82_FR_4810 82 FR 4800 - Donations of Technology and Support Services To Enforce Intellectual Property Rights

82 FR 4800 - Donations of Technology and Support Services To Enforce Intellectual Property Rights

DEPARTMENT OF HOMELAND SECURITY
U.S. Customs and Border Protection
DEPARTMENT OF THE TREASURY

Federal Register Volume 82, Issue 10 (January 17, 2017)

Page Range4800-4803
FR Document2017-00653

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.

Federal Register, Volume 82 Issue 10 (Tuesday, January 17, 2017)
[Federal Register Volume 82, Number 10 (Tuesday, January 17, 2017)]
[Proposed Rules]
[Pages 4800-4803]
From the Federal Register Online  [www.thefederalregister.org]
[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 http://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 http://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 http://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.
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    \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 
http://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. http://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 
http://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.
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    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 [email protected], 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



                                                  4800                        Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules

                                                  § 71.1       [Amended]                                     intellectual property rights. Specifically,            Protection (CBP) also invites comments
                                                  ■ 2. The incorporation by reference in                     CBP is proposing amendments to                         that relate to the economic,
                                                  14 CFR 71.1 of Federal Aviation                            implement a section of the Trade                       environmental, or federalism effects that
                                                  Administration Order 7400.11A,                             Facilitation and Trade Enforcement Act                 might result from this proposed
                                                  Airspace Designations and Reporting                        of 2015 which requires CBP to prescribe                rulemaking. Comments that will provide
                                                  Points, dated August 3, 2016, effective                    regulatory procedures for the donation                 the most assistance to CBP will
                                                  September 15, 2016, is amended as                          of technologies, training, or other                    reference a specific portion of the
                                                  follows:                                                   support services for the purpose of                    proposed rulemaking, explain the
                                                                                                             assisting CBP in intellectual property                 reason for any recommended change,
                                                  Paragraph 6003. Class E Airspace
                                                                                                             enforcement. The proposed regulations                  and include data, information, or
                                                  Designated as an Extension to a Class C
                                                  Surface Area.                                              would enhance CBP’s intellectual                       authority that supports such
                                                                                                             property rights enforcement capabilities.              recommended change. See ADDRESSES
                                                  *        *      *       *      *                                                                                  above for information on how to submit
                                                                                                             DATES: Comments must be received on
                                                  AEA NJ E3 Atlantic City, NJ [Amended]                      or before March 3, 2017.                               comments.
                                                  Atlantic City International Airport, NJ                    ADDRESSES: You may submit comments,                    Background
                                                    (Lat. 39°27′27″ N., long. 74°34′38″ W.)                  identified by docket number, by one of
                                                  Atlantic City VORTAC                                                                                                 The Trade Facilitation and Trade
                                                                                                             the following methods:                                 Enforcement Act of 2015 (TFTEA),
                                                    (Lat. 39°27′21″ N., long. 74°34′35″ W.)
                                                                                                                • Federal eRulemaking Portal at                     Public Law 114–125, 130 Stat. 122 (19
                                                     That airspace extending upward from the                 http://www.regulations.gov. Follow the
                                                  surface within 2.7 miles either side of the                                                                       U.S.C. 4301 note), enacted February 24,
                                                                                                             instructions for submitting comments                   2016, includes an assortment of trade
                                                  Atlantic City VORTAC 303° radial extending
                                                  from the 5-mile radius to 7.4 miles northwest              via Docket No. USCBP–2016–0076.                        facilitation and trade enforcement
                                                  of Atlantic City International Airport.                       • Mail: Trade and Commercial
                                                                                                                                                                    provisions, including several that focus
                                                                                                             Regulations Branch, Regulations and                    on improving CBP’s intellectual
                                                  Paragraph 6005. Class E Airspace Areas                     Rulings, Office of Trade, U.S. Customs
                                                  Extending Upward From 700 Feet or More                                                                            property rights (IPR) enforcement at the
                                                                                                             and Border Protection, 90 K Street NE.,                border. Section 308(d) of the TFTEA
                                                  Above the Surface of the Earth.
                                                                                                             10th Floor, Washington, DC 20229–                      requires the Commissioner of CBP to
                                                  *        *      *       *      *                           1177.                                                  prescribe regulations that will enable
                                                  AEA NJ E5 Atlantic City, NJ [Amended]                         Instructions: All submissions received
                                                                                                                                                                    CBP to receive donations of
                                                  Atlantic City International Airport, NJ
                                                                                                             must include the agency name and                       technologies, training, and other
