83 FR 31764 - Notice of Issuance of Final Determination Concerning Malarone Tablets

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

Federal Register Volume 83, Issue 131 (July 9, 2018)

Page Range		31764-31766
FR Document		2018-14632

This document provides notice that U.S. Customs and Border Protection (``CBP'') has issued a final determination concerning the country of origin of Malarone tablets. Based upon the facts presented, CBP has concluded that the country of origin of the Malarone tablets is Canada for purposes of U.S. Government procurement.

Federal Register, Volume 83 Issue 131 (Monday, July 9, 2018)

[Federal Register Volume 83, Number 131 (Monday, July 9, 2018)]
[Notices]
[Pages 31764-31766]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-14632]

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DEPARTMENT OF HOMELAND SECURITY

U.S. Customs and Border Protection

Notice of Issuance of Final Determination Concerning Malarone
Tablets

AGENCY: U.S. Customs and Border Protection, Department of Homeland
Security.

ACTION: Notice of final determination.

-----------------------------------------------------------------------

SUMMARY: This document provides notice that U.S. Customs and Border
Protection (``CBP'') has issued a final determination concerning the
country of origin of Malarone tablets. Based upon the facts presented,
CBP has concluded that the country of origin of the Malarone tablets is
Canada for purposes of U.S. Government procurement.

DATES: This final determination was issued on July 2, 2018. A copy of
the final determination is attached. Any party-at-interest may seek
judicial review of this final determination within August 8, 2018.

FOR FURTHER INFORMATION CONTACT: Ross M. Cunningham, Valuation and
Special Programs Branch, Regulations and Rulings, Office of Trade,
(202) 325-0034.

SUPPLEMENTARY INFORMATION: Notice is hereby given that on July 2, 2018,
pursuant to subpart B of Part 177, U.S. Customs and Border Protection
Regulations (19 CFR part 177, subpart B), CBP issued one final
determination concerning the country of origin of Malarone tablets,
which may be offered to the U.S. Government under an undesignated
government procurement contract. This final determination (HQ H290684)
was issued 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 the processing in Canada will result in a substantial
transformation. Therefore, the country of origin for purposes of U.S.
Government procurement of the Malarone tablets is Canada.
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.

Dated: July 2, 2018.
Alice A. Kipel,
Executive Director, Regulations and Rulings, Office of Trade.
HQ H290684
July 2, 2018
OT:RR:CTF:VS H290684 RMC
CATEGORY: Origin
Nicolas Guzman
Drinker Biddle & Reath LLP
1500 K Street NW
Suite 1100
Washington, DC 20005-1209

Re: U.S. Government Procurement; Country of Origin of Malarone Tablets;
Substantial Transformation

Dear Mr. Guzman:
This is in response to your letter, dated September 13, 2017,
requesting a final determination on behalf of GlaxoSmithKline LLP
(``GSK'') pursuant to subpart B of Part 177 of the U.S. Customs and
Border Protection (``CBP'') Regulations (19 C.F.R. Part 177). A
teleconference was held with counsel for GSK on June 8, 2018.
This final determination concerns the country of origin of Malarone
tablets. As a U.S. importer, GSK is a party-at-interest within the
meaning of 19 C.F.R. Sec. 177.22(d)(1) and is entitled to request this
final determination.

FACTS:

GSK is a global healthcare company that researches, develops, and
manufactures pharmaceutical medicines, vaccines, and consumer
healthcare products. At issue in this case are tablets sold under the
brand name Malarone, which are indicated for the prevention and
treatment of acute, uncomplicated Plasmodium falciparum malaria. GSK
states that Malarone tablets have been shown to be effective in regions
where other malaria drugs such as chloroquine, halofantrine,
mefloquine, and amodiaquine may have unacceptable failure rates,
presumably due to drug resistance.
According to the FDA prescribing information, Malarone is a fixed-
dose combination of atovaquone and proguanil hydrochloride. See
Prescribing Information, https://www.fda.gov/ohrms/dockets/ac/05/briefing/2005-4089b1_05_05_atovaquone.pdf (last visited Dec. 11, 2017).
The chemical name of atovaquone 11 is trans-2-[4-(4
chlorophenyl)cyclohexyl]-3-hydroxy-1,4-naphthalenedione and the
molecular formula for atovaquone is C22H19ClO3. The chemical name of
proguanil hydrochloride is 1-(4-chlorophenyl)-5-isopropyl-biguanide
hydrochloride and the chemical formula for proguanil hydrochloride is
C11H16ClN5HCl. Each Malarone Tablet contains 250 milligrams of
atovaquone and 100 milligrams of proguanil hydrochloride.
The FDA prescribing information also describes the microbiology or
``mechanism of action'' of atovaquone and proguanil hydrochloride. It
states that atovaquone and proguanil hydrochloride ``interfere with 2
different pathways involved in the biosynthesis of pyrimidines required
for nucleic acid replication. Atovaquone is a selective inhibitor of
parasite mitochondrial electron transport. Proguanil hydrochloride
primarily exerts its effect by means of the metabolite cycloguanil, a
dihydrofolate reductase inhibitor. Inhibition of dihydrofolate
reductase in the malaria

[[Page 31765]]

parasite disrupts deoxythymidylate synthesis.''
GSK notes that atovaquone by itself is not indicated for the
prevention or treatment of malaria. By itself, atovaquone is used for
other purposes, such as the treatment of acute pneumocystis carinii
pneumonia and cerebral toxoplasmosis. In contrast, proguanil
hydrochloride can be used to treat malaria. However, GSK cites to
several academic studies that conclude that the combination of
atovaquone and proguanil hydrochloride provides a more effective
treatment compared to taking proguanil hydrochloride alone. GSK
therefore states that atovaquone and proguanil are ``synergistic in
their mechanisms of action,'' resulting in the increased effectiveness
of Malarone tablets compared to taking atovaquone or proguanil
hydrochloride alone.
The manufacturing process for GSK's Malarone tablets begins in
India, where the Malarone tablets' two active pharmaceutical
ingredients (``APIs''), atovaquone and proguanil hydrochloride, are
manufactured. After the two APIs are manufactured in India, they are
imported into Canada for further processing at GSK's Mississauga,
Ontario facility (``GSK Canada''). At GSK Canada, the two APIs are
combined in a process that begins by producing a dry mix of the APIs,
low-substituted hydroxpropyl cellulose NF, microcrystalline cellulose
NF, and sodium starch glycolate NF. The dry mix is then combined with
the following inactive ingredients, which are each sourced from the
United States or a TAA-eligible country, to produce granules:
Povidone K30 USP
Polaxamer 188 NF
Sofium Starch Glycolate NF
Hydroxy Propyl Cellulose NF
Purified Water USP
Microcrystalline Cellulose NF
Alcohol USP
Next, the granules are dried, milled into a dry powder, blended
with magnesium stearate NF, and compressed into tablets. Finally, a
film coat mix is added and the tablets are polished.
Once the manufacturing process is complete, the finished Malarone
tablets are exported to a GSK facility in Zebulon, North Carolina.
There, the tablets are packaged and labeled for sale to Prasco
Laboratories, which markets and distributes the tablets under their own
labeling as an authorized generic product under an agreement with GSK.

ISSUE:

What is the country of origin of the Malarone tablets for purposes
of U.S. Government procurement?

LAW AND ANALYSIS:

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, pursuant
to subpart B of Part 177, 19 C.F.R. Sec. 177.21 et seq., which
implements Title III of the Trade Agreements Act of 1979, as amended
(19 U.S.C. Sec. 2511 et seq.).
Under the rule of origin set forth under 19 U.S.C. Sec.
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 C.F.R. Sec. 177.22(a).
A substantial transformation occurs when an article emerges from a
process with a new name, character, and use different from that
possessed by the article prior to processing. A substantial
transformation will not result from a minor manufacturing or combining
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. However, where the processing from bulk
form into measured doses involves the combination of two or more APIs,
and the resulting combination offers additional medicinal benefits
compared to taking each API alone, CBP has held that a substantial
transformation occurred. See, e.g., HQ 563207, dated June 1, 2005.
For example, in HQ 563207, CBP held that the combination of two
APIs to form Actoplus Met, an alternative treatment for type 2
diabetes, constituted a substantial transformation. The first API,
Pioglitazone HCI sourced from Japan or other countries, functioned as
an insulin sensitizer that targets insulin resistance in the body. The
second API, biguanide sourced from Japan, Spain, and other countries,
functioned to decrease the amount of glucose produced by the liver and
make muscle tissue more sensitive to insulin so glucose can be
absorbed. In Japan, the two APIs were mixed together to form a fixed-
combination drug called Actoplus Met. In holding that a substantial
transformation occurred when the APIs were combined in Japan to produce
Actoplus Met, CBP emphasized that ``[w]hile we note that pioglitazone
and metformin may be prescribed separately, the final product, Actoplus
Met, increases the individual effectiveness of piofliazone and
metformin in treating type 2 diabetes patients.''
Similarly, in HQ H253443, dated March 13, 2015, CBP held that the
combination of two APIs in China to produce Prepopik, ``a dual-acting
osmotic and stimulant laxative bowel preparation for a colonoscopy in
adults,'' constituted a substantial transformation. Although the
importer claimed that Country A-origin sodium picosulfate was the only
API in Prepopik, CBP found that the Country B-origin magnesium oxide
ingredient also qualified as an API. CBP further found that taking
Prepopik had ``a more stimulative laxative effect'' than taking each of
the APIs individually and therefore held that a substantial
transformation occurred when the APIs were combined in China.
Here, as in HQ 563207 and HQ H253443, two separate APIs are mixed
to create a fixed combination drug that offers additional medicinal
benefits compared to taking each API alone. The first API, atovaquone,
is not indicated for the prevention or treatment of malaria. The second
API, proguanil hydrochloride, is used to treat malaria, but is less
effective than Malarone. This is because of the ``synergies in [the
APIs'] method of action,'' which result in a product that
``interfere[s] with 2 different pathways'' to prevent and treat
malaria. Under these circumstances, the combination of atovaquone,
proguanil

[[Page 31766]]

hydrochloride, and inactive ingredients to form Malarone tablets in
Canada results in a substantial transformation. The country of origin
of the Malarone tablets is therefore Canada.

HOLDING:

The country of origin of the Malarone tablets for purposes of U.S.
Government procurement is Canada.
Notice of this final determination will be given in the Federal
Register, as required by 19 C.F.R. Sec. 177.29. Any party-at-interest
other than the party which requested this final determination may
request, pursuant to 19 C.F.R. Sec. 177.31, that CBP reexamine the
matter anew and issue a new final determination. Pursuant to 19 C.F.R.
Sec. 177.30, any party-at-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,

Alice A. Kipel,
Executive Director, Regulations & Rulings Office of Trade.

