controlling Emissions of HFC-23.

    (a) No later than October 1, 2022, as compared to the amount of
chemical intentionally produced on a facility line, no more than 0.1
percent of HFC-23 created on the line may be emitted.
    (1) Requests for extension. The producer may submit a request to
the relevant Agency official to request a six-month extension, with a
possibility of one additional six-month extension, to meeting the 0.1
percent HCFC-23 limit in Sec.  82.15(a)(3). No entity may have a
compliance date later than October 1, 2023.
    (2) Timing of request. The extension request must be submitted to
EPA no later than August 1, 2022 for a first-time extension or February
1, 2023 for a second extension.
    (3) Content of request. The extension request must contain the
following information:
    (i) Name of the facility submitting the request; contact
information for a person at the facility; and the address of the
facility.
    (ii) A description of the specific actions the facility has taken
to improve their HFC-23 control, capture, and destruction; the
facility's plans to meet the 0.1% HFC-23 limit including the expected
date by which the equipment will be installed and operating; and
verification that the facility has met all applicable reporting
requirements.
    (4) Review of request. Starting on the first working day following
receipt by the relevant Agency official of a complete request for
extension, the official will initiate review of the information
submitted under paragraph (a)(3) of this section and take action within
30 working days. Any grant of a compliance deferral will be made
public.
    (b) Captured HFC-23 is permitted to be destroyed at a different
facility than where it is produced. In such instances, the
transportation to and destruction at the different facility will be
incorporated into calculations of whether the producer meets the 0.1
percent standard outlined in paragraph (a) of this section.

Sec.  84.29   Destruction of regulated substances.

    (a) The following technologies are approved by the Administrator
for destruction of all regulated substances except for HFC-23:
    (1) Cement kiln;
    (2) Gaseous/fume oxidation;
    (3) Liquid injection incineration;
    (4) Porous thermal reactor;
    (5) Reactor cracking;
    (6) Rotary kiln incineration;
    (7) Argon plasma arc;
    (8) Nitrogen plasma arc;
    (9) Portable plasma arc;
    (10) Chemical reaction with hydrogen and carbon dioxide;
    (11) Gas phase catalytic de-halogenation; and
    (12) Superheated steam reactor.
    (b) The following technologies are approved by the Administrator
for destruction of HFC-23:
    (1) Gaseous/fume oxidation;
    (2) Liquid injection incineration;
    (3) Reactor cracking;
    (4) Rotary kiln incineration;
    (5) Argon plasma arc;
    (6) Nitrogen plasma arc;
    (7) Chemical reaction with hydrogen and carbon dioxide; and
    (8) Superheated steam reactor.

Sec.  84.31   Recordkeeping and reporting.

    (a) Recordkeeping and reporting. Any person who produces, imports,
exports, transforms, uses as a process agent, destroys, or reclaims
regulated substances must comply with the following recordkeeping and
reporting requirements:
    (1) Reports required by this Sec.  84.31 must be submitted within
45 days of the end of the applicable reporting period, unless otherwise
specified.
    (2) Reports petitions, and any related supporting documents must be
submitted electronically in a format specified by the Administrator.
    (3) Records and copies of reports required by this section must be
retained for five years.
    (4) Quantities of regulated substances must be stated in terms of
kilograms unless otherwise specified.
    (5) Reports are no longer required if an entity notifies the
Administrator that they have permanently ceased production, import,
export, destruction, transformation, use as a process agent, or
reclamation of regulated substance.
    (b) Producers. Persons (``producers'') who produce regulated
substances must comply with the following recordkeeping and reporting
requirements:
    (1) One-time report. Within 120 days of January 1, 2022, or within
120 days of the date that a producer first produces a regulated
substance, whichever is later, every producer must submit to the
Administrator a report describing:
    (i) The method by which the producer in practice measures daily
quantities of regulated substances produced;
    (ii) Conversion factors by which the daily records as currently
maintained can be converted into kilograms of regulated substances
produced, including any constants or assumptions used in making those
calculations (e.g., tank specifications, ambient temperature or
pressure, density of the regulated substance);
    (iii) Internal accounting procedures for determining plant-wide
production;
    (iv) The quantity of any fugitive losses accounted for in the
production figures;
    (v) A list of any coproducts, byproducts, or emissions from the
production line of any regulated substance that are other regulated
substances, ozone-depleting substances listed in 40 CFR part 82,
subpart A, or hazardous air pollutants initially identified in Section
112 of the Clean Air Act, and as revised through rulemaking and
codified in 40 CFR 63.
    (vi) The estimated percent efficiency of the production process for
the regulated substance, and
    (vii) A description of any processes that use a regulated substance
as a process agent. Within 60 days of any change in the measurement
procedures or the information specified in the above report, the
producer must submit a report specifying the revised data or procedures
to the relevant Agency official.
    (2) Reporting--producers. Within 45 days after the end of each
quarter, each producer of a regulated substance must provide to the
relevant Agency official a report containing the following information
for each facility:
    (i) The quantity (in kilograms) of production of each regulated
substance used in processes resulting in their transformation by the
producer and the quantity (in kilograms) intended for transformation by
a second party;
    (ii) The quantity (in kilograms) of production of each regulated
substance used in processes resulting in their destruction by the
producer and the quantity (in kilograms) intended for destruction by a
second party;
    (iii) The quantity (in kilograms) of production of each regulated
substance used as a process agent by the producer and the quantity (in
kilograms) intended for use as a process agent by a second party;
    (iv) The expended allowances for each regulated substance and the

