35 Table 5a. Annual Burden and Cost for the Federal Government to Implement ( First Year)

Proposed NESHAP for Existing Carbon Black Production Facilities A B C D E F Burden item Technical Technical Management Clerical Total cost hours per Occurrences hours per year hours per year hours per year per year occurrence per year ( C = A x B) ( C x 0.05) ( C x 0.1)

@ $ 34.00 @ $ 56.00 @ $ 17.00 Review initial notification reports 8 7 56 2.8 5.6 $ 2,156 Review notifications of compliance status 10 7 70 3.5 7 $ 2,695 Review semiannual summary reports 15 14 210 10.5 21 $ 8,085 Review notifications of performance tests 4 1 4 0.2 0.4 $ 154 Attend initial performance tests 120 1 120 6 12 $ 4,620 Review test results 10 1 10 0.5 1 $ 385 Total hours 470 23.5 47 Total costs $ 18,095


[Federal Register Volume 85, Number 36 (Monday, February 24, 2020)]
[Rules and Regulations]
[Pages 10274-10278]
[FR Doc No: 2020-02941]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 738, 740, and 742

[Docket No.<PHONE_NUMBER>]
RIN 0694-AH93

Amendments to Country Groups for Russia and Yemen Under the
Export Administration Regulations

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Final rule.

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

SUMMARY: In this final rule, the Bureau of Industry and Security (BIS)
amends the Export Administration Regulations (EAR) to revise the
Country Group designations for the Russian Federation (Russia) and
Yemen based on national security and foreign policy concerns, including
proliferation-related concerns. This action is intended to facilitate
and support accountability in connection with exports and reexports of
items to these destinations under the EAR, and is part of a larger
effort to restructure and re-align the Country Groups based on the
aforementioned interests.

DATES: This rule is effective February 24, 2020.

FOR FURTHER INFORMATION CONTACT: Jodi.Kouts, Director, Chemical and
Biological Controls Division, at email<EMAIL_ADDRESS>or by
phone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    The Bureau of Industry and Security (BIS) is currently undertaking
a comprehensive review of all Country Groups in the Export
Administration Regulations (EAR) to ensure that they appropriately
reflect current U.S. national security and foreign policy, including
nonproliferation interests.
    The foundation of this rule derives from the structure and purposes
of the Commerce Country Chart found in Supplement No. 1 to part 738 and
the Country Groups found in Supplement No. 1 to part 740 of the EAR.
The Country Chart contains licensing requirements based on the
destination to which items listed on the Commerce Control List (CCL)
(Supplement No. 1 to part 774) will be exported or reexported and their
corresponding ``Reason for Control,'' which is found in the CCL entry.
An ``X'' in the cell where the ``reason for control'' column intersects
with the row of the destination indicates a license requirement.
Licenses are required to export and reexport items under the EAR for
multilateral reasons (i.e., chemical and biological (CB), nuclear
nonproliferation (NP), national security (NS), and missile technology
(MT)); and for unilateral reasons (i.e., region stability (RS), crime
control (CC) and anti-terrorism (AT)), as well as to implement controls
for firearms convention (FC) and United Nations Security Council
purposes. Controls for United Nations Security Council purposes are
identified by the abbreviation ``UN'' in the applicable CCL entries.
The ``UN'' reason for control is described in Sec.  746. 2(b) of the
EAR.
    In combination with the CCL--the list of items classified and set-
out as Export Control Classification Numbers (ECCNs) and arranged by
categories--the Country Chart allows an exporter to determine whether a
license is required for the export or reexport of an item on the CCL to
the destinations on the Chart, unless otherwise specified in the
particular ECCN entry on the CCL. The lists of Country Groups (A, B, D
and E) set out countries with respect to relative risk and record of
like-minded export controls, and importantly, as a basis for the
availability of exceptions from license requirements described in part
740 (License Exceptions) of the EAR, provided the conditions for the
use of the License Exception are met. Country Groups may also be used
when describing license review policy.
    The two lists--the Commerce Country Chart and Country Groups--were
developed for separate purposes and allow for systematic licensing
determinations. Country Groups are not reviewed unless a license is
required by the Country Chart for exports and reexports of items listed
in the CCL, unless, as mentioned above, otherwise indicated in the ECCN
entry on the CCL.
    Continuing to apply the structure and purposes of the Country Chart
and Country Groups in furtherance of U.S. national security and foreign
policy, including nonproliferation interests, this rule is part of
BIS's review of Country Groups. BIS has determined the current Country
Group designations for Russia and Yemen should be changed to address
U.S. national security, foreign policy, including proliferation
concerns as further described below.
    Specifically, this rule removes Russia from more favorable
treatment under Country Groups A:2 and A:4 and adds it to Country
Groups D:2 and D:4 based on nuclear and missile technology
proliferation concerns, respectively. BIS also amends the licensing
policy for related items to reflect a presumption of denial consistent
with the Country Group changes. Separately, this rule removes Yemen
from more favorable treatment under Country Group B and adds it to
Country Group D:1 to reflect national security concerns.
    As a result of these Country Group changes, certain license
exceptions are no longer available for Russia and Yemen, and licenses
are now required for those destinations in connection with exports,
reexports, and transfers (in-country) of certain controlled items. In
addition, certain transactions may be subject to more stringent
licensing review policies or additional prohibitions as outlined in
other parts of the EAR. With these actions, BIS seeks to ensure
accountability for exports and reexports of items to these
destinations. This rule is the first action related to the larger
effort to re-structure and re-align the Country Groups set forth in
Supplement No. 1 to Part 740 of the EAR.

Specific Amendments

Russia: Country Groups A and D

    In this rule, BIS removes Russia from Country Groups A:2 (Missile
Technology Control Regime) and A:4 (Nuclear Suppliers Group) to address
U.S. concerns about diversion of U.S.-origin items to or from Russia
for prohibited end uses and end users. This rule removes the ``X'' from
Column ``[A:2]'' and the ``X'' from Column ``[A:4]'' in Supplement No.
1 to Part 740 for ``Russia.'' In relation to the changes to Country
Groups A:2 and A:4 for Russia, this rule also adds Russia to Country
Groups of concern D:2 (Nuclear) and D:4 (Missile Technology). This rule
adds an ``X'' in Column ``[D:2]'' and an ``X'' in Column ``[D:4]'' in
Supplement No. 1 to Part 740 for ``Russia.'' Consistent with adding
``Russia'' to Country Group ``[D:2],'' this rule adds an ``X'' in
Column ``NP 1'' for ``Russia'' in Supplement No. 1 to Part 738--
Commerce Country Chart. Finally, BIS revises the licensing policy for
items to Russia to a policy of presumption of denial when the items are
controlled for reasons described under Sec.  742.2 (Proliferation of
chemical and biological weapons), Sec.  742.3 (Nuclear
nonproliferation), or Sec.  742.5 (Missile technology) of the EAR.
However, with regard to NP and MT controls, applications for exports
and reexports of items, which include commodities, software and
technology, to Russia in support of U.S.-Russia civil space cooperation
activities or commercial space launches will be reviewed on a case-by-
case basis.

    These amendments are consistent with the purpose of this rule to
address U.S. concerns about Russia's lack of cooperation and
accountability for U.S.-origin items and diversion to unauthorized or
prohibited proliferation activities, end uses, and end users.
Specifically, Russia has not been cooperative in allowing BIS to
perform pre-license checks or post-shipment verifications related to
U.S.-origin goods. The presumption of denial under Sec.  742.2 further
accentuates the seriousness with which the United States takes Russia's
use of a ``novichok'' nerve agent in the attack against Sergei Skripal
and his daughter Yulia Skripal in the United Kingdom on March 4, 2018.

Yemen: Country Groups B and D:1

    In this rule, BIS removes Yemen from Country Group B and places
Yemen in the country group of concern for national security reasons,
Country Group D:1 (National Security). Specifically, this rule removes
``Yemen'' from Country Group B in Supplement No. 1 to part 740, and
adds an ``X'' in Column ``[D:1]'' of that Supplement for ``Yemen.''
    These changes are being made to address concerns about diversion of
U.S.-origin items in Yemen for unauthorized purposes, including
prohibited proliferation activities, end uses, and end users. In
addition, there are concerns about the diversion to unauthorized and
prohibited end uses and users of U.S.-origin items controlled for
national security reasons. The ongoing conflict in Yemen has fostered
international terrorism and instability in the Arabian Peninsula,
including the proliferation of small arms, unmanned aerial systems, and
missiles.

