[Federal Register: May 24, 2006 (Volume 71, Number 100)]
[Notices]
[Page 29928-29929]
[DOCID:fr24my06-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP01-409-006, CP01-410-005, CP01-411-008, and CP01-444-
005]

Calypso U.S. Pipeline, LLC; Notice of Filing

May 16, 2006.
    Take notice that on May 9, 2006, Calypso U.S. Pipeline, LLC
(Calypso) filed an application pursuant to sections 3 and 7 of the
Natural Gas Act (NGA) and part 157 of the Commission's Rules and
Regulations for modifications of the Order Issuing Certificates,
section 3 Authorization, and Presidential Permit issued to Calypso on
March 24, 2004. The primary modifications would alter an aspect of the
construction methodology to be used for the pipeline and enlarge the
diameter of the pipeline. This filing is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, please
contact FERC Online Support at<EMAIL_ADDRESS>or toll free
at<PHONE_NUMBER>, or for TTY, contact<PHONE_NUMBER>.
    The changes for which approval is sought in the application
include: (i) Authority to modify near shore horizontal directional
drilling construction to constructing a tunnel of approximately 10-foot
diameter from a landward point located in Port Everglade, Florida to
appoint approximately 3.20 miles seaward on the sub-sea floor where the
depth is about 126 feet, (ii) authority to expand the diameter of the
pipeline from its originally certificated 24 inches to 30 inches; (iii)
authority to defer the in-service date to June 30, 2010; (iv) approval
of various conforming changes to the rates set forth in Calypso's pro
forma tariff; and (v) modification of certain conditions to
construction set forth in the Commission's original certificate order.
The proposed changes will not affect the certificated capacity of
832,000 MMBtu/day.
    Any questions regarding the application may be directed to Timothy
Fisk, Vice President and Operations Officer, Calypso U.S. Pipeline,
LLC, 1990 Post Oak Boulevard, Suite 1900, Houston, Texas 77056.
Telephone number is<PHONE_NUMBER>.
    Any person wishing to obtain legal status by becoming a party to
the proceedings for this project should, on or before the below listed
comment date, file with the Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426, a motion to intervene in
accordance with the requirements of the Commission's Rules of Practice
and Procedure (18 CFR 385.214 or 385.211). A person obtaining party
status will be placed on the service list maintained by the Secretary
of the Commission and will receive copies of all documents filed by the
applicant and by all other parties. A party must submit 14 copies of
filings made with the Commission and must mail a copy to the applicant
and to every other party in the proceeding. Only parties to the
proceeding can ask

for court review of Commission orders in the proceeding.
    Motions to intervene, protests and comments may be filed
electronically via the Internet in lieu of paper, see, 18 CFR 385.2001
(a)(1)(iii) and the instructions on the Commission's Web site under the
``e-Filing'' link. The Commission strongly encourages electronic
filings.
    Comment Date: June 6, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-7892 Filed 5-23-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 18, 2008 (Volume 73, Number 76)]
[Proposed Rules]
[Page 21076-21083]
[DOCID:fr18ap08-15]

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DEPARTMENT OF COMMERCE

Bureau of Industry and Security

15 CFR Parts 736, 740, 742, 744, 748, 752, 760, and 772

[Docket No. 080220216-8518-01]
RIN 0694-AD59

Conforming Changes to Certain End-User/End-Use Based Controls in
the EAR; Clarification of the Term ``Transfer'' and Related Terms as
Used in the EAR

AGENCY: Bureau of Industry and Security, Commerce.

ACTION: Proposed rule.

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SUMMARY: The Bureau of Industry and Security (BIS) proposes to amend
the Export Administration Regulations (EAR) by making conforming
changes in certain end-user/end-use controls in the EAR to ensure that
the terminology used to describe each type of end-user/end-use control
is consistent, to the fullest extent possible, with the terminology in
other such controls in the EAR. The proposed amendments would clarify
that a party cannot proceed with an export, reexport, or transfer (in-
country) that is in transit at the time the party is informed by BIS
that a license is required (in accordance with certain end-user/end-use
controls in the EAR), unless that party first obtains a license from
BIS authorizing the completion of the transaction. These proposed
changes to part 744 are intended to enhance the ability of BIS to stop
items subject to the EAR, including items not on the Commerce Control
List, from being exported, reexported or transferred (in-country) when
there is an unacceptable risk that such items will be used in, or
diverted to, any of the proliferation activities specified in
Sec. Sec.  744.2, 744.3, 744.4 and 744.6 of the EAR. This rule also
proposes to amend the EAR by revising the definition of the term
``transfer'' and certain related terms, to provide greater clarity
regarding these provisions.

DATES: Comments must be received by June 17, 2008.

ADDRESSES: Written comments on this rule may be sent to the Federal
Register eRulemaking Portal: http://www.regulations.gov, or by e-mail
to<EMAIL_ADDRESS>Include RIN 0694-AD59 in the subject
line of the message. Comments may be submitted by mail or hand delivery
to Timothy Mooney, Office of Exporter Services, Regulatory Policy
Division, Bureau of Industry and Security, U.S. Department of Commerce,
14th St. &

Pennsylvania Avenue, NW., Room H2705, Washington, DC 20230, ATTN: RIN
0694-AD59; or by fax to<PHONE_NUMBER>.
    Send comments regarding the collection of information to David
Rostker, Office of Management and Budget (OMB), by e-mail to David--
<EMAIL_ADDRESS>or by fax to<PHONE_NUMBER>; and to the Regulatory
Policy Division, Bureau of Industry and Security, U.S. Department of
Commerce, 14th St. & Pennsylvania Avenue, NW., Room H2705, Washington,
DC 20230.

FOR FURTHER INFORMATION CONTACT: Timothy Mooney, Office of Exporter
Services, Bureau of Industry and Security, U.S. Department of Commerce;
by telephone:<PHONE_NUMBER>; or by fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

