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jstallworth on DSK7TPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices
Gibson-Thomsen Co., 27 C.C.P.A. 267
(1940); and, National Juice Products
Association v. United States, 628 F.
Supp. 978 (Ct. Int’l Trade 1986).
In determining whether a substantial
transformation occurs in the
manufacture of chemical products such
as pharmaceuticals, CBP has
consistently examined the complexity of
the processing and whether the final
article retains the essential identity and
character of the raw material. To that
end, CBP has generally held that the
processing of pharmaceutical products
from bulk form into measured doses
does not result in a substantial
transformation of the product. See e.g.,
Headquarters Ruling Letter (‘‘HQ’’)
561975, dated April 3, 2002; HQ
561544, dated May 1, 2000; and, HQ
735146, dated November 15, 1993.
For instance, in HQ 561975, the
anesthetic drug sevoflurane imported
into the U.S. in bulk form and processed
into dosage form by extensive testing
operations, followed by filtering and
packaging into bottles, was found not to
have undergone a substantial
transformation in the U.S. There was no
change in name (the product was
identified as sevoflurane in both its bulk
and processed form). The sevoflurane
retained its chemical and physical
properties after the U.S. processing.
Lastly, because the imported bulk
sevoflurane had a predetermined
medicinal use as an inhalable anesthetic
drug, the processing in the United States
resulted in no change in the product’s
use.
Likewise, in HQ 561544, the testing,
filtering and sterile packaging of
Geneticin Sulfate bulk powder, to create
Geneticin Selective Antibiotic, was not
found to have substantially transformed
the antibiotic substance because the
processing only involved the removal of
impurities from the bulk chemical and
the placement of the chemical into
smaller packaging.
In HQ 735146, 100 percent pure
acetaminophen imported from China
was blended with excipients in the
United States, granulated and sold to
pharmaceutical companies to process
into tablets for retail sale under private
labels. It was found that the process in
the United States did not substantially
transform the imported product because
the product was referred to as
acetaminophen before importation and
after U.S. processing, its use was for
medicinal purposes and continued to be
so used after U.S. processing, and the
granulating process minimally affected
the chemical and physical properties of
the acetaminophen.
In HQ H233356 dated December 26,
2012, mefenamic acid imported from

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India was blended with excipients and
packaged into dosage form in the United
States. Based on prior rulings, we found
that the specific processing consisting of
blending the active ingredients with
inactive ingredients in a tumbler and
then encapsulating and packaging the
product did not substantially transform
the mefenamic acid because its
chemical character remained the same.
As such, we found that the country of
origin of the Ponstel (mefenamic acid)
capsules was India, where the
mefanamic acid was manufactured.
In this case, the processing performed
in the U.S. does not result in a change
in the medicinal use of the finished
product and the active ingredient. The
Acyclovir retains its chemical and
physical properties and is merely put
into a dosage form and is packaged for
sale. The active ingredient does not
undergo a change in name, character or
use. Therefore, in accordance with our
prior rulings, we find that no substantial
transformation occurs in U.S., and for
purposes of government procurement,
the Acyclovir tablets would be
considered a product where the active
ingredient was produced, which would
be China and India.
HOLDING:
Based upon the facts in this case, we
find that the imported Acyclovir is not
substantially transformed in U.S.
Accordingly, the country of origin for
government procurement purposes of
the Acyclovir tablets is China and India,
where the active ingredient is produced.
Notice of this final determination will
be given in the Federal Register, as
required by 19 CFR 177.29. Any partyat-interest other than the party which
requested this final determination may
request, pursuant to 19 CFR 177.31 that
CBP reexamine the matter anew and
issue a new final determination.
Pursuant to 19 CFR 177.30, any partyat-interest may, within 30 days of
publication of the Federal Register
notice referenced above, seek judicial
review of this final determination before
the Court of International Trade.
Sincerely,
Myles B. Harmon Acting Executive Director
Office of Regulations and Rulings
Office of International Trade
[FR Doc. 2015–28827 Filed 11–12–15; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0124]

Agency Information Collection
Activities: Cargo Container and Road
Vehicle Certification for Transport
Under Customs Seal
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 30-Day notice and request for
comments; extension of an existing
collection of information.
AGENCY:

U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: Cargo Container and
Road Vehicle for Transport under
Customs Seal. This is a proposed
extension of an information collection
that was previously approved. CBP is
proposing that this information
collection be extended with no change
to the burden hours or to the
information collected. This document is
published to obtain comments from the
public and affected agencies.
DATES: Written comments should be
received on or before December 14, 2015
to be assured of consideration.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to oira_submission@
omb.eop.gov or faxed to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: This
proposed information collection was
previously published in the Federal
Register (80 FR 48117) on August 11,
2015, allowing for a 60-day comment
period. This notice allows for an
additional 30 days for public comments.
This process is conducted in accordance
with 5 CFR 1320.10. CBP invites the
general public and other Federal
SUMMARY:

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jstallworth on DSK7TPTVN1PROD with NOTICES

