Donations of Technology and Support Services To Enforce Intellectual Property Rights, 4800-4803 [2017-00653]
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§ 71.1
Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of Federal Aviation
Administration Order 7400.11A,
Airspace Designations and Reporting
Points, dated August 3, 2016, effective
September 15, 2016, is amended as
follows:
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Paragraph 6003. Class E Airspace
Designated as an Extension to a Class C
Surface Area.
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AEA NJ E3 Atlantic City, NJ [Amended]
Atlantic City International Airport, NJ
(Lat. 39°27′27″ N., long. 74°34′38″ W.)
Atlantic City VORTAC
(Lat. 39°27′21″ N., long. 74°34′35″ W.)
That airspace extending upward from the
surface within 2.7 miles either side of the
Atlantic City VORTAC 303° radial extending
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of Atlantic City International Airport.
Paragraph 6005. Class E Airspace Areas
Extending Upward From 700 Feet or More
Above the Surface of the Earth.
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AEA NJ E5 Atlantic City, NJ [Amended]
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That airspace extending upward from 700
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Issued in College Park, Georgia, on
December 29, 2016.
Debra L. Hogan,
Acting Manager, Operations Support Group,
Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2017–00302 Filed 1–13–17; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
DEPARTMENT OF THE TREASURY
19 CFR Part 133
[USCBP–2016–0076]
RIN 1515–AE21
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Donations of Technology and Support
Services To Enforce Intellectual
Property Rights
U.S. Customs and Border
Protection, Department of Homeland
Security; Department of the Treasury.
ACTION: Notice of proposed rulemaking.
AGENCY:
This document proposes
amendments to the U.S. Customs and
Border Protection (CBP) regulations
pertaining to the enforcement of
SUMMARY:
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intellectual property rights. Specifically,
CBP is proposing amendments to
implement a section of the Trade
Facilitation and Trade Enforcement Act
of 2015 which requires CBP to prescribe
regulatory procedures for the donation
of technologies, training, or other
support services for the purpose of
assisting CBP in intellectual property
enforcement. The proposed regulations
would enhance CBP’s intellectual
property rights enforcement capabilities.
DATES: Comments must be received on
or before March 3, 2017.
ADDRESSES: You may submit comments,
identified by docket number, by one of
the following methods:
• Federal eRulemaking Portal at
https://www.regulations.gov. Follow the
instructions for submitting comments
via Docket No. USCBP–2016–0076.
• Mail: Trade and Commercial
Regulations Branch, Regulations and
Rulings, Office of Trade, U.S. Customs
and Border Protection, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177.
Instructions: All submissions received
must include the agency name and
docket number for this rulemaking. All
comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
detailed instructions on submitting
comments and additional information
on the rulemaking process, see the
‘‘Public Participation’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov. Submitted
comments may be inspected during
regular business days between the hours
of 9 a.m. and 4:30 p.m. at the Trade and
Commercial Regulations Branch,
Regulations and Rulings, Office of
Trade, Customs and Border Protection,
90 K Street NE., 10th Floor, Washington,
DC 20229–1177. Arrangements to
inspect submitted comments should be
made in advance by calling Mr. Joseph
Clark at (202) 325–0118.
FOR FURTHER INFORMATION CONTACT:
Garrett D. Wright, Chief, Donations
Acceptance Program, Office of Field
Operations, U.S. Customs and Border
Protection, telephone (202) 344–2344.
SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons are invited to
participate in this rulemaking by
submitting written data, views, or
arguments on all aspects of the
proposed rule. U.S. Customs and Border
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Protection (CBP) also invites comments
that relate to the economic,
environmental, or federalism effects that
might result from this proposed
rulemaking. Comments that will provide
the most assistance to CBP will
reference a specific portion of the
proposed rulemaking, explain the
reason for any recommended change,
and include data, information, or
authority that supports such
recommended change. See ADDRESSES
above for information on how to submit
comments.
Background
The Trade Facilitation and Trade
Enforcement Act of 2015 (TFTEA),
Public Law 114–125, 130 Stat. 122 (19
U.S.C. 4301 note), enacted February 24,
2016, includes an assortment of trade
facilitation and trade enforcement
provisions, including several that focus
on improving CBP’s intellectual
property rights (IPR) enforcement at the
border. Section 308(d) of the TFTEA
requires the Commissioner of CBP to
prescribe regulations that will enable
CBP to receive donations of
technologies, training, and other
support services for the purpose of
assisting CBP in detecting and
identifying imports that infringe
intellectual property rights.
In House Report 114–114, the House
Ways and Means Committee stated that
CBP should take steps to ensure that
personnel dedicated to enforcement of
IPR are effectively trained to detect and
identify infringing imports. The
Committee noted that much of the
expertise in this area lies within the
private sector, and that companies are
most knowledgeable about their
products and can provide valuable
training to CBP on detection. H.R. 114–
114 at 76.
Discussion of Proposed Amendments
New Subpart H to Part 133—Donations
of Intellectual Property Rights
Technology and Support Services
§ 133.61
This document proposes to
implement section 308(d) of the TFTEA
by promulgating a new subpart H to part
133 of title 19 of the Code of Federal
Regulations, entitled ‘‘[D]onations of
Intellectual Property Rights Technology
and Support Services,’’ which would
provide for the receipt and acceptance
by CBP of donations of hardware,
software, equipment, and similar
technologies, as well as training and
support services, for the purpose of
assisting CBP in enforcing IPR. It is also
proposed to add and reserve subpart G
to part 133.
