82 FR 40793 - Sunshine Act Meetings

INTER-AMERICAN FOUNDATION

Federal Register Volume 82, Issue 165 (August 28, 2017)

Page Range		40793-40793
FR Document		2017-18263

Federal Register, Volume 82 Issue 165 (Monday, August 28, 2017)

[Federal Register Volume 82, Number 165 (Monday, August 28, 2017)]
[Notices]
[Page 40793]
From the Federal Register Online  [www.thefederalregister.org]
[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

Federal Register / Vol. 82, No. 165 / Monday, August 28, 2017 / Notices 40793

process that leaves the identity of the article United States did not result in a change in The role of the Board in funding
intact. See United States v. Gibson-Thomsen the product’s use. The country of origin of decisions.
Co., 27 C.C.P.A. 267 (1940); and National the finished product was therefore Japan.
FOR DIAL-IN INFORMATION CONTACT: Karen
Juice Products Ass’n v. United States, 628 Here, as in the cases cited above, the
F.Supp. 978 (Ct. Int’l Trade 1986). processing of bulk imported pharmaceuticals Vargas, Executive Assistant, (202) 524–
In determining whether a substantial into dosage form will not result in a 8869.
transformation occurs in the manufacture of substantial transformation. In this case, the CONTACT PERSON FOR MORE INFORMATION:
chemical products such as pharmaceuticals, processing begins with Taiwanese-origin Paul Zimmerman, General Counsel,
CBP has consistently examined the bulk pravastatin sodium and, after this (202) 683–7118.
complexity of the processing and whether the product is combined with inactive
final article retains the essential identity and ingredients in India, results in pravastatin Paul Zimmerman,
character of the raw material. To that end, sodium tablets in individual doses of 10, 20, General Counsel.
CBP has generally held that the processing of 40, or 80 milligrams. Because the product is [FR Doc. 2017–18263 Filed 8–24–17; 4:15 pm]
pharmaceutical products from bulk form into referred to as ‘‘pravastatin sodium’’ both BILLING CODE 7025–01–P
measured doses does not result in a before and after the Indian processing, no
substantial transformation of the product. change in name occurs in India. Furthermore,
See, e.g., Headquarters Ruling (‘‘HQ’’) no change in character occurs in India
561975, dated April 3, 2002; HQ 561544, because the pravastatin sodium maintains the DEPARTMENT OF THE INTERIOR
dated May 1, 2000; HQ 735146, dated same chemical and physical properties both
November 15, 1993; HQ H267177, dated before and after the Indian processing. Fish and Wildlife Service
November 5, 2016; HQ H233356, dated Finally, because the imported, bulk-form
December 26, 2012; and, HQ 561975, dated [FWS–R8–ES–2017–N084; FF08EVEN00–
pravastatin sodium had a predetermined FXFR1337088SSO0]
April 3, 2002. medicinal use as an antilipimic agent that is
For example, in HQ H267177, CBP held used to reduce the risk of myocardial
that Indian- and Chinese-origin Acyclovir
Marine Mammal Protection Act; Stock
infarction, no change in use occurs after Assessment Report for the Southern
was not substantially transformed in the processing in India. Under these
United States when it was combined with circumstances, and consistent with previous
Sea Otter in California
excipients and processed into tablets. In that CBP rulings, we find that the country of AGENCY: Fish and Wildlife Service,
case, the Indian or Chinese Acyclovir was the origin of the final product is Taiwan, where
only active pharmaceutical ingredient in the
Interior.
the active ingredient was produced.
final product. Accordingly, we found that the ACTION: Notice of availability; response
processing performed in the United States HOLDING: to comments.
did not result in a change in the medicinal The country of origin of the pravastatin
use of the finished product. Furthermore, the sodium tablets for purposes of U.S. SUMMARY: In accordance with the
Acyclovir maintained its chemical and Government procurement is Taiwan. Marine Mammal Protection Act of 1972,
physical characteristics and did not undergo Notice of this final determination will be as amended (MMPA), and its