quantity (in kilograms) of each regulated substance produced;
    (v) The quantity (in kilograms) of regulated substances sold or
transferred during the quarter to a person other than the producer for
use in processes resulting in their transformation, destruction, or use
as a process agent;
    (vi) The quantity (in kilograms) of regulated substances produced
by the producer that were exported by the producer or by other U.S.
companies to a foreign country, that will be transformed or destroyed
and therefore were not produced expending production or consumption
allowances;
    (vii) For transformation in the United States or by a person in a
foreign country, one copy of a transformation verification from the
transformer for the specific regulated substance(s) and a list of
additional quantities shipped to that same transformer for the quarter;
    (viii) For destruction in the United States or by a person in a
foreign country of a regulated substance that was produced without
allowances, one copy of a destruction verification for each particular
destroyer confirming it destroyed the same regulated substance, and a
list of additional quantities shipped to that same destroyer for the
quarter;
    (ix) A list of the application-specific allowance holders from whom
orders were placed, and the quantity (in kilograms) of specific
regulated substances produced for those listed applications; and
    (x) For the fourth quarter report only, the quantity of each
regulated substance held in inventory on December 31.
    (3) Recordkeeping--producers. Every producer of a regulated
substance must maintain the following records:
    (i) Dated records of the quantity (in kilograms) of each regulated
substance produced at each facility;
    (ii) Dated records of the quantity (in kilograms) of regulated
substances produced for use in processes that result in their
transformation, destruction, or as a process agent;
    (iii) Dated records of the quantity (in kilograms) of regulated
substances sold for use in processes that result in their
transformation, destruction, or as a process agent;
    (iv) Dated records of the quantity (in kilograms) of regulated
substances produced by expending conferred application-specific
allowances and quantity sold for use in each listed application;
    (v) Copies of invoices or receipts documenting sale of regulated
substances for use in processes that result in their transformation,
destruction, or as a process agent;
    (vi) Dated records of the quantity (in kilograms) of each regulated
substance used at each facility as feedstocks or destroyed in the
manufacture of a regulated substance or in the manufacture of any other
substance, and any regulated substance introduced into the production
process of the same regulated substance at each facility;
    (vii) Dated records of the quantity (in kilograms) of each
regulated substance used at each facility as a process agent;
    (viii) Dated records identifying the quantity (in kilograms) of
each chemical not a regulated substance produced within each facility
also producing one or more regulated substances;
    (ix) Dated records of the quantity (in kilograms) of raw materials
and feedstock chemicals used at each facility for the production of
regulated substances;
    (x) Dated records of the shipments of each regulated substance
produced at each plant;
    (xi) Dated records of batch tests of regulated substances packaged
for sale or distribution;
    (xii) The quantity (in kilograms) of regulated substances, the date
received, and names and addresses of the source of used materials