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
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New subpart H, as set forth in
proposed new § 133.61, prescribes the
methods by which donations of IPR
technology and support services may be
made. Specifically, proposed 19 CFR
133.61(a) sets forth the scope of this
section and identifies the relevant
authority. Proposed 19 CFR 133.61(b)
prescribes the conditions applicable to a
donation offer and provides that CBP
will notify the donor, in writing, if
additional information is requested or if
CBP has determined that it will not
accept the donation. In this regard, it is
noted that CBP will take into
consideration all aspects of the
proposed donation offer, including
whether such offer would pose a real or
potential conflict between the interests
of the donor and the interests of the
government. Proposed 19 CFR 133.61(c)
provides that if CBP elects to accept a
donation offer, CBP will enter into a
signed, written agreement with an
authorized representative of the
donating entity that commemorates all
applicable terms and conditions, and
that an agreement to accept training and
other support services must provide that
the services or training are offered
without the expectation of payment and
that the service provider expressly
waives any future claims against the
government.
Authority To Accept Donations
As noted above, pursuant to section
308(d) of the TFTEA, CBP is required to
prescribe regulatory procedures for
donations of hardware, software,
equipment, and similar technologies, as
well as training and support services,
for the purpose of assisting CBP in
enforcing IPR.
Acceptance of such donations must
also be consistent with either section
482 of the Homeland Security Act of
2002, as amended by section 2 of the
Cross-Border Trade Enhancement Act of
2016 (Pub. L. 114–279), or section 507
of the Department of Homeland Security
Appropriations Act of 2004 (Pub. L.
108–90).
Section 482 of the Homeland Security
Act replaced section 559 of Title V of
Division F of the Consolidated
Appropriations Act, 2014 (Pub. L. 113–
76) and permits CBP, in consultation
with the General Services
Administration (GSA), to ‘‘enter into an
agreement with any entity to accept a
donation of personal property, money,
or nonpersonal services’’ to be used for
certain CBP activities at most ports of
entry where CBP performs inspection
services. Generally speaking, donations
may be used for certain activities of
CBP’s Office of Field Operations,
including expenses related to ‘‘(A)
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furniture, equipment, or technology,
including the installation or deployment
of such items; and (B) the operation and
maintenance of such furniture, fixtures,
equipment or technology.’’ Section
482(a)(3). To implement section 482,
CBP will build upon its experience in
implementing section 559 of Title V of
Division F of the Consolidated
Appropriations Act, 2014, where CBP
and the GSA issued the Section 559
Donation Acceptance Authority
Proposal Evaluation Procedures &
Criteria Framework in October, 2014.1
Pursuant to Section 482(c)(3), CBP in
consultation with GSA will establish
criteria for evaluating donation
proposals under Section 482 and make
such criteria publicly available.
Donations that may not be accepted
under section 482 may be considered
under section 507 of the DHS
Appropriations Act of 2004. Section 507
of the DHS Appropriations Act of 2004
made the DHS Gifts and Donations
account (formerly the Federal
Emergency Management Agency
‘‘Bequests and Gifts’’ account)
‘‘available to the Department of
Homeland Security . . . for the
Secretary of Homeland Security to
accept, hold, administer and utilize gifts
and bequests, including property, to
facilitate the work of the Department of
Homeland Security.’’ Title V, Public
Law 108–90, 117 Stat. 1153–1154. DHS
policy on the acceptance of gifts
pursuant to section 507 is contained in
DHS Directive 112–02 and DHS
Instruction 112–02–001. The Secretary
of DHS delegated the authority to accept
and utilize gifts to the heads of certain
DHS components, including the
Commissioner of CBP, in DHS
Delegation 0006.
Executive Orders 13563 and 12866
Executive Orders 13563 and 12866
direct agencies to assess the 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, distributive 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
1 https://www.cbp.gov/document/guidance/
section-559-donation-acceptance-authorityproposal-evaluation-procedures-and. Section 483 of
the Homeland Security Act, as amended by the
Cross-Border Trade Enhancement Act, also exempts
from section 482 existing agreements entered into
pursuant to section 559, as well as proposals
already accepted for consideration by CBP.
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proposed rule is not a ‘‘significant
regulatory action,’’ under section 3(f) of
Executive Order 12866. Accordingly,
the Office of Management and Budget
has not reviewed this regulation.
This rule proposes amendments to the
CBP regulations that would prescribe
procedures for the voluntary donation of
technology, training, and other support
services for the purpose of assisting CBP
in enforcing IPR, as required by section
308(d) of the Trade Facilitation and
Trade Enforcement Act of 2015, Public
Law 114–125, 130 Stat. 122 (19 U.S.C.
4301 note). These donations would
improve CBP’s knowledge of
intellectual property and improve its
ability to detect infringing articles and
prevent their importation.