Conforming Changes to Certain End-User/End-Use Based Controls in the
EAR

    Part 744 of the EAR deals with the end-user and end-use based
control policy under the EAR. Section 744.3 prohibits exports,
reexports and transfers (in-country) of items subject to the EAR to
certain missile-related end-uses. Section 744.4 prohibits exports,
reexports and transfers (in-country) of items subject to the EAR to
certain chemical and biological proliferation activities. Section 744.6
prohibits certain activities by U.S. persons in support of certain
nuclear, missile, chemical, or biological end-uses. Section 744.2
presently prohibits exports and reexports of items subject to the EAR
to certain nuclear proliferation activities. This rule proposes to add
transfer (in-country) to the scope of the prohibition set forth in
Sec.  744.2 to ensure that the language in that section conforms with
the language in Sec. Sec.  744.3, 744.4 and 744.6.
    Within each of these sections of part 744, there is a paragraph b
that includes ``is informed'' provisions that set out the requirements
of what persons need to do once they are informed by BIS that their
transactions would be subject to the prohibitions set forth in
Sec. Sec.  744.2, 744.3, 744.4 or 744.6. Under the current EAR, there
are minor differences in the terminology used to describe the end-user/
end-use controls in each of these sections. This rule proposes to amend
the end-user/end-use controls in these sections of part 744 to ensure
that the terminology used in any one of these sections conforms, to the
fullest extent possible, with the terminology used in the other
sections. These proposed changes are intended to make the end-user/end-
use controls in part 744 of the EAR more consistent as well as
transparent, so that members of the public can more clearly understand
their obligations under the EAR.
    In addition, this rule proposes to add new provisions to Sec.
744.1 to clarify that a party cannot proceed with an export, reexport,
or transfer (in-country) that is in transit at the time the party is
informed by BIS that a license is required (in accordance with the end-
user/end-use controls in Sec. Sec.  744.2, 744.3, 744.4 or 744.6 of the
EAR), unless that party first obtains a license from BIS authorizing
the completion of the transaction. This rule proposes that once a
person ``is informed'' by BIS that a transaction is subject to one of
the prohibitions in Sec. Sec.  744.2, 744.3, 744.4 or 744.6, a person
would be required to apply for authorization from BIS before proceeding
with the transaction. This rule further proposes to amend the EAR to
clearly explain the steps a person must take if an item included in
such a transaction is already in transit when a person ``is informed''
by BIS.
    These proposed changes to part 744 are intended to enhance the
ability of BIS to stop items subject to the EAR, including items not on
the Commerce Control List, from being exported, reexported or
transferred (in-country) when there is an unacceptable risk that such
items will be used in, or diverted to, any of the proliferation
activities specified in Sec. Sec.  744.2, 744.3, 744.4 and 744.6 of the
EAR.
    This clarification is consistent with UN Security Council
Resolution 1540 (2004), which includes binding obligations on all UN
Member States to prevent the proliferation of nuclear, chemical, or
biological weapons and their means of delivery, including by
establishing appropriate controls over related materials. UNSCR 1540
stipulates that States are to establish, develop, review and maintain
appropriate effective national export and transshipment controls over
such items, including appropriate laws and regulations to control
export, transit, transshipment and re-export; and to establish and
enforce appropriate criminal or civil penalties for violations of such
export control laws and regulations.
    Through this clarification, the United States is continuing to
carry out its commitment to the Proliferation Security Initiative (PSI)
Statement of Interdiction Principles, which states that PSI partners
will work to strengthen their relevant national legal authorities where
necessary and not to allow any persons subject to their jurisdiction to
transport or assist in the transport of any cargoes of weapons of mass
destruction (WMD), their delivery systems, or related materials to or
from states or non-state actors of proliferation concern. The PSI is a
global effort that aims to stop shipments of WMD, their delivery
systems, and related materials flowing to or from states or non-state
actors of proliferation concern. Announced by President Bush on May 31,
2003, the PSI stems from the National Strategy to Combat Weapons of
Mass Destruction issued in December 2002. That strategy recognizes the
need for more robust tools to defeat the proliferation of WMD around
the world, and specifically identifies interdiction as an area where
greater focus will be placed. The PSI is a set of activities, not a
formal treaty-based organization, that focuses on establishing greater
coordination among its partner states when a particular action is
needed.
    This rule makes the following specific revisions to the EAR:
    1. In Sec.  744.1 (General Provisions), this rule proposes to amend
paragraph (a)(1) (Introduction), by adding ``transfer (in-country)'' to
specify clearly that the prohibitions in Sec. Sec.  744.2, 744.3, 744.4
and 744.6 also apply to such scenarios. This rule also proposes to
amend paragraph (b)(2) (Determine Applicability), by adding a sentence
at the end of that paragraph that states ``For exports, reexports or
transfers (in-country) that are in transit at the time you are informed
by BIS that a license is required in accordance with Sec. Sec.
744.2(b), 744.3(b), 744.4(b) or 744.6(b) of the EAR, you may not
proceed any further with the transaction, unless you first obtain a
license from BIS (see part 748 of the EAR for instructions on how to
apply for a license).'' This rule also proposes to amend paragraph
(a)(1) by adding ``transfer (in-country)'' to specify clearly that the
prohibition specified in Sec.  744.5 also applies to such scenarios.
    2. In Sec.  744.2 (Restrictions on Certain Nuclear End-Uses), this
rule proposes to amend paragraph (a) (General Prohibition) by
clarifying that this prohibition in Sec.  744.2 also applies to
transfers (in-country) to conform with the language used in Sec. Sec.
744.3, 744.4 and 744.6. In paragraph (b) (Additional Prohibition), this
rule proposes to amend the heading to clarify that this paragraph
applies an additional prohibition ``on persons informed by BIS''. Also
in paragraph (b), this rule proposes to amend the ``is informed''
provisions to conform with the ``is informed'' provisions in Sec. Sec.
744.3, 744.4 and 744.6. Specifically, the proposed rule would remove
the phrase ``exporters or reexporters'', replace it

with the term ``persons'' in three locations, and add the phrase
``transfer (in-country)'' to clarify that this prohibition also applies
to transfers (in-country). Also in paragraph (b), this rule proposes to
add the phrase ``or for the export, reexport, or transfer (in-
country)'' before the phrase ``of specified items'' in the first
sentence, among other minor changes, to conform with Sec. Sec.  744.3,
744.4 and 744.6.
    3. In Sec.  744.3 (Restrictions on Certain Rocket Systems
(Including Ballistic Missile Systems and Space Launch Vehicles and
Sounding Rockets) and Unmanned Air Vehicles (Including Cruise Missile
Systems, Target Drones and Reconnaissance Drones) End-Uses), this rule
proposes to amend paragraph (a) (General Prohibition) by inserting the
word ``that'' after the phrase, ``* * * or transfer you know'' and by
deleting the word ``the'' in the phrase ``at the time of export'' to
conform with Sec. Sec.  744.2, 744.4 and 744.6. In paragraph (b)
(Additional Prohibition), this rule proposes to amend the heading to
clarify that this paragraph applies an additional prohibition ``on
persons informed by BIS''. Also in paragraph (b), this rule proposes to
amend the ``is informed'' provisions by adding the word ``persons'' in
two locations, by adding the phrase ``(in-country)'' after the word
transfer and by adding the phrase ``or for the export, reexport, or
transfer (in-country)'' before the phrase ``of specified items'' in the
first sentence, among other minor changes, to conform with Sec. Sec.
744.2, 744.4 and 744.6.
    4. In Sec.  744.6 (Restrictions on Certain Activities of U.S.
Persons), this rule proposes to amend paragraph (a) (General
Prohibition) to conform with Sec. Sec.  744.2, 744.3 and 744.4 by
adding the phrase ``(in-country)'' after the word ``transfer'' in
paragraphs (a)(1)(i) and (a)(1)(ii) and in paragraph (a)(3) to clarify
that this prohibition in Sec.  744.6 also applies to transfers (in-
country). In paragraph (b) (Additional Prohibitions on U.S. persons
informed by BIS) this rule proposes to update the ``is informed''
provisions to conform with Sec. Sec.  744.2, 744.3 and 744.4;
specifically by adding the phrase ``by specific notice'' after the word
``individually'' in the first sentence and by removing the term
``exporter'' and replacing it with the term ``U.S. persons'' in the
last sentence.
    5. In Sec.  744.5 (Restrictions on Certain Maritime Nuclear
Propulsion End-Uses), this rule proposes to amend paragraph (a)
(General Prohibition) by clarifying that this prohibition in Sec.
744.5 also applies to transfers (in-country). With this proposed rule,
this paragraph (a) would prohibit the exports, reexports, and transfers
(in-country) of items subject to the EAR to defined nuclear maritime
end-uses in Sec.  744.5.

Revisions to Definitions of Transfer and Related Terms

    In Sec.  772.1 (Definitions of Terms as Used in the Export
Administration Regulations), this rule proposes to revise the term
``transfer'' to clarify that the term merely refers to a conveyance of
items. This rule proposes to further clarify the definition by
including the definition of ``in-country transfer/transfer (in-
country)'' as an ancillary definition to the term ``transfer'',
referring to the conveyance of items within a single foreign country.
These proposed revisions will provide greater clarity regarding the
meaning of these defined terms under the EAR. In a note at the end of
these definitions, this rule adds cross references to Sec. Sec.
750.7(c) (Changes to a license) and 764.2(e) (Acting with knowledge of
a violation). The term ``transfer'' may also be included on licenses
issued by BIS. In that regard, these cross references are a reminder to
persons involved with items authorized by a BIS license that changes
that can be made to a BIS license are the non-material changes
described in Sec.  750.7(c). In addition, persons should be aware that
any person that knowingly makes a material change to a BIS license
without proper authorization would violate Sec.  764.2(e) of the EAR.
    This rule also proposes to correct several places in the EAR where
the term ``transfer'' is used, but the intended meaning is ``transfer
(in-country)'' or ``in-country transfer''. Specifically, references to
the term ``transfer'' in Sec.  736.2, General Order No. 2 to Supp. No.
1 to part 736, Sec. Sec.  740.5, 740.7, 740.9, 740.11, 740.17, 742.15,
744.3, 744.4, 744.6, Supp. No. 2 to part 748, Sec. Sec.  752.5, 752.8,
752.16, and Supplement No. 3 to part 752 are proposed to be clarified
with this rule. This rule also proposes to clarify that the term
``retransfer'' means ``in-country transfer'' by replacing the term
``retransfer'' with the term ``transfer (in-country)'' in Sec. Sec.
740.11, 740.17, 742.15, 752.5, and Supp. No. 3 to part 752. This rule
also proposes to clarify that the terms ``transferred'' and
``transfer'', in the context of Sec. Sec.  760.1 and 760.3, mean
``assigned to'' and ``assignment'', respectively.
    Although the Export Administration Act expired on August 20, 2001,
the President, through Executive Order 13222 of August 17, 2001, 3 CFR,
2001 Comp., p. 783 (2002), as extended by the Notice of August 15,
2007, 72 FR 46137 (August 16, 2007), has continued the Export
Administration Regulations in effect under the International Emergency
Economic Powers Act.