containing regulated substances which are recycled or reclaimed at each
plant;
    (xiii) Records of the date, the regulated substance, and the
estimated quantity of any spill or release of a regulated substance
that equals or exceeds 100 pounds;
    (xiv) The transformation verification in the case of
transformation, or the destruction verification in the case of
destruction, showing that the purchaser or recipient of a regulated
substance, in the United States or in another foreign country,
certifies the intent to either transform or destroy the regulated
substance, or sell the regulated substance for transformation or
destruction in cases when allowances were not expended; and
    (xv) The certifications from application-specific allowance holders
stating that the regulated substances were purchased solely for an
application listed in Sec.  84.5(c)(2) and will not be resold for use
in a different application or used in any other manufacturing process;
    (4) Additional Requirements: Producers of HFC-23. (i) Each producer
of HFC-23 must include the following additional information in their
one-time report:
    (A) Information on the capacity to produce the intended chemical on
the line on which HFC-23 is produced;
    (B) Description of what is being done at the facility to control
the creation of HFC-23 and its emissions;
    (C) Identification of approved destruction technology and its
location intended for use for HFC-23 destruction;
    (D) A copy of the destruction removal efficiency report associated
with the destruction technology;
    (ii) Each producer of HFC-23 must include the following additional
information in their fourth quarter report:
    (A) Annual facility level data on HFC-23 in metric tons on:
Emissions; generated; generated and captured; generated and captured
for feedstock use in the United States; generated and captured for
destruction; used for feedstock without prior capture; and destroyed
without prior capture.
    (B) [Reserved]
    (iii) If captured HFC-23 is destroyed in a subsequent control
period, producers must submit records to EPA indicating the HFC-23 has
been destroyed within 45 days after destruction occurs.
    (iv) In developing any required report, each producer of HFC-23
must abide by the following monitoring and quality assurance and
control provisions:
    (A) To calculate the quantities of HFC-23 generated and captured
for any use, generated and captured for destruction, used for feedstock
without prior capture, and destroyed without prior capture, facilities
shall comply with the monitoring methods and quality assurance and
control requirements set forth at 40 CFR 98.414 and the calculation
methods set forth at 40 CFR 98.413, except 40 CFR 98.414(p) shall not
apply.
    (B) To calculate the quantity of HFC-23 emitted, facilities shall
comply with the monitoring methods and quality assurance and control
requirements set forth at 40 CFR 98.124 and the calculation methods set
forth at 40 CFR 98.123.
    (5) Agency assumption--For any person who fails to maintain the
records required by this paragraph, or to submit the report required by
this paragraph, EPA may assume that the person has produced at full
capacity during the period for which records were not kept.
    (c) Importers. Persons (``importers'') who import regulated
substances must comply with the following recordkeeping and reporting
requirements:
    (1) Reporting--importers. For each quarter, an importer of a
regulated substance must submit to the relevant Agency official a
report containing the following information:

    (i) Summaries of the records required in paragraphs (c)(2)(i)
through (xvi) of this section for the previous quarter;
    (ii) The total quantity (in kilograms) imported of each regulated
substance for that quarter;
    (iii) The commodity code for the regulated substances or blends
imported;
    (iv) A list of the application-specific allowance holders from whom
orders were placed, number of application-specific allowances
conferred, and the quantity (in kilograms) of specific regulated
substances imported for those listed applications;
    (v) The quantity (in kilograms) of regulated substances imported
for use in processes resulting in their transformation or destruction;
    (vi) The quantity (in kilograms) of regulated substances sold or
transferred during that quarter to each person for use in processes
resulting in their transformation or destruction;
    (vii) The transformation verifications showing that the purchaser
or recipient of imported regulated substances intends to transform
those substances or destruction verifications showing that the
purchaser or recipient intends to destroy the regulated substances; and
    (viii) For the fourth quarter report only, the quantity of each
regulated substance held in inventory on December 31.
    (2) Recordkeeping--importers. An importer of a regulated substance
must maintain the following records:
    (i) The quantity (in kilograms) of each regulated substance
imported, either alone or in mixtures, including the percentage of each
mixture which consists of a regulated substance;
    (ii) The quantity (in kilograms) of used regulated substances
imported for destruction under the process described in Sec.  84.25(b);
    (iii) The quantity (in kilograms) of regulated substances imported
for use in processes resulting in their transformation or destruction;
    (iv) The quantity (in kilograms) of regulated substances imported
and sold for use in processes that result in their transformation or
destruction;
    (v) The date on which the regulated substances were imported;
    (vi) The port of entry through which the regulated substances
passed;
    (vii) The country from which the imported regulated substances were
imported;
    (viii) The commodity code for the regulated substances imported;
    (ix) The importer number for the shipment;
    (x) A copy of the bill of lading for the import;
    (xi) The invoice for the import;
    (xii) The U.S. Customs entry number;
    (xiii) Dated records documenting the sale or transfer of regulated
substances for use in processes resulting in their transformation or
destruction;
    (xiv) Copies of transformation verifications or destruction
verifications indicating that the regulated substances will be
transformed or destroyed;
    (xv) Dated records of the quantity of regulated substances imported
for an application listed at Sec.  84.5(c)(2);
    (xvi) The certifications from application-specific allowance
holders stating that the regulated substances were purchased solely for
an application listed in Sec.  84.5(c)(2) and will not be resold for
use in a different application or used in any other manufacturing
process; and
    (xvii) Dated records of batch tests of regulated substances
packaged for sale or distribution; and
    (3) Transhipments. (i) A person must notify the relevant Agency
official of each individual shipment of a regulated substance that is
to be transhipped through the United States. The notification is
required at least 30 working days before the shipment is to leave the
foreign port of export, and contain the following information:
    (A) Name, commodity code, and quantity in kilograms of each
regulated substance to be transhipped;
    (B) Name and address of the importer, the importer ID number, and
the contact person's name, email address, and phone number;
    (C) Source country; and
    (D) The U.S. port of entry, the expected date of entry, and the
vessel transporting the material. If at the time of submitting the
petition the importer does not know this information, the importer is
required to notify the relevant Agency official of this information
prior to the entry of the individual shipment into the United States.
    (ii) The person in paragraph (c)(3)(i) of this section must notify
the relevant Agency official of each individual shipment of a regulated
substance that is to be transhipped when it departs the United States.
The notification is required at least 30 working days before the
shipment leaves the port in the United States, and contain the
following information:
    (A) Name, commodity code, and quantity in kilograms of each
regulated substance to be transhipped;
    (B) Name and address of the importer, the importer ID number, and
the contact person's name, email address, and phone number; and
    (C) Date of departure, name of vessel.
    (iii) Any person who tranships a regulated substance must maintain
records that indicate:
    (A) That the regulated substance shipment originated in a foreign
country;
    (B) That the regulated substance shipment is destined for another
foreign country; and
    (C) That the regulated substance shipment will not enter interstate
commerce within the United States.
    (4) Additional recordkeeping requirements--importers of used
regulated substances for destruction. A person receiving a non-
objection notice from the relevant Agency official to import used
regulated substances for destruction must maintain the following
records:
    (i) A copy of the petition to import for destruction;
    (ii) The EPA non-objection notice;
    (iii) A copy of the export license, export license application, or
official communication from the appropriate government agency in the
country of export;
    (iv) An English translation of the document in paragraph
(c)(4)(iii) of this section.
    (v) U.S. Customs entry documents for the import that must include
the commodity codes;
    (vi) The date, amount, and name of the regulated substances sent
for destruction, per shipment;
    (vii) An invoice from the destruction facility verifying the
shipment was received; and
    (viii) Records from the destruction facility indicating that the
substance has been destroyed.
    (5) Recordkeeping requirements--aggregators. A person aggregating a
regulated substance prior to destruction must:
    (i) Maintain transactional records that include the name and
address of the entity from whom they received the regulated substance
imported for destruction;
    (ii) Maintain transactional records that include the name and
address of the entity to whom they sent the regulated substance
imported for destruction;
    (iii) Maintain records that include the date and quantity of the
imported regulated substance received for destruction;
    (iv) Maintain records that include the date and quantity of the
imported regulated substance sent for destruction; and
    (v) If the person is the final aggregator of such a regulated
substance before the material is destroyed, maintain a copy of records
indicating that the substance has been destroyed.

