30 Day FRN

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estimated for an average respondent to
respond: 2,384 responses at 2 hours per
response.
(6) An estimate of the total public
burden (in hours) associated with the
collection: 4,768 annual burden hours.
If you need a copy of the information
collection instrument with
supplementary documents, or need
additional information, please visit
http://www.regulations.gov. We may
also be contacted at: USCIS, Office of
Policy and Strategy, Regulatory
Coordination Division, 20
Massachusetts Avenue NW.,
Washington, DC 20529–2140;
Telephone 202–272–8377.
Dated: January 8, 2013.
Laura Dawkins,
Chief, Regulatory Coordination Division,
Office of Policy and Strategy, U.S. Citizenship
and Immigration Services, Department of
Homeland Security.
[FR Doc. 2013–00471 Filed 1–10–13; 8:45 am]
BILLING CODE 9111–97–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Agency Information Collection
Activities: Application To Establish a
Centralized Examination Station
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 60-Day notice and request for
comments; Extension of an existing
collection of information.
AGENCY:

As part of its continuing effort
to reduce paperwork and respondent
burden, CBP invites the general public
and other Federal agencies to comment
on an information collection
requirement concerning the:
Application to Establish a Centralized
Examination Station. This request for
comment is being made pursuant to the
Paperwork Reduction Act of 1995 (Pub.
L. 104–13).
DATES: Written comments should be
received on or before March 12, 2013, to
be assured of consideration.
ADDRESSES: Direct all written comments
to U.S. Customs and Border Protection,
Attn: Tracey Denning, Office of
Regulations and Rulings, 799 9th Street
NW., 5th Floor, Washington, DC 20229–
1177.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Office of Regulations and Rulings, 799

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SUMMARY:

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9th Street NW., 5th Floor, Washington,
DC. 20229–1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13).
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 burden to respondents or
record keepers from the collection of
information (a total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for Office of Management and
Budget (OMB) approval. All comments
will become a matter of public record.
In this document CBP is soliciting
comments concerning the following
information collection:
Title: Application to Establish a
Centralized Examination Station.
OMB Number: 1651–0061.
Form Number: None.
Abstract: A Customs and Border
Protection (CBP) port director decides
when his or her port needs one or more
Centralized Examination Stations (CES).
If it is decided that a CES is needed, the
port director solicits applications to
operate a CES. The information
contained in the application will be
used to determine the suitability of the
applicant’s facility; the fairness of fee
structure; and knowledge of cargo
handling operations and of CBP
procedures. The names of all corporate
officers and all employees who will
come in contact with uncleared cargo
will also be provided so that CBP may
perform background investigations. The
CES application is provided for by 19
CFR 118.11 and is authorized by 19 USC
1499, Tariff Act of 1930.
Current Actions: This submission is
being made to extend the expiration
date with no changes to the burden
hours or to the information collected.
Type of Review: Extension (without
change).
Affected Public: Businesses.
Estimated Number of Respondents:
50.
Estimated Time per Respondent: 2
hours.

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Estimated Total Annual Burden
Hours: 100.
Dated: January 8, 2013.
Tracey Denning,
Agency Clearance Officer, U.S. Customs and
Border Protection.
[FR Doc. 2013–00415 Filed 1–10–13; 8:45 am]
BILLING CODE 9111–14–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
Notice of Issuance of Final
Determination Concerning Rybix®
(Tramadol Hydrochloride) Tablets
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: Notice of final determination.
AGENCY:

This document provides
notice that U.S. Customs and Border
Protection (‘‘CBP’’) has issued a final
determination concerning the country of
origin of Rybix® (tramadol
hydrochloride) tablets. Based upon the
facts presented, CBP has concluded in
the final determination that India is the
country of origin of the Rybix (tramadol
hydrochloride) tablets for purposes of
U.S. Government procurement.
DATES: The final determination was
issued on December 26, 2012. A copy of
the final determination is attached. Any
party-at-interest, as defined in 19 CFR
§ 177.22(d), may seek judicial review of
this final determination on or before
February 11, 2013.
FOR FURTHER INFORMATION CONTACT:
Karen S. Greene, Valuation and Special
Programs Branch: (202) 325–0041.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that on December 26, 2012,
pursuant to subpart B of Part 177,
Customs and Border Protection
Regulations (19 CFR part 177, subpart
B), CBP issued a final determination
concerning the country of origin of
Rybix (tramadol hydrochloride) tablets,
which may be offered to the U.S.
Government under an undesignated
government procurement contract. This
final determination, in HQ H215656,
was issued at the request of Shionogi
Inc., under procedures set forth at 19
CFR part 177, subpart B, which
implements Title III of the Trade
Agreements Act of 1979, as amended
(19 U.S.C. 2511–18). In the final
determination CBP concluded that,
based upon the facts presented,
tramadol hydrochloride from India,
blended with excipients and packaged
into dosage form in France, was not
substantially transformed in France,
SUMMARY:

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Federal Register / Vol. 78, No. 8 / Friday, January 11, 2013 / Notices
such that India is the country of origin
of the finished Rybix (tramadol
hydrochloride) tablets for purposes of
U.S. Government procurement.
Section 177.29, CBP Regulations (19
CFR 177.29), provides that a notice of
final determination shall be published
in the Federal Register within 60 days
of the date the final determination is
issued. Section 177.30, CBP Regulations
(19 CFR 177.30), provides that any
party-at-interest, as defined in 19 CFR
177.22(d), may seek judicial review of a
final determination within 30 days of
publication of such determination in the
Federal Register.

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Dated: December 26, 2012.
Jeremy Baskin,
Acting Executive Director, Regulations and
Rulings, Office of International Trade.
Attachment
HQ H215656
December 26, 2012
MAR–02 OT:RR:CTF:VS KSG
CATEGORY: Origin
Alan M. Kirschenbaum
Hyman, Phelps & McNamara P.C.
700 13th Street, NW.
Suite 1200
Washington, DC 20815
RE: U.S. Government procurement; Trade
Agreement Act; Country of Origin of
Rybix ODT; substantial transformation
Dear Mr. Kirschenbaum:
This is in response to your eruling request,
submitted April 6, 2012, requesting a final
determination on behalf of Shionogi Inc.,
pursuant to subpart B of Part 177 of the U.S.
Customs and Border Protection (‘‘CBP’’)
Regulations (19 CFR Part 177) which was
forwarded to this office for a response. Under
these regulations, which implement Title III
of the Trade Agreements Act of 1979
(‘‘TAA’’), as amended (19 U.S.C. 2511 et
seq.). CBP issues country of origin advisory
rulings and final determinations as to
whether an article is or would be a product
of a designated country or instrumentality for
the purposes of granting waivers of certain
‘‘Buy American’’ restrictions in U.S. law or
practice for products offered for sale to the
U.S. Government.
This final determination concerns the
country of origin of Rybix ODT (tramadol
hydrochloride orally disintegrating tablets).
As a U.S. importer, Shionogi Inc. is a partyat-interest within the meaning of 19 CFR
177.22(d)(1), and is entitled to request this
final determination.
FACTS:
Rybix ODT is a pharmaceutical product
used for the management of moderate to
moderately severe pain in adults. The active
pharmaceutical ingredient (‘‘API’’), tramadol
hydrochloride, is manufactured in India. The
API is shipped to France where it undergoes
four stages of manufacturing. Inactive
ingredients (excipients) used in production
in France are: aspartame, copovidone,
crospovidone, ethylcellulose, magnesium

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stearate, mannitol 60, mannitol M300, mint
rootbeer flavor, and silicon dioxide.
The first stage of French manufacturing is
preparation of tramadol hydrochloride
granules (the API). The API and silicon
dioxide are de-lumped and granulated with
a suspension of ethylcellulose, copovidone,
silicon dioxide, and ethanol. The uncoated
granules are sieved and sized. These granules
are then coated and sieved to remove any
granules larger than 710 microns.
The second stage of French manufacturing
is preparation of the tablet blend. A number
of excipients such as mint rootbeer flavor,
aspartame, crospovidone, mannitol 60, and
mannitol M300, are de-lumped by passing
them through a sieve. An excipient is defined
on www.thefreedictionary.com as ‘‘an
inactive substance that serves as the vehicle
or medium for a drug’’ or ‘‘a substance, such
as sugar or gum, used to prepare a drug or
drugs in a form suitable for administration.’’
The excipients are combined to make a flavor
preblend. The tramadol hydrochloride coated
granules are also de-lumped by passing them
through a screen and then the flavor preblend
is added and blended. The blended product
is discharged into polyethylene-lined drums.
The third stage of French manufacturing is
tablet compression. Magnesium stearate is
sprayed onto upper and lower punch faces
on a tablet press (to prevent sticking) and
tablets are formed. The bulk tablets are
collected in polyethylene-lined foil bags,
which are heat-sealed and packaged in
fiberboard drums.
The fourth stage of French manufacturing
is packaging in child-resistant blister packs.
The tablets are fed through a tablet feeder
and packaged into cold form blisters sealed
with child-resistant blister lidstock. The
blister pack cards are then packed into
cartons of 30 tablets each with FDAcompliant labeling, packaged in cartons and
shipped to the importer’s warehouses in the
U.S.
ISSUE:
What is the country of origin of imported
Rybix ODT (tramadol hydrochloride),
processed as described above?
LAW AND ANALYSIS:
Pursuant to Subpart B of Part 177, 19 CFR
177.21 et seq., which implements Title III of
the Trade Agreements Act of 1979, as
amended (19 U.S.C. 2511 et seq.), CBP issues
country of origin advisory rulings and final
determinations as to whether an article is or
would be a product of a designated country
or instrumentality for the purposes of
granting waivers if certain ‘‘Buy American’’
restrictions in U.S. law or practice for
products offered for sale to the U.S.
government. Under the rule of origin set forth
under 19 U.S.C. 2518(4)(B), an article is a
product of a country or instrumentality only
if (i) it is wholly the growth, product, or
manufacture of that country or
instrumentality, or (ii) in the case of an
article which consists in whole or in part of
materials from another country or
instrumentality, it has been substantially
transformed into a new and different article
of commerce with a name, character, or use
distinct from that of the article or articles
from which it was so transformed. See also
19 CFR 177.22(a).