Rulemaking Requirements

    1. This proposed rule has been determined to be not significant for
purposes of E.O. 12866.
    2. Notwithstanding any other provision of law, no person is
required to respond to, nor shall any person be subject to a penalty
for failure to comply with a collection of information, subject to the
requirements of the Paperwork Reduction Act, unless that collection of
information displays a currently valid Office of Management and Budget
Control Number. This proposed rule involves a collection of information
subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et
seq.). This collection has been approved by the Office of Management
and Budget under control number 0694-0088, ``Multi-Purpose
Application,'' which carries a burden hour estimate of 58 minutes for a
manual or electronic submission. This proposed rule is expected to have
a minimal increase on the total number of license applications
submitted to BIS. Send comments regarding these burden estimates or any
other aspect of these collections of information, including suggestions
for reducing the burden, to David Rostker, Office of Management and
Budget (OMB), and to the Regulatory Policy Division, Bureau of Industry
and Security as indicated in the ADDRESSES section of this rule.
    3. This rule does not contain policies with Federalism implications
as that term is defined under E.O. 13132.
    4. The provisions of the Administrative Procedure Act (5 U.S.C.
553) requiring notice of proposed rulemaking, the opportunity for
public participation, and a delay in effective date, are inapplicable
because this regulation involves a military and foreign affairs
function of the United States (5 U.S.C. 553(a)(1)). Further, no other
law requires that a notice of proposed rulemaking and an opportunity
for public comment be given for this rule. Because a notice of proposed
rulemaking and an opportunity for public comment are not required to be
given for this rule under the Administrative Procedure Act or by any
other law, the analytical requirements of the Regulatory Flexibility
Act (5 U.S.C. 601 et seq.) are not applicable. However, in order to
obtain the benefit of a variety of viewpoints before publishing any
final rule, BIS is issuing this proposed rule with request for
comments. Comments must be received by BIS no later than

June 17, 2008. In developing a final rule, BIS will consider all
comments received on or before that date. Comments received after the
end of the comment period will be considered if possible, but their
consideration cannot be assured. BIS will not accept public comments
accompanied by a request that a part or all of the material be treated
confidentially because of its business proprietary nature or for any
other reason. BIS will return such comments and materials to the
persons submitting the comments and will not consider them in the
development of the final rule. All public comments on this proposed
rule must be in writing (including fax or e-mail) and will be a matter
of public record, available for public inspection and copying at the
Federal eRulemaking Portal at http://www.regulations.gov and on the BIS
Freedom of Information Act (FOIA) Web site at http://www.bis.doc.gov/
foia. BIS does not maintain a separate public inspection facility. If
you have technical difficulties accessing this Web site, please call
BIS's Office of Administration at<PHONE_NUMBER> for assistance.

List of Subjects

15 CFR Part 736 and 772

    Exports.

15 CFR Part 740, 748, and 752

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

15 CFR Part 742

    Exports, Terrorism.

15 CFR Part 744

    Exports, Reporting and recordkeeping requirements, Terrorism.

15 CFR Part 760

    Boycotts, Exports, Reporting and recordkeeping requirements.
    Accordingly, parts 736, 740, 742, 744, 748, 752, 760, and 772 of
the Export Administration Regulations (15 CFR parts 730-774) are
proposed to be amended as follows:

PART 736--[AMENDED]

    1. The authority citation for 15 CFR part 736 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 2151 (note), Pub. L. 108-175; E.O. 12938, 59 FR 59099, 3
CFR, 1994 Comp., p. 950; E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp.
p. 219; E.O. 13026, 61 FR 58767, 3 CFR, 1996 Comp., p. 228; E.O.
13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13338, 69 FR
26751, May 13, 2004; Notice of August 3, 2006, 71 FR 44551 (August
7, 2006); Notice of October 27, 2006, 71 FR 64109 (October 31,
2006); Notice of August 15, 2007, 72 FR 46137 (August 16, 2007).

    2. Section 736.2 is amended by revising the first sentence of
paragraph (b)(10) to read as follows:

Sec.  736.2  General prohibitions and determination of applicability.

* * * * *
    (b) * * *
    (10) * * * You may not sell, transfer, export, reexport, finance,
order, buy, remove, conceal, store, use, loan, dispose of, transport,
forward, or otherwise service, in whole or in part, any item subject to
the EAR and exported or to be exported with knowledge that a violation
of the Export Administration Regulations, the Export Administration Act
or any order, license, License Exception, or other authorization issued
thereunder has occurred, is about to occur, or is intended to occur in
connection with the item. * * *
    3. General Order No. 2 to Supplement No. 1 to part 736, is amended
by revising the last sentence of paragraph (b) to read as follows:

Supplement No. 1 to Part 736--General Orders

* * * * *

General Order No. 2

* * * * *
    (b) * * * License conditions requiring written U.S. Government
authorization for the reexport, transfer (in-country), or resale of
items already exported or reexported remain in effect, and requests
for BIS authorization to reexport, transfer (in-country), or sell
such items will require interagency approval.
* * * * *

PART 740--[AMENDED]

    4. The authority citation for 15 CFR part 740 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
Sec. 901-911, Pub. L. 106-387; E.O. 13026, 61 FR 58767, 3 CFR, 1996
Comp., p. 228; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783;
Notice of August 3, 2006, 71 FR 44551 (August 7, 2006); Notice of
August 15, 2007, 72 FR 46137 (August 16, 2007).

    5. Section 740.5 is amended by revising paragraph (b)(1) to read as
follows:

Sec.  740.5  Civil end-users (CIV).

* * * * *
    (b) Restrictions.--(1) Restricted end-users and end-uses. You may
not use CIV if you ``know'' the item will be or is intended to be
exported, reexported, or transferred (in-country) to military uses or
military end-users. Such exports, reexports, and transfers (in-country)
will continue to require a license. In addition to conventional
military activities, military uses include any proliferation activities
described and prohibited by part 744 of the EAR.
* * * * *
    6. Section 740.7 is amended:
    a. By revising the first sentence of paragraph (b)(3); and
    b. By revising paragraph (b)(5) to read as follows:

Sec.  740.7  Computers (APP).

* * * * *
    (b) * * *
    (3) Computers and software eligible for License Exception APP may
not be reexported or transferred (in-country) without prior
authorization from BIS, i.e., a license, a permissive reexport, another
License Exception, or ``No License Required''. * * *
    (4) * * *
    (5) License Exception APP does not authorize exports, reexports and
transfers (in-country) for nuclear, chemical, biological, or missile
end-users and end-uses subject to license requirements under Sec.
744.2, Sec.  744.3, Sec.  744.4, and Sec.  744.5 of the EAR. Such
exports, reexports and transfers (in-country) will continue to require
a license and will be considered on a case-by-case basis. Reexports and
transfers (in-country) to these end-users and end-uses in eligible
countries are strictly prohibited without prior authorization.
* * * * *
    7. Section 740.9 is amended by revising paragraph (a)(2)(ix)(A) to
read as follows:

Sec.  740.9  Temporary imports, exports, and reexports (TMP).