Because donations under this rule
would be voluntary, CBP assumes that
entities would only make donations if
they believe it is in their best interest to
do so. The cost of the donation itself,
including any training provided, would
vary greatly depending on the
particulars of the donation. Due to a
lack of data on the types of donations
that entities would offer as a result of
this rulemaking, CBP is unable to
estimate the cost of these donations to
the public. In addition to the cost of the
donated product or training itself,
donors would bear some paperwork
related costs with this rule. Under this
rule, if finalized, entities must submit
an offer of a donation in writing to CBP
and provide all pertinent details
regarding the scope, purpose, expected
benefits, intended use, estimated costs,
and proposed conditions of the
donation. Based on discussions with
CBP’s Office of Field Operations, CBP
estimates that approximately 50 entities
would make donations annually and
that there would be one donation made
per entity annually, for a total of 50
donations per year. CBP estimates that
it would take an entity approximately 2
hours to write the offer of donation. In
most cases, CBP believes that attorneys
either employed or hired by the donor
would write the offer of donation.
Considering the median hourly wage of
an attorney of $80.83,2 3 writing the
2 Source of median wage rate: U.S. Bureau of
Labor Statistics. Occupational Employment
Statistics, ‘‘May 2014 National Occupational
Employment and Wage Estimates, United States—
Median Hourly Wage by Occupation Code: 23–
1011.’’ Updated March 25, 2015. Available at https://
www.bls.gov/oes/2014/may/oes231011.htm.
Accessed June 15, 2015. CBP adjusted this figure,
which was in 2014 U.S. dollars, to 2015 U.S. dollars
by applying a 1.0 percent annual growth rate to the
figure, as recommended by the U.S. Department of
Transportation’s value of travel time guidance.
Source: U.S. Department of Transportation, Office
of Transportation Policy. The Value of Travel Time
Savings: Departmental Guidance for Conducting
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Continued
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
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offers of donation would result in a total
annual time cost to donors of $8,083
($80.83 * 2 hours * 50 written donation
proposals). This would equate to a cost
of $161.66 per entity. CBP again notes
that this is a voluntary program, and
entities would only provide donations if
the benefits of doing so outweigh the
costs.
In addition to donor costs, this rule
would introduce a time cost to CBP to
process each offer of donation. As with
donor costs, CBP’s cost to receive and
learn about the donated article would
depend on the particulars of the
donation. Also, accepting the donation
is voluntary on CBP’s part and the
agency would only accept the donation
if it is in CBP’s best interest to do so.
In addition to CBP’s costs associated
with receiving and learning about the
donated article, there are quantifiable
costs to CBP related to evaluating the
donation and making a decision on
whether to accept it under the
conditions provided. CBP estimates, at a
minimum, the agency’s evaluation time
to be approximately 10 hours for each
of the 50 donations made to CBP
annually. CBP predicts that in most
cases, each written offer of donation
would be evaluated by five CBP
employees. Based on the average hourly
wage for a general CBP employee of
$55.91,4 evaluating the 50 offers of
donation each year would result in an
annual time cost to CBP of $139,775.00
($55.91 * 5 CBP employees * 10 hours
* 50 written donation proposals). On
Economic Evaluations Revision 2 (2015 Update),
‘‘Table 4 (Revision 2-corrected): Recommended
Hourly Values of Travel Time Savings.’’ April 29,
2015. https://www.transportation.gov/sites/dot.gov/
files/docs/Revised%20Departmental%20
Guidance%20on%20Valuation%20of%20
Travel%20Time%20in%20Economic%20
Analysis.pdf. Accessed June 1, 2016.
3 The total compensation to wages and salaries
ratio is equal to the calculated average of the 2014
quarterly estimates (shown under Mar., June, Sep.,
Dec.) of the total compensation cost per hour
worked for Professional and Related occupations
(49.69) divided by the calculated average of the
2014 quarterly estimates (shown under Mar., June,
Sep., Dec.) of wages and salaries cost per hour
worked for the same occupation category (34.315).
Source of total compensation to wages and salaries
ratio data: U.S. Bureau of Labor Statistics. Employer
Costs for Employee Compensation. Employer Costs
for Employee Compensation Historical Listing
March 2004–December 2015, ‘‘Table 3. Civilian
workers, by occupational group: employer costs per
hours worked for employee compensation and costs
as a percentage of total compensation, 2004–2015
by Respondent Type: Professional and related
occupations.’’ June 10, 2015. Available at https://
www.bls.gov/ncs/ect/sp/ececqrtn.pdf. Accessed
June 15, 2015.
4 CBP bases this wage on the FY 2015 salary and
benefits of the national average of general, non-CBP
Officer/frontline CBP positions, which is equal to
a GS–12, Step 5. Source: Email correspondence
with CBP’s Office of Administration on June 25,
2015.
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17:33 Jan 13, 2017
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average, each offer of donation would
cost CBP $2,795.50 in evaluation time
costs.
In summary, this rule could result in
a total quantifiable annual cost to the
public of $8,083 and a total annual cost
to CBP of $139,775.00. Additionally, the
public would bear a cost equal to the
value of the donation and CBP would
bear a cost to accept the donation. As
these costs would vary depending on
the particulars of the donation, CBP is
unable to quantify them in this analysis.
Because donations are voluntary for
both the donor and CBP, donations
would presumably only occur if the
benefits to each party outweigh the
costs.
Along with costs, the proposed rule
would provide benefits to the donor and
CBP. In particular, the proposed rule
would enhance CBP’s IPR enforcement
capabilities by making donations of
authentication devices, equipment, and
training available to CBP personnel.
This would help protect the entities
making donations from the illegal
importation of IPR-infringing products.