a change in name, character, or use. given in the Federal Register, as required by implementing regulations, we, the U.S.
Consistent with our previous rulings, we 19 CFR 177.29. Any party-at-interest other Fish and Wildlife Service (Service),
held that processing the Acyclovir into than the party which requested this final announce that we have revised our
dosage form and packaging it for sale in the determination may request, pursuant to 19 stock assessment report (SAR) for the
United States did not constitute a substantial CFR 177.31, that CBP reexamine the matter southern sea otter stock in the State of
transformation. Accordingly, the country of anew and issue a new final determination. California, including incorporation of
origin of the final product for purposes of Pursuant to 19 CFR 177.30, any party-at-
U.S. Government procurement was either public comments. We now make our
interest may, within 30 days of publication
China or India, where the active ingredient of the Federal Register Notice referenced final revised SAR available to the
was produced. above, seek judicial review of this final public.
Similarly, in HQ H233356, CBP held that determination before the Court of ADDRESSES: Document Availability: You
the processing and packaging of imported International Trade. may obtain a copy of the SAR from our
mefenamic acid into dosage form in the Sincerely, Web site at https://www.fws.gov/
United States did not constitute substantial
transformation. Based on previous CBP Alice A. Kipel, ventura/endangered/species/info/
rulings, we found that the specific U.S. Executive Director, sso.html. Alternatively, you may contact
processing—which involved blending the Regulations & Rulings, the Ventura Fish and Wildlife Office,
active ingredients with inactive ingredients Office of Trade. U.S. Fish and Wildlife Service, 2493
in a tumbler and then encapsulating and [FR Doc. 2017–18205 Filed 8–25–17; 8:45 am] Portola Road, Suite B, Ventura, CA
packaging the product—did not substantially BILLING CODE 9111–14–P 93003; telephone: 805–644–1766.
transform the mefenamic acid because its FOR FURTHER INFORMATION CONTACT: For
chemical character remained the same. information on the methods, data, and
Accordingly, we held that the country of
results of the stock assessment, contact
origin of the final product was India, where INTER-AMERICAN FOUNDATION
the mefanamic acid was produced. Lilian Carswell by telephone (805–677–
In HQ 561975, we also held that the 3325) or by email (Lilian_Carswell@
Sunshine Act Meetings
processing of imported bulk Japanese-origin fws.gov). Persons who use a
anesthetic drugs into dosage form in the TIME AND DATE: September 6, 2017, telecommunications device for the deaf
United States did not constitute substantial 11:00 a.m.–12:00 p.m. (TDD) may call the Federal Relay
transformation. Although the bulk form of Service at 800–877–8339.
the drug underwent testing operations, PLACE: Via tele-conference hosted at
asabaliauskas on DSKBBXCHB2PROD with NOTICES

SUPPLEMENTARY INFORMATION: We are
filtering, and packaging in the United States, Inter-American Foundation, 1331
Pennsylvania Ave. Suite 1200, NW., announcing the availability of the final
these processes did not change the chemical
or physical properties of the drug. Washington, DC 20004. revised SAR for the southern sea otter
Furthermore, there was no change in the (Enhydra lutris nereis) stock in the State
STATUS: Meeting of the Board of
product’s name, which was referred to as of California.
Directors, Open to the public.
sevoflurane in both its bulk and processed Background
form. Additionally, because the imported MATTERS TO BE CONSIDERED: Next steps
bulk drug had a predetermined medicinal use for updating advisory council Under the MMPA (16 U.S.C. 1361 et
as an anesthetic drug, the processing in the membership. seq.) and its implementing regulations

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Document Created: 2017-08-28 11:30:04
Document Modified: 2017-08-28 11:30:04

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		September 6, 2017, 11:00 a.m.-12:00 p.m.
FR Citation		82 FR 40793