70246

Federal Register / Vol. 80, No. 219 / Friday, November 13, 2015 / Notices

agencies to comment on proposed and/
or continuing information collections
pursuant to the Paperwork Reduction
Act of 1995 (Pub. L. 104–13; 44 U.S.C.
3507). The comments should address:
(a) Whether the collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s
estimates of the burden of the collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden, including the use
of automated collection techniques or
the use of other forms of information
technology; and (e) the annual costs to
respondents or record keepers from the
collection of information (total capital/
startup costs and operations and
maintenance costs). The comments that
are submitted will be summarized and
included in the CBP request for OMB
approval. All comments will become a
matter of public record. In this
document, CBP is soliciting comments
concerning the following information
collection:
Title: Cargo Container and Road
Vehicle for Transport under Customs
Seal.
OMB Number: 1651–0124.
Abstract: The United States is a
signatory to several international
Customs conventions and is responsible
for specifying the technical
requirements that containers and road
vehicles must meet to be acceptable for
transport under Customs seal. Customs
and Border Protection (CBP) has the
responsibility of collecting information
for the purpose of certifying containers
and vehicles for international transport
under Customs seal. A certification of
compliance facilitates the movement of
containers and road vehicles across
international territories. The procedures
for obtaining a certification of a
container or vehicle are set forth in 19
CFR part 115.
Action: CBP proposes to extend the
expiration date of this information
collection with no change to the burden
hours or to the information collected.
Type of Review: Extension (without
change).
Affected Public: Businesses.
Estimated Number of Respondents:
25.
Estimated Number of Annual
Responses per Respondent: 120.
Estimated Time per Response: 3.5
hours.
Estimated Total Annual Burden
Hours: 10,500.

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Dated: November 4, 2015.
Tracey Denning,
Agency Clearance Officer, U.S. Customs and
Border Protection.
[FR Doc. 2015–28828 Filed 11–12–15; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Agency Information Collection
Activities: National Initiative for
Cybersecurity Careers and Studies
(NICCS) Cybersecurity Training and
Education Catalog (Training/Workforce
Development Catalog) Collection
Cybersecurity Education &
Awareness Office (CE&A), DHS.
ACTION: 30-Day notice and request for
comments; reinstatement with change,
1601–0016.
AGENCY:

The Department of Homeland
Security, Cybersecurity Education &
Awareness Office (CE&A), will submit
the following Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995 (Pub. L. 104–13, 44 U.S.C. Chapter
35). DHS previously published this
information collection request (ICR) in
the Federal Register on Wednesday,
September 2, 2015 at 80 FR 53180 for
a 60-day public comment period. No
comments were received by DHS. The
purpose of this notice is to allow
additional 30-days for public comments.
DATES: Comments are encouraged and
will be accepted until January 12, 2016.
This process is conducted in accordance
with 5 CFR 1320.1.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to OMB Desk Officer, Department of
Homeland Security and sent via
electronic mail to oira_submission@
omb.eop.gov or faxed to (202) 395–5806.
SUPPLEMENTARY INFORMATION: Title II,
Homeland Security Act, 6 U.S.C.
121(d)(1) To access, receive, and
analyze laws enforcement information,
intelligence information and other
information from agencies of the Federal
Government, State and local
government agencies . . . and Private
sector entities and to integrate such
information in support of the mission
responsibilities of the Department. The
following authorities also permit DHS to
collect information of the type
contemplated: Federal Information
SUMMARY:

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Security Management Act of 2002
(FISMA), 44 U.S.C. 3546; Homeland
Security Presidential Directive (HSPD)
7, ‘‘Critical Infrastructure Identification,
Prioritization, and Protection’’ (2003);
and NSPD–54/HSPD–23, ‘‘Cybersecurity
Policy’’ (2009).
In May 2009, the President ordered a
Cyberspace Policy Review to develop a
comprehensive approach to secure and
defend America’s infrastructure. The
review built upon the Comprehensive
National Cybersecurity Initiative (CNCI).
In response to increased cyber threats
across the Nation, the National Initiative
for Cybersecurity Education (NICE)
expanded from a previous effort, the
CNCI #8. NICE formed in March 2011,
and is a nationally coordinated effort
comprised of over 20 federal
departments and agencies, and
numerous partners in academia and
industry. NICE focuses on cybersecurity
awareness, education, training and
professional development. NICE seeks
to encourage and build cybersecurity
awareness and competency across the
Nation and to develop an agile, highly
skilled cybersecurity workforce.
The NICCS Portal is a national online
resource for cybersecurity awareness,
education, talent management, and
professional development and training.
NICCS Portal is an implementation tool
for NICE. Its mission is to provide
comprehensive cybersecurity resources
to the public.
To promote cybersecurity education,
and to provide a comprehensive
resource for the Nation, NICE developed
the Cybersecurity Training and
Education Catalog. The Cybersecurity
Training and Education Catalog will be
hosted on the NICCS Portal. Training
Course and certification information
will be included in the Training/
Workforce Development Catalog. Note:
Any information received from the
public in support of the NICCS Portal
and Cybersecurity Training and
Education Catalog is completely
voluntary. Organizations and
individuals who do not provide
information can still utilize the NICCS
Portal and Cybersecurity Training and
Education Catalog without restriction or
penalty. An organization or individual
who wants their information removed
from the NICCS Portal and/or
Cybersecurity Training and Education
Catalog can email the NICCS
Supervisory Office. There are no
requirements for a provider to fill out a
specific form for their information to be
removed; standard email requests will
be honored. Department of Homeland
Security (DHS) Cybersecurity Education
& Awareness Office (CE&A) intends for
the collected information from the

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