* * * * *
    (a) * * *
    (2) * * *
    (ix) Temporary exports to a U.S. subsidiary, affiliate or facility
in Country Group B.
    (A) Components, parts, tools or test equipment exported by a U.S.
person to its subsidiary, affiliate or facility in a country listed in
Country Group B (see Supplement No. 1 to this part) that is owned or
controlled by the U.S. person, if the components, part, tool or test
equipment is to be used for manufacture, assembly, testing, production
or modification, provided that no components, parts, tools or test
equipment or the direct product of such components, parts, tools or
test equipment are transferred (in-country) or reexported from such
subsidiary, affiliate or facility without prior authorization by BIS.
* * * * *

    8. Section 740.11 is amended by revising paragraph (c)(3) to read
as follows:

Sec.  740.11  Governments, international organizations, and
international inspections under the Chemical Weapons Convention (GOV).

* * * * *
    (c) * * *
    (3) Confidentiality. The application of the provisions of this
paragraph (c) is subject to the condition that the confidentiality of
business information is strictly protected in accordance with
applicable provisions of the EAR and other U.S. laws regarding the use
and transfer of U.S. goods and services.
* * * * *
    9. Section 740.17 is amended by revising the second sentence of the
introductory text of paragraph (a)(1) to read as follows:

Sec.  740.17  Encryption commodities and software (ENC).

* * * * *
    (a) * * *
    (1) * * * Any encryption item produced or developed with an item
exported or reexported under this paragraph (a)(1) is subject to the
EAR and requires review and authorization before any sale or transfer
outside of the private sector end-user that developed it. * * *
* * * * *

PART 742--[AMENDED]

    10. The authority citation for 15 CFR part 742 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; Sec. 901-911, Pub. L. 106-
387; Sec. 221, Pub. L. 107-56; 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 of May 7, 2003, 68 FR 26459, May
16, 2003; Notice of August 3, 2006, 71 FR 44551 (August 7, 2006);
Notice of October 27, 2006, 71 FR 64109 (October 31, 2006); Notice
of August 15, 2007, 72 FR 46137 (August 16, 2007).

    11. Section 742.15 is amended by revising the second sentence of
paragraph (b)(3)(i) to read as follows:

Sec.  742.15  Encryption items.

* * * * *
    (b) * * *
    (3) * * *
    (i) * * *
    All items produced or developed by U.S. subsidiaries with
encryption commodities, software and technology exported under this
paragraph are subject to the EAR and require review and authorization
before any sale or transfer outside of the U.S. company.
* * * * *

PART 744--[AMENDED]

    12. The authority citation for 15 CFR part 744 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
22 U.S.C. 3201 et seq.; 42 U.S.C. 2139a; Sec. 901-911, Pub. L. 106-
387; Sec. 221, Pub. L. 107-56; 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. 12947, 60
FR 5079, 3 CFR, 1995 Comp., p. 356; E.O. 13026, 61 FR 58767, 3 CFR,
1996 Comp., p. 228; E.O. 13099, 63 FR 45167, 3 CFR, 1998 Comp., p.
208; E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; E.O. 13224,
66 FR 49079, 3 CFR, 2001 Comp., p. 786; Notice of August 3, 2006, 71
FR 44551 (August 7, 2006); Notice of October 27, 2006, 71 FR 64109
(October 31, 2006); Notice of August 15, 2007, 72 FR 46137 (August
16, 2007).

    13. Section 744.1 is amended by revising paragraphs (a)(1) and
(b)(2) to read as follows:

Sec.  744.1  General provisions.

    (a)(1) Introduction. In this part, references to the EAR are
references to 15 CFR chapter VII, subchapter C. This part contains
prohibitions against exports, reexports, and selected transfers to
certain end-users and end-uses as introduced under General Prohibition
Five (End-use/End-users) and Nine (Orders, Terms, and Conditions),
unless authorized by BIS. Sections 744.2, 744.3, 744.4 prohibit
exports, reexports and transfers (in-country) of items subject to the
EAR to defined nuclear, missile, and chemical and biological
proliferation activities. Section 744.5 prohibits exports, reexports
and transfers (in-country) of items subject to the EAR to defined
nuclear maritime end-uses. Section 744.6 prohibits certain activities
by U.S. persons in support of certain nuclear, missile, chemical, or
biological end-uses. Section 744.7 prohibits exports and reexports of
certain items for certain aircraft and vessels. Section 744.9 prohibits
U.S. persons from providing technical assistance to certain foreign
persons seeking to develop or manufacture certain encryption
commodities or software. Section 744.10 prohibits exports and reexports
of any item subject to the EAR to Russian entities, included in
Supplement No. 4 of this part. Sections 744.12, 744.13 and 744.14
prohibit exports and reexports of any item subject to the EAR to
persons designated as Specially Designated Global Terrorists, Specially
Designated Terrorists, or Foreign Terrorist Organizations,
respectively. Section 744.19 sets forth BIS's licensing policy for
applications for exports or reexports when a party to the transaction
is an entity that has been sanctioned pursuant to any of three
specified statutes that require certain license applications to be
denied. Section 744.20 requires a license, to the extent specified in
Supplement No. 4 to this part, for exports and reexports of items
subject to the EAR destined to certain sanctioned entities listed in
Supplement No. 4 to this part. Section 744.15 describes restrictions on
exports and reexports to persons named in general orders. In addition,
these sections include license review standards for export license
applications submitted as required by these sections. It should also be
noted that part 764 of the EAR prohibits exports, reexports and certain
transfers of items subject to the EAR to denied parties.
* * * * *
    (b) * * *
    (2) Determine applicability. Second, determine whether any of the
end-use and end-user prohibitions described in this part are applicable
to your planned export, reexport, transfer (in-country) or other
activity. See Supplement No. 1 to part 732 for guidance. For exports,
reexports or transfers (in-country) that are in transit at the time you
are informed by BIS that a license is required in accordance with
Sec. Sec.  744.2(b), 744.3(b), 744.4(b) or 744.6(b) of the EAR, you may
not proceed any further with the transaction unless you first obtain a
license from BIS (see part 748 of the EAR for instructions on how to
apply for a license). The provisions of Sec.  748.4(d)(2) shall not
apply to license applications submitted pursuant to a notification from
BIS that occurs while an export, reexport, or transfer (in-country) is
in transit.
* * * * *
    14. Section 744.2 is amended by revising paragraph (a) introductory
text and paragraph (b) to read as follows:

Sec.  744.2  Restrictions on certain nuclear end-uses.

    (a) General prohibition. In addition to the license requirements
for items specified on the CCL, you may not export, reexport, or
transfer (in-country) to any destination, other than countries in
Supplement No. 3 to this part, an item subject to the EAR without a
license if, at the time of export, reexport, or transfer (in-country)
you know \1\ that

the item will be used directly or indirectly in any one or more of the
following activities described in paragraphs (a)(1), (a)(2), and (a)(3)
of this section:
---------------------------------------------------------------------------

    \1\ Part 772 of the EAR defines ``knowledge'' for all of the EAR
except part 760, Restrictive Trade Practices and Boycotts. The
definition, which includes variants such as ``know'' and ``reason to
know'', encompasses more than positive knowledge. Thus, the use of
``know'' in this section in place of the former wording ``know or
have reason to know'' does not lessen or otherwise change the
responsibilities of persons subject to the EAR.
---------------------------------------------------------------------------

* * * * *
    (b) Additional prohibition on persons informed by BIS. BIS may
inform persons, either individually by specific notice or through
amendment to the EAR, that a license is required for a specific export,
reexport, or transfer (in-country), or for the export, reexport, or
transfer (in-country) of specified items to a certain end-user, because
there is an unacceptable risk of use in, or diversion to, the
activities specified in paragraph (a) of this section. Specific notice
is to be given only by, or at the direction of, the Deputy Assistant
Secretary for Export Administration. When such notice is provided
orally, it will be followed by a written notice within two working days
signed by the Deputy Assistant Secretary for Export Administration.
However, the absence of any such notification does not excuse persons
from compliance with the license requirements of paragraph (a) of this
section.
* * * * *
    15. Section 744.3 is amended:
    a. By revising paragraph (a) introductory text;
    b. By revising paragraph (b); and
    c. By revising paragraph (d)(1) to read as follows:

Sec.  744.3  Restrictions on certain rocket systems (including
ballistic missile systems and space launch vehicles and sounding
rockets) and unmanned air vehicles (including cruise missile systems,
target drones and reconnaissance drones) end-uses.