    (d) Exporters. Persons (``exporters'') who export regulated
substances must comply with the following reporting requirements:
    (1) Reporting requirements--exporters. For any exports of regulated
substances not reported under paragraph (b)(2) of this section, each
exporter who exported a regulated substance must submit to the relevant
Agency official the following information within 45 days after the end
of each quarter in which the unreported exports left the United States:
    (i) The names and addresses of the exporter and the recipient of
the exports;
    (ii) The exporter's Employer Identification Number;
    (iii) The quantity of each specific regulated substance exported,
including the quantity of regulated substance that is used, reclaimed,
or recycled;
    (iv) The date on which, and the port from which, the regulated
substances were exported from the United States or its territories;
    (v) The country to which the regulated substances were exported;
    (vi) The commodity code for the regulated substances shipped;
    (vii) For persons exporting for transformation or destruction of
the regulated substance, the invoice or sales agreement containing
language similar to the transformation verifications that importers
use, or destruction verifications showing that the purchaser or
recipient intends to destroy the regulated substances; and
    (viii) For the fourth quarter report only, the quantity of each
regulated substance held in inventory on December 31.
    (2) Used regulated substances. Any exporter of used regulated
substances must indicate on the bill of lading or invoice that the
regulated substance is used.
    (e) Second-party transformation and destruction. Any person who
transforms or destroys regulated substances must comply with the
following recordkeeping and reporting requirements:
    (1) Reporting--second-party transformation and destruction. Any
person who transforms or destroys regulated substances and who has
submitted a transformation verification ((paragraph (e)(3) of this
section) or a destruction verification (paragraph (e)(4) of this
section) to the producer or importer of the regulated substances, must
report the following for each facility:
    (i) The names and quantities (in kilograms) of the regulated
substances transformed for each calendar year within 45 days after the
end of that year; and
    (ii) The names and quantities (in kilograms) of the regulated
substances destroyed for each calendar year within 45 days after the
end of that year.
    (2) Recordkeeping--second-party transformation and destruction. Any
person who transforms or destroys regulated substances produced or
imported by another person must maintain the following:
    (i) Copies of the invoices or receipts documenting the sale or
transfer of the regulated substances to the person;
    (ii) Records identifying the producer or importer of the regulated
substances received by the person;
    (iii) Dated records of inventories of regulated substances at each
plant on the first day of each quarter;
    (iv) Dated records of the quantity (in kilograms) of each regulated
substance transformed or destroyed;
    (v) In the case where regulated substances were purchased or
transferred for transformation purposes, a copy of the person's
transformation verification;
    (vi) Dated records of the names, commercial use, and quantities (in
kilograms) of the resulting chemical(s) when the regulated substances
are transformed; and
    (vii) Dated records of shipments to purchasers of the resulting
chemical(s) when the regulated substances are transformed.
    (viii) In the case where regulated substances were purchased or
transferred for destruction purposes, a copy of the person's
destruction verification.
    (3) Transformation verifications. Any person who purchases
regulated substances for purposes of transformation must provide the
producer or importer of the regulated substances with a transformation
verification that the regulated substances are to be used in processes
that result in their transformation. The verification can only be valid
for up to 60 days. The transformation verification shall include the
following:
    (i) Identity and address of the person intending to transform the
regulated substances;
    (ii) The quantity (in kilograms) of regulated substances intended
for transformation;
    (iii) Identity of shipments by purchase order number(s), purchaser
account number(s), location(s), or other means of identification;
    (iv) Period of time over which the person intends to transform the
regulated substances; and
    (v) Signature and title of the verifying person.
    (4) Destruction verifications. Any person who purchases or receives
and subsequently destroys regulated substances that were originally
produced or imported without expending allowances shall provide the
producer or importer from whom it purchased or received the regulated
substances with a verification that the regulated substances will be
used in processes that result in their destruction. The destruction
verification shall include the following:
    (i) Identity and address of the person intending to destroy
regulated substances;
    (ii) The quantity (in kilograms) of regulated substances intended
for destruction;
    (iii) Identity of shipments by purchase order number(s), purchaser
account number(s), location(s), or other means of identification;
    (iv) The destruction efficiency at which such substances will be
destroyed;
    (v) Period of time over which the person intends to destroy
regulated substances; and
    (vi) Signature and title of the verifying person.
    (5) Transformation reporting--one time report. Any person who
transforms a regulated substance must provide a one-time report
containing the following information:
    (i) A description of the transformation use;
    (ii) A description of all technologies and actions taken to
minimize emissions of regulated substances;
    (iii) The name of the product manufactured in the process;
    (iv) A list of any coproducts, byproducts, or emissions from the
production line of any regulated substance that are other regulated
substances, ozone-depleting substances listed in 40 CFR part 82,
subpart A, or hazardous air pollutants initially identified in Section
112 of the Clean Air Act, and as revised through rulemaking and
codified in 40 CFR part 63;
    (v) The estimated annual fugitive emissions by chemical associated
with the transformation process;
    (vi) The anticipated ratio of regulated substance used for
transformation to the amount of end product manufactured; and
    (vii) A mass balance equation of the transformation reaction.
    (f) All destruction facilities--(1) Destruction--one-time report.
Within 120 days of January 1, 2022, or within 120 days of the date that
an entity first destroys a regulated substance, whichever is later,
every person who

