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13676 Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Rules and Regulations
DEPARTMENT OF HOMELAND September 26, 2008, implements the CBP’s Response
SECURITY prohibitions and conditions of the JADE Requiring an importer to conduct lab
Act. (See Annex of Presidential testing on the merchandise to be
U.S. Customs and Border Protection Proclamation 8294 for Additional U.S. imported goes beyond the explicit
Note 4 to Chapter 71, Harmonized Tariff statutory requirements and the importer
DEPARTMENT OF THE TREASURY Schedule of the United States certification requirement of 19 CFR
(‘‘HTSUS’’)). 12.151(d). Additional U.S. Note 4(a),
19 CFR Parts 12 and 163 On January 16, 2009, U.S. Customs Chapter 71, HTSUS, provides that the
[USCBP–2008–0111; CBP Dec. 10–04] and Border Protection (‘‘CBP’’) presentation of an entry for any good
published CBP Dec. 09–01 in the under heading 7103, 7113, or 7116 is
RIN 1505–AC06 Federal Register (74 FR 2844), setting deemed to be a certification by the
Prohibitions and Conditions for forth interim amendments to implement importer that any jadeite or rubies
Importation of Burmese and Non- certain provisions of the JADE Act and contained in such good were not mined
Burmese Covered Articles of Jadeite, Presidential Proclamation 8294 by in or extracted from Burma. As such, the
Rubies, and Articles of Jewelry prohibiting the importation of ‘‘Burmese presentation of an entry serves as the
Containing Jadeite or Rubies covered articles’’ (jadeite, rubies, and importer certification. If an importer
articles of jewelry containing jadeite or elects to test the imported gems to
AGENCY: U.S. Customs and Border rubies, mined or extracted from Burma), bolster the information provided by the
Protection, Department of Homeland and by setting forth conditions for the exporter, the results of the testing will
Security; Department of the Treasury. importation of ‘‘non-Burmese covered serve to reflect upon the importer’s level
ACTION: Final rule. articles’’ (jadeite, rubies, and articles of of reasonable care used and will be
jewelry containing jadeite or rubies, objective evidence that the goods were
SUMMARY: This document adopts as a mined or extracted from a country other not mined in or extracted from Burma.
final rule, interim amendments to title than Burma). CBP concurs with the commenter
19 of the Code of Federal Regulations Although the interim regulations were regarding retaining the 5-year record
(‘‘19 CFR’’) which were published in the promulgated without prior public notice retention period in the final rule as set
Federal Register on January 16, 2009, as and comment procedures and took forth in § 12.151(e) as well as the
CBP Dec. 09–01 to implement the effect on January 16, 2009, CBP Dec. 09– requirement in § 12.151(f) that the
prohibitions and conditions for 01 provided for the submission of importer must provide, upon CBP’s
importation of Burmese and non- public comments that would be request, all documentation to support
Burmese covered articles of jadeite, considered before adopting the interim the importer and exporter certifications.
rubies, and articles of jewelry regulations as a final rule. The
containing jadeite or rubies. Comment
prescribed public comment period
DATES: Final rule effective April 22, closed on March 17, 2009. The commenter recommended that
2010. only government-validated certificates
Discussion of Comment Received in of origin from the country in which the
FOR FURTHER INFORMATION CONTACT:
Response to CBP Dec. 09–01 jadeite or rubies are mined or extracted
Cathy Sauceda, Director, Import Safety
One commenter responded to the be accepted as verifiable evidence, and
and Interagency requirements Division,
solicitation of comments on the interim that protocols related to the issuance of
Office of International Trade (202) 863–
regulations set forth in CBP Dec. 09–01. the exporter’s government-validated
6556, or Brenda Brockman Smith,
The commenter stated that the interim certification guaranteeing non-Burmese
Executive Director, Trade Policy and
origin should require random spot
Programs, Office of International Trade final rule provided ‘‘an excellent
testing by an independent gemological
(202) 863–6406. platform that offers both very workable
laboratory accredited by CBP to verify
SUPPLEMENTARY INFORMATION: and realistic means to uphold the law as
non-Burmese origin.