    (a) General prohibition. In addition to the license requirements
for items specified on the CCL, you may not export, reexport, or
transfer (in-country) an item subject to the EAR without a license if,
at the time of export, reexport or transfer (in-country) you know that
the item:
* * * * *
    (b) Additional prohibition on persons informed by BIS. BIS may
inform persons, either individually by specific notice or through
amendment to the EAR, that a license is required for a specific export,
reexport or transfer (in-country) or for the export, reexport, or
transfer (in-country) of specified items to a certain end-user, because
there is an unacceptable risk of use in, or diversion to, the
activities specified in paragraphs (a)(1) or (a)(2) of this section.
Specific notice is to be given only by, or at the direction of, the
Deputy Assistant Secretary for Export Administration. When such notice
is provided orally, it will be followed by a written notice within two
working days signed by the Deputy Assistant Secretary for Export
Administration. However, the absence of any such notification does not
excuse persons from compliance with the license requirements of
paragraphs (a)(1), (a)(2), or (a)(3) of this section.
* * * * *
    (d) License review standards.
    (1) Applications to export, reexport or transfer (in-country) the
items subject to this section will be considered on a case-by-case
basis to determine whether the export, reexport or transfer (in-
country) would make a material contribution to the proliferation of
certain rocket systems, or unmanned air vehicles. When an export,
reexport or transfer (in-country) is deemed to make a material
contribution, the license will be denied.
* * * * *
    16. Section 744.4 is amended:
    a. By revising paragraph (a); and
    b. By revising paragraph (d)(1) to read as follows:

Sec.  744.4  Restrictions on certain chemical and biological weapons
end-uses.

    (a) General prohibition.
    In addition to the license requirements for items specified on the
CCL, you may not export, reexport, or transfer (in-country) an item
subject to the EAR without a license if, at the time of export,
reexport, or transfer (in-country) you know that the item will be used
in the design, development, production, stockpiling, or use of chemical
or biological weapons in or by any country or destination, worldwide.
* * * * *
    (d) License review standards.
    (1) Applications to export, reexport, or transfer (in-country)
items subject to this section will be considered on a case-by-case
basis to determine whether the export, reexport, or transfer (in-
country) would make a material contribution to the design, development,
production, stockpiling, or use of chemical or biological weapons. When
an export, reexport, or transfer (in-country) is deemed to make such a
contribution, the license will be denied.
* * * * *
    17. Section 744.5 is amended by revising the first sentence of
paragraph (a) to read as follows:

Sec.  744.5  Restrictions on certain maritime nuclear end-uses.

    (a) In addition to the license requirements for items specified on
the CCL, you may not export, reexport, or transfer (in-country) certain
technology subject to the EAR without a license if at the time of the
export, reexport, or transfer (in-country) you know the item is for use
in connection with a foreign maritime nuclear propulsion project. * * *
* * * * *
    18. Section 744.6 is amended:
    a. By revising paragraph (a)(1)(i) introductory text;
    b. By revising paragraph (a)(1)(ii);
    c. By revising paragraph (a)(3); and
    d. By revising paragraph (b) to read as follows:

Sec.  744.6  Restrictions on certain activities of U.S. persons.

    (a) * * *
    (1) * * *
    (i) No U.S. person as defined in paragraph (c) of this section may,
without a license from BIS, export, reexport, or transfer (in-country)
an item where that person knows that such item:
    (ii) No U.S. person shall, without a license from BIS, knowingly
support an export, reexport, or transfer (in-country) that does not
have a license as required by this section. Support means any action,
including financing, transportation, and freight forwarding, by which a
person facilitates an export, reexport, or transfer (in-country).
    (2) * * *
    (3) Whole plant requirement. No U.S. person shall, without a
license from BIS, participate in the design, construction, export,
reexport, or transfer (in-country) of a whole plant to make chemical
weapons precursors identified in ECCN 1C350, in countries other than
those listed in Country Group A:3 (Australia Group) (See Supplement No.
1 to part 740 of the EAR).
    (b) Additional prohibitions on U.S. persons informed by BIS. BIS
may inform U.S. persons, either individually by specific notice or
through amendment to the EAR, that a license is required because an
activity could involve the types of participation and support described
in paragraph (a) of this section. Specific notice is to be given only
by, or at the direction of, the Deputy Assistant Secretary for Export
Administration. When such notice is provided orally, it will be
followed by a written notice within two working days signed by the
Deputy Assistant

Secretary for Export Administration. However, the absence of any such
notification does not excuse the U.S. person from compliance with the
license requirements of paragraph (a) of this section.
* * * * *

PART 748--[AMENDED]

    19. The authority citation for 15 CFR part 748 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 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; Notice of August 3, 2006, 71 FR
44551 (August 7, 2006); Notice of August 15, 2007, 72 FR 46137
(August 16, 2007).

    20. Supplement No. 2 to part 748 is amended by revising paragraph
(c)(2) to read as follows:

Supplement No. 2 to Part 748--Unique Application and Submission
Requirements

* * * * *
    (c) * * *
    (2) Security Safeguard Plan requirement. The United States
requires security safeguards for exports, reexports, and transfers
(in-country) of High Performance Computers (HPCs) to ensure that
they are used for peaceful purposes. If you are submitting a license
application for an export, reexport, or in-country transfer of a
high performance computer to or within a destination in Computer
Tier 3 (see Sec.  740.7(c)(1) of the EAR) or to Cuba, Iran, North
Korea, Sudan, or Syria you must include with your license
application a security safeguard plan signed by the end-user, who
may also be the ultimate consignee. This requirement also applies to
exports, reexports, and transfers (in-country) of components or
electronic assemblies to upgrade existing ``computer'' installations
in those countries. A sample security safeguard plan is posted on
BIS's Web page at http://www.bis.doc.gov/hpcs/
SecuritySafeguardPlans.html.
* * * * *

PART 752--[AMENDED]

    21. The authority citation for 15 CFR part 752 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13020, 61 FR 54079, 3 CFR, 1996 Comp., p. 219; E.O. 13222, 66
FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August 3, 2006, 71 FR
44551 (August 7, 2006); Notice of August 15, 2007, 72 FR 46137
(August 16, 2007).

    22. Section 752.5 is amended by revising the undesignated paragraph
at the end of (c)(8)(ii) to read as follows:

Sec.  752.5  Steps you must follow to apply for an SCL.

* * * * *
    (c) * * *
    (8) * * *
    (ii) * * *
    No chemicals or chemical equipment received under this Special
Comprehensive License will be transferred, resold, or reexported to a
destination or end-user that requires a license, unless the new end-
user has been approved by the Bureau of Industry and Security, and in
no case will the items be transferred, resold, or reexported to a party
who is not the end-user.
* * * * *
    23. Section 752.8 is amended by revising the last sentence of
paragraph (a) to read as follows:

Sec.  752.8  SCL application review process.

    (a) * * * In reviewing and approving a specific SCL request, BIS
retains the right to limit the eligibility of items or to prohibit the
export, reexport, or transfer (in-country) of items under the SCL to
specific firms, individuals, or countries.
* * * * *
    24. Section 752.16 is amended by revising paragraph (a)(1)(v) to
read as follows:

Sec.  752.16  Administrative actions.