[FR Doc. 2018-14632 Filed 7-6-18; 8:45 am]
BILLING CODE 9111-14-P

Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices 31765

parasite disrupts deoxythymidylate ISSUE: the resulting combination offers
synthesis.’’ What is the country of origin of the additional medicinal benefits compared
GSK notes that atovaquone by itself is Malarone tablets for purposes of U.S. to taking each API alone, CBP has held
not indicated for the prevention or Government procurement? that a substantial transformation
treatment of malaria. By itself, occurred. See, e.g., HQ 563207, dated
LAW AND ANALYSIS: June 1, 2005.
atovaquone is used for other purposes,
such as the treatment of acute CBP issues country of origin advisory For example, in HQ 563207, CBP held
pneumocystis carinii pneumonia and rulings and final determinations as to that the combination of two APIs to
whether an article is or would be a form Actoplus Met, an alternative
cerebral toxoplasmosis. In contrast,
product of a designated country or treatment for type 2 diabetes,
proguanil hydrochloride can be used to
instrumentality for the purposes of constituted a substantial transformation.
treat malaria. However, GSK cites to
granting waivers of certain ‘‘Buy The first API, Pioglitazone HCI sourced
several academic studies that conclude
American’’ restrictions in U.S. law or from Japan or other countries,
that the combination of atovaquone and
practice for products offered for sale to functioned as an insulin sensitizer that
proguanil hydrochloride provides a
the U.S. Government, pursuant to targets insulin resistance in the body.
more effective treatment compared to
subpart B of Part 177, 19 C.F.R. § 177.21 The second API, biguanide sourced
taking proguanil hydrochloride alone.
et seq., which implements Title III of the from Japan, Spain, and other countries,
GSK therefore states that atovaquone
Trade Agreements Act of 1979, as functioned to decrease the amount of
and proguanil are ‘‘synergistic in their glucose produced by the liver and make
mechanisms of action,’’ resulting in the amended (19 U.S.C. § 2511 et seq.).
Under the rule of origin set forth muscle tissue more sensitive to insulin
increased effectiveness of Malarone so glucose can be absorbed. In Japan, the
tablets compared to taking atovaquone under 19 U.S.C. § 2518(4)(B):
two APIs were mixed together to form
or proguanil hydrochloride alone. An article is a product of a country or
a fixed-combination drug called
instrumentality only if (i) it is wholly the
The manufacturing process for GSK’s growth, product, or manufacture of that Actoplus Met. In holding that a
Malarone tablets begins in India, where country or instrumentality, or (ii) in the case substantial transformation occurred
the Malarone tablets’ two active of an article which consists in whole or in when the APIs were combined in Japan
pharmaceutical ingredients (‘‘APIs’’), part of materials from another country or to produce Actoplus Met, CBP
atovaquone and proguanil instrumentality, it has been substantially emphasized that ‘‘[w]hile we note that
hydrochloride, are manufactured. After transformed into a new and different article pioglitazone and metformin may be
the two APIs are manufactured in India, of commerce with a name, character, or use prescribed separately, the final product,
distinct from that of the article or articles
they are imported into Canada for Actoplus Met, increases the individual
from which it was so transformed.
further processing at GSK’s Mississauga, effectiveness of piofliazone and
Ontario facility (‘‘GSK Canada’’). At See also 19 C.F.R. § 177.22(a). metformin in treating type 2 diabetes
GSK Canada, the two APIs are combined A substantial transformation occurs patients.’’
in a process that begins by producing a when an article emerges from a process Similarly, in HQ H253443, dated
dry mix of the APIs, low-substituted with a new name, character, and use March 13, 2015, CBP held that the
hydroxpropyl cellulose NF, different from that possessed by the combination of two APIs in China to
microcrystalline cellulose NF, and article prior to processing. A substantial produce Prepopik, ‘‘a dual-acting
sodium starch glycolate NF. The dry transformation will not result from a osmotic and stimulant laxative bowel
mix is then combined with the minor manufacturing or combining preparation for a colonoscopy in
following inactive ingredients, which process that leaves the identity of the adults,’’ constituted a substantial
are each sourced from the United States article intact. See United States v. transformation. Although the importer
or a TAA-eligible country, to produce Gibson-Thomsen Co., 27 C.C.P.A. 267 claimed that Country A-origin sodium
granules: (1940); and National Juice Products picosulfate was the only API in
Ass’n v. United States, 628 F. Supp. 978 Prepopik, CBP found that the Country
• Povidone K30 USP (Ct. Int’l Trade 1986). B-origin magnesium oxide ingredient
• Polaxamer 188 NF In determining whether a substantial also qualified as an API. CBP further
• Sofium Starch Glycolate NF transformation occurs in the found that taking Prepopik had ‘‘a more
manufacture of chemical products such stimulative laxative effect’’ than taking
• Hydroxy Propyl Cellulose NF
as pharmaceuticals, CBP has each of the APIs individually and
• Purified Water USP consistently examined the complexity of therefore held that a substantial
• Microcrystalline Cellulose NF the processing and whether the final transformation occurred when the APIs
• Alcohol USP article retains the essential identity and were combined in China.
character of the raw material. To that Here, as in HQ 563207 and HQ
Next, the granules are dried, milled end, CBP has generally held that the H253443, two separate APIs are mixed
into a dry powder, blended with processing of pharmaceutical products to create a fixed combination drug that
magnesium stearate NF, and from bulk form into measured doses offers additional medicinal benefits
compressed into tablets. Finally, a film does not result in a substantial compared to taking each API alone. The
coat mix is added and the tablets are transformation of the product. See, e.g., first API, atovaquone, is not indicated
polished. Headquarters Ruling (‘‘HQ’’) 561975, for the prevention or treatment of
Once the manufacturing process is dated April 3, 2002; HQ 561544, dated malaria. The second API, proguanil
complete, the finished Malarone tablets May 1, 2000; HQ 735146, dated hydrochloride, is used to treat malaria,
sradovich on DSK3GMQ082PROD with NOTICES