The value of this benefit would vary
depending on how much an entity
believes IPR enforcement would
improve because of its donation. As
stated earlier, an entity would only
make the donation if it believes the
benefits of improved IPR enforcement
outweigh the costs.
entities. Given these reasons, CBP
certifies that this rule, if finalized, will
not have a significant economic impact
on a substantial number of small
entities. CBP invites public comments
on this determination.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5
U.S.C. 601 et. seq.), as amended by the
Small Business Regulatory Enforcement
and Fairness Act of 1996, requires
agencies to assess the impact of
regulations on small entities. A small
entity may be a small business (defined
as any independently owned and
operated business not dominant in its
field that qualifies as a small business
per the Small Business Act); a small notfor-profit organization; or a small
governmental jurisdiction (locality with
fewer than 50,000 people).
This proposed rule, if finalized,
would allow entities to voluntarily
donate technology, training, and other
support services to improve CBP’s
ability to enforce IPR potentially related
to their goods. As any entity with
intellectual property could make these
donations, this rule may affect a
substantial number of small entities.
However, this rule imposes no new
obligations on entities, including those
considered small. Any small entity that
chooses to make these donations would
presumably do so because it believes the
benefits of donating exceed the costs.
Therefore, this rule would not have a
significant economic impact on small
This proposed regulation is being
issued in accordance with 19 CFR
0.1(a)(1) pertaining to the Secretary of
the Treasury’s authority (or that of his
delegate) to approve regulations related
to certain customs revenue functions.
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Paperwork Reduction Act
An agency may not conduct, and a
person is not required to respond to, a
collection of information unless the
collection of information displays a
valid control number assigned by OMB.
OMB approved collection 1651–0123
will be amended to reflect a new
information collection proposed by this
rule for written offers of donations to
CBP of technology, training, and other
support services in accordance with 19
CFR 133.61(b). CBP estimates that this
rule would result in 50 responses each
year and 100 burden hours to
respondents annually. The new
information collection would reflect the
burden hours for each written offer of
donation provided to CBP as follows:
Estimated number of annual
respondents: 50.
Estimated number of annual
responses: 50.
Estimated time burden per response:
2 hours.
Estimated total annual time burden:
100 hours.
Signing Authority
List of Subjects
19 CFR Part 133
Circumvention devices, Copying or
simulating trademarks, Copyrights,
Counterfeit goods, Customs duties and
inspection, Detentions, Donations,
Reporting and recordkeeping
requirements, Restricted merchandise,
Seizures and forfeitures, Technology,
Trademarks, Trade names, Support
services.
Proposed Amendments to Part 133 of
the CBP Regulations
For the reasons set forth in the
preamble, CBP proposes to amend 19
CFR part 133 as set forth below:
PART 133—TRADEMARKS, TRADE
NAMES, AND COPYRIGHTS
1. The general authority citation for
part 133 continues, and the specific
authority for new subpart H is added, to
read as follows:
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Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules
Authority: 15 U.S.C. 1124, 1125, 1127; 17
U.S.C. 101, 601, 602, 603; 19 U.S.C. 66, 1202,
1499, 1526, 1624; 31 U.S.C. 9701.
*
*
*
*
*
Section 133.61 also issued under Sec.
308(d), Pub. L. 114–125; Sec. 507, Pub. L.
108–90; Sec. 2, Pub. L. 114–279.
Subpart G—[Reserved].
2. Add and reserve subpart G.
3. Add subpart H, consisting of
§ 133.61, to read as follows:
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(a) Scope. The Commissioner of U.S.
Customs and Border Protection (CBP) is
authorized to accept donations of
hardware, software, equipment, and
similar technologies, as well as donated
support services and training, from
private sector entities, for the purpose of
assisting CBP in enforcing intellectual
property rights. Such acceptance must
be consistent with the conditions set
forth in this section and section 308(d)
of the Trade Facilitation and Trade
Enforcement Act of 2015, as well as
either section 482 of the Homeland
Security Act of 2002 or section 507 of
the DHS Appropriations Act of 2004.
(b) Donation offer. A donation offer
must be submitted to CBP either via
email, to IPRdonations@cbp.dhs.gov, or
mailed to the attention of the Executive
Assistant Commissioner, Office of Field
Operations, or his/her designee. The
donation offer must describe the
proposed donation in sufficient detail to
enable CBP to determine its
compatibility with existing CBP
technologies, networks, and facilities
(e.g. operating system or similar
requirements, power supply
requirements, item size and weight,
etc.). The donation offer must also
include information pertaining to the
donation’s scope, purpose, expected
benefits, intended use, costs, and
attached conditions, as applicable, that
is sufficient to enable CBP to evaluate
the donation and make a determination
as to whether to accept it. CBP will
notify the donor, in writing, if
additional information is requested or if
CBP has determined that it will not
accept the donation.
(c) Agreement to accept donation. If
CBP accepts a donation of hardware,
software, equipment, technologies, or to
accept training and other support
services, for the purpose of enforcing
intellectual property rights, CBP will
enter into a signed, written agreement
with an authorized representative of the
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SUMMARY:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that we consider
your comment on the draft guidance
before we issue the final version of the
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2008–D–0096 for ‘‘Control of Listeria
monocytogenes in Ready-To-Eat Foods.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
[FR Doc. 2017–00653 Filed 1–13–17; 8:45 am]
§ 133.61 Donations of intellectual property
rights technology and support services.
guidance, submit either electronic or
written comments on the draft guidance
by July 26, 2017.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
R. Gil Kerlikowske,
Commissioner.