                                                    (Lat. 39°27′27″ N., long. 74°34′38″ W.)                  docket number for this rulemaking. All                 support services for the purpose of
                                                    That airspace extending upward from 700
                                                                                                             comments received will be posted                       assisting CBP in detecting and
                                                  feet above the surface within a 7.2-mile                   without change to http://                              identifying imports that infringe
                                                  radius of Atlantic City International Airport.             www.regulations.gov, including any                     intellectual property rights.
                                                                                                             personal information provided. For                        In House Report 114–114, the House
                                                    Issued in College Park, Georgia, on
                                                  December 29, 2016.
                                                                                                             detailed instructions on submitting                    Ways and Means Committee stated that
                                                                                                             comments and additional information                    CBP should take steps to ensure that
                                                  Debra L. Hogan,
                                                                                                             on the rulemaking process, see the                     personnel dedicated to enforcement of
                                                  Acting Manager, Operations Support Group,                  ‘‘Public Participation’’ heading of the
                                                  Eastern Service Center, Air Traffic                                                                               IPR are effectively trained to detect and
                                                                                                             SUPPLEMENTARY INFORMATION section of                   identify infringing imports. The
                                                  Organization.
                                                                                                             this document.                                         Committee noted that much of the
                                                  [FR Doc. 2017–00302 Filed 1–13–17; 8:45 am]
                                                                                                                Docket: For access to the docket to                 expertise in this area lies within the
                                                  BILLING CODE 4910–13–P
                                                                                                             read background documents or                           private sector, and that companies are
                                                                                                             comments received, go to http://                       most knowledgeable about their
                                                                                                             www.regulations.gov. Submitted                         products and can provide valuable
                                                  DEPARTMENT OF HOMELAND                                     comments may be inspected during                       training to CBP on detection. H.R. 114–
                                                  SECURITY                                                   regular business days between the hours                114 at 76.
                                                                                                             of 9 a.m. and 4:30 p.m. at the Trade and
                                                  U.S. Customs and Border Protection                         Commercial Regulations Branch,                         Discussion of Proposed Amendments
                                                                                                             Regulations and Rulings, Office of                     New Subpart H to Part 133—Donations
                                                  DEPARTMENT OF THE TREASURY                                 Trade, Customs and Border Protection,                  of Intellectual Property Rights
                                                                                                             90 K Street NE., 10th Floor, Washington,               Technology and Support Services
                                                  19 CFR Part 133                                            DC 20229–1177. Arrangements to
                                                  [USCBP–2016–0076]                                          inspect submitted comments should be                   § 133.61
                                                                                                             made in advance by calling Mr. Joseph                    This document proposes to
                                                  RIN 1515–AE21                                              Clark at (202) 325–0118.                               implement section 308(d) of the TFTEA
                                                                                                             FOR FURTHER INFORMATION CONTACT:                       by promulgating a new subpart H to part
                                                  Donations of Technology and Support
                                                                                                             Garrett D. Wright, Chief, Donations                    133 of title 19 of the Code of Federal
                                                  Services To Enforce Intellectual
                                                                                                             Acceptance Program, Office of Field                    Regulations, entitled ‘‘[D]onations of
                                                  Property Rights
                                                                                                             Operations, U.S. Customs and Border                    Intellectual Property Rights Technology
                                                  AGENCY:  U.S. Customs and Border                           Protection, telephone (202) 344–2344.                  and Support Services,’’ which would
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                  Protection, Department of Homeland                         SUPPLEMENTARY INFORMATION:                             provide for the receipt and acceptance
                                                  Security; Department of the Treasury.                                                                             by CBP of donations of hardware,
                                                                                                             Public Participation                                   software, equipment, and similar
                                                  ACTION: Notice of proposed rulemaking.
                                                                                                               Interested persons are invited to                    technologies, as well as training and
                                                  SUMMARY:  This document proposes                           participate in this rulemaking by                      support services, for the purpose of
                                                  amendments to the U.S. Customs and                         submitting written data, views, or                     assisting CBP in enforcing IPR. It is also
                                                  Border Protection (CBP) regulations                        arguments on all aspects of the                        proposed to add and reserve subpart G
                                                  pertaining to the enforcement of                           proposed rule. U.S. Customs and Border                 to part 133.