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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, filtering and
packaging does not result in a substantial
transformation. See Headquarters Ruling
Letter (‘‘HRL’’) H197582, dated August 9,
2012, HRL 561975, dated April 3, 2002, HRL
561544, dated May 1, 2000.
In HRL 561975, dated April 3, 2002, an
anesthetic drug known as sevofurane was
imported in bulk form from Japan and in the
U.S., processed into dosage form, filtered and
subjected to FDA testing. CBP held that the
imported good did not undergo a substantial
transformation in the U.S.—the chemical and
physical properties of the drug remained the
same, and the medicinal use did not change.
Likewise, in HRL 561544, dated May 1,
2000, 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 HRL H040735, dated January 21, 2009,
CBP considered whether imported
Sumatriptan was substantially transformed in
the UK, where it was compounded with
sodium chloride and water using helium USP
for a processing aid to reduce dissolved air.
The pharmaceutical then went through a
series of sterilizing filters, and was filled into
an empty capsule subassembly. The drug
capsule subassembly, which contained the
dose of sumatriptan succinate, and the
actuator subassembly, which consisted of a
nitrogen gas powered ram and piston, were
then combined. CBP held that the active
ingredient which was produced in India, did
not undergo a substantial transformation
even though the injection system was
sophisticated and valuable. The active
ingredient did not undergo a change in
character.
In this case, the processing in France does
not result in a change in the medicinal use
of the finished product and the active
ingredient retains its chemical and physical
properties and is merely put into a dosage
form and packaged. The active ingredient
does not undergo a change in name, character
or use. Accordingly, we find that there no
substantial transformation occurs in France,
and the imported product would be
considered a product of India for purposes of
government procurement.
HOLDING:
Based upon the facts in this case, we find
that the imported Rybix ODT (tramadol
hydrochloride) is not substantially
transformed in France. The country of origin
for government procurement purposes is
India.
Notice of this final determination will be
given in the Federal Register, as required by
19 C.F.R. 177.29. Any party-at-interest other

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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 party-atinterest 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,
Jeremy Baskin
Acting Executive Director
Office of Regulations and Rulings,
Office of International Trade
[FR Doc. 2013–00414 Filed 1–10–13; 8:45 am]
BILLING CODE P

[Docket No. FR–5681–N–02]

Federal Property Suitable as Facilities
To Assist the Homeless
Office of the Assistant
Secretary for Community Planning and
Development, HUD.
ACTION: Notice.
AGENCY:

This Notice identifies
unutilized, underutilized, excess, and
surplus Federal property reviewed by
HUD for suitability for possible use to
assist the homeless.
FOR FURTHER INFORMATION CONTACT:
Juanita Perry, Department of Housing
and Urban Development, 451 Seventh
Street SW., Room 7262, Washington, DC
20410; telephone (202) 402–3970; TTY
number for the hearing- and speechimpaired (202) 708–2565, (these
telephone numbers are not toll-free), or
call the toll-free Title V information line
at 800–927–7588.
SUPPLEMENTARY INFORMATION: In
accordance with the December 12, 1988
court order in National Coalition for the
Homeless v. Veterans Administration,
No. 88–2503–OG (D.D.C.), HUD
publishes a Notice, on a weekly basis,
identifying unutilized, underutilized,
excess and surplus Federal buildings
and real property that HUD has
reviewed for suitability for use to assist
the homeless. Today’s Notice is for the
purpose of announcing that no
additional properties have been
determined suitable or unsuitable this
week.
SUMMARY:

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[Docket No. FR–5613–N–12]