Approved: January 09, 2017.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
Subpart H—Donations of Intellectual
Property Rights Technology and
Support Services.
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donor. The agreement must contain all
applicable terms and conditions of the
donation. An agreement to accept
training and other support services must
provide that the services or training are
offered without the expectation of
payment, and that the service provider
expressly waives any future claims
against the government.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 117
[Docket No. FDA–2008–D–0096 (Formerly
Docket No. 2007D–0494)]
Control of Listeria monocytogenes in
Ready-To-Eat Foods: Revised Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of availability.
The Food and Drug
Administration (FDA, we, or Agency) is
announcing the availability of a revised
draft guidance for industry entitled
‘‘Control of Listeria monocytogenes in
Ready-To-Eat Foods.’’ The revised draft
guidance is intended for any person
who is subject to our regulation entitled
‘‘Current Good Manufacturing Practice,
Hazard Analysis, and Risk-Based
Preventive Controls for Human Food’’
and who manufactures, processes,
packs, or holds ready-to-eat (RTE) foods.
The revised draft guidance is intended
to help such persons comply with the
requirements of that regulation with
respect to measures that can
significantly minimize or prevent the
contamination of RTE food with L.
monocytogenes whenever a RTE food is
exposed to the environment prior to
packaging and the packaged food does
not receive a treatment or otherwise
include a control measure (such as a
formulation lethal to L. monocytogenes)
that would significantly minimize L.
monocytogenes.
DATES:
PO 00000
Frm 00006
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17JAP1
Agencies
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Proposed Rules]
[Pages 4800-4803]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00653]
=======================================================================
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DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
DEPARTMENT OF THE TREASURY
19 CFR Part 133
[USCBP-2016-0076]
RIN 1515-AE21
Donations of Technology and Support Services To Enforce
Intellectual Property Rights
AGENCY: U.S. Customs and Border Protection, Department of Homeland
Security; Department of the Treasury.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This document proposes amendments to the U.S. Customs and
Border Protection (CBP) regulations pertaining to the enforcement of
intellectual property rights. Specifically, CBP is proposing amendments
to implement a section of the Trade Facilitation and Trade Enforcement
Act of 2015 which requires CBP to prescribe regulatory procedures for
the donation of technologies, training, or other support services for
the purpose of assisting CBP in intellectual property enforcement. The
proposed regulations would enhance CBP's intellectual property rights
enforcement capabilities.
DATES: Comments must be received on or before March 3, 2017.
ADDRESSES: You may submit comments, identified by docket number, by one
of the following methods:
Federal eRulemaking Portal at https://www.regulations.gov.
Follow the instructions for submitting comments via Docket No. USCBP-
2016-0076.
Mail: Trade and Commercial Regulations Branch, Regulations
and Rulings, Office of Trade, U.S. Customs and Border Protection, 90 K
Street NE., 10th Floor, Washington, DC 20229-1177.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received will be
posted without change to https://www.regulations.gov, including any
personal information provided. For detailed instructions on submitting
comments and additional information on the rulemaking process, see the
``Public Participation'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov. Submitted comments
may be inspected during regular business days between the hours of 9
a.m. and 4:30 p.m. at the Trade and Commercial Regulations Branch,
Regulations and Rulings, Office of Trade, Customs and Border
Protection, 90 K Street NE., 10th Floor, Washington, DC 20229-1177.
Arrangements to inspect submitted comments should be made in advance by
calling Mr. Joseph Clark at (202) 325-0118.
FOR FURTHER INFORMATION CONTACT: Garrett D. Wright, Chief, Donations
Acceptance Program, Office of Field Operations, U.S. Customs and Border
Protection, telephone (202) 344-2344.
SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons are invited to participate in this rulemaking by
submitting written data, views, or arguments on all aspects of the
proposed rule. U.S. Customs and Border Protection (CBP) also invites
comments that relate to the economic, environmental, or federalism
effects that might result from this proposed rulemaking. Comments that
will provide the most assistance to CBP will reference a specific
portion of the proposed rulemaking, explain the reason for any
recommended change, and include data, information, or authority that
supports such recommended change. See ADDRESSES above for information
on how to submit comments.
Background
The Trade Facilitation and Trade Enforcement Act of 2015 (TFTEA),
Public Law 114-125, 130 Stat. 122 (19 U.S.C. 4301 note), enacted
February 24, 2016, includes an assortment of trade facilitation and
trade enforcement provisions, including several that focus on improving
CBP's intellectual property rights (IPR) enforcement at the border.
Section 308(d) of the TFTEA requires the Commissioner of CBP to
prescribe regulations that will enable CBP to receive donations of
technologies, training, and other support services for the purpose of
assisting CBP in detecting and identifying imports that infringe
intellectual property rights.
In House Report 114-114, the House Ways and Means Committee stated
that CBP should take steps to ensure that personnel dedicated to
enforcement of IPR are effectively trained to detect and identify
infringing imports. The Committee noted that much of the expertise in
this area lies within the private sector, and that companies are most
knowledgeable about their products and can provide valuable training to
CBP on detection. H.R. 114-114 at 76.