are exported to a GSK facility in November 15, 1993; HQ H267177, dated but is less effective than Malarone. This
Zebulon, North Carolina. There, the November 5, 2016; HQ H233356, dated is because of the ‘‘synergies in [the
tablets are packaged and labeled for sale December 26, 2012; and, HQ 561975, APIs’] method of action,’’ which result
to Prasco Laboratories, which markets dated April 3, 2002. However, where the in a product that ‘‘interfere[s] with 2
and distributes the tablets under their processing from bulk form into different pathways’’ to prevent and treat
own labeling as an authorized generic measured doses involves the malaria. Under these circumstances, the
product under an agreement with GSK. combination of two or more APIs, and combination of atovaquone, proguanil

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31766 Federal Register / Vol. 83, No. 131 / Monday, July 9, 2018 / Notices

hydrochloride, and inactive ingredients by contacting Jan Zegarra, U.S. Fish and and grasses (Rı́os-López and Thomas
to form Malarone tablets in Canada Wildlife Service, Caribbean Ecological 2007). The species is currently
results in a substantial transformation. Services Field Office, P.O. Box 491, threatened by the combined influences
The country of origin of the Malarone Boquerón, PR 00622; tel. (787) 851– of urban development, activities
tablets is therefore Canada. 7297; or by visiting the Service’s associated with the operation and future
Caribbean Field Office website at closure of the Toa Baja municipal
HOLDING:
https://www.fws.gov/caribbean/ES/ landfill, activities associated with
The country of origin of the Malarone Index.html. clearing water channels for flood
tablets for purposes of U.S. Government Comment submission: You may control, and invasive wetland plant
procurement is Canada. submit comments by one of the species. Additional threats include
Notice of this final determination will following methods: restricted distribution and highly
be given in the Federal Register, as 1. Submit written comments and specialized ecological requirements,
required by 19 C.F.R. § 177.29. Any materials by mail or hand-delivery to which may exacerbate other potential
party-at-interest other than the party Jan Zegarra, at the above address. threats like landfill leachate pollution,
which requested this final 2. Fax them to (787) 851–7440. the use of herbicides, brush fires,
determination may request, pursuant to 3. Send comments by email to jan_ competition, and environmental effects
19 C.F.R. § 177.31, that CBP reexamine zegarra@fws.gov. Please include ‘‘Coquı́
resulting from climate change.
the matter anew and issue a new final llanero Draft Recovery Plan Comments’’
determination. Pursuant to 19 C.F.R. in the subject line. Under the ESA, the Service added the
§ 177.30, any party-at-interest may, For additional information about coquı́ llanero as an endangered species
within 30 days of publication of the submitting comments, see Request for to the Federal List of Endangered and
Federal Register Notice referenced Public Comments. Threatened Wildlife in title 50 of the
above, seek judicial review of this final FOR FURTHER INFORMATION CONTACT: Jan Code of Federal Regulations on October
determination before the Court of Zegarra at (787) 851–7297, or see 4, 2012 (77 FR 60778). The 2012 final
International Trade. ADDRESSES for further methods of rule also designated critical habitat,
Sincerely, contact. covering an area of 615 ac (249 ha), for
the species.
Alice A. Kipel, SUPPLEMENTARY INFORMATION: We, the
Executive Director, Regulations & Rulings U.S. Fish and Wildlife Service, The recovery strategy for the coquı́
Office of Trade. announce the availability of the draft llanero includes protection and
[FR Doc. 2018–14632 Filed 7–6–18; 8:45 am] recovery plan for the endangered coquı́ management of occupied habitat and
BILLING CODE 9111–14–P llanero (Eleutherodactylus juanariveroi). suitable unoccupied habitat for
The draft recovery plan includes potential future introductions, and
specific recovery objectives and criteria addresses immediate threats that led to
DEPARTMENT OF THE INTERIOR that must be met in order for us to its listing. Because of stressors like