destroys regulated substances, whether in a process for destruction or
for disposal of a used substance, shall provide EPA with a report
containing the following information:
    (i) The destruction unit's destruction efficiency;
    (ii) The methods used to record the volume destroyed;
    (iii) The methods used to determine destruction efficiency;
    (iv) The name of other relevant federal or state regulations that
may apply to the destruction process; and
    (v) Any changes to the information in this paragraph must be
reflected in a revision to be submitted to EPA within 60 days of the
change(s).
    (2) Proof of destruction. Any person who destroys used regulated
substances for disposal of that substance, shall provide the importer
or aggregator with a record indicating the substance was destroyed
within 30 days of the date of destruction.
    (g) Process agents--(1) Reporting--one time report. Any person who
uses a regulated substance as a process agent must provide a one-time
report containing the following information:
    (i) A description of the process agent use which includes details
of the percentages of process agent retained within the process,
recovered after the process, and emitted or entrained in the final
product;
    (ii) A description of all technologies and actions taken to
minimize emissions of regulated substances;
    (iii) The name of the product and byproducts manufactured in the
process; and
    (iv) The anticipated ratio of process agent emissions to end
product manufactured.
    (2) Annual report. Any person who uses a regulated substance as a
process agent must provide an annual report containing the following
information:
    (i) Contact information including email address and phone number
for a primary and alternate contact person;
    (ii) The amount of regulated substance used as a process agent;
    (iii) The amount of product and the amount of byproducts
manufactured (including amounts eventually destroyed or used as
feedstock);
    (iv) The stack point source emissions; and
    (v) A description of any HFC emission reduction actions planned or
currently under investigation.
    (i) Holders of application-specific allowances--(1) Reporting. Any
person allocated application-specific allowances must submit to the
relevant Agency official a report containing the following information
by July 31 and January 31 of each year:
    (i) The quantity (in kilograms) of each regulated substance that
was used for their application during previous six months;
    (ii) The quantity of regulated substances acquired through
conferring allowances that were imported during the previous six
months;
    (iii) The quantity of regulated substances acquired through
conferring allowances that were produced domestically during the
previous six months;
    (iv) The companies to which application-specific allowances were
conferred;
    (v) The quantity of regulated substances purchased without
expending application-specific allowances during the previous six
months (i.e., from the open market);
    (vi) The quantity of inventory of each regulated substance held by
the reporting company or held under contract by another company for the
reporting company's use on the last day of the previous six-month
period;
    (vii) The quantity of each regulated substance contained in
exported products during the previous six months; and
    (viii) The quantity of each regulated substance that was destroyed
or recycled during the previous six months.
    (2) Application. In addition to the information in paragraph (i)(1)
of this section, the report due by July 31 must include a request for
application-specific allowances for the next calendar year which would
include the following:
    (i) Total quantity (in kilograms) of all regulated substances
acquired and used in the previous three years;
    (ii) Information on suppliers;
    (iii) whether HFCs were acquired through domestic production or
import;
    (iv) Whether HFCs were acquired through conferring allowances or
from the general market; quantities held in inventory; and
    (v) A description of plans to transition to regulated substances
with a lower exchange value or alternatives to regulated substances.
    (3) Recordkeeping. Entities allocated application-specific
allowances must maintain the following records for five years:
    (i) Records necessary to develop the biannual reports;
    (ii) A copy of certifications provided to producers and/or
importers when conferring allowances;
    (iii) A copy of the annual submission requesting application-
specific allowances;
    (iv) Invoice and order records related to the purchase of regulated
substances;
    (v) Records related to the transfer of allocation-specific
allowances to other entities; and
    (vi) Records documenting the use of regulated substances.
    (j) Reclaimers. Persons (``reclaimers'') who reclaim regulated
substances must comply with the following recordkeeping and reporting
requirements:
    (1) One time report. By February 14, 2022, any person who reclaims
a regulated substance must provide a one-time report containing the
following information:
    (i) The quantity of each regulated substance held in inventory as
of December 31, 2021;
    (ii) The name of the laboratory that conducts the batch testing and
a signed statement from that laboratory confirming there is an ongoing
business relationship with the reclaimer,
    (iii) The number of batches tested for each regulated substance or
blend containing a regulated substance in the prior year,
    (iv) The number of batches that did not meet the specifications in
appendix A of 40 CFR part 82, subpart F in the prior year.
    (2) Quarterly Reporting. For each quarter, a reclaimer of a
regulated substance must submit to the relevant Agency official a
report containing the following information:
    (i) The quantity of material (the combined mass of regulated
substance and contaminants) by regulated substance sent to them for
reclamation, the total mass of each regulated substance, and the total
mass of waste products.
    (ii) The quantity of each regulated substance held in inventory
onsite at the end of each quarter broken out by recovered, reclaimed,
and virgin.
    (3) Recordkeeping. (i) Reclaimers must maintain records, by batch,
of the results of the analysis conducted to verify that reclaimed
regulated substance meets the necessary specifications in Appendix A to
40 CFR part 82, subpart F, based on AHRI Standard 700-2016. Such
records must be maintained for five years.
    (ii) Reclaimers must maintain records of the names and addresses of
persons sending them material for reclamation and the quantity of the
material (the combined mass of regulated substance and contaminants) by
regulated substance sent to them for reclamation. Such records must be
maintained on a transactional basis for five years.