written and to support the spirit of the
Background law drafted by U.S. Congress.’’ The CBP’s Response
On July 29, 2008, the President signed commenter offered a few suggestions. A The commenter’s recommendations
into law the Tom Lantos Block Burmese description of the commenter’s with respect to foreign government
JADE (Junta’s Anti-Democratic Efforts) suggestions and CBP’s analysis are set certification and validation of exporter
Act of 2008 (Pub. L. 110–286) (the forth below. certificates cannot be enforced by CBP
‘‘JADE Act’’). Section 6 of the JADE Act because no international arrangement,
Comment
amends the Burmese Freedom and similar to the Kimberley Process
Democracy Act of 2003 (Pub. L. 108–61) The commenter recommended that in Certification Scheme for conflict
(as so amended, the ‘‘BFDA’’) by adding order to support the importer diamonds, currently exists for jadeite or
a new section 3A that prohibits the certification under Additional U.S. Note rubies from Burma.
importation of jadeite and rubies mined 4(a), Chapter 71, HTSUS, importers be
or extracted from Burma, and articles of required, at their sole expense, to Comment
jewelry containing jadeite or rubies confirm the veracity of their The commenter recommended that as
mined or extracted from Burma certification of non-Burmese covered a condition for export with the intent of
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(Burmese covered articles). Section 3A articles by conducting random spot re-importation into the United States,
of the JADE Act also regulates the checks utilizing lab testing by an CBP should require that any Burmese
importation of jadeite and rubies mined independent gemological laboratory covered article be detailed in such a
or extracted from a country other than accredited by CBP. The commenter also way so as to ensure the same article is
Burma, and articles of jewelry recommends requiring the importer to the one considered for re-importation to
containing jadeite or rubies mined or maintain records showing a history of prevent circumvention of the JADE
extracted from a country other than the auditing process for a period of at sanctions. Further, the commenter
Burma (non-Burmese covered articles). least five years, and to make such recommended that for the re-
Presidential Proclamation 8294 of records available to CBP upon request. importation of non-Burmese covered
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Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Rules and Regulations 13677
articles, the original country of origin accuracy of documentation is this rulemaking. Accordingly, this final
certificate be required, including a susceptible to the risk for fraud. rule is not subject to the regulatory
statement detailing any transformation analysis requirements or other
CBP’s Response
that may have occurred. requirements of 5 U.S.C. 603 and 604.
CBP acknowledges that until there is
CBP’s Response an international certification scheme in Paperwork Reduction Act
On CBP Form 4457, Certificate of place, the authenticity and accuracy of The collections of information in this
Registration for Personal Effects Taken documentation in the required ‘‘system final rule have previously been
Abroad, CBP collects information from of verifiable controls’’ is susceptible to reviewed and approved by the Office of
the owner in advance of departure fraud. CBP will enforce the JADE Act Management and Budget in accordance
concerning articles that will be re- through the use of an importer’s and with the requirements of the Paperwork
imported into the United States. In exporter’s certification and the other Reduction Act (44 U.S.C. 3507) under
addition, on CBP Form 4455, Certificate applicable customs laws. control number 1651–0133.
of Registration, CBP collects information The collections of information in
Comment
about articles that are exported from the these regulations are contained in
United States via a carrier for alteration, The commenter recommended that § 12.151(d) (19 CFR 12.151(d)). This
repairs, use abroad, replacement, or importers should be required to provide information is used by CBP to fulfill its
processing that will be re-imported into a written warranty to each buyer or information collection obligations under
the United States and that may be ultimate consignee of non-Burmese section 3A(c)(1) of the BFDA, as
subject to duty for the cost or value of covered articles, affirming that an amended, and Additional U.S. Note 4,
the alteration, repair, or processing. established system of verified controls Chapter 71, HTSUS, required in
Completion of this form is mandatory. from the mine to the supplier is in place connection with entry of non-Burmese
Although CBP cannot ensure that the and that officially validated certification covered articles. The likely respondents
item being re-imported is the actual has accompanied the articles at all are business organizations, including
item that was exported unless the article stages. importers and brokers.