Impact of Removing Russia From Country Groups A:2 and A:4 and Adding to
Country Groups D:2 and D:4

    The removal of Russia from Country Groups A:2 and A:4 means a
number of license exceptions are no longer available for Russia, and
previously eligible items now require a license to Russia. Consistent
with removing Russia from Country Groups A:2 and A:4 and adding it to
Country Group D:2, a license is required for the export or reexport of
items subject to NP 1 controls as identified in the applicable Export
Control Classification Numbers (ECCNs) in Supplement No. 1 to part 774
(The Commerce Control List). Denoting this license requirement, this
final rule adds an ``X'' in the NP 1 column of the nuclear
nonproliferation column in Supplement No. 1 to part 738 of the EAR for
Russia. License applications for these items will be reviewed with a
presumption of denial. Consistent with adding Russia to Country Group
D:2, the general prohibition in paragraph (a)(1)(i)(A) of Sec.  744.6,
Restrictions on certain activities of U.S. persons, will be applicable
if the U.S. person exports, reexports, or transfers (in-country) with
``knowledge'' of a prohibited end use in or by Russia.
    Consistent with adding Russia to Country Group D:4, the general
prohibitions in paragraphs (a)(1) and (3) of Sec.  744.3, Restrictions
on certain rocket systems (including ballistic missiles, space launch
vehicles and sounding rockets) and unmanned aerial vehicles (including
cruise missiles, target drones and reconnaissance drones) end-uses,
will be applicable if the exporter, reexporter, or transferor has
``knowledge'' the transaction involves one of those prohibited end uses
in or by Russia. In addition, consistent with adding Russia to Country
Group D:4, the general prohibitions in Sec.  744.6 under paragraphs
(a)(1)(i)(B) and (a)(2)(i) will be applicable if the U.S. person
exports, reexports, or transfers (in country) with ``knowledge'' of one
of those prohibited end uses in or by Russia, or engages in one of
those prohibited activities with ``knowledge'' that it will directly
assist such an end use.

Impact of Removing Yemen From Country Group B and Adding to D:1

    The removal of Yemen from County Group B means that the following
license exceptions will no longer be available: Sec.  740.3, Shipments
of limited value (LVS); Sec.  740.4, Shipments to Country Group B
countries (GBS); and Sec.  740.6, Technology and software under
restriction (TSR). As a corollary, Yemen's addition to Country Group
D:1 means that the following license exceptions, or other portions
thereof, which include limitations related to Country Group D, will no
longer be available: Sec.  740.9, Temporary imports, exports,
reexports, and transfers (in-country) (TMP); Sec.  740.10, Servicing
and replacement of parts and equipment (RPL); Sec.  740.12, Gift
parcels and humanitarian donations (GFT); Sec.  740.14, Baggage (BAG);
Sec.  740.15, Aircraft and vessels (AVS); Sec.  740.16, Additional
permissive reexports (APR); and Sec.  740.17, Encryption, commodities,
software, and technology (ENC).
    Section 742.4(b)(2) of the EAR states the licensing policy for
exports and reexports of national-security controlled items to
destinations in Country Group D:1. That licensing policy is to approve
applications when BIS determines, on a case-by-case basis, that the
items are for civilian use or otherwise would not make a significant
contribution to the military potential of the country of destination
that would prove detrimental to the national security of the United
States. License applications to export or reexport national security
controlled items to Yemen will now be subject to this licensing policy.
    In addition, Yemen's placement in Country Group D:1 will result in
the imposition of restrictions on the export, reexport, and transfer
(in-country) of certain microprocessors to military end uses and end
users in Yemen, pursuant to Sec.  744.17, Restrictions on certain
exports, reexports, and transfers (in-country) of microprocessors and
associated ``software'' and ``technology'' for `military end uses' and
to `military end users.' Furthermore, restrictions on certain exports
and reexports to vessels and aircraft located in Yemeni ports or
registered in Yemen will become effective pursuant to Sec.  744.7,
Restrictions on certain exports to and for the use of certain foreign
vessels or aircraft. Finally, the addition of Yemen to Country Group
D:1 will expand the licensing requirements for reexports of the
foreign-produced direct product of U.S.-origin technology and software
to Yemen pursuant to Sec.  736.2(b)(3), General Prohibition Three.

Export Control Reform Act of 2018

    On August 13, 2018, the President signed into law the John S.
McCain National Defense Authorization Act for Fiscal Year 2019, which
included the Export Control Reform Act of 2018 (ECRA) (50 U.S.C. 4801-
4852). ECRA provides the legal basis for BIS's principal authorities
and serves as the authority under which BIS issues this rule. As set
forth in Section 1768 of ECRA, all delegations, rules, regulations,
orders, determinations, licenses, or other forms of administrative
action that were made, issued, conducted, or allowed to become
effective under the Export Administration Act of 1979 (50 U.S.C. 4601
et seq.) (as in effect on August 12, 2018, and as continued in effect
pursuant to the International Emergency Economic Powers Act (50 U.S.C.
1701 et seq.)), or under the Export Administration Regulations, and
were in effect as of August 13, 2018, shall continue in effect
according to their terms until modified, superseded, set aside, or
revoked under the authority of ECRA.

Rulemaking Requirements

    1. Executive Orders 13563 and 12866 direct agencies to assess all
costs and benefits of available regulatory alternatives and, if
regulation is

necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distribute impacts, and equity). Executive Order 13563
emphasizes the importance of quantifying both costs and benefits, of
reducing costs, of harmonizing rules, and of promoting flexibility.
This final rule has been designated a ``significant regulatory
action,'' although not economically significant, under section 3(f) of
Executive Order 12866. This final rule will support the national
security and foreign policy objectives of the United States by
broadening the U.S. Government's visibility into exports, reexports,
and transfers (in-country), for a country of concern when the
transactions involve national security controlled items and items
controlled for proliferation reasons.
    2. Notwithstanding any other provision of law, no person may be
required to respond to or be subject to a penalty for failure to comply
with a collection of information, subject to the requirements of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) (PRA), unless
that collection of information displays a currently valid Office of
Management and Budget (OMB) Control Number. This regulation involves a
collection currently approved by OMB under control number 0694-0088,
Simplified Network Application Processing System. This collection
includes, among other things, license applications, and carries a
burden estimate of 42.5 minutes for a manual or electronic submission
for a total burden estimate of 31,878 hours. BIS expects the burden
hours associated with this collection to increase slightly by 4 hours
for an estimated cost increase of $120. This increase is not expected
to exceed the existing estimates currently associated with OMB control
number 0694-0088.
    3. This rule does not contain policies with federalism implications
as that term is defined under Executive Order 13132.
    4. Pursuant to section 1762 of the Export Control Reform Act of
2018 (50 U.S.C. 4801-4852), which was included in the John S. McCain
National Defense Authorization Act for Fiscal Year 2019, this action is
exempt from the Administrative Procedure Act (5 U.S.C. 553)
requirements for notice of proposed rulemaking, opportunity for public
participation, and delay in effective date.
    5. Because a notice of proposed rulemaking and an opportunity for
public comment are not required to be given for this rule by 5 U.S.C.
553, or by any other law, the analytical requirements of the Regulatory
Flexibility Act, 5 U.S.C. 601, et seq., are not applicable.
Accordingly, no regulatory flexibility analysis is required, and none
has been prepared.
    6. This final rule is not subject to the requirements of Executive
Order 13771 (82 FR 9339, February 3, 2017) because it is issued with
respect to a national security function of the United States. The cost-
benefit analysis required pursuant to Executive Orders 12866 and 13563
indicates that this rule is intended to improve national security as
its primary direct benefit. Specifically, revising the status of the
Country Group designations for Russia and Yemen in this rule protects
the United States and allies by serving the priorities of reducing the
risk that exports, reexports, and transfers (in-country) of items
subject to the EAR could be diverted and contribute to weapons of mass
destruction proliferation and the military capability of countries of
concern, contrary to U.S. national security interests. Accordingly,
this rule meets the requirements set forth in the April 5, 2017 OMB
guidance implementing Executive Order 13771 (82 FR 9339, February 3,
2017), regarding what constitutes a regulation issued ``with respect to
a national security function of the United States,'' and is, therefore,
exempt from the requirements of Executive Order 13771.

