Sunshine Act Meetings, 40793 [2017-18263]
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Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices
process that leaves the identity of the article
intact. See United States v. Gibson-Thomsen
Co., 27 C.C.P.A. 267 (1940); and National
Juice Products Ass’n 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 (‘‘HQ’’)
561975, dated April 3, 2002; HQ 561544,
dated May 1, 2000; HQ 735146, dated
November 15, 1993; HQ H267177, dated
November 5, 2016; HQ H233356, dated
December 26, 2012; and, HQ 561975, dated
April 3, 2002.
For example, in HQ H267177, CBP held
that Indian- and Chinese-origin Acyclovir
was not substantially transformed in the
United States when it was combined with
excipients and processed into tablets. In that
case, the Indian or Chinese Acyclovir was the
only active pharmaceutical ingredient in the
final product. Accordingly, we found that the
processing performed in the United States
did not result in a change in the medicinal
use of the finished product. Furthermore, the
Acyclovir maintained its chemical and
physical characteristics and did not undergo
a change in name, character, or use.
Consistent with our previous rulings, we
held that processing the Acyclovir into
dosage form and packaging it for sale in the
United States did not constitute a substantial
transformation. Accordingly, the country of
origin of the final product for purposes of
U.S. Government procurement was either
China or India, where the active ingredient
was produced.
Similarly, in HQ H233356, CBP held that
the processing and packaging of imported
mefenamic acid into dosage form in the
United States did not constitute substantial
transformation. Based on previous CBP
rulings, we found that the specific U.S.
processing—which involved 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.
Accordingly, we held that the country of
origin of the final product was India, where
the mefanamic acid was produced.
In HQ 561975, we also held that the
processing of imported bulk Japanese-origin
anesthetic drugs into dosage form in the
United States did not constitute substantial
transformation. Although the bulk form of
the drug underwent testing operations,
filtering, and packaging in the United States,
these processes did not change the chemical
or physical properties of the drug.
Furthermore, there was no change in the
product’s name, which was referred to as
sevoflurane in both its bulk and processed
form. Additionally, because the imported
bulk drug had a predetermined medicinal use
as an anesthetic drug, the processing in the
VerDate Sep<11>2014
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United States did not result in a change in
the product’s use. The country of origin of
the finished product was therefore Japan.
Here, as in the cases cited above, the
processing of bulk imported pharmaceuticals
into dosage form will not result in a
substantial transformation. In this case, the
processing begins with Taiwanese-origin
bulk pravastatin sodium and, after this
product is combined with inactive
ingredients in India, results in pravastatin
sodium tablets in individual doses of 10, 20,
40, or 80 milligrams. Because the product is
referred to as ‘‘pravastatin sodium’’ both
before and after the Indian processing, no
change in name occurs in India. Furthermore,
no change in character occurs in India
because the pravastatin sodium maintains the
same chemical and physical properties both
before and after the Indian processing.
Finally, because the imported, bulk-form
pravastatin sodium had a predetermined
medicinal use as an antilipimic agent that is
used to reduce the risk of myocardial
infarction, no change in use occurs after
processing in India. Under these
circumstances, and consistent with previous
CBP rulings, we find that the country of
origin of the final product is Taiwan, where
the active ingredient was produced.
HOLDING:
The country of origin of the pravastatin
sodium tablets for purposes of U.S.
Government procurement is Taiwan.
Notice of this final determination will be
given in the Federal Register, as required by
19 CFR 177.29. Any party-at-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 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,
Alice A. Kipel,
Executive Director,
Regulations & Rulings,
Office of Trade.
[FR Doc. 2017–18205 Filed 8–25–17; 8:45 am]
BILLING CODE 9111–14–P
INTER-AMERICAN FOUNDATION
Sunshine Act Meetings
September 6, 2017,
11:00 a.m.–12:00 p.m.
PLACE: Via tele-conference hosted at
Inter-American Foundation, 1331
Pennsylvania Ave. Suite 1200, NW.,
Washington, DC 20004.
STATUS: Meeting of the Board of
Directors, Open to the public.
MATTERS TO BE CONSIDERED: Next steps
for updating advisory council
membership.
TIME AND DATE:
PO 00000
Frm 00050
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40793
The role of the Board in funding
decisions.
FOR DIAL-IN INFORMATION CONTACT: Karen
Vargas, Executive Assistant, (202) 524–
8869.
CONTACT PERSON FOR MORE INFORMATION:
Paul Zimmerman, General Counsel,
(202) 683–7118.
Paul Zimmerman,
General Counsel.
[FR Doc. 2017–18263 Filed 8–24–17; 4:15 pm]
BILLING CODE 7025–01–P
DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–R8–ES–2017–N084; FF08EVEN00–
FXFR1337088SSO0]
Marine Mammal Protection Act; Stock
Assessment Report for the Southern
Sea Otter in California
Fish and Wildlife Service,
Interior.
ACTION: Notice of availability; response
to comments.
AGENCY:
In accordance with the
Marine Mammal Protection Act of 1972,
as amended (MMPA), and its
implementing regulations, we, the U.S.
Fish and Wildlife Service (Service),
announce that we have revised our
stock assessment report (SAR) for the
southern sea otter stock in the State of
California, including incorporation of
public comments. We now make our
final revised SAR available to the
public.
ADDRESSES: Document Availability: You
may obtain a copy of the SAR from our
Web site at https://www.fws.gov/
ventura/endangered/species/info/
sso.html. Alternatively, you may contact
the Ventura Fish and Wildlife Office,
U.S. Fish and Wildlife Service, 2493
Portola Road, Suite B, Ventura, CA
93003; telephone: 805–644–1766.
FOR FURTHER INFORMATION CONTACT: For
information on the methods, data, and
results of the stock assessment, contact
Lilian Carswell by telephone (805–677–
3325) or by email (Lilian_Carswell@
fws.gov). Persons who use a
telecommunications device for the deaf
(TDD) may call the Federal Relay
Service at 800–877–8339.
SUPPLEMENTARY INFORMATION: We are
announcing the availability of the final
revised SAR for the southern sea otter
(Enhydra lutris nereis) stock in the State
of California.
SUMMARY:
Background
Under the MMPA (16 U.S.C. 1361 et
seq.) and its implementing regulations
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[Federal Register Volume 82, Number 165 (Monday, August 28, 2017)]
[Notices]
[Page 40793]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18263]
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INTER-AMERICAN FOUNDATION
Sunshine Act Meetings
TIME AND DATE: September 6, 2017, 11:00 a.m.-12:00 p.m.
PLACE: Via tele-conference hosted at Inter-American Foundation, 1331
Pennsylvania Ave. Suite 1200, NW., Washington, DC 20004.
STATUS: Meeting of the Board of Directors, Open to the public.
MATTERS TO BE CONSIDERED: Next steps for updating advisory council
membership.
The role of the Board in funding decisions.
FOR DIAL-IN INFORMATION CONTACT: Karen Vargas, Executive Assistant,
(202) 524-8869.
CONTACT PERSON FOR MORE INFORMATION: Paul Zimmerman, General Counsel,
(202) 683-7118.
Paul Zimmerman,
General Counsel.
[FR Doc. 2017-18263 Filed 8-24-17; 4:15 pm]
BILLING CODE 7025-01-P