has permanent identifying information CBP’s Response The estimated average annual burden
such as etched or engraved serial associated with the collection of
The commenter’s suggestion that the information in this final rule is 0.2
numbers, CBP will endeavor to use the
importer issue a written warranty to the hours per respondent or record keeper.
information contained on these forms to
ultimate consumer goes beyond what is Under the Paperwork Reduction Act, an
prevent the circumvention of the JADE
required by the JADE Act. Accordingly, agency may not conduct or sponsor, and
sanctions when a covered article is
CBP cannot prescribe in this final rule a person is not required to respond to,
exported with the intention of re-
such entry requirements that are not a collection of information unless it
importation. As is the case with all CBP
mandated by the Act. displays a valid OMB control number.
forms, the importer is responsible for
the truthfulness of the information Conclusion Signing Authority
submitted on the form. As indicated in the above discussion, This document is being issued in
Comment CBP is unable to adopt the commenter’s accordance with § 0.1(a)(1) of the CBP
suggestions given the current statutory regulations (19 CFR 0.1(a)(1)) pertaining
The commenter asserts that there is a scheme. Accordingly, the interim rule
risk that the personal-use exemption to the authority of the Secretary of the
published as CBP Dec. 09–01 is being Treasury (or his/her delegate) to
will be used as a means to circumvent adopted as a final rule.
the prohibitions and conditions for the approve regulations related to certain
importation of non-Burmese covered Executive Order 12866 customs revenue functions.
articles. The commenter recommended CBP has determined that this List of Subjects
increased scrutiny be placed on document does not meet the criteria for
individuals claiming a personal-use 19 CFR Part 12
a ‘‘significant regulatory action’’ as
exemption and that random spot-testing specified in Executive Order 12866 of Customs duties and inspection,
be conducted to verify the imported September 30, 1993 (58 FR 51735, Economic sanctions, Entry of
goods are in fact non-Burmese covered October 1993). merchandise, Foreign assets control,
articles. Imports, Licensing, Prohibited
Regulatory Flexibility Act merchandise, Reporting and
CBP’s Response
CBP Dec. 09–01 was issued as an recordkeeping requirements, Restricted
CBP appreciates the commenter’s interim rule rather than a notice of merchandise, Sanctions.
concerns and the underlying rationale. proposed rulemaking because CBP had
19 CFR Part 163
Any Burmese covered articles or non- determined that, pursuant to the
Burmese covered articles that are provisions of 5 U.S.C. 553(b)(B) of the Administrative practice and
imported into the United States in Administrative Procedure Act, prior procedure, Customs duties and
violation of any prohibition of the JADE public notice and comment procedures inspection, Exports, Imports, Penalties,
Act are subject to all applicable seizure on the interim regulations were Reporting and recordkeeping
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and forfeiture laws to the same extent as impracticable and contrary to public requirements.
any other violation of the customs laws. interest, and that there was good cause Amendments to the CBP Regulations
for the rule to become effective
Comment
immediately upon publication since the ■ Accordingly, the interim rule
The commenter stated that the JADE Act is already in effect. Because amending parts 12 and 163 of the CBP
reliance on a ‘‘paper-only’’ system of no notice of proposed rulemaking was regulations (19 CFR parts 12 and 163),
verifiable controls without built-in required, the provisions of the which was published at 74 FR 2844 on
safeguards such as random spot lab Regulatory Flexibility Act, as amended January 16, 2009, is adopted as a final
testing to verify authenticity and (5 U.S.C. 601 et seq.), do not apply to rule.