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                                                                         Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules                                                     4801

                                                    New subpart H, as set forth in                        furniture, equipment, or technology,                   proposed rule is not a ‘‘significant
                                                  proposed new § 133.61, prescribes the                   including the installation or deployment               regulatory action,’’ under section 3(f) of
                                                  methods by which donations of IPR                       of such items; and (B) the operation and               Executive Order 12866. Accordingly,
                                                  technology and support services may be                  maintenance of such furniture, fixtures,               the Office of Management and Budget
                                                  made. Specifically, proposed 19 CFR                     equipment or technology.’’ Section                     has not reviewed this regulation.
                                                  133.61(a) sets forth the scope of this                  482(a)(3). To implement section 482,                      This rule proposes amendments to the
                                                  section and identifies the relevant                     CBP will build upon its experience in                  CBP regulations that would prescribe
                                                  authority. Proposed 19 CFR 133.61(b)                    implementing section 559 of Title V of                 procedures for the voluntary donation of
                                                  prescribes the conditions applicable to a               Division F of the Consolidated                         technology, training, and other support
                                                  donation offer and provides that CBP                    Appropriations Act, 2014, where CBP                    services for the purpose of assisting CBP
                                                  will notify the donor, in writing, if                   and the GSA issued the Section 559                     in enforcing IPR, as required by section
                                                  additional information is requested or if               Donation Acceptance Authority                          308(d) of the Trade Facilitation and
                                                  CBP has determined that it will not                     Proposal Evaluation Procedures &                       Trade Enforcement Act of 2015, Public
                                                  accept the donation. In this regard, it is              Criteria Framework in October, 2014.1                  Law 114–125, 130 Stat. 122 (19 U.S.C.
                                                  noted that CBP will take into                           Pursuant to Section 482(c)(3), CBP in                  4301 note). These donations would
                                                  consideration all aspects of the                        consultation with GSA will establish                   improve CBP’s knowledge of
                                                  proposed donation offer, including                      criteria for evaluating donation                       intellectual property and improve its
                                                  whether such offer would pose a real or                 proposals under Section 482 and make                   ability to detect infringing articles and
                                                  potential conflict between the interests                such criteria publicly available.                      prevent their importation.
                                                  of the donor and the interests of the                      Donations that may not be accepted                     Because donations under this rule
                                                  government. Proposed 19 CFR 133.61(c)                   under section 482 may be considered                    would be voluntary, CBP assumes that
                                                  provides that if CBP elects to accept a                 under section 507 of the DHS                           entities would only make donations if
                                                  donation offer, CBP will enter into a                   Appropriations Act of 2004. Section 507                they believe it is in their best interest to
                                                  signed, written agreement with an                       of the DHS Appropriations Act of 2004                  do so. The cost of the donation itself,
                                                  authorized representative of the                        made the DHS Gifts and Donations                       including any training provided, would
                                                  donating entity that commemorates all                   account (formerly the Federal                          vary greatly depending on the
                                                  applicable terms and conditions, and                    Emergency Management Agency                            particulars of the donation. Due to a
                                                  that an agreement to accept training and                ‘‘Bequests and Gifts’’ account)                        lack of data on the types of donations
                                                  other support services must provide that                ‘‘available to the Department of                       that entities would offer as a result of
                                                  the services or training are offered                    Homeland Security . . . for the                        this rulemaking, CBP is unable to
                                                  without the expectation of payment and                  Secretary of Homeland Security to                      estimate the cost of these donations to
                                                  that the service provider expressly                     accept, hold, administer and utilize gifts             the public. In addition to the cost of the
                                                  waives any future claims against the                    and bequests, including property, to                   donated product or training itself,
                                                  government.                                             facilitate the work of the Department of               donors would bear some paperwork
                                                                                                          Homeland Security.’’ Title V, Public                   related costs with this rule. Under this
                                                  Authority To Accept Donations                                                                                  rule, if finalized, entities must submit
                                                                                                          Law 108–90, 117 Stat. 1153–1154. DHS
                                                    As noted above, pursuant to section                   policy on the acceptance of gifts                      an offer of a donation in writing to CBP
                                                  308(d) of the TFTEA, CBP is required to                 pursuant to section 507 is contained in                and provide all pertinent details
                                                  prescribe regulatory procedures for                     DHS Directive 112–02 and DHS                           regarding the scope, purpose, expected
                                                  donations of hardware, software,                        Instruction 112–02–001. The Secretary                  benefits, intended use, estimated costs,
                                                  equipment, and similar technologies, as                 of DHS delegated the authority to accept               and proposed conditions of the
                                                  well as training and support services,                  and utilize gifts to the heads of certain              donation. Based on discussions with
                                                  for the purpose of assisting CBP in                     DHS components, including the                          CBP’s Office of Field Operations, CBP
                                                  enforcing IPR.                                          Commissioner of CBP, in DHS                            estimates that approximately 50 entities
                                                    Acceptance of such donations must                                                                            would make donations annually and
                                                                                                          Delegation 0006.
                                                  also be consistent with either section                                                                         that there would be one donation made
                                                  482 of the Homeland Security Act of                     Executive Orders 13563 and 12866                       per entity annually, for a total of 50
                                                  2002, as amended by section 2 of the                       Executive Orders 13563 and 12866                    donations per year. CBP estimates that
                                                  Cross-Border Trade Enhancement Act of                   direct agencies to assess the costs and                it would take an entity approximately 2
                                                  2016 (Pub. L. 114–279), or section 507                  benefits of available regulatory                       hours to write the offer of donation. In
                                                  of the Department of Homeland Security                  alternatives and, if regulation is                     most cases, CBP believes that attorneys
                                                  Appropriations Act of 2004 (Pub. L.                     necessary, to select regulatory                        either employed or hired by the donor
                                                  108–90).                                                approaches that maximize net benefits                  would write the offer of donation.
                                                    Section 482 of the Homeland Security                  (including potential economic,                         Considering the median hourly wage of
                                                  Act replaced section 559 of Title V of                  environmental, public health and safety                an attorney of $80.83,2 3 writing the
                                                  Division F of the Consolidated                          effects, distributive impacts, and
                                                  Appropriations Act, 2014 (Pub. L. 113–                  equity). Executive Order 13563
                                                                                                                                                                    2 Source of median wage rate: U.S. Bureau of