Privacy Act; Notification of New
Privacy Act System of Records, PrePurchase Homeownership Counseling
Demonstration and Impact Evaluation
Random Assignment and Service
Tracking (RAST) System
Office of the Chief Information
Officer, HUD.
ACTION: Establishment of a new Privacy
Act System of Records.
AGENCY:

The Department of Housing
and Urban Development (HUD)
proposes to establish a new record
system to add to its inventory of systems
of records subject to the Privacy Act of
1974 (5 U.S.C. 552a), as amended. The
proposed new system of record is the
Pre-Purchase Homeownership
Counseling Demonstration and Impact
Evaluation Random Assignment and
Service Tracking (RAST) System. This
system will be used by HUD’s Office of
Policy Development and Research
(PD&R) and its contractors to conduct a
random assignment and impact
evaluation study of the impact that
different types of pre-purchase
counseling have on mortgage
preparedness, homeowner outcomes,
and loan performance for prospective
low-to-moderate income, first-time
homebuyers. Refer to the ‘‘Purpose’’
section to obtain detailed information
about the purpose of this study.
DATES: Effective Date: This action shall
be effective without further notice on
February 11, 2013 unless comments are
received that would result in a contrary
determination.
Comments Due Date: February 11,
2013.
ADDRESSES: Interested persons are
invited to submit comments regarding
this notice to the Rules Docket Clerk,
Office of General Counsel, Room 10276,
Department of Housing and Urban
Development, 451 Seventh Street SW.,
Washington, DC 20410.
Communications should refer to the
above docket number and title. A copy
of each communication submitted will
be available for public inspection and
copying between 8:00 a.m. and 5:00
p.m. weekdays at the above address.
FOR FURTHER INFORMATION CONTACT:
Donna Robinson-Staton, Chief Privacy
Officer, Department of Housing and
Urban Development, 451 Seventh Street
SW., (Attention: Capitol View Building,
4th Floor), Washington, DC 20410,
Telephone Number (202) 402–8073.
(This is not a toll-free number.) A
SUMMARY:

DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT

Dated: January 3, 2013.
Mark Johnston,
Deputy Assistant Secretary for Special Needs.
[FR Doc. 2013–00152 Filed 1–10–13; 8:45 am]
BILLING CODE 4210–67–P

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URBAN DEVELOPMENT

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telecommunication device for hearingand speech-impaired individuals (TTY)
is available at 1–800–877–8339 (Federal
Information Relay Service).
Pursuant
to the Privacy Act of 1974 (5 U.S.C.
552a), as amended notice is given that
HUD proposes to establish a new system
of records as identified as Pre-Purchase
Homeownership Counseling
Demonstration and Impact Evaluation
Random Assignment and Service
Tracking (RAST) System. Title 5 U.S.C.
552a (e)(4) and (11) provide that the
public be afforded a 30-day period in
which to comment on the new system
of records, and require published notice
of the existence and character of the
system of records. The new system
report was submitted to the Office of
Management and Budget (OMB), the
Senate Committee on Governmental
Affairs, and the House Committee on
Government Reform pursuant to
paragraph 4c of Appendix 1 to OMB
Circular No. A–130, ‘‘Federal Agency
Responsibilities for Maintaining
Records About Individuals,’’ July 25,
1994; 59 FR 37914.

SUPPLEMENTARY INFORMATION:

Authority: 5 U.S.C. 552a 88 Stat. 1896; 42
U.S.C. 3535(d).
Dated: December 11, 2012.
Jerry E. Williams,
Chief Information Officer.
PDR/RRE.01
SYSTEM NAME:

Pre-Purchase Homeownership
Counseling Demonstration and Impact
Evaluation Random Assignment and
Service Tracking (RAST) System.
SYSTEM LOCATION:

Pre-Purchase Homeownership
Counseling Demonstration and Impact
Evaluation data files are to be located at
Abt Associates Inc., 55 Wheeler Street,
Cambridge, MA 02138; Abt Associates
Inc., 4550 Montgomery Avenue,
Bethesda, MD 20814; Abt Associates
Inc., 275 Seventh Avenue, Suite 2700,
New York, NY 10001; Sage Computing
Inc., 11491 Sunset Hills Road, Suite
350, Reston, VA 20190; HUD Office of
Policy Development and Research, 451
7th Street SW., Rm. 8120, Washington,
DC 20410; HUD Records Management
Facility, 451 7th Street SW., Rm. B229,
Washington, DC 20410.
CATEGORIES OF INDIVIDUALS COVERED BY THE
SYSTEM:

Households enrolled in the PrePurchase Homeownership Counseling
Demonstration and Impact Evaluation.

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