Discussion of Proposed Amendments
New Subpart H to Part 133--Donations of Intellectual Property Rights
Technology and Support Services
Sec. 133.61
This document proposes to implement section 308(d) of the TFTEA by
promulgating a new subpart H to part 133 of title 19 of the Code of
Federal Regulations, entitled ``[D]onations of Intellectual Property
Rights Technology and Support Services,'' which would provide for the
receipt and acceptance by CBP of donations of hardware, software,
equipment, and similar technologies, as well as training and support
services, for the purpose of assisting CBP in enforcing IPR. It is also
proposed to add and reserve subpart G to part 133.
[[Page 4801]]
New subpart H, as set forth in proposed new Sec. 133.61,
prescribes the methods by which donations of IPR technology and support
services may be made. Specifically, proposed 19 CFR 133.61(a) sets
forth the scope of this section and identifies the relevant authority.
Proposed 19 CFR 133.61(b) prescribes the conditions applicable to a
donation offer and provides that CBP will notify the donor, in writing,
if additional information is requested or if CBP has determined that it
will not accept the donation. In this regard, it is noted that CBP will
take into consideration all aspects of the proposed donation offer,
including whether such offer would pose a real or potential conflict
between the interests of the donor and the interests of the government.
Proposed 19 CFR 133.61(c) provides that if CBP elects to accept a
donation offer, CBP will enter into a signed, written agreement with an
authorized representative of the donating entity that commemorates all
applicable terms and conditions, and that an agreement to accept
training and other support services must provide that the services or
training are offered without the expectation of payment and that the
service provider expressly waives any future claims against the
government.
Authority To Accept Donations
As noted above, pursuant to section 308(d) of the TFTEA, CBP is
required to prescribe regulatory procedures for donations of hardware,
software, equipment, and similar technologies, as well as training and
support services, for the purpose of assisting CBP in enforcing IPR.
Acceptance of such donations must also be consistent with either
section 482 of the Homeland Security Act of 2002, as amended by section
2 of the Cross-Border Trade Enhancement Act of 2016 (Pub. L. 114-279),
or section 507 of the Department of Homeland Security Appropriations
Act of 2004 (Pub. L. 108-90).
Section 482 of the Homeland Security Act replaced section 559 of
Title V of Division F of the Consolidated Appropriations Act, 2014
(Pub. L. 113-76) and permits CBP, in consultation with the General
Services Administration (GSA), to ``enter into an agreement with any
entity to accept a donation of personal property, money, or nonpersonal
services'' to be used for certain CBP activities at most ports of entry
where CBP performs inspection services. Generally speaking, donations
may be used for certain activities of CBP's Office of Field Operations,
including expenses related to ``(A) furniture, equipment, or
technology, including the installation or deployment of such items; and
(B) the operation and maintenance of such furniture, fixtures,
equipment or technology.'' Section 482(a)(3). To implement section 482,
CBP will build upon its experience in implementing section 559 of Title
V of Division F of the Consolidated Appropriations Act, 2014, where CBP
and the GSA issued the Section 559 Donation Acceptance Authority
Proposal Evaluation Procedures & Criteria Framework in October,
2014.\1\ Pursuant to Section 482(c)(3), CBP in consultation with GSA
will establish criteria for evaluating donation proposals under Section
482 and make such criteria publicly available.
---------------------------------------------------------------------------
\1\ https://www.cbp.gov/document/guidance/section-559-donation-acceptance-authority-proposal-evaluation-procedures-and. Section 483
of the Homeland Security Act, as amended by the Cross-Border Trade
Enhancement Act, also exempts from section 482 existing agreements
entered into pursuant to section 559, as well as proposals already
accepted for consideration by CBP.
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Donations that may not be accepted under section 482 may be
considered under section 507 of the DHS Appropriations Act of 2004.
Section 507 of the DHS Appropriations Act of 2004 made the DHS Gifts
and Donations account (formerly the Federal Emergency Management Agency
``Bequests and Gifts'' account) ``available to the Department of
Homeland Security . . . for the Secretary of Homeland Security to
accept, hold, administer and utilize gifts and bequests, including
property, to facilitate the work of the Department of Homeland
Security.'' Title V, Public Law 108-90, 117 Stat. 1153-1154. DHS policy
on the acceptance of gifts pursuant to section 507 is contained in DHS
Directive 112-02 and DHS Instruction 112-02-001. The Secretary of DHS
delegated the authority to accept and utilize gifts to the heads of
certain DHS components, including the Commissioner of CBP, in DHS
Delegation 0006.
Executive Orders 13563 and 12866
Executive Orders 13563 and 12866 direct agencies to assess the
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, distributive 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 proposed rule is not a ``significant regulatory
action,'' under section 3(f) of Executive Order 12866. Accordingly, the
Office of Management and Budget has not reviewed this regulation.
This rule proposes amendments to the CBP regulations that would
prescribe procedures for the voluntary donation of technology,
training, and other support services for the purpose of assisting CBP
in enforcing IPR, as required by section 308(d) of the Trade
Facilitation and Trade Enforcement Act of 2015, Public Law 114-125, 130
Stat. 122 (19 U.S.C. 4301 note). These donations would improve CBP's
knowledge of intellectual property and improve its ability to detect
infringing articles and prevent their importation.