Savings Clause

    Shipments of items removed from license exception eligibility or
eligibility for export, reexport or transfer (in country) without a
license as a result of this regulatory action that were on dock for
loading, on lighter, laden aboard and exporting carrier, or en route
aboard a carrier to a port of export, on February 24, 2020, pursuant to
actual orders for exports, reexports and transfers (in country) to a
foreign destination, may proceed to that destination under the previous
license exception eligibility or without a license so long as they have
been exported, reexported or transferred (in-country) before 30 days
from date of publication. Any such items not actually exported,
reexported or transferred (in-country) before midnight on March 25,
2020 require a license in accordance with this final rule.

List of Subjects

15 CFR Part 738

    Exports.

15 CFR Part 740

    Administrative practice and procedure, Exports, Reporting and
recordkeeping requirements.

15 CFR Part 742

    Exports, Terrorism.

    Accordingly, parts 738, 740, and 742 of the Export Administration
Regulations (15 CFR parts 730-774) are amended as follows:

PART 738--COMMERCE CONTROL LIST OVERVIEW AND THE COUNTRY CHART

0
1. The authority citation for part 738 is revised to read as follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 10 U.S.C. 7420; 10 U.S.C. 7430(e); 22 U.S.C.
287c; 22 U.S.C. 3201 et seq.; 22 U.S.C. 6004; 42 U.S.C. 2139a; 15
U.S.C. 1824a; 50 U.S.C. 4305; 22 U.S.C. 7201 et seq.; 22 U.S.C.
7210; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783.

0
2. Supplement No. 1 to part 738 is amended by revising the entry for
``Russia'' to read as follows:

                                                                      Supplement No. 1 to Part 738--Commerce Country Chart
                                                                                [Reason for control]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                 Chemical and biological          Nuclear        National security   Missile  Regional stability    Firearms            Crime control           Anti-terrorism
                                         weapons             nonproliferation  --------------------   tech                         convention  -------------------------------------------------
          Countries          --------------------------------------------------                    --------------------------------------------
                                CB 1      CB 2      CB 3      NP 1      NP 2      NS 1      NS 2      MT 1      RS 1      RS 2        FC 1        CC 1      CC 2      CC 3      AT 1      AT 2
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                                * * * * * * *
Russia \6\..................        X         X         X         X   ........        X         X         X         X         X   ............        X         X   ........  ........  ........

                                                                                * * * * * * *
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
 * * * * * * *
\6\ See Sec.   746.5 for additional license requirements under the Russian Industry Sector Sanctions for ECCNs 0A998, 1C992, 3A229, 3A231, 3A232, 6A991, 8A992, and 8D999.

* * * * *

PART 740--LICENSE EXCEPTIONS

0
3. The authority citation for part 740 continues to read as follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 7201 et seq.; E.O. 13026, 61 FR
58767, 3 CFR, 1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR,
2001 Comp., p. 783.

0
4. Supplement No. 1 to part 740 is amended by:
0
a. In the Country Group A table:
0
i. Revising the table headings for [A:2] and [A:4], the entries for
Russia and Ukraine, and footnote 2; and
0
ii. Redesignating footnote 3 as footnote 4, adding a new footnote 3,
and revising newly redesignated footnote 4; and
0
b. In the Country Group D table, revising the entries for Russia and
Yemen and footnote 1.
    The revisions read as follows:

                                                      Supplement No. 1 to Part 740--Country Groups
                                                                    [Country Group A]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               [A:1]       [A:2] Missile
                                                             Wassenaar      technology         [A:3]       [A:4] Nuclear
                         Country                           participating  control regime     Australia       suppliers         [A:5]           [A:6]
                                                            states \1\          \2\            group         group \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
Russia 1 2 3............................................  ..............  ..............  ..............  ..............  ..............  ..............

                                                                      * * * * * * *
Ukraine \4\.............................................  ..............               X               X               X  ..............  ..............

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Country Group A:1 is a list of the Wassenaar Arrangement Participating States, except for Malta, Russia and Ukraine.
\2\ Country Group A:2 is a list of the Missile Technology Control Regime countries, except for Russia.
\3\ Country Group A:4 is a list of the Nuclear Suppliers Group countries, except for the People's Republic of China (PRC) and Russia.
\4\ For purposes of this supplement, as well as any other EAR provision that references the Country Groups, the designations for Ukraine also apply to
  the Crimea region of Ukraine. See Sec.   746.6(c) of the EAR for an exhaustive listing of license exceptions that are available for the Crimea region
  of Ukraine. No other EAR license exceptions are available for the Crimea region of Ukraine. The Crimea region of Ukraine includes the land territory
  in that region as well as any maritime area over which sovereignty, sovereign rights, or jurisdiction is claimed based on purported annexation of that
  land territory.
 * * * * * * *

                                                [Country Group D]
----------------------------------------------------------------------------------------------------------------
                                      [D: 1]                          [D: 3]                        [D: 5] U.S.
             Country                 National     [D: 2] Nuclear    Chemical &    [D: 4] Missile  arms embargoed
                                     security                       biological      technology     countries \1\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *

                                                  * * * * * * *
Russia..........................               X               X               X               X  ..............

                                                  * * * * * * *
Yemen...........................               X  ..............               X               X  ..............

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Note to Country Group D:5: Countries subject to U.S. arms embargoes are identified by the State Department
  through notices published in the Federal Register. The list of arms embargoed destinations in this table is
  drawn from 22 CFR 126.1 and State Department Federal Register notices related to arms embargoes (compiled at
  http://www.pmddtc.state.gov/embargoed_countries/index.html) and will be amended when the State Department
  publishes subsequent notices. If there are any discrepancies between the list of countries in this table and
  the countries identified by the State Department as subject to a U.S. arms embargo (in the Federal Register),
  the State Department's list of countries subject to U.S. arms embargoes shall be controlling.

* * * * *

PART 742--CONTROL POLICY--CCL BASED CONTROLS

0
5. The authority citation for part 742 is revised to read as follows:

    Authority:  50 U.S.C. 4801-4852; 50 U.S.C. 4601 et seq.; 50
U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; 22
U.S.C. 7201 et seq.; 22 U.S.C. 7210; Sec. 1503, Pub. L. 108-11, 117
Stat. 559; E.O. 12058, 43 FR 20947, 3 CFR, 1978 Comp., p. 179; E.O.
12851, 58 FR 33181, 3 CFR, 1993 Comp., p. 608; E.O. 12938, 59 FR
59099, 3 CFR, 1994 Comp., p. 950; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p.
783; Presidential Determination 2003-23, 68 FR 26459, 3 CFR, 2004
Comp., p. 320; Notice of November 12, 2019, 84 FR 61817 (November
13, 2018).

0
6. Section 742.2 is amended by revising paragraph (b)(4) to read as
follows:

Sec.  742.2  Proliferation of chemical and biological weapons.

* * * * *
    (b) * * *
    (4) License applications for items described in paragraph (a) of
this section, when destined for the People's Republic of China will be
reviewed in accordance with the licensing policies in both paragraph
(b) of this section and Sec.  742.4(b)(7). When such items are destined
to Russia, license applications will be reviewed under a presumption of
denial.
* * * * *

0
7. Section 742.3 is amended by revising paragraph (b)(4) to read as
follows:

Sec.  742.3  Nuclear nonproliferation.

* * * * *
    (b) * * *
    (4) License applications for items described in paragraph (a) of
this section, when destined for the People's Republic of China will be
reviewed in accordance with the licensing policies in both paragraph
(b) of this section and Sec.  742.4(b)(7). When such items are destined
to Russia, license applications will be reviewed under a presumption of
denial. However, exports and reexports of items to Russia in support of
U.S.-Russia civil space cooperation activities or commercial space
launches will be reviewed on a case-by-case basis.
* * * * *

0
8. Section 742.5 is amended by adding two sentences at the end of
paragraph (b)(5) to read as follows:

Sec.  742.5  Missile technology.