remove this species from listing under reduced geographic distribution, limited
Fish and Wildlife Service the Endangered Species Act of 1973, as dispersal capabilities, and the species’
[FWS–R4–ES–2015–N040; amended (ESA; 16 U.S.C. 1531 et seq.). specialized breeding requirements, the
FXES11130400000C2–156–FF04E00000] We request review and comment on this species is likely to have reduced
draft recovery plan from local, State, adaptive capacity. Therefore, in order to
Endangered and Threatened Wildlife and Federal agencies and the public. meet the recovery goal of delisting, we
and Plants; Draft Recovery Plan for must increase the number of coquı́
Background
Coquı́ Llanero llanero populations. This strategy seeks
The coquı́ llanero is a small frog to safeguard the only existing coquı́
AGENCY: Fish and Wildlife Service, species endemic to Puerto Rico. In 2007, llanero population in case the species
Interior. it was described as a new species of the does not withstand or recover from a
ACTION: Notice of availability and genus Eleutherodactylus, family stochastic or catastrophic event.
request for public comment. Leptodactylidae. Males measure
approximately 0.58 in (14.7 mm), and Section 4(f) of the ESA requires the
SUMMARY: We, the U.S. Fish and females 0.62 in (15.8 mm). It has the development of recovery plans for listed
Wildlife Service, announce the smallest clutch size of all species, unless such a plan would not
availability of the draft recovery plan for Eleutherodactylus species on Puerto promote the conservation of a particular
the endangered coquı́ llanero, a frog Rico, and a high-frequency call. The species. Recovery plans describe actions
endemic to Puerto Rico. The draft only population estimate available for considered necessary for conservation of
recovery plan includes specific recovery the coquı́ llanero indicates a mean the species, establish criteria for
objectives and criteria that must be met population size of 473.3 ± 186 downlisting or delisting, and estimate
in order for us to remove this species individuals per ha (or 192 per ac; Rı́os- time and cost for implementing recovery
from listing under the Endangered López pers. comm. 2011). measures. Section 4(f) of the ESA also
Species Act of 1973, as amended. We The coquı́ llanero is currently known requires us to provide public notice and
request review and comment on this to be restricted to one freshwater an opportunity for public review and
draft recovery plan from local, State, herbaceous wetland in the municipality comment during recovery plan
and Federal agencies, and the public. of Toa Baja, Puerto Rico. The development. We will consider all
sradovich on DSK3GMQ082PROD with NOTICES

DATES: In order to be considered, herbaceous vegetation in the wetland information presented during a public
comments on the draft recovery plan consists of Blechnum serrulatum comment period prior to approval of
must be received on or before (toothed midsorus fern), Thelypteris each new or revised recovery plan. We
September 7, 2018. interrupta (willdenow’s maiden fern), and other Federal agencies will take
ADDRESSES: Sagittaria lancifolia (bulltongue these comments into account in the
Document availability: You may arrowhead), Cyperus sp. (flatsedges), course of implementing approved
obtain a copy of this draft recovery plan Eleocharis sp. (spike rushes), and vines recovery plans.

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Document Created: 2018-07-07 00:41:40
Document Modified: 2018-07-07 00:41:40

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
Action		Notice of final determination.
Dates		This final determination was issued on July 2, 2018. A copy of the final determination is attached. Any party-at-interest may seek judicial review of this final determination within August 8, 2018.
Contact		Ross M. Cunningham, Valuation and Special Programs Branch, Regulations and Rulings, Office of Trade, (202) 325-0034.
FR Citation		83 FR 31764

83 FR 31764 - Notice of Issuance of Final Determination Concerning Malarone Tablets

DEPARTMENT OF HOMELAND SECURITYU.S. Customs and Border Protection

Federal Register Volume 83, Issue 131 (July 9, 2018)

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