Sec.  84.33   Auditing of recordkeeping and reporting.

    (a) Any person receiving production allowances, consumption
allowances, or

application-specific allowances, as well as any person who exports or
reclaims a regulated substance must arrange for third-party auditing of
reports submitted to the EPA.
    (b) Auditors must review the inputs the regulated entities used to
develop quarterly and annual reports including, as appropriate:
    (1) The amount of production and consumption allowances allocated;
    (2) The amount, timing, and parties to allowance transfers, and the
associated documentation and offset amount;
    (3) The amount of regulated substances imported, exported,
produced, destroyed, transformed, or reclaimed;
    (4) For allocation-specific allowances, the amounts of allowances
conferred, regulated substances purchased, the specific application for
which the regulated substances were provided, and the names, telephone
numbers, and email addresses for contact persons for the recipient
companies;
    (5) The date and the port from which regulated substances were
imported or exported;
    (6) A copy of the bill of lading and the invoice indicating the
quantity of regulated substances imported or exported;
    (7) Relevant commodity codes;
    (8) The number and type of railcars, ISO tanks, individual
cylinders or drums, small cans, or other containers used to store and
transport regulated substances;
    (9) List of certification identifications used; and
    (10) Other information deemed relevant.
    (c) An auditor must meet the following requirements:
    (1) The auditor must be a certified public accountant, or firm of
such accountants, that is independent of the regulated person. Such an
auditor must comply with the AICPA Code of Professional Conduct,
including its independence requirements, the AICPA Statements on
Quality Control Standards (SQCS) No. 8, A Firm's System of Quality
Control (both incorporated by reference in 40 CFR1090.95), and
applicable rules of state boards of public accountancy. Such an auditor
must also perform the attestation engagement in accordance with the
AICPA Statements on Standards for Attestation Engagements (SSAE) No.
18, Attestation Standards: Clarification and Recodification,
(incorporated by reference in 40 CFR 1090.95).
    (2) The auditor must meet the independence requirements in
paragraph (f) of this section.
    (3) Any auditor suspended or debarred under 2 CFR part 1532 or 48
CFR part 9, subpart 9.4, is not qualified to perform attestation
engagements under this section.
    (d) All reports required under this paragraph must be signed and
certified as meeting all the applicable requirements of this subpart by
the independent third-party auditor or a responsible corporate officer
of the independent third-party auditor.
    (e) The following provisions apply to each audit performed under
this section:
    (1) The auditor must prepare a report identifying the applicable
procedures specified in this section along with the auditor's
corresponding findings for each procedure. The auditor must submit the
report electronically to EPA by May 31 of the year following the
compliance period.
    (2) The auditor must identify any instances where compared values
do not agree or where specified values do not meet applicable
requirements under this part.
    (3) Laboratory analysis refers to the original test result for each
analysis of a product's properties.
    (4) For a reclaimer that relies on a third-party laboratory for
batch testing, the laboratory analysis consists of the results provided
by the third-party laboratory.
    (f) The independent third party, their contractors, subcontractors,
and their organizations must be independent of the regulated party. All
the criteria listed in paragraphs (a)(1) and (2) of this section must
be met by each person involved in the specified activities in this
section that the independent third party is hired to perform for a
regulated party.
    (1) Employment criteria. No person employed by an independent third
party, including contractor and subcontractor personnel, who is
involved in a specified activity performed by the independent third
party under the provisions of this section, may be employed, currently
or previously, by the regulated party for any duration within the 12
months preceding the date when the regulated party hired the
independent third party to provide services under this section.
    (2) Financial criteria. (i) The third-party's personnel, the third-
party's organization, or any organization or individual that may be
contracted or subcontracted by the third party must meet all the
following requirements:
    (A) Have received no more than one-quarter of their revenue from
the regulated party during the year prior to the date of hire of the
third party by the regulated party for any purpose.
    (B) Have no interest in the regulated party's business. Income
received from the third party to perform specified activities under
this section is excepted.
    (C) Not receive compensation for any specified activity in this
section that is dependent on the outcome of the specified activity.
    (ii) The regulated party must be free from any interest in the
third-party's business.