Because donations under this rule would be voluntary, CBP assumes
that entities would only make donations if they believe it is in their
best interest to do so. The cost of the donation itself, including any
training provided, would vary greatly depending on the particulars of
the donation. Due to a lack of data on the types of donations that
entities would offer as a result of this rulemaking, CBP is unable to
estimate the cost of these donations to the public. In addition to the
cost of the donated product or training itself, donors would bear some
paperwork related costs with this rule. Under this rule, if finalized,
entities must submit an offer of a donation in writing to CBP and
provide all pertinent details regarding the scope, purpose, expected
benefits, intended use, estimated costs, and proposed conditions of the
donation. Based on discussions with CBP's Office of Field Operations,
CBP estimates that approximately 50 entities would make donations
annually and that there would be one donation made per entity annually,
for a total of 50 donations per year. CBP estimates that it would take
an entity approximately 2 hours to write the offer of donation. In most
cases, CBP believes that attorneys either employed or hired by the
donor would write the offer of donation. Considering the median hourly
wage of an attorney of $80.83,2 3 writing the
[[Page 4802]]
offers of donation would result in a total annual time cost to donors
of $8,083 ($80.83 * 2 hours * 50 written donation proposals). This
would equate to a cost of $161.66 per entity. CBP again notes that this
is a voluntary program, and entities would only provide donations if
the benefits of doing so outweigh the costs.
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\2\ Source of median wage rate: U.S. Bureau of Labor Statistics.
Occupational Employment Statistics, ``May 2014 National Occupational
Employment and Wage Estimates, United States--Median Hourly Wage by
Occupation Code: 23-1011.'' Updated March 25, 2015. Available at
https://www.bls.gov/oes/2014/may/oes231011.htm. Accessed June 15,
2015. CBP adjusted this figure, which was in 2014 U.S. dollars, to
2015 U.S. dollars by applying a 1.0 percent annual growth rate to
the figure, as recommended by the U.S. Department of
Transportation's value of travel time guidance. Source: U.S.
Department of Transportation, Office of Transportation Policy. The
Value of Travel Time Savings: Departmental Guidance for Conducting
Economic Evaluations Revision 2 (2015 Update), ``Table 4 (Revision
2-corrected): Recommended Hourly Values of Travel Time Savings.''
April 29, 2015. https://www.transportation.gov/sites/dot.gov/files/docs/Revised%20Departmental%20Guidance%20on%20Valuation%20of%20Travel%20Time%20in%20Economic%20Analysis.pdf. Accessed June 1, 2016.
\3\ The total compensation to wages and salaries ratio is equal
to the calculated average of the 2014 quarterly estimates (shown
under Mar., June, Sep., Dec.) of the total compensation cost per
hour worked for Professional and Related occupations (49.69) divided
by the calculated average of the 2014 quarterly estimates (shown
under Mar., June, Sep., Dec.) of wages and salaries cost per hour
worked for the same occupation category (34.315). Source of total
compensation to wages and salaries ratio data: U.S. Bureau of Labor
Statistics. Employer Costs for Employee Compensation. Employer Costs
for Employee Compensation Historical Listing March 2004-December
2015, ``Table 3. Civilian workers, by occupational group: employer
costs per hours worked for employee compensation and costs as a
percentage of total compensation, 2004-2015 by Respondent Type:
Professional and related occupations.'' June 10, 2015. Available at
https://www.bls.gov/ncs/ect/sp/ececqrtn.pdf. Accessed June 15, 2015.
---------------------------------------------------------------------------
In addition to donor costs, this rule would introduce a time cost
to CBP to process each offer of donation. As with donor costs, CBP's
cost to receive and learn about the donated article would depend on the
particulars of the donation. Also, accepting the donation is voluntary
on CBP's part and the agency would only accept the donation if it is in
CBP's best interest to do so. In addition to CBP's costs associated
with receiving and learning about the donated article, there are
quantifiable costs to CBP related to evaluating the donation and making
a decision on whether to accept it under the conditions provided. CBP
estimates, at a minimum, the agency's evaluation time to be
approximately 10 hours for each of the 50 donations made to CBP
annually. CBP predicts that in most cases, each written offer of
donation would be evaluated by five CBP employees. Based on the average
hourly wage for a general CBP employee of $55.91,\4\ evaluating the 50
offers of donation each year would result in an annual time cost to CBP
of $139,775.00 ($55.91 * 5 CBP employees * 10 hours * 50 written
donation proposals). On average, each offer of donation would cost CBP
$2,795.50 in evaluation time costs.
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\4\ CBP bases this wage on the FY 2015 salary and benefits of
the national average of general, non-CBP Officer/frontline CBP
positions, which is equal to a GS-12, Step 5. Source: Email
correspondence with CBP's Office of Administration on June 25, 2015.
---------------------------------------------------------------------------
In summary, this rule could result in a total quantifiable annual
cost to the public of $8,083 and a total annual cost to CBP of
$139,775.00. Additionally, the public would bear a cost equal to the
value of the donation and CBP would bear a cost to accept the donation.
As these costs would vary depending on the particulars of the donation,
CBP is unable to quantify them in this analysis. Because donations are
voluntary for both the donor and CBP, donations would presumably only
occur if the benefits to each party outweigh the costs.
Along with costs, the proposed rule would provide benefits to the
donor and CBP. In particular, the proposed rule would enhance CBP's IPR
enforcement capabilities by making donations of authentication devices,
equipment, and training available to CBP personnel. This would help
protect the entities making donations from the illegal importation of
IPR-infringing products. The value of this benefit would vary depending
on how much an entity believes IPR enforcement would improve because of
its donation. As stated earlier, an entity would only make the donation
if it believes the benefits of improved IPR enforcement outweigh the
costs.