* * * * *
    (b) * * *

    (5) * * * When such items are destined to Russia, license
applications will be reviewed under a presumption of denial. However,
exports and reexports of items to Russia in support of U.S.-Russia
civil space cooperation activities or commercial space launches will be
reviewed on a case-by-case basis.
* * * * *

    Dated: February 10, 2020.
Richard E. Ashooh,
Assistant Secretary for Export Administration.
[FR Doc. 2020-02941 Filed 2-21-20; 8:45 am]
 BILLING CODE 3510-33-P


[Federal Register: October 22, 2008 (Volume 73, Number 205)]
[Rules and Regulations]
[Page 62893-62897]
[DOCID:fr22oc08-15]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R03-OAR-2007-0522; FRL-8731-8]

Approval and Promulgation of Air Quality Implementation Plans;
Virginia; Major New Source Review for Nonattainment Areas

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: EPA is granting limited approval of a State Implementation
Plan (SIP) revision submitted by the Commonwealth of Virginia. This
revision action establishes the limited approval of a State
Implementation Plan (SIP) revision submitted by the Commonwealth of
Virginia on February 12, 2007. The intended effect of this action is to
grant limited approval of the September 1, 2006 regulatory amendments
to Virginia's existing new source review permit program for owners of
sources located or locating in new source review nonattainment areas.
This action is also providing full approval of a related SIP revision
submitted by the Commonwealth on December 16, 2003, pertaining to
amendments made to Virginia's existing nonattainment new source review
permit program at that time. This action is being taken under the Clean
Air Act (CAA or the Act).

DATES: Effective Date: This final rule is effective on November 21,
2008.

ADDRESSES: EPA has established a docket for this action under Docket ID
Number EPA-R03-OAR-2007-0522. All documents in the docket are listed in
the http://www.regulations.gov Web site. Although listed in the
electronic docket, some information is not publicly available, i.e.,
confidential business information (CBI) or other information whose
disclosure is restricted by statute. Certain other material, such as
copyrighted material, is not placed on the Internet and will be
publicly available only in hard copy form. Publicly available docket
materials are available either electronically through http://
www.regulations.gov or in hard copy for public inspection during normal
business hours at the Air Protection Division, U.S. Environmental
Protection Agency, Region III, 1650

Arch Street, Philadelphia, Pennsylvania 19103. Copies of the State
submittal are available at the Virginia Department of Environmental
Quality, 629 East Main Street, Richmond, Virginia, 23219.

FOR FURTHER INFORMATION CONTACT: Sharon McCauley,<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    On June 27, 2008 (73 FR 36477), EPA published a notice of proposed
rulemaking (NPR) proposing limited approval of amendments to Virginia's
existing new source review permit program for owners of sources located
or locating in nonattainment new source review (NNSR) areas, as
submitted to EPA as revisions to the Virginia SIP on February 12, 2007
and approval of certain other amendments to Virginia regulations
submitted to EPA on December 16, 2003.
    The February 12, 2007 SIP revision submission consisted of
amendments to Legislative Rules 9 VAC 5 Chapter 50, Article 4--
Stationary Sources and 9 VAC 5 Chapter 80, Article 9--Permits for
Construction and Major Modification of Major Stationary Sources of Air
Pollution which Cause or Contribute to Nonattainment. These rules were
adopted by the Commonwealth of Virginia State Air Pollution Control
Board on June 21, 2006 and became effective September 1, 2006. The
December 16, 2003 SIP revision submission consisted of additional
amendments to Legislative Rule 9 VAC Chapter 80, Article 9--Permits for
Construction and Major Modification of Major Stationary Sources of Air
Pollution which Cause or Contribute to Nonattainment.
    In this action, EPA is granting limited approval of the February
12, 2007 amendments to Chapter 50, Article 4 and Chapter 80, Article 9,
as well as full approval of the December 16, 2003 amendments to Chapter
80, Article 9. Virginia also submitted changes to 9 VAC Chapter 80,
Article 6--Permits for New and Modified Stationary Sources as part of
the February 12, 2007 SIP revision. However, as stated in the NPR, EPA
is not taking any action on Chapter 80, Article 6 at this time.

II. Summary of SIP Revision

Why is Virginia changing its NSR program?

    In its December 2002 regulatory action, EPA changed many aspects of
the regulations governing the PSD and nonattainment NSR programs,
collectively referred to as ``NSR''. Virginia accepted the conceptual
framework of EPA's NSR reform revisions but tailored the program to
their State-specific objectives. Virginia's regulations differ in some
respects from EPA's regulations. However, these differences are not
significant. EPA has concluded that Virginia's regulations conform to
the minimum program elements in 40 CFR 51.165 despite some variations
in their rules from the federal program. Notable variations were
described in the proposal action and will not be restated here.

III. Limited Approval

Why is EPA granting only ``limited approval'' of Virginia's NSR
regulations, effective September 1, 2006 for Nonattainment NSR areas?

    Virginia's regulation 9 VAC 5-80-2010 added a new definition for
``baseline actual emissions'' to reflect changes to the NSR program
found in the 2002 Federal NSR Reform rule. Virginia's definition for
``baseline actual emissions'' varies from the Federal definition at 40
CFR 51.166(b)(47) in two ways. First, for both electric generating
units (EGUs) and non-EGUs, Virginia's rule allows the use of different
baselines for different pollutants if the owner can demonstrate to the
satisfaction of the State Air Pollution Control Board (Board) that a
different baseline period for a different pollutant(s) is more
appropriate due to extenuating circumstances. This is acceptable to
EPA.
    However, for non-EGUs, the 24-month baseline period must occur
within the five-year period preceding the date the owner begins actual
construction or the permit application is deemed complete, whichever is
earlier, unless the Board allows a different time period that it deems
is more representative of normal source operations. Allowing a more
representative period by the Board is acceptable, however, the
Commonwealth's regulations could be interpreted to allow this period to
be established beyond the 10-year time period allowed in the Federal
NSR Reform rule.
    As described in our June 27 proposed rule the Virginia regulations
meet the general Federal criteria for expanding the lookback period
beyond the old requirement of the most recent 24-month period, and in
this respect are consistent with Federal requirements.
    EPA is granting limited approval because the language of the
regulation does not limit the look-back period to the Federally
mandated 10 years. Virginia has represented to EPA that the regulation
was not intended to allow sources to extend the look-back period beyond
10 years. EPA would look unfavorably upon any use of discretion by
Virginia that would allow for baselines that exceed a 10-year lookback
period. EPA expects Virginia to correct the definition at 9 VAC 5-80-
2010 by limiting the discretionary lookback period to 10 years. When
Virginia makes this amendment, they may submit the revised regulation
for consideration for full approval of the Nonattainment NSR program.
    Despite the fact that the Virginia nonattainment new source review
regulations may literally be construed to allow for a source to look
beyond the 10 years prescribed by the Federal regulations, the Virginia
regulations nevertheless will strengthen the Virginia SIP.

IV. General Information Pertaining to SIP Submittals From the
Commonwealth of Virginia

    In 1995, Virginia adopted legislation that provides, subject to
certain conditions, for an environmental assessment (audit)
``privilege'' for voluntary compliance evaluations performed by a
regulated entity. The legislation further addresses the relative burden
of proof for parties either asserting the privilege or seeking
disclosure of documents for which the privilege is claimed. Virginia's
legislation also provides, subject to certain conditions, for a penalty
waiver for violations of environmental laws when a regulated entity
discovers such violations pursuant to a voluntary compliance evaluation
and voluntarily discloses such violations to the Commonwealth and takes
prompt and appropriate measures to remedy the violations. Virginia's
Voluntary Environmental Assessment Privilege Law, Va. Code Sec. 10.1-
1198, provides a privilege that protects from disclosure documents and
information about the content of those documents that are the product
of a voluntary environmental assessment. The Privilege Law does not
extend to documents or information (1) that are generated or developed
before the commencement of a voluntary environmental assessment; (2)
that are prepared independently of the assessment process; (3) that
demonstrate a clear, imminent and substantial danger to the public
health or environment; or (4) that are required by law.
    On January 12, 1998, the Commonwealth of Virginia Office of the
Attorney General provided a legal opinion that states that the
Privilege law, Va. Code Sec. 10.1-1198, precludes granting a privilege
to documents and information ``required by law,''