                                                  76) and permits CBP, in consultation                    emphasizes the importance of
                                                                                                                                                                 Labor Statistics. Occupational Employment
                                                                                                                                                                 Statistics, ‘‘May 2014 National Occupational
                                                  with the General Services                               quantifying both costs and benefits, of                Employment and Wage Estimates, United States—
                                                  Administration (GSA), to ‘‘enter into an                reducing costs, of harmonizing rules,                  Median Hourly Wage by Occupation Code: 23–
                                                  agreement with any entity to accept a                                                                          1011.’’ Updated March 25, 2015. Available at http://
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                                                                                                          and of promoting flexibility. This                     www.bls.gov/oes/2014/may/oes231011.htm.
                                                  donation of personal property, money,
                                                                                                                                                                 Accessed June 15, 2015. CBP adjusted this figure,
                                                  or nonpersonal services’’ to be used for                  1 https://www.cbp.gov/document/guidance/             which was in 2014 U.S. dollars, to 2015 U.S. dollars
                                                  certain CBP activities at most ports of                 section-559-donation-acceptance-authority-             by applying a 1.0 percent annual growth rate to the
                                                  entry where CBP performs inspection                     proposal-evaluation-procedures-and. Section 483 of     figure, as recommended by the U.S. Department of
                                                  services. Generally speaking, donations                 the Homeland Security Act, as amended by the           Transportation’s value of travel time guidance.
                                                                                                          Cross-Border Trade Enhancement Act, also exempts       Source: U.S. Department of Transportation, Office
                                                  may be used for certain activities of                   from section 482 existing agreements entered into      of Transportation Policy. The Value of Travel Time
                                                  CBP’s Office of Field Operations,                       pursuant to section 559, as well as proposals          Savings: Departmental Guidance for Conducting
                                                  including expenses related to ‘‘(A)                     already accepted for consideration by CBP.                                                        Continued