    (a)(1) * * *
    (v) Require that certain exports, reexports, or transfers (in-
country) be individually authorized by BIS;
* * * * *
    25. Supplement No. 3 to part 752 is amended by revising Block (8)
paragraph (iv) to read as follows:

Supplement No. 3 to Part 752--Instructions on Completing Form BIS-752
``Statement by Consignee in Support of Special Comprehensive License''

* * * * *

Block 8: Disposition or Use of Items.

* * * * *
    (iv) Item (d): Complete this Block if your company plans to
transfer or resell within the country of import. State the end-use
of your customers. If you plan to transfer to end-users that require
prior approval by BIS, complete and attach Form BIS-748P-B, End-User
Appendix.
* * * * *

PART 760--[AMENDED]

    26. The authority citation for 15 CFR part 760 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
3, 2006, 71 FR 44551 (August 7, 2006); Notice of August 15, 2007, 72
FR 46137 (August 16, 2007).

    27. Section 760.1 is amended by revising the first and second
sentences of paragraph (b)(4)(viii) to read as follows:

Sec.  760.1  Definitions.

* * * * *
    (b) * * *
    (4) * * *
    (viii) At the request of country Y, A, an individual employed by
U.S. company B, is assigned to company C as an employee. C is a foreign
company owned and controlled by country Y. A, a U.S. national who will
reside in Y, has agreed to the assignment provided he is able to retain
his insurance, pension, and other benefits. * * *
* * * * *
    28. Section 760.3 is amended by revising the first sentence of
paragraph (f)(4)(i) to read as follows:

Sec.  760.3  Exceptions to prohibitions.

* * * * *
    (f) * * *
    (4) * * *
    (i) A, a U.S. individual employed by B, a U.S. manufacturer of
sporting goods with a plant in boycotting country Y, wishes to obtain a
work visa so that he may be assigned to the plant in Y. * * *
* * * * *

PART 772--[AMENDED]

    29. The authority citation for 15 CFR part 772 continues to read as
follows:

    Authority: 50 U.S.C. app. 2401 et seq.; 50 U.S.C. 1701 et seq.;
E.O. 13222, 66 FR 44025, 3 CFR, 2001 Comp., p. 783; Notice of August
3, 2006, 71 FR 44551 (August 7, 2006); Notice of August 15, 2007, 72
FR 46137 (August 16, 2007).

    30. Section 772.1 is amended by revising the definition of
``transfer.''

Sec.  772.1  Definitions of terms as used in the Export Administration
Regulations (EAR).

* * * * *
    Transfer. A shipment, transmission, or release to any person of
items subject to the EAR either within the United States or outside the
United States.
    (a) In-country transfer/transfer (in-country). The shipment,
transmission, or release of items subject to the EAR from one person to
another person that occurs outside the United States within a single
foreign country.
    (b) Reserved.

    Note to the definition of transfer:
    This definition of transfer does not apply to Sec.  750.10 or
Supplement No. 8 to part 760 of the EAR. The term ``transfer'' may
also be included on licenses issued by BIS. In that regard, the
changes that can be made to a BIS license are the non-material
changes described in Sec.  750.7(c). Any other change to a BIS
license without authorization is a

violation of the EAR. See Sec. Sec.  750.7(c) and 764.2(e).

* * * * *

    Dated: April 9, 2008.
Matthew S. Borman,
Acting Assistant Secretary for Export Administration.
 [FR Doc. E8-8197 Filed 4-17-08; 8:45 am]

BILLING CODE 3510-33-P


[Federal Register Volume 87, Number 144 (Thursday, July 28, 2022)]
[Notices]
[Pages 45328-45331]
[FR Doc No: 2022-16175]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-1590]

Food Safety Modernization Act Voluntary Qualified Importer
Program User Fee Rate for Fiscal Year 2023

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
fiscal year (FY) 2023 annual fee rate for importers approved to
participate in the Voluntary Qualified Importer Program that is
authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as
amended by the FDA Food Safety Modernization Act (FSMA).

DATES: This fee is effective on August 1, 2022, and will remain in
effect through September 30, 2023.

FOR FURTHER INFORMATION CONTACT: Donald Prater, Office of Food Policy
and Response, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 3202, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 302 of FSMA (Pub L. 111-353), Voluntary Qualified Importer
Program (VQIP), amended the FD&C Act to create a new provision, section
806, under the same name. Section 806 of the FD&C Act (21 U.S.C. 384b)
directs FDA to establish a program to provide for the expedited review
and importation of food offered for importation by importers who have
voluntarily agreed to participate in such program, and a process,
consistent with section 808 of the FD&C Act (21 U.S.C. 384d), for the
issuance of a facility certification to accompany a food offered for
importation by importers participating in the VQIP.
    Section 743 of the FD&C Act (21 U.S.C. 379j-31) authorizes FDA to
assess and collect fees from each importer participating in VQIP to
cover FDA's costs of administering the program. Each fiscal year, fees
are to be established based on an estimate of 100 percent of the costs
for the year. The fee rates must be published in a Federal Register
notice not later than 60 days before the start of each FY (section
743(b)(1) of the FD&C Act). After FDA approves a VQIP application, the
user fee must be paid before October 1, the start of the VQIP FY, to
begin receiving benefits for that VQIP fiscal year.
    The FY 2023 VQIP user fee will support benefits from October 1,
2022, through September 30, 2023.

II. Estimating the Average Cost of a Supported Direct FDA Work Hour for
FY 2023

    FDA is required to estimate 100 percent of its costs for each
activity in order to establish fee rates for FY 2023. In each year, the
costs of salary (or personnel compensation) and benefits for FDA
employees account for between 50 and 60 percent of the funds available
to, and used by, FDA. Almost all of the remaining funds (operating
funds) available to FDA are used to support FDA employees for paying
rent, travel, utility, information technology (IT), and other operating
costs.

A. Estimating the Full Cost per Direct Work Hour in FY 2023

    Full-time Equivalent (FTE) reflects the total number of regular
straight-time hours (not including overtime or holiday hours) worked by
employees, divided by the number of compensable hours applicable to
each fiscal year. Annual leave, sick leave, compensatory time off, and
other approved leave categories are considered ``hours worked'' for
purposes of defining FTE employment.
    In general, the starting point for estimating the full cost per
direct work hour is to estimate the cost of an FTE or paid staff year.
Calculating an Agency-wide total cost per FTE requires three primary
cost elements: payroll, non-payroll, and rent.
    We have used an average of past year cost elements to predict the
FY 2023 cost. The FY 2023 FDA-wide average

cost for payroll (salaries and benefits) is $173,393; non-payroll
(including equipment, supplies, IT, general and administrative
overhead) is $103,078; and rent (including cost allocation analysis and
adjustments for other rent and rent-related costs) is $23,944 per paid
staff year, excluding travel costs.
    Summing the average cost of an FTE for payroll, non-payroll, and
rent, brings the FY 2023 average fully supported cost to $300,416 \1\
per FTE, excluding travel costs. FDA will use this base unit fee in
determining the hourly fee rate for VQIP fees for FY 2023 prior to
including domestic or foreign travel costs as applicable for the
activity.
---------------------------------------------------------------------------

    \1\ Total includes rounding.
---------------------------------------------------------------------------

    To calculate an hourly rate, FDA must divide the FY 2023 average
fully supported cost of $300,416 per FTE by the average number of
supported direct FDA work hours in FY 2021 (the last FY for which data
are available). See table 1.

Table 1--Supported Direct FDA Work Hours in a Paid Staff Year in FY 2021
------------------------------------------------------------------------

------------------------------------------------------------------------
Total number of hours in a paid staff year..............           2,080
Less:
    11 paid holidays....................................             -88
    20 days of annual leave.............................            -160
    10 days of sick leave...............................             -80
    12.5 days of training...............................            -100
    22 days of general administration...................            -176
    26.5 days of travel.................................            -212
    2 hours of meetings per week........................            -104
                                                         ---------------
        Net Supported Direct FDA Work Hours Available              1,160
         for Assignments................................
------------------------------------------------------------------------

    Dividing the average fully supported FTE cost in FY 2023 ($300,416)
by the total number of supported direct work hours available for
assignment in FY 2021 (1,160) results in an average fully supported
cost of $259 (rounded to the nearest dollar), excluding inspection
travel costs, per supported direct work hour in FY 2023.