including documents and information ``required by Federal law to
maintain program delegation, authorization or approval,'' since
Virginia must ``enforce Federally authorized environmental programs in
a manner that is no less stringent than their Federal counterparts * *
*.'' The opinion concludes that ``[r]egarding Sec.  10.1-1198,
therefore, documents or other information needed for civil or criminal
enforcement under one of these programs could not be privileged because
such documents and information are essential to pursuing enforcement in
a manner required by Federal law to maintain program delegation,
authorization or approval.''
    Virginia's Immunity law, Va. Code Sec. 10.1-1199, provides that
``[t]o the extent consistent with requirements imposed by Federal
law,'' any person making a voluntary disclosure of information to a
state agency regarding a violation of an environmental statute,
regulation, permit, or administrative order is granted immunity from
administrative or civil penalty. The Attorney General's January 12,
1998 opinion states that the quoted language renders this statute
inapplicable to enforcement of any Federally authorized programs, since
``no immunity could be afforded from administrative, civil, or criminal
penalties because granting such immunity would not be consistent with
Federal law, which is one of the criteria for immunity.''
    Therefore, EPA has determined that Virginia's Privilege and
Immunity statutes will not preclude the Commonwealth from enforcing its
NSR program consistent with the Federal requirements. In any event,
because EPA has also determined that a state audit privilege and
immunity law can affect only state enforcement and cannot have any
impact on Federal enforcement authorities, EPA may at any time invoke
its authority under the CAA, including, for example, sections 113, 167,
205, 211 or 213, to enforce the requirements or prohibitions of the
state plan, independently of any state enforcement effort. In addition,
citizen enforcement under section 304 of the Clean Air Act is likewise
unaffected by this, or any, state audit privilege or immunity law.
    Other specific requirements of this SIP revision and the rationale
for EPA's proposed action are explained in the NPR and will not be
restated here. No public comments were received on the NPR.

V. Final Action

    EPA has determined that those regulatory amendments to the
nonattainment NSR program at Chapter 50, Article 4 and Chapter 80,
Article 9 that were submitted on February 12, 2007 are being granted
limited approval as noted in Section III above. EPA has also determined
that the regulatory amendments to the nonattainment NSR permit program
at Chapter 80, Article 9, as submitted on December 16, 2003 are fully
approvable. EPA has determined that these regulatory revisions meet the
minimum requirements of 40 CFR 51.165 and the Clean Air Act.

VI. Statutory and Executive Order Reviews

A. General Requirements

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and therefore is not
subject to review by the Office of Management and Budget. For this
reason, this action is also not subject to Executive Order 13211,
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001). This action
merely approves state law as meeting Federal requirements and imposes
no additional requirements beyond those imposed by state law.
Accordingly, the Administrator certifies that this rule will not have a
significant economic impact on a substantial number of small entities
under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). Because
this rule approves pre-existing requirements under state law and does
not impose any additional enforceable duty beyond that required by
state law, it does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). This rule also does not
have tribal implications because it will not have a substantial direct
effect on one or more Indian tribes, on the relationship between the
Federal Government and Indian tribes, or on the distribution of power
and responsibilities between the Federal Government and Indian tribes,
as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action also does not have Federalism implications because it does
not have substantial direct effects 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,
as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).
This action merely approves a state rule implementing a Federal
requirement, and does not alter the relationship or the distribution of
power and responsibilities established in the Clean Air Act. This rule
also is not subject to Executive Order 13045 (62 FR 19885, April 23,
1997), because it approves a state rule implementing a Federal
standard.
    In reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act. In
this context, in the absence of a prior existing requirement for the
State to use voluntary consensus standards (VCS), EPA has no authority
to disapprove a SIP submission for failure to use VCS. It would thus be
inconsistent with applicable law for EPA, when it reviews a SIP
submission, to use VCS in place of a SIP submission that otherwise
satisfies the provisions of the Clean Air Act. Thus, the requirements
of section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not
impose an information collection burden under the provisions of the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

B. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this rule and other
required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. This rule is not a
``major rule'' as defined by 5 U.S.C. 804(2).

C. Petitions for Judicial Review

    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by December 22, 2008. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this rule for the purposes of judicial
review nor does it extend the time within which a petition for judicial
review may be filed, and shall not postpone the effectiveness of such
rule or action. This action granting limited approval of the Virginia
nonattainment new source review program for sources locating or located
in nonattainment areas may not be challenged later in

proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Dated: October 9, 2008.
William T. Wisniewski,
Acting Regional Administrator, Region III.

0
40 CFR part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for 40 CFR part 52 continues to read as
follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart VV--Virginia

0
2. In Sec.  52.2420, the table in paragraph (c) is amended by:
0
a. Revising the existing entry for 5-50-270.
0
b. Revising the existing entries for 5-80-2000 through 5-80-2090, 5-80-
2100 through 5-80-2140, and 5-80-2150 through 5-80-2190.
0
c. Adding new entries for 5-80-2091, 5-80-2144, 5-80-2200, 5-80-2210,
5-80-2220, 5-80-2230 and 5-80-2240.
0
d. Removing the existing entries for 5-80-2100 and 5-80-2160.
    The additions and revisions read as follows:

Sec.  52.2420  Identification of plan.

* * * * *
    (c) * * *

                                  EPA-Approved Regulations in the Virginia SIP
----------------------------------------------------------------------------------------------------------------
  State citation (9 VAC 5                                State                              Explanation [former
        Chapter 80)              Title/subject      effective date    EPA approval date        SIP citation]
----------------------------------------------------------------------------------------------------------------

----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
                 Chapter 50 Article 4 Standards of Performance for Stationary Sources (Rule 5-4)
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
5-50-270...................  Standards for Major            9/1/06  10/22/08 [Insert page  Changes ``Qualifying
                              Stationary Sources                     number where the       pollutant'' to
                              (Nonattainment                         document begins].      ``Regulated NSR
                              Areas).                                                       pollutant''. Limited
                                                                                Approval.

----------------------------------------------------------------------------------------------------------------
                                                  * * * * * * *
   Chapter 80 Article 9 Permits for Major Stationary Sources and Major Modifications Locating in Nonattainment
                                                      Areas
----------------------------------------------------------------------------------------------------------------
5-80-2000..................  Applicability........          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                                                            9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2010..................  Definitions..........          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                                                            9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2020..................  General..............          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                                                            9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2030..................  Applications.........          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                                                            9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2040..................  Application                    5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              information required.         9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2050..................  Standards and                  5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              conditions for                9/1/06   number where the       1/06 amendments.
                              granting permits.                      document begins].
5-80-2060..................  Action on permit               5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              applications.                 9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2070..................  Public participation.          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                                                            9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2080..................  Compliance                     5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              determination and             9/1/06   number where the       1/06 amendments.
                              verification by                        document begins].
                              performance testing.
5-80-2090..................  Application review             5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              and analysis.                 9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2091..................  Source Obligation....          9/1/06  10/22/08 [Insert page  New. Limited
                                                                     number where the       Approval.
                                                                     document begins].

5-80-2110..................  Interstate Pollution           5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              Abatement.                    9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2120..................  Offsets..............          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                                                            9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2130..................  De minimus increases           5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              and stationary                9/1/06   number where the       1/06 amendments.
                              source modification                    document begins].
                              alternatives for
                              ozone nonattainment
                              areas classified as
                              serious or severe in
                              9 VAC 5-20-204.
5-80-2140..................  Exception............          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                                                            9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2144..................  Actuals plantwide              9/1/06  10/22/08 [Insert page  New. Limited
                              applicability limits                   number where the       Approval.
                              (PALs).                                document begins].
5-80-2150..................  Compliance with local          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              zoning requirements.          9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2170..................  Transfer of permits..          5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                                                            9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2180..................  Permit invalidation,           5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              revocation and                9/1/06   number where the       1/06 amendments.
                              enforcement.                           document begins].
5-80-2190..................  Existence of permit            5/1/02  10/22/08 [Insert page  Limited Approval of 9/
                              no defense.                   9/1/06   number where the       1/06 amendments.
                                                                     document begins].
5-80-2200..................  Changes to permits...          5/1/02  10/22/08 [Insert page  New. Limited Approval
                                                            9/1/06   number where the       of 9/1/06
                                                                     document begins].      amendments.
5-80-2210..................  Administrative permit          5/1/02  10/22/08 [Insert page  New. Limited Approval
                              amendments.                   9/1/06   number where the       of 9/1/06
                                                                     document begins].      amendments.
5-80-2220..................  Minor permit                   5/1/02  10/22/08 [Insert page  New. Limited Approval
                              amendments.                   9/1/06   number where the       of 9/1/06
                                                                     document begins].      amendments.
5-80-2230..................  Significant amendment          5/1/02  10/22/08 [Insert page  New. Limited Approval
                              procedures.                   9/1/06   number where the       of 9/1/06
                                                                     document begins].      amendments.
5-80-2240..................  Reopening for cause..          5/1/02  10/22/08 [Insert page  New. Limited Approval
                                                            9/1/06   number where the       of 9/1/06
                                                                     document begins].      amendments.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
 [FR Doc. E8-25019 Filed 10-21-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Page 13128]
[FR Doc No: 2018-06118]

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

ENVIRONMENTAL PROTECTION AGENCY

[FRL-9975-95--Region 4; CERCLA-04-2018-3750]

Black Leaf Chemical Superfund Site; Louisville, Jefferson County,
Kentucky; Notice of Settlement

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of settlement.