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                                                  4802                    Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules

                                                  offers of donation would result in a total              average, each offer of donation would                  entities. Given these reasons, CBP
                                                  annual time cost to donors of $8,083                    cost CBP $2,795.50 in evaluation time                  certifies that this rule, if finalized, will
                                                  ($80.83 * 2 hours * 50 written donation                 costs.                                                 not have a significant economic impact
                                                  proposals). This would equate to a cost                    In summary, this rule could result in               on a substantial number of small
                                                  of $161.66 per entity. CBP again notes                  a total quantifiable annual cost to the                entities. CBP invites public comments
                                                  that this is a voluntary program, and                   public of $8,083 and a total annual cost               on this determination.
                                                  entities would only provide donations if                to CBP of $139,775.00. Additionally, the
                                                  the benefits of doing so outweigh the                   public would bear a cost equal to the                  Paperwork Reduction Act
                                                  costs.                                                  value of the donation and CBP would                      An agency may not conduct, and a
                                                     In addition to donor costs, this rule                bear a cost to accept the donation. As                 person is not required to respond to, a
                                                  would introduce a time cost to CBP to                   these costs would vary depending on                    collection of information unless the
                                                  process each offer of donation. As with                 the particulars of the donation, CBP is                collection of information displays a
                                                  donor costs, CBP’s cost to receive and                  unable to quantify them in this analysis.              valid control number assigned by OMB.
                                                  learn about the donated article would                   Because donations are voluntary for                      OMB approved collection 1651–0123
                                                  depend on the particulars of the                        both the donor and CBP, donations                      will be amended to reflect a new
                                                  donation. Also, accepting the donation                  would presumably only occur if the                     information collection proposed by this
                                                  is voluntary on CBP’s part and the                      benefits to each party outweigh the                    rule for written offers of donations to
                                                  agency would only accept the donation                   costs.                                                 CBP of technology, training, and other
                                                  if it is in CBP’s best interest to do so.                  Along with costs, the proposed rule                 support services in accordance with 19
                                                  In addition to CBP’s costs associated                   would provide benefits to the donor and                CFR 133.61(b). CBP estimates that this
                                                  with receiving and learning about the                   CBP. In particular, the proposed rule                  rule would result in 50 responses each
                                                  donated article, there are quantifiable                 would enhance CBP’s IPR enforcement                    year and 100 burden hours to
                                                  costs to CBP related to evaluating the                  capabilities by making donations of                    respondents annually. The new
                                                  donation and making a decision on                       authentication devices, equipment, and                 information collection would reflect the
                                                  whether to accept it under the                          training available to CBP personnel.                   burden hours for each written offer of
                                                  conditions provided. CBP estimates, at a                This would help protect the entities                   donation provided to CBP as follows:
                                                  minimum, the agency’s evaluation time                   making donations from the illegal                        Estimated number of annual
                                                  to be approximately 10 hours for each                   importation of IPR-infringing products.
                                                                                                                                                                 respondents: 50.
                                                  of the 50 donations made to CBP                         The value of this benefit would vary
                                                                                                                                                                   Estimated number of annual
                                                  annually. CBP predicts that in most                     depending on how much an entity
                                                                                                                                                                 responses: 50.
                                                  cases, each written offer of donation                   believes IPR enforcement would
                                                                                                          improve because of its donation. As                      Estimated time burden per response:
                                                  would be evaluated by five CBP                                                                                 2 hours.
                                                  employees. Based on the average hourly                  stated earlier, an entity would only
                                                                                                          make the donation if it believes the                     Estimated total annual time burden:
                                                  wage for a general CBP employee of                                                                             100 hours.
                                                  $55.91,4 evaluating the 50 offers of                    benefits of improved IPR enforcement