Regulatory Flexibility Act
The Regulatory Flexibility Act (5 U.S.C. 601 et. seq.), as amended
by the Small Business Regulatory Enforcement and Fairness Act of 1996,
requires agencies to assess the impact of regulations on small
entities. A small entity may be a small business (defined as any
independently owned and operated business not dominant in its field
that qualifies as a small business per the Small Business Act); a small
not-for-profit organization; or a small governmental jurisdiction
(locality with fewer than 50,000 people).
This proposed rule, if finalized, would allow entities to
voluntarily donate technology, training, and other support services to
improve CBP's ability to enforce IPR potentially related to their
goods. As any entity with intellectual property could make these
donations, this rule may affect a substantial number of small entities.
However, this rule imposes no new obligations on entities, including
those considered small. Any small entity that chooses to make these
donations would presumably do so because it believes the benefits of
donating exceed the costs. Therefore, this rule would not have a
significant economic impact on small entities. Given these reasons, CBP
certifies that this rule, if finalized, will not have a significant
economic impact on a substantial number of small entities. CBP invites
public comments on this determination.
Paperwork Reduction Act
An agency may not conduct, and a person is not required to respond
to, a collection of information unless the collection of information
displays a valid control number assigned by OMB.
OMB approved collection 1651-0123 will be amended to reflect a new
information collection proposed by this rule for written offers of
donations to CBP of technology, training, and other support services in
accordance with 19 CFR 133.61(b). CBP estimates that this rule would
result in 50 responses each year and 100 burden hours to respondents
annually. The new information collection would reflect the burden hours
for each written offer of donation provided to CBP as follows:
Estimated number of annual respondents: 50.
Estimated number of annual responses: 50.
Estimated time burden per response: 2 hours.
Estimated total annual time burden: 100 hours.
Signing Authority
This proposed regulation is being issued in accordance with 19 CFR
0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or
that of his delegate) to approve regulations related to certain customs
revenue functions.
List of Subjects
19 CFR Part 133
Circumvention devices, Copying or simulating trademarks,
Copyrights, Counterfeit goods, Customs duties and inspection,
Detentions, Donations, Reporting and recordkeeping requirements,
Restricted merchandise, Seizures and forfeitures, Technology,
Trademarks, Trade names, Support services.
Proposed Amendments to Part 133 of the CBP Regulations
For the reasons set forth in the preamble, CBP proposes to amend 19
CFR part 133 as set forth below:
PART 133--TRADEMARKS, TRADE NAMES, AND COPYRIGHTS
0
1. The general authority citation for part 133 continues, and the
specific authority for new subpart H is added, to read as follows:
[[Page 4803]]
Authority: 15 U.S.C. 1124, 1125, 1127; 17 U.S.C. 101, 601, 602,
603; 19 U.S.C. 66, 1202, 1499, 1526, 1624; 31 U.S.C. 9701.
* * * * *
Section 133.61 also issued under Sec. 308(d), Pub. L. 114-125;
Sec. 507, Pub. L. 108-90; Sec. 2, Pub. L. 114-279.
Subpart G--[Reserved].
0
2. Add and reserve subpart G.
0
3. Add subpart H, consisting of Sec. 133.61, to read as follows:
Subpart H--Donations of Intellectual Property Rights Technology and
Support Services.
Sec. 133.61 Donations of intellectual property rights technology and
support services.
(a) Scope. The Commissioner of U.S. Customs and Border Protection
(CBP) is authorized to accept donations of hardware, software,
equipment, and similar technologies, as well as donated support
services and training, from private sector entities, for the purpose of
assisting CBP in enforcing intellectual property rights. Such
acceptance must be consistent with the conditions set forth in this
section and section 308(d) of the Trade Facilitation and Trade
Enforcement Act of 2015, as well as either section 482 of the Homeland
Security Act of 2002 or section 507 of the DHS Appropriations Act of
2004.
(b) Donation offer. A donation offer must be submitted to CBP
either via email, to IPRdonations@cbp.dhs.gov, or mailed to the
attention of the Executive Assistant Commissioner, Office of Field
Operations, or his/her designee. The donation offer must describe the
proposed donation in sufficient detail to enable CBP to determine its
compatibility with existing CBP technologies, networks, and facilities
(e.g. operating system or similar requirements, power supply
requirements, item size and weight, etc.). The donation offer must also
include information pertaining to the donation's scope, purpose,
expected benefits, intended use, costs, and attached conditions, as
applicable, that is sufficient to enable CBP to evaluate the donation
and make a determination as to whether to accept it. CBP will notify
the donor, in writing, if additional information is requested or if CBP
has determined that it will not accept the donation.
(c) Agreement to accept donation. If CBP accepts a donation of
hardware, software, equipment, technologies, or to accept training and
other support services, for the purpose of enforcing intellectual
property rights, CBP will enter into a signed, written agreement with
an authorized representative of the donor. The agreement must contain
all applicable terms and conditions of the donation. An agreement to
accept training and other support services must provide that the
services or training are offered without the expectation of payment,
and that the service provider expressly waives any future claims
against the government.
R. Gil Kerlikowske,
Commissioner.
Approved: January 09, 2017.
Timothy E. Skud,
Deputy Assistant Secretary of the Treasury.
[FR Doc. 2017-00653 Filed 1-13-17; 8:45 am]
BILLING CODE 9111-14-P