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

SUMMARY: Under 122(h) of the Comprehensive Environmental Response,
Compensation and Liability Act (CERCLA), the United States
Environmental Protection Agency has entered into a settlement with
ExxonMobil Corporation, Grief, Inc., and Occidental Chemical
Corporation concerning the Black Leaf Chemical Superfund Site located
in Louisville, Jefferson County, Kentucky. The settlement addresses
recovery of CERCLA costs for sampling, removal actions on 10
residential properties and investigation activities performed by the
EPA at the Site.

DATES: The Agency will consider public comments on the settlement until
April 26, 2018. The Agency will consider all comments received and may
modify or withdraw its consent to the proposed settlement if comments
received disclose facts or considerations which indicate that the
proposed settlement is inappropriate, improper, or inadequate.

ADDRESSES: Copies of the settlement are available from the Agency by
contacting Ms. Paula V. Painter, Program Analyst or accessing the
Agency's website using the contact information provided in this notice.
Comments may also be submitted by referencing the Site's name through
one of the following methods:
     Internet: https://www.epa.gov/aboutepa/about-epa-region-4-southeast#r4-public-notices
     U.S. Mail: U.S. Environmental Protection Agency, Superfund
Division, Attn: Paula V. Painter, 61 Forsyth Street SW, Atlanta,
Georgia 30303
     Email: [email protected]

FOR FURTHER INFORMATION CONTACT: Paula V. Painter at 404/562-8887.

    Dated: February 22, 2018.
Randall Chaffins,
Acting Chief, Enforcement and Community Engagement Branch, Superfund
Division.
[FR Doc. 2018-06118 Filed 3-26-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: July 14, 2008 (Volume 73, Number 135)]
[Notices]
[Page 40336]
[DOCID:fr14jy08-55]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. PR08-15-000; PR08-15-001]

Energy Transfer Fuel, L.P. Notice of Shortened Comment Period

July 7, 2008.
    Take notice that on July 3, 2008, Energy Transfer Fuel, L.P. filed
a Stipulation and Agreement of Settlement (Settlement) in the above-
docketed proceeding. Included in its filing was a request to shorten
the period for filing initial and reply comments in response to the
Settlement.
    We are shortening the date for filing initial comments to and
including July 9, 2008. Reply comments should be filed on or before
July 11, 2008.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-15877 Filed 7-11-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 103 (Thursday, May 29, 2014)]
[Notices]
[Pages 30912-30914]
[FR Doc No: 2014-12419]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-72223; File No. SR-NSCC-2014-04]

Self-Regulatory Organizations; National Securities Clearing
Corporation; Order Approving Proposed Rule Change to Effect Processing
Enhancements to the NSCC Automated Customer Account Transfer Service

May 22, 2014.

I. Introduction

    On March 27, 2014, National Securities Clearing Corporation
(``NSCC'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\
proposed rule change SR-NSCC-2014-04 (``Proposed Rule Change'') \3\ to
implement processing enhancements \4\ to NSCC's Automated Customer
Account Transfer Service (``ACATS'').\5\ The Proposed Rule Change was
published for comment in the Federal Register on April 11, 2014.\6\ The
Commission did not receive comments on the Proposed Rule Change. This
order approves the Proposed Rule Change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Defined terms not defined herein have the meaning set forth
in NSCC's Rules and Procedures (``Rules''), available at http://
dtcc.com/~/media/Files/Downloads/legal/rules/nscc--rules.ashx.
    \4\ NSCC will announce the implementation of this Proposed Rule
Change via an Important Notice to Members.
    \5\ The Depository Trust Company (``DTC'') filed a corresponding
proposed rule change with the Commission. See Release No. 34-71886
(Mar. 27, 2014), 79 FR 20260 (Apr. 11, 2014) (SR-DTC-2014-04) (``DTC
Proposal'').
    \6\ Release No. 34-71887 (Mar. 27, 2014), 79 FR 20290 (Apr. 11,
2014) (SR-NSCC-2014-04).
---------------------------------------------------------------------------

II. Description

A. Current ACATS Process

    ACATS enables NSCC Members (``Members'') to automatically transfer
customer accounts among themselves.\7\ A Member to whom a customer's
securities account is to be transferred (``Receiving Member'') may
initiate the account transfer process by submitting a Transfer
Initiation Request to NSCC. When the Member who is to deliver the
customer's securities account through ACATS (``Delivering Member'')
accepts the request, NSCC will cause eligible securities in that
account to enter NSCC's Continuous Net Settlement Accounting Operation
(``CNS'') prior to the settlement cycle on the day before Settlement
Date. Securities that are not eligible for CNS but are eligible for
settlement at DTC (``Non-CNS DTC-Eligible Securities'') may be settled
either through another NSCC service or outside of NSCC, depending on
the asset type.
---------------------------------------------------------------------------

    \7\ ACATS is a non-guaranteed service and transfers are not
subject to risk management by NSCC.
---------------------------------------------------------------------------

    In order to incentivize the Delivering Member to make delivery of
the securities, the Delivering Member is charged with a money
settlement debit and the Receiving Member with a money settlement
credit (``Incentive Charges''). Incentive Charges are then reversed
when the securities transfer is complete.
    For ACATS transfers of CNS-eligible securities, NSCC tracks the
receive and deliver obligations in CNS so that NSCC is able to reverse
the uncompleted transfers of a Member that is party to the transfer but
fails to meet its money settlement obligation to NSCC or NSCC ceases to
act for such Member (collectively, ``Fails to Settle''). However, if
two or more Members Fail to Settle, then NSCC may not be able to
identify completed versus uncompleted transfers because ACATS
securities that settle via CNS are fungible with CNS's other activity
and are netted with the guaranteed trades in the same securities that
settle in CNS. As a result, in such a scenario, NSCC may have to
reverse all ACATS transfers relating to those Members, whether or not
the transactions were completed, in order to eliminate the Incentive
Charges.
    For ACATS transfers of Non-CNS DTC-Eligible Securities, the
Delivering Member that fails to make delivery of the securities
(``Fails to Deliver'') will receive a money debit (i.e., an Incentive
Charge) for the full value of the securities. However, NSCC does not
track the completion of those transfers. Thus, if the Delivering Member
ultimately Fails to Settle, NSCC will reverse the Member's ACATS
transfers in order to eliminate the associated money debit.

B. New ACATS Process

    The Proposed Rule Change will create a new ACATS process (``ACATS
Settlement Accounting Operation'') for both CNS-eligible and Non-CNS
DTC-Eligible Securities that will operate outside of CNS. The
initiation of an ACATS transfer will remain the same. However, all
transfers through the ACATS Settlement Accounting Operation will be
made without the application of Incentive Charges (i.e., the transfers
will be made free-of-value). Additionally, applicable ACATS transfers
will be aggregated into one receive and one deliver obligation per
security, per Member. Those obligations will be processed through the
Member's corresponding receive or deliver subaccounts at NSCC, which
NSCC will require each Member participating in the ACATS Settlement
Accounting Operation to establish and maintain.\8\ NSCC will not net
the obligations between a Member's subaccounts.
---------------------------------------------------------------------------

    \8\ An NSCC account at DTC will be established to accommodate
processing of these transfers.
---------------------------------------------------------------------------