                                                  donation each year would result in an                   outweigh the costs.                                    Signing Authority
                                                  annual time cost to CBP of $139,775.00                  Regulatory Flexibility Act                                This proposed regulation is being
                                                  ($55.91 * 5 CBP employees * 10 hours                                                                           issued in accordance with 19 CFR
                                                                                                             The Regulatory Flexibility Act (5
                                                  * 50 written donation proposals). On                    U.S.C. 601 et. seq.), as amended by the                0.1(a)(1) pertaining to the Secretary of
                                                                                                          Small Business Regulatory Enforcement                  the Treasury’s authority (or that of his
                                                  Economic Evaluations Revision 2 (2015 Update),
                                                  ‘‘Table 4 (Revision 2-corrected): Recommended           and Fairness Act of 1996, requires                     delegate) to approve regulations related
                                                  Hourly Values of Travel Time Savings.’’ April 29,       agencies to assess the impact of                       to certain customs revenue functions.
                                                  2015. http://www.transportation.gov/sites/dot.gov/      regulations on small entities. A small                 List of Subjects
                                                  files/docs/Revised%20Departmental%20                    entity may be a small business (defined
                                                  Guidance%20on%20Valuation%20of%20
                                                  Travel%20Time%20in%20Economic%20                        as any independently owned and                         19 CFR Part 133
                                                  Analysis.pdf. Accessed June 1, 2016.                    operated business not dominant in its                    Circumvention devices, Copying or
                                                     3 The total compensation to wages and salaries       field that qualifies as a small business               simulating trademarks, Copyrights,
                                                  ratio is equal to the calculated average of the 2014    per the Small Business Act); a small not-
                                                  quarterly estimates (shown under Mar., June, Sep.,                                                             Counterfeit goods, Customs duties and
                                                  Dec.) of the total compensation cost per hour
                                                                                                          for-profit organization; or a small                    inspection, Detentions, Donations,
                                                  worked for Professional and Related occupations         governmental jurisdiction (locality with               Reporting and recordkeeping
                                                  (49.69) divided by the calculated average of the        fewer than 50,000 people).                             requirements, Restricted merchandise,
                                                  2014 quarterly estimates (shown under Mar., June,          This proposed rule, if finalized,                   Seizures and forfeitures, Technology,
                                                  Sep., Dec.) of wages and salaries cost per hour         would allow entities to voluntarily
                                                  worked for the same occupation category (34.315).                                                              Trademarks, Trade names, Support
                                                  Source of total compensation to wages and salaries      donate technology, training, and other                 services.
                                                  ratio data: U.S. Bureau of Labor Statistics. Employer   support services to improve CBP’s
                                                  Costs for Employee Compensation. Employer Costs         ability to enforce IPR potentially related             Proposed Amendments to Part 133 of
                                                  for Employee Compensation Historical Listing            to their goods. As any entity with                     the CBP Regulations
                                                  March 2004–December 2015, ‘‘Table 3. Civilian
                                                  workers, by occupational group: employer costs per      intellectual property could make these                   For the reasons set forth in the
                                                  hours worked for employee compensation and costs        donations, this rule may affect a                      preamble, CBP proposes to amend 19
                                                  as a percentage of total compensation, 2004–2015        substantial number of small entities.
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                                                  by Respondent Type: Professional and related                                                                   CFR part 133 as set forth below:
                                                                                                          However, this rule imposes no new
                                                  occupations.’’ June 10, 2015. Available at http://
                                                  www.bls.gov/ncs/ect/sp/ececqrtn.pdf. Accessed           obligations on entities, including those               PART 133—TRADEMARKS, TRADE
                                                  June 15, 2015.                                          considered small. Any small entity that                NAMES, AND COPYRIGHTS
                                                     4 CBP bases this wage on the FY 2015 salary and      chooses to make these donations would
                                                  benefits of the national average of general, non-CBP    presumably do so because it believes the               ■ 1. The general authority citation for
                                                  Officer/frontline CBP positions, which is equal to
                                                  a GS–12, Step 5. Source: Email correspondence
                                                                                                          benefits of donating exceed the costs.                 part 133 continues, and the specific
                                                  with CBP’s Office of Administration on June 25,         Therefore, this rule would not have a                  authority for new subpart H is added, to
                                                  2015.                                                   significant economic impact on small                   read as follows:


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                                                                           Federal Register / Vol. 82, No. 10 / Tuesday, January 17, 2017 / Proposed Rules                                          4803

                                                    Authority: 15 U.S.C. 1124, 1125, 1127; 17             donor. The agreement must contain all                  guidance, submit either electronic or
                                                  U.S.C. 101, 601, 602, 603; 19 U.S.C. 66, 1202,          applicable terms and conditions of the                 written comments on the draft guidance
                                                  1499, 1526, 1624; 31 U.S.C. 9701.                       donation. An agreement to accept                       by July 26, 2017.
                                                  *      *     *       *      *                           training and other support services must               ADDRESSES: You may submit comments
                                                    Section 133.61 also issued under Sec.                 provide that the services or training are              as follows:
                                                  308(d), Pub. L. 114–125; Sec. 507, Pub. L.              offered without the expectation of
                                                  108–90; Sec. 2, Pub. L. 114–279.                        payment, and that the service provider                 Electronic Submissions
                                                                                                          expressly waives any future claims                       Submit electronic comments in the
                                                  Subpart G—[Reserved].
                                                                                                          against the government.                                following way:
                                                  ■ 2. Add and reserve subpart G.                                                                                  • Federal eRulemaking Portal:
                                                  ■ 3. Add subpart H, consisting of                       R. Gil Kerlikowske,                                    https://www.regulations.gov. Follow the
                                                  § 133.61, to read as follows:                           Commissioner.                                          instructions for submitting comments.
                                                                                                            Approved: January 09, 2017.                          Comments submitted electronically,
                                                  Subpart H—Donations of Intellectual                     Timothy E. Skud,                                       including attachments, to https://
                                                  Property Rights Technology and                          Deputy Assistant Secretary of the Treasury.            www.regulations.gov will be posted to
                                                  Support Services.                                       [FR Doc. 2017–00653 Filed 1–13–17; 8:45 am]            the docket unchanged. Because your
                                                                                                          BILLING CODE 9111–14–P
                                                                                                                                                                 comment will be made public, you are
                                                  § 133.61 Donations of intellectual property
                                                  rights technology and support services.                                                                        solely responsible for ensuring that your
                                                                                                                                                                 comment does not include any
                                                     (a) Scope. The Commissioner of U.S.
                                                                                                                                                                 confidential information that you or a
                                                  Customs and Border Protection (CBP) is                  DEPARTMENT OF HEALTH AND
                                                                                                                                                                 third party may not wish to be posted,
                                                  authorized to accept donations of                       HUMAN SERVICES
                                                                                                                                                                 such as medical information, your or
                                                  hardware, software, equipment, and
                                                                                                          Food and Drug Administration                           anyone else’s Social Security number, or
                                                  similar technologies, as well as donated
                                                                                                                                                                 confidential business information, such
                                                  support services and training, from
                                                                                                          21 CFR Part 117                                        as a manufacturing process. Please note
                                                  private sector entities, for the purpose of
                                                                                                                                                                 that if you include your name, contact
                                                  assisting CBP in enforcing intellectual                 [Docket No. FDA–2008–D–0096 (Formerly                  information, or other information that
                                                  property rights. Such acceptance must                   Docket No. 2007D–0494)]                                identifies you in the body of your
                                                  be consistent with the conditions set
                                                                                                                                                                 comments, that information will be
                                                  forth in this section and section 308(d)                Control of Listeria monocytogenes in
                                                                                                                                                                 posted on https://www.regulations.gov.
                                                  of the Trade Facilitation and Trade                     Ready-To-Eat Foods: Revised Draft                        • If you want to submit a comment
                                                  Enforcement Act of 2015, as well as                     Guidance for Industry; Availability                    with confidential information that you
                                                  either section 482 of the Homeland                                                                             do not wish to be made available to the
                                                  Security Act of 2002 or section 507 of                  AGENCY:    Food and Drug Administration,
                                                                                                          HHS.                                                   public, submit the comment as a
                                                  the DHS Appropriations Act of 2004.                                                                            written/paper submission and in the
                                                     (b) Donation offer. A donation offer                 ACTION:   Notification of availability.
                                                                                                                                                                 manner detailed (see ‘‘Written/Paper
                                                  must be submitted to CBP either via
                                                                                                          SUMMARY:   The Food and Drug                           Submissions’’ and ‘‘Instructions’’).
                                                  email, to IPRdonations@cbp.dhs.gov, or
                                                                                                          Administration (FDA, we, or Agency) is                 Written/Paper Submissions
                                                  mailed to the attention of the Executive
                                                                                                          announcing the availability of a revised