B. Adjusting FY 2021 Travel Costs for Inflation To Estimate FY 2023
Travel Costs

    To adjust the hourly rate for FY 2023, FDA must estimate the cost
of inflation in each year for FY 2022 and FY 2023. FDA uses the method
prescribed for estimating inflationary costs under the Prescription
Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1)
(21 U.S.C. 379h(c)(1)), the statutory method for inflation adjustment
in the FD&C Act that FDA has used consistently. FDA previously
determined the FY 2022 inflation rate to be 2.2013 percent; this rate
was published in the FY 2022 PDUFA user fee rates notice in the Federal
Register (August 16, 2021, 86 FR 45732). Utilizing the method set forth
in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation
rate of 2.2013 percent for FY 2022 and 1.6404 percent for FY 2023. FDA
intends to use these inflation rates to make inflation adjustments for
FY 2023; the derivation of this rate will be published in the Federal
Register in the FY 2023 notice for the PDUFA user fee rates. The
compounded inflation rate for FYs 2022 and 2023 is 1.038778 (or 3.8778
percent) (calculated as 1 plus 2.2013 percent times 1 plus 1.6404
percent).
    The average fully supported cost per supported direct FDA work
hour, excluding travel costs, of $259 already takes into account
inflation as the calculation above is based on FY 2023 predicted costs.
FDA will use this base unit fee in determining the hourly fee rate for
VQIP fees for FY 2023 prior to including domestic or foreign travel
costs as applicable for the activity. In FY 2021, FDA's Office of
Regulatory Affairs (ORA) spent a total of $4,920,033 for domestic
regulatory inspection travel costs and General Services Administration
Vehicle costs related to FDA's Center for Food Safety and Applied
Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) field
activities programs. The total ORA domestic travel costs spent is then
divided by the 4,965 CFSAN and CVM domestic inspections, which averages
a total of $991 per inspection. These inspections average 46.43 hours
per inspection. Dividing $991 per inspection by 46.43 hours per
inspection results in a total and an additional cost of $21 (rounded to
the nearest dollar) per hour spent for domestic inspection travel costs
in FY 2021. To adjust for the $21 per hour additional domestic cost
inflation increases for FY 2022 and FY 2023, FDA must multiply the FY
2022 PDUFA inflation rate adjustor (1.022013) by the FY 2023 PDUFA
inflation rate adjustor (1.038778) times the $21 additional domestic
cost, which results in an estimated cost of $22 (rounded to the nearest
dollar) per paid hour in addition to $259 for a total of $281 per paid
hour ($259 plus $22) for each direct hour of work requiring domestic
inspection travel. FDA will use these rates in charging fees in FY 2023
when domestic travel is required.
    In FY 2020,\2\ ORA spent a total of $1,449,058 on 171 foreign
inspection trips related to FDA's CFSAN and CVM field activities
programs, which averaged a total of $8,474 per foreign inspection trip.
These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing
$8,474 per trip by 120 hours per trip results in a total and an
additional cost of $71 (rounded to the nearest dollar) per paid hour
spent for foreign inspection travel costs in FY 2020. To adjust $71 for
inflationary increases in FY 2021, FY 2022, and FY 2023, FDA must
multiply it by the same inflation factors mentioned previously in this
document (1.022013 and 1.038778) and the inflation factor for FY 2021
\3\ (1.013493), which results in an estimated cost of $75 (rounded to
the nearest dollar) per paid hour in addition to $259 for a total of
$334 per paid hour ($259 plus $75) for each direct hour of work
requiring foreign inspection travel. FDA will use these rates in
charging fees in FY 2023 when foreign travel is required.
---------------------------------------------------------------------------

    \2\ We use FY 2020 numbers for the foreign inspection travel
costs due to the limited number of inspections done in FY2021 due to
travel restrictions caused by the COVID-19 Pandemic.
    \3\ FDA previously determined the FY 2021 inflation rate to be
1.3493 percent; this rate was published in the FY 2021 PDUFA user
fee rates notice in the Federal Register (August 3, 2020, 85 FR
46651).

                 Table 2--FSMA Fee Schedule for FY 2023
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2023
------------------------------------------------------------------------
Hourly rate without travel..............................            $259
Hourly rate if domestic travel is required..............             281
Hourly rate if foreign travel is required...............             334
------------------------------------------------------------------------

III. Fees for Importers Approved To Participate in the Voluntary
Qualified Importer Program Under Section 743 of the FD&C Act

    FDA assesses fees for VQIP annually. Table 3 provides an overview
of the fees for FY 2023.

            Table 3--FSMA VQIP User Fee Schedule for FY 2023
------------------------------------------------------------------------
                                                          Fee rates for
                      Fee category                           FY 2023
------------------------------------------------------------------------
VQIP User Fee..........................................         $12,962
------------------------------------------------------------------------

    Section 743 of the FD&C Act requires that each importer
participating in VQIP pay a fee to cover FDA's costs of administering
the program. This fee represents the estimated average cost of the work
FDA performs in reviewing and evaluating a VQIP importer. At this time,
FDA is not offering an adjusted fee for small businesses. As required
by section 743(b)(2)(B)(iii) of the FD&C Act, FDA previously published
a set of guidelines in consideration of the burden of the VQIP fee on
small businesses and provided for a period of public comment on the
guidelines (80 FR 32136, June 5, 2015). While we did receive some
comments in response, they did not address the questions posed, i.e.,
how a small business fee reduction should be structured, what
percentage of fee reduction would be appropriate, or what alternative
structures FDA might consider to indirectly reduce fees for small
businesses by charging different fee amounts to different VQIP
participants. We plan on monitoring costs and collecting data to
determine if, in future fiscal years, we will provide for a small
business fee reduction. Consistent with section 743(b)(2)(B)(iii) of
the FD&C Act, we will adjust the fee schedule for small businesses only
through notice and comment rulemaking.
    The fee is based on the fully supported FTE hourly rates and
estimates of the number of hours it would take FDA to perform relevant
activities. These estimates represent FDA's current thinking, and as
the program evolves, FDA will reconsider the estimated hours. We
estimate that it would take, on average, 39 person-hours to review a
new VQIP application (including communication provided through the VQIP
Importer's Help Desk), 28 person-hours to review a returning VQIP
application (including communication provided through the VQIP
Importer's Help Desk), 16 person-hours for an onsite performance
evaluation of a domestic VQIP importer (including travel and other
steps necessary for a fully supported FTE to complete and document an
onsite assessment), and 34 person-hours for an onsite performance
evaluation of a foreign VQIP importer (including travel and other steps
necessary for a fully supported FTE to complete and document an onsite
assessment). Additional costs include maintenance and support costs of
IT of administering benefits of the program. These costs are estimated
to be $2,600 per VQIP importer.
    Based on updated data, FDA anticipates that there may be up to four
returning VQIP applicants and up to two new applicants this fiscal
year. FDA employees are likely to review new VQIP applications from
their worksites, so we use the fully supported FTE hourly rate
excluding travel, $259 per hour, to calculate the portion of the user
fee attributable to those activities: $259/hour multiplied by 39 hours
equaling $10,101. FDA employees are likely to review returning VQIP
applications from their worksites, so we use the fully supported FTE
hourly rate excluding travel, $259 per hour, to calculate the portion
of the user fee attributable to those activities: $259/hour multiplied
by 28 hours equaling $7,252.
    FDA employees will conduct a VQIP inspection to verify the
eligibility criteria and full implementation of the food safety and
food defense systems established in the Quality Assurance Program. A
VQIP importer may be located inside or outside of the United States.
However, this fiscal year, all VQIP importers will be located inside
the United States. Three VQIP applicants may have an associated VQIP
inspection.
    FDA employees are likely to prepare for and report on the
performance evaluation of a domestic VQIP importer at an FTE's
worksite, so we use the fully supported FTE hourly rate excluding
travel, $259 per hour, to calculate the portion of the user fee
attributable to those activities: $259 per hour multiplied by 8 hours
equaling $2,072. For the portion of the fee covering onsite evaluation
of a domestic VQIP importer, we use the fully supported FTE hourly rate
for work requiring domestic travel, $281 per hour, to calculate the
portion of the user fee attributable to those activities: $281 per hour
multiplied by 8 hours (i.e., one fully supported FTE for 1 day onsite
amounting to 8 hours) equaling $2,248. Therefore, the total cost of
conducting the domestic performance evaluation of a VQIP importer is
determined to be $2,072 plus $2,248 equaling $4,320.
    Coordination of the onsite performance evaluation of a foreign VQIP
importer is estimated to take place at an FTE's worksite, so we use the
fully supported FTE hourly rate excluding travel, $259 per hour, to
calculate the portion of the user fee attributable to those activities:
$259 per hour multiplied by 10 hours equaling $2,590. For the portion
of the fee covering onsite evaluation of a foreign VQIP importer, we
use the fully supported FTE hourly rate for work requiring foreign
travel, $334 per hour, to calculate the portion of the user fee
attributable to those activities: $334 per hour multiplied by 24 hours
(i.e., one fully supported FTE for travel ((2 travel days for 8 hours
each day) plus (1 day onsite for 8 hours))) equaling $8,016. Therefore,
the total cost of conducting the foreign performance evaluation of a
VQIP importer is determined to be $2,590 plus $8,016 equaling $10,606.
    Therefore, the estimated average cost of the work FDA performs in
total for approving an application for a VQIP importer in FY 2023 based
on these figures would be $2,600 plus ($10,101 multiplied by one-third)
plus ($7,252 multiplied by two-thirds) plus ($4,320 multiplied by one-
half) equaling $12,962.