    Under the Proposed Rule Change, after NSCC receives securities from
Delivering Members, NSCC will allocate those securities to Receiving
Members. The allocation of these securities will be governed by an
algorithm formulated by NSCC. To maximize customer account deliveries,
NSCC will instruct DTC to deliver shares out of a Delivering Member's
account to satisfy first the Delivering Member's ACATS obligations, and
then the Delivering Member's outstanding CNS obligations.
    The ACATS Settlement Accounting Operation will enable NSCC to track
ACATS obligations at the Member level, so NSCC can identify and
reverse, as necessary, any uncompleted ACATS transfers in the event
that one or more Members Fail to Settle on the scheduled ACATS
settlement date.\9\ An ACATS transfer of a Member that Fails to Settle
will be deemed uncompleted if the Member is: (i) the Delivering Member
and it has Failed to Deliver to NSCC all or a portion of the securities
associated with the ACATS transfer, or (ii) the Receiving Member and it
has failed to receive from NSCC all or a portion of the securities
associated with the ACATS transfer (``Fail to Receive''). However, in
either case, where the Delivering Member has made a partial

delivery for an amount of the securities to NSCC (``Delivered Amount'')
the transfer will be: (i) deemed completed for any amount of the
securities received from NSCC by the Receiving Member up to an amount
not to exceed the Delivered Amount (``Received Amount''), and (ii)
deemed uncompleted for any amount of the securities scheduled for
delivery other than the Received Amount, in which case only the
uncompleted portion of the obligation will be subject to reversal.
---------------------------------------------------------------------------

    \9\ The current process only provides for tracking of a single
Member default for this purpose.
---------------------------------------------------------------------------

    In the event that a Delivering Member and Receiving Member to the
same ACATS transfer Fail to Settle on the same settlement day, then any
transfer deemed uncompleted for the Delivering Member will also be
deemed uncompleted as to the Receiving Member, and vice versa. NSCC
will then notify firms with the details associated with the securities
subject to the reversal and firms will need to reestablish customer
positions accordingly.
    The fact that deliveries will be made free-of-value in the new
ACATS process will obviate any need to reverse completed
transactions.\10\ Securities associated with completed ACATS transfers
will remain with the Receiving Member, thus ensuring that customer
account transfers to new firms are maximized.
---------------------------------------------------------------------------

    \10\ DTC will inform NSCC through the DTC/NSCC interface as to
when deliveries are complete.
---------------------------------------------------------------------------

    If a scheduled securities delivery or receive through ACATS
Settlement Accounting Operation for a transaction Fails to Deliver or
Fails to Receive at the end of the day, but the corresponding Member
has not Failed to Settle, NSCC will apply a funds settlement debit to
the Delivering Member and a funds settlement credit to the Receiving
Member prior to final settlement. For CNS-eligible securities, the
money amount will be 100 percent of the CNS market value.\11\ For Non-
CNS DTC-Eligible Securities, the money amount will be 100 percent of
the ACATS market value. When the Member makes final money settlement,
the failed obligations will take one of two paths depending on whether
they involve CNS-eligible or Non-CNS DTC-Eligible Securities.
---------------------------------------------------------------------------

    \11\ If a market price is unavailable, then NSCC will use the
value provided by the Delivering Member.
---------------------------------------------------------------------------

    For an ACATS obligation in CNS-eligible securities where there has
been a Fail to Deliver or Receive but not a Fail to Settle, the
obligation will enter the applicable Member's general CNS account. The
obligation will then be netted with regular CNS processing. Because
NSCC has collected the full value on the securities, NSCC will
guarantee settlement for the obligations upon their inclusion in CNS.
    For Non-CNS DTC-Eligible Securities, NSCC will provide instructions
to both the Delivering Member and Receiving Member to settle the failed
obligation directly with each other. These transactions will be
automatically entered into NSCC's Obligation Warehouse system, if
eligible.
    The new ACATS process will also provide for ``Level 1'' delivery
exemptions that will allow Members to indicate that deliver obligations
in the ACATS Settlement Accounting Operation should not be
automatically settled against their current DTC position. With respect
to same day settling transactions, Members may select a standing
exemption to permit all such short positions to be delivered.
Additionally, during the daytime cycle, a Member may override the one-
day settling exemption, as well as other exemptions entered by the
Member the previous evening. To use this feature, the Member should
prepare a Delivery Order (``DO'') and submit it to DTC in the normal
manner.
    With this Proposed Rule Change, NSCC will also ensure that neither
DTC nor NSCC will have a lien on securities delivered to a receiver as
a result of an ACATS transfer. Because the new ACATS process will
allocate shares to the Receiving Member via an algorithm that NSCC will
establish for this purpose, as discussed above, DTC will credit the
shares to the Receiving Members Minimum Amount (``MA'') or non-lien/
non-collateral account at DTC.
    Final accounting reports for the ACATS Settlement Accounting
Operation will be provided in conjunction with the final CNS accounting
reports. However, reporting along with the CNS accounting reports will
have no effect on the status of the reported ACATS transactions as non-
guaranteed.

C. Elimination of Short Cover Charge and Long Allocation Reversals

    An ACATS short cover charge is a dollar amount guaranteed by NSCC
to DTC for the value of securities delivered from a DTC Participant
account to NSCC for CNS processing by NSCC. NSCC's guaranty to DTC for
the short cover charge will no longer be applicable because, under the
new ACATS process, the deliveries no longer present risk to DTC. As
such, DTC will delete provisions in its procedures related to ACATS
short cover charges.\12\ No change to NSCC's Rules is required.
---------------------------------------------------------------------------

    \12\ See DTC Proposal, 79 FR 20260.
---------------------------------------------------------------------------

    At NSCC, under the current ACATS process, long allocations may be
reversed if the NSCC Member Fails to Settle. Because ACATS transfers
under the new process will not generate any funds settlement
obligations, this reversal is eliminated. As such, DTC will delete
provisions in its procedures describing the reversal of ACATS long
allocations.\13\ No change to NSCC's Rules is required.
---------------------------------------------------------------------------

    \13\ Id.
---------------------------------------------------------------------------

III. Discussion and Commission Finding

    Section 19(b)(2)(C) of the Act \14\ directs the Commission to
approve a proposed rule change of a self-regulatory organization if it
finds that such proposed rule change is consistent with the
requirements of the Act and rules and regulations thereunder applicable
to such organization. Section 17A(b)(3)(F) of the Act \15\ requires
that the rules of a clearing agency be designed to, among other things,
``promote the prompt and accurate clearance and settlement of
securities transactions and . . . to assure the safeguarding of
securities and funds which are in the custody or control of the
clearing agency or for which it is responsible.'' \16\ The Commission
finds that the Proposed Rule Change is consistent with these
requirements because the new ACATS processing system will enhance
NSCC's ability to track receive and deliver obligations associated with
ACATS activity and preclude the reversal of completed ACATS transfers
in the event that multiple Members Fail to Settle.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(2)(C).
    \15\ 15 U.S.C. 78q-1(b)(3)(F).
    \16\ 15 U.S.C. 78q-1(b)(3)(F).
---------------------------------------------------------------------------

    Further, Commission Rules 17Ad-22(d)(3) \17\ and 17Ad-22(d)(12)
\18\ require that registered clearing agencies establish, implement,
maintain and enforce written policies and procedures reasonable
designed to ``[h]old assets in a manner that minimizes risk of loss or
of delay in its access to them . . .'' \19\ and ``[e]sure that final
settlement occurs no later than the end of the settlement day; and
require that intraday or real-time finality be provided where necessary
to reduce risks.'' \20\
---------------------------------------------------------------------------

    \17\ 17 CFR 240.17Ad-22(d)(3).
    \18\ 17 CFR 240.17Ad-22(d)(12).
    \19\ 17 CFR 240.17Ad-22(d)(3).
    \20\ 17 CFR 240.17Ad-22(d)(12).
---------------------------------------------------------------------------

    Currently, if two or more Members Fail to Settle, NSCC may need to
reverse all ACATS transactions relating to those Members, whether or
not the transactions are completed. The potential that NSCC may be
required to reverse all transactions, including transactions that have
already

completed, may delay a Receiving Member's ability to access the account
being transferred and delay final settlement of the ACATS transfer.
Under the Proposed Rule Change, NSCC will be able to identify and
reverse only uncompleted ACATS obligations in the event of a multiple
Member default, thus minimizing the risk of delayed access to settled
ACATS transfers. As such, the Commission finds the Proposed Rule Change
consistent with Rules 17Ad-22(d)(3) \21\ and 17Ad-22(d)(12).\22\
---------------------------------------------------------------------------