Subpart B--[RESERVED]

Appendix A to Part 84--Regulated Substances

          HFCs Listed as Regulated Substances in the AIM Act 1
------------------------------------------------------------------------
                                                                Exchange
            HFC                      Chemical formula            value
------------------------------------------------------------------------
HFC-134....................  CHF2CHF2........................      1,100
HFC-134a...................  CH2FCF3.........................      1,430
HFC-143....................  CH2FCHF2........................        353
HFC-245fa..................  CHF2CH2CF3......................      1,030
HFC-365mfc.................  CF3CH2CF2CH3....................        794
HFC-227ea..................  CF3CHFCF3.......................      3,220
HFC-236cb..................  CH2FCF2CF3......................      1,340
HFC-236ea..................  CHF2CHFCF3......................      1,370
HFC-236fa..................  CF3CH2CF3.......................      9,810
HFC-245ca..................  CH2FCF2CHF2.....................        693
HFC-43-10mee...............  CF3CHFCHFCF2CF3.................      1,640
HFC-32.....................  CH2F2...........................        675
HFC-125....................  CHF2CF3.........................      3,500
HFC-143a...................  CH3CF3..........................      4,470
HFC-41.....................  CH3F............................         92
HFC-152....................  CH2FCH2F........................         53
HFC-152a...................  CH3CHF2.........................        124
HFC-23.....................  CHF3............................     14,800
------------------------------------------------------------------------
\1\ This table includes all isomers of the substances above, regardless
  of whether the isomer is explicitly listed on its own.

[FR Doc. 2021-09545 Filed 5-18-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Pages 63219-63220]
[FR Doc No: 2013-24786]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1156]

International Conference on Harmonisation; Draft Guidance on
Elemental Impurities; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Elemental Impurities.''
Prepared under the auspices of the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH), this guidance is intended to
develop a harmonized approach for the control of elemental impurities
that helps industry avoid the uncertainty and duplication of work
resulting from differing requirements across ICH regions. It includes
the specific elements to be limited and the appropriate limits for
impurities, and emphasizes control of supply chains and risk
assessments. It is expected to provide appropriate safety-based limits
for the control of elemental impurities, consistent expectations for
test requirements and regulatory filings, and a global policy for
limiting elemental impurities, both qualitatively and quantitatively,
in drug products and ingredients.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115 (g)(5)), to ensure that the Agency considers your comment on
this draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by December 23, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002, or
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The draft guidance may also be obtained by
mail by calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the
SUPPLEMENTARY INFORMATION section for electronic access to the draft
guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Regarding the guidance: John Kauffman,
CDER, Food and Drug Administration, 1114 Market St., DPA Facility,
suite 1002, St. Louis, MO 63101,<PHONE_NUMBER>. Regarding the ICH:
Michelle Limoli, International Programs, CDER, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3342, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote
international harmonization of regulatory requirements. FDA has
participated in many meetings designed to enhance harmonization and is
committed to seeking scientifically based harmonized technical
procedures for pharmaceutical development. One of the goals of
harmonization is to identify and then reduce differences in technical
requirements for drug development among regulatory agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA;
and the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as

observers from the World Health Organization, Health Canada, and the
European Free Trade Area.
    In June 2013, the ICH Steering Committee agreed that a draft
guidance entitled ``Elemental Impurities'' should be made available for
public comment. The draft guidance is the product of the Quality Expert
Working Group of the ICH. Comments about this draft will be considered
by FDA and the Q3D Expert Working Group.
    The draft guidance provides guidance on control of elemental
impurities and expectations for test requirements for regulatory
filings.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: October 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24786 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P


"Johansson, Robert"<EMAIL_ADDRESS> 07/10/2007 05:23 PM

To

Ron Evans/RTP/USEPA/US@EPA, Marjorie Jones/RTP/USEPA/US@EPA

cc

Subject

RIA list of remaining issues

Hi Ron and Margie,

Please find enclosed the interagency review list of remaining issues on the RIA.

Cheers,

Rob

________________________________________________

Robert Johansson, Ph.D.

OMB/OIRA/NREA

725 17th St. NW, Room 10202

Washington, DC 20503

(P)<PHONE_NUMBER>

(F)<PHONE_NUMBER>

(E<EMAIL_ADDRESS>