                                                  Assistant Commissioner, Office of Field                                                                           Submit written/paper submissions as
                                                                                                          draft guidance for industry entitled
                                                  Operations, or his/her designee. The                                                                           follows:
                                                                                                          ‘‘Control of Listeria monocytogenes in
                                                  donation offer must describe the
                                                                                                          Ready-To-Eat Foods.’’ The revised draft                   • Mail/Hand delivery/Courier (for
                                                  proposed donation in sufficient detail to                                                                      written/paper submissions): Division of
                                                                                                          guidance is intended for any person
                                                  enable CBP to determine its                                                                                    Dockets Management (HFA–305), Food
                                                                                                          who is subject to our regulation entitled
                                                  compatibility with existing CBP                                                                                and Drug Administration, 5630 Fishers
                                                                                                          ‘‘Current Good Manufacturing Practice,
                                                  technologies, networks, and facilities                                                                         Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                          Hazard Analysis, and Risk-Based
                                                  (e.g. operating system or similar
                                                                                                          Preventive Controls for Human Food’’                      • For written/paper comments
                                                  requirements, power supply                                                                                     submitted to the Division of Dockets
                                                                                                          and who manufactures, processes,
                                                  requirements, item size and weight,                                                                            Management, FDA will post your
                                                                                                          packs, or holds ready-to-eat (RTE) foods.
                                                  etc.). The donation offer must also                                                                            comment, as well as any attachments,
                                                                                                          The revised draft guidance is intended
                                                  include information pertaining to the                                                                          except for information submitted,
                                                                                                          to help such persons comply with the
                                                  donation’s scope, purpose, expected                                                                            marked and identified, as confidential,
                                                                                                          requirements of that regulation with
                                                  benefits, intended use, costs, and                                                                             if submitted as detailed in
                                                                                                          respect to measures that can
                                                  attached conditions, as applicable, that                                                                       ‘‘Instructions.’’
                                                                                                          significantly minimize or prevent the
                                                  is sufficient to enable CBP to evaluate                                                                           Instructions: All submissions received
                                                                                                          contamination of RTE food with L.
                                                  the donation and make a determination                                                                          must include the Docket No. FDA–
                                                                                                          monocytogenes whenever a RTE food is
                                                  as to whether to accept it. CBP will                                                                           2008–D–0096 for ‘‘Control of Listeria
                                                                                                          exposed to the environment prior to
                                                  notify the donor, in writing, if                                                                               monocytogenes in Ready-To-Eat Foods.’’
                                                                                                          packaging and the packaged food does
                                                  additional information is requested or if                                                                      Received comments will be placed in
                                                                                                          not receive a treatment or otherwise
                                                  CBP has determined that it will not                                                                            the docket and, except for those
                                                                                                          include a control measure (such as a
                                                  accept the donation.                                                                                           submitted as ‘‘Confidential
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                                                     (c) Agreement to accept donation. If                 formulation lethal to L. monocytogenes)
                                                                                                                                                                 Submissions,’’ publicly viewable at
                                                  CBP accepts a donation of hardware,                     that would significantly minimize L.
                                                                                                                                                                 https://www.regulations.gov or at the
                                                  software, equipment, technologies, or to                monocytogenes.
                                                                                                                                                                 Division of Dockets Management
                                                  accept training and other support                       DATES: Although you can comment on                     between 9 a.m. and 4 p.m., Monday
                                                  services, for the purpose of enforcing                  any guidance at any time (see 21 CFR                   through Friday.
                                                  intellectual property rights, CBP will                  10.115(g)(5)), to ensure that we consider                 • Confidential Submissions—To
                                                  enter into a signed, written agreement                  your comment on the draft guidance                     submit a comment with confidential
                                                  with an authorized representative of the                before we issue the final version of the               information that you do not wish to be


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Document Created: 2017-01-14 01:44:57
Document Modified: 2017-01-14 01:44:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionNotice of proposed rulemaking.
DatesComments must be received on or before March 3, 2017.
ContactGarrett D. Wright, Chief, Donations Acceptance Program, Office of Field Operations, U.S. Customs and Border Protection, telephone (202) 344-2344.
FR Citation82 FR 4800 
RIN Number1515-AE21
CFR AssociatedCircumvention 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 and Support Services

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