    \21\ 17 CFR 240.17Ad-22(d)(3).
    \22\ 17 CFR 240.17Ad-22(d)(12).
---------------------------------------------------------------------------

IV. Conclusion

    On the basis of the foregoing, the Commission finds that the
proposal is consistent with the requirements of the Act and in
particular with the requirements of Section 17A of the Act \23\ and the
rules and regulations thereunder.
---------------------------------------------------------------------------

    \23\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    It is therefore ordered, pursuant to Section 19(b)(2) of the Act,
that the proposed rule change SR-NSCC-2014-04 be, and it hereby is,
approved.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\24\
---------------------------------------------------------------------------

    \24\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-12419 Filed 5-28-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 88, Number 130 (Monday, July 10, 2023)]
[Notices]
[Pages 43567-43569]
[FR Doc No: 2023-14467]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-1168]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Human Cells, Tissues,
and Cellular and Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the
collection of information by August 9, 2023.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0543. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Human Cells, Tissues, and Cellular and Tissue-Based Products--21 CFR
Part 1271

OMB Control Number 0910-0543--Extension

    This information collection helps support the implementation of
statutory and regulatory requirements that govern certain human cells,
tissues, and cellular and tissue-based products (HCT/Ps). Manufacturers
of HCT/Ps regulated solely under the authority of section 361 of the
Public Health Service Act (the PHS Act) (42 U.S.C. 264) are required to
register and list HCT/Ps pursuant to part 1271 (21 CFR part 1271)
whether or not the HCT/P enters into interstate commerce. Manufacturers
of HCT/Ps regulated as drugs, devices and/or biological products under
section 351 of the PHS Act (42 U.S.C. 262) and/or section 201 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321), are required to
register and list HCT/Ps following the procedures in part 207 (21 CFR
part 207) (if a drug and/or biological product) or part 807 (21 CFR
part 807) (if a device). Information collection associated with the
registration and listing requirements in parts 207 and 807 are
currently approved in OMB control numbers 0910-0045 and 0910-0625,
respectively.
    Agency regulations in part 1271 set forth general provisions
applicable to HCT/Ps in subpart A (Sec. Sec.  1271.1 through 1271.20).
Those HCT/Ps that are regulated solely under the authority of section
361 of the PHS Act are described in Sec.  1271.10. Provisions in part
1271, subpart B (Sec. Sec.  1271.21 through 1271.37), establish
procedures for registration and listing including format and content
elements along with scheduled timeframes for the submission of certain
information and action by FDA. The regulations also provide for waivers
from the electronic format requirement, amendments to establishment
registration, and requesting information on registration and listing
from FDA.
    Registrants use Form FDA 3356, Establishment Registration and
Listing for HCT/Ps, to submit HCT/P establishment registration and
listing information to the Electronic Human Cell and Tissue
Establishment Registration System (eHCTERS). Electronic submission of
HCT/P establishment and product listing information is required under
Sec.  1271.22. However, a request for waiver of the electronic
submission requirement may be submitted pursuant to Sec.  1271.23. If
the waiver request is granted, Form FDA 3356 (and accompanying
instructions) may be downloaded to complete and submit by mail. The
Tissue Establishment Registration page (https://www.fda.gov/vaccines-blood-biologics/biologics-establishment-registration/tissue-establishment-registration) provides access to eHCTERS, instructions
for using eHCTERS, and other resource information that may be helpful
to respondents.
    Provisions in part 1271, subpart C (Sec. Sec.  1271.45 through
1271.90), establish requirements for determining donor eligibility,
including donor screening and testing, explaining these requirements
are a component of current good tissue practice (CGTP) requirements set
forth in part 1271, subpart D (Sec. Sec.  1271.145 through 1271.320).
The provisions in part 1271, subparts C and D, govern the methods used
in, and the facilities and controls used for, the manufacture of HCT/
Ps, including, but not limited to all steps in recovery, donor
screening, donor testing, processing, storage, labeling, packaging, and
distribution.
    The regulations in part 1271, subpart E and subpart F (Sec. Sec.
1271.330 through 1271.440), establish additional requirements for
establishments described in Sec.  1271.10, including inspection and
enforcement provisions, and recordkeeping requirements providing for
the retention, notification to third parties, and disclosure of such
records to FDA.
    In the Federal Register of April 19, 2023 (88 FR 24193), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment in response to the
notice. The comment was outside the scope of the four collection of
information topics on which the notice solicited comments.
    Description of Respondents: Respondents to this information
collection are establishments that recover, process, store, label,
package, or distribute any HCT/P that is regulated solely under section
361 of the PHS Act and regulations in part 1271 or perform donor
screening or testing.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
     21 CFR section; reporting activities         Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses                                                     \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.10(b)(1) and 1271.21(b); register and              2,374               1           2,374  0.5 (30 minutes).........................           1,187
 submit list of each HCT/P manufactured by
 existing establishments.
1271.10(b)(1) and (2), 1271.21(a), and                    157               1             157  0.75 (45 minutes)........................             118
 1271.25(a) and (b); register and submit list
 of each HCT/P manufactured by new
 establishments.
1271.10(b)(2), 1271.21(c)(ii), and                        566               1             566  0.5 (30 minutes).........................             283
 1271.25(c); update list.
1271.23; request electronic format waiver....               1               1               1  1........................................               1
1271.26; location/ownership amendments.......             346               1             346  0.25 (15 minutes)........................              87
1271.155(a); request exemption or alternative              18           1.333              24  3........................................              72
 to any requirement.
1271.350(a)(1) and (3); investigate and                    15          14.266             214  1........................................             214
 report adverse actions.
1271.420(a); notify FDA (imports)............             200             2.8             560  0.25 (15 minutes)........................             140
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............          23.399           4,242  .........................................           2,102
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the nearest whole number.

    Based on current data from eHCTERS, we estimate there are 2,374
HCT/P current registrants and 157 new registrants, for a total of 2,531
respondents annually. Information collection provisions that include
reporting activities are identified in table 1. The estimated burden
for each of the individual reporting activities was calculated based on
the annual number of submissions, averaged among respondents, and based
on informal communications with industry.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
   21 CFR part 1271; establish and maintain       Number of      records per    Total annual                                                Total hours
                   records                      recordkeepers   recordkeeper       records        Average burden per recordkeeping \2\          \3\
                                                                     \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.47; Establishing SOPs...................             157               1             157  48.......................................           7,536
1271.47; Updating SOPs.......................           2,374               1           2,374  24.......................................          56,976
1271 Subparts C & D: Establishing and                   2,531        3,311.36       8,381,049  0.26 (~15 minutes).......................       2,170,493
 maintaining records documenting methods used
 in, and the facilities and controls used
 for, the manufacture of HCT/Ps, including
 but not limited to all steps in recovery,
 donor screening, donor testing, processing,
 storage, labeling, packaging, and
 distribution.
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............       8,383,580  .........................................       2,235,005
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded to the nearest hundredth.
\3\ Rounded to the nearest whole number.

    To calculate burden associated with the establishment and
maintenance of operating procedures in accordance with applicable CGTP
requirements, we assume twice the time is necessary for new
establishments. Burden we attribute to recordkeeping activities
associated with the remaining provisions in part 1271 is assumed to be
distributed among the individual elements and averaged among
respondents.

                                               Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
 21 CFR part 1271--human cells, tissues, and      Number of      disclosures    Total annual
 cellular and tissue-based products; activity    respondents   per respondent    disclosures       Average burden per disclosure \2\        Total hours
                                                                     \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Disclosing information as required under                1,611        4,984.75       8,030,435  0.30 (~18 minutes).......................       2,389,226
 applicable good manufacturing practices/CGTP
 provisions.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Decimals rounded to the nearest hundredth.

    As part of the recordkeeping requirements, certain provisions in
part 1271 require the disclosure of information to third parties,
particularly as it pertains to the distribution of HCT/Ps. We estimate
a proportion of the respondents to the information collection (1,611)
will incur burden resulting from these disclosures and have therefore
accounted for burden that may be attributable to these distinct
activities.
    Our estimated burden for the information collection reflects an
overall reduction of 150,137 hours and 347,843 responses annually,
which corresponds to a decrease in the number HCT/P establishments and
a decrease in the number HCT/Ps distributed since our last evaluation.

    Dated: July 3, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-14467 Filed 7-7-23; 8:45 am]
BILLING CODE 4164-01-P