IV. How must the fee be paid?

    An invoice will be sent to VQIP importers approved to participate
in the program. Payment must be made prior to October 1, 2022, to be
eligible for VQIP participation for the benefit year beginning October
1, 2022. FDA will not refund the VQIP user fee for any reason.
    The payment must be made in U.S. currency from a U.S. bank by one
of the following methods: wire transfer, electronically, check, bank
draft, or U.S. postal money order made payable to the Food and Drug
Administration. The preferred payment method is online using an
electronic check (Automated Clearing House (ACH), also known as eCheck)
or credit card (Discover, VISA, MasterCard, American Express). Secure
electronic payments can be submitted using the User Fees Payment Portal
at https://userfees.fda.gov/pay. (Note: only full payments are
accepted. No partial payments can be made online.) Once you have found
your invoice, select

``Pay Now'' to be redirected to Pay.gov. Electronic payment options are
based on the balance due. Payment by credit card is available only for
balances less than $25,000. If the balance exceeds this amount, only
the ACH option is available. Payments must be made using U.S. bank
accounts as well as U.S. credit cards. When paying by check, bank
draft, or U.S. postal money order, please include the invoice number.
Also write the FDA post office box number (P.O. Box 979108) on the
enclosed check, bank draft, or money order. Mail the payment including
the invoice number on the check stub to: Food and Drug Administration,
P.O. Box 979108, St. Louis, MO 63197-9000.
    When paying by wire transfer, it is required that the invoice
number is included; without the invoice number the payment may not be
applied. The originating financial institution may charge a wire
transfer fee. If the financial institution charges a wire transfer fee,
it is required to add that amount to the payment to ensure that the
invoice is paid in full. For international wire transfers, please
inquire with the financial institutions prior to submitting the
payment. Use the following account information when sending a wire
transfer: U.S. Department of the Treasury, TREAS NYC, 33 Liberty St.,
New York, NY 10045, Account Name: Food and Drug Administration, Account
No.: 75060099, Routing No.: 021030004, Swift No.: FRNYUS33.
    To send a check by a courier such as Federal Express, the courier
must deliver the check to: U.S. Bank, Attn: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This address is for
courier delivery only. If you have any questions concerning courier
delivery, contact U.S. Bank at<PHONE_NUMBER>. This phone number is only
for questions about courier delivery.) The tax identification number of
FDA is 53-0196965. (Note: Invoice copies do not need to be submitted to
FDA with the payments.)

V. What are the consequences of not paying this fee?

    The consequences of not paying these fees are outlined in Section J
of ``FDA's Voluntary Qualified Importer Program; Guidance for
Industry'' document (available at https://www.fda.gov/media/92196/download). If the user fee is not paid before October 1, a VQIP
importer will not be eligible to participate in VQIP. For the first
year a VQIP application is approved, if the user fee is not paid before
October 1, 2022, you are not eligible to participate in VQIP. If you
subsequently pay the user fee, FDA will begin your benefits after we
receive the full payment. The user fee may not be paid after December
31, 2022. For a subsequent year, if you do not pay the user fee before
October 1, FDA will send a Notice of Intent to Revoke your
participation in VQIP. If you do not pay the user fee within 30 days of
the date of the Notice of Intent to Revoke, we will revoke your
participation in VQIP.

    Dated: July 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-16175 Filed 7-27-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 74, Number 79 (Monday, April 27, 2009)]
[Notices]
[Pages 19097-19098]
[FR Doc No: E9-9474]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0664]

Computational Modeling for Cardiovascular Devices; Public
Workshop

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice of public workshop.

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

    The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Computational Modeling for Cardiovascular
Devices.'' FDA is co-sponsoring the conference with the National Heart,
Blood and Lung Institute of the National Institutes of Health and the
National Science Foundation. The purpose of the public workshop is to
facilitate discussion among FDA and other interested parties on the use
of computational modeling in the design, development, and evaluation of
cardiovascular medical devices.
    Date and Time: The public workshop will be held on June 1 and 2,
2009, from 8 a.m. to 5 p.m.
    Location: The public workshop will be held at the Hilton Washington
DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville,
MD 20852.
    Contact Person: Donna R. Lochner, Center for Devices and
Radiological Health (HFZ-450), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Why Are We Holding This Public Workshop?

    The purpose of the public workshop is to facilitate discussion
among FDA and other interested parties on the use of computational
modeling in cardiovascular device design, development, and evaluation.

II. What Are the Topics We Intend to Address at the Public Workshop?

    We hope to discuss a large number of issues at the public workshop,
including, but not limited to:
     Multi-scale modeling.
     Imaging for cardiovascular device modeling.
     Physiologic input data for cardiovascular device modeling.
     Device-specific issues related to modeling, including a
focus on heart valves, drug-eluting and bare metal stents, endovascular
stents, cardiac rhythm management, and mechanical and circulatory
support devices.

     Regulatory issues with implementation of computer
modeling.

III. Is There a Fee and How Do I Register for the Public Workshop?

    There is a fee to attend the public workshop to defray the costs of
meals provided and other expenses. The fee for the public workshop is
$250. The registration process will be handled by BL Seamon. BL Seamon
has extensive experience in planning, executing, and organizing
educational meetings. Register online at http://www.blseamon.com.
Although the facility is spacious, registration will be on a first-
come, first-served basis.
    If you need special accommodations due to a disability, please
contact Donna R. Lochner at least 7 days before the public workshop.

IV. Where Can I Find Out More About This Public Workshop?

    Background information on the public workshop, registration
information, the agenda, information about lodging, and other relevant
information will be posted, as it becomes available, on the Internet at
http://www.fda.gov/cdrh/dsma/workshop.html.

    Dated: April 16, 2009.
Daniel G. Schultz,
Director, Center for Devices and Radiological Health.
[FR Doc. E9-9474 Filed 4-27-09; 8:45 am]
BILLING CODE 4160-01-S