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13678 Federal Register / Vol. 75, No. 55 / Tuesday, March 23, 2010 / Rules and Regulations
Approved: March 10, 2010. PART 3—PRODUCT JURISDICTION and Chemical Evaluation Section, Office
Timothy E. Skud, of Diversion Control, Drug Enforcement
Deputy Assistant Secretary of the Treasury. ■ 1. The authority citation for 21 CFR Administration, 8701 Morrissette Drive,
David V. Aguilar, part 3 continues to read as follows: Springfield, VA 22152; telephone: (202)
Acting Deputy Commissioner, U.S. Customs Authority: 21 U.S.C. 321, 351, 353, 355, 307–7183.
and Border Protection. 360, 360c–360f, 360h–360j, 360gg–360ss, SUPPLEMENTARY INFORMATION: On August
[FR Doc. 2010–6387 Filed 3–22–10; 8:45 am] 360bbb–2, 371(a), 379e, 381, 394; 42 U.S.C. 28, 2009, the DEA published an interim
216, 262, 264. rule with request for comments [74 FR
BILLING CODE 9111–14–P
44281]. This interim rule updated the
§ 3.6 [Amended]
Table of Excluded Nonnarcotic Products
■ 2. Section 3.6 is amended by found in 21 CFR 1308.22 to include the
DEPARTMENT OF HEALTH AND removing ‘‘(HFG–3), Food and Drug Nasal Decongestant Inhaler/Vapor
HUMAN SERVICES Administration, 15800 Crabbs Branch Inhaler (containing 50 mg
Way, suite 200, Rockville, MD 20855, Levmetamfetamine) manufactured by
Food and Drug Administration 301–427–1934’’and by adding in its Classic Pharmaceuticals, LLC and
place ‘‘Food and Drug Administration, marketed under various private labels
21 CFR Part 3 10903 New Hampshire Ave., Bldg. 32, (to include the ‘‘Premier Value’’ and
rm. 5129, Silver Spring, MD 20993– ‘‘Kroger’’ labels). This nonnarcotic drug
[Docket No. FDA–2010–N–0010] 0002, 301–796–8930,’’. product, which may be lawfully sold
Dated: March 17, 2010. over the counter without a prescription
Product Jurisdiction; Change of Leslie Kux, under the Federal Food, Drug, and
Address and Telephone Number; Cosmetic Act (21 U.S.C. 301 et seq.), is
Acting Assistant Commissioner for Policy.
Technical Amendment excluded from provisions of the
[FR Doc. 2010–6246 Filed 3–22–10; 8:45 am]
Controlled Substances Act (CSA)
AGENCY: Food and Drug Administration, BILLING CODE 4160–01–S pursuant to 21 U.S.C. 811(g)(1).
HHS.
ACTION: Final rule; technical
Comments Received
amendment. DEPARTMENT OF JUSTICE DEA did not receive any comments to
its interim rule published August 28,
SUMMARY: The Food and Drug Drug Enforcement Administration 2009, regarding this exemption.
Administration (FDA) is amending its Therefore, DEA is issuing this
regulations to reflect a change in the 21 CFR Part 1308 rulemaking to finalize the interim rule
address and telephone number for the without change.
[Docket No. DEA–329F]
Office of Combination Products (OCP).
This action is editorial in nature and is RIN 1117–AB23 Background
intended to improve the accuracy of the The CSA, specifically 21 U.S.C.
agency’s regulations. Schedules of Controlled Substances; 811(g)(1), states that the Attorney
DATES: Effective Date: April 19, 2010.
Table of Excluded Nonnarcotic General shall by regulation exclude any
Products: Nasal Decongestant Inhalers nonnarcotic drug which contains a
FOR FURTHER INFORMATION CONTACT: John Manufactured by Classic controlled substance from the
Barlow Weiner, Office of Combination Pharmaceuticals, LLC application of the CSA, if such drug
Products, Food and Drug
may, under the Federal Food, Drug, and
Administration, 10903 New Hampshire AGENCY: Drug Enforcement
Cosmetic Act (21 U.S.C. 301 et seq.), be
Ave., Bldg. 32, rm. 5130, Silver Spring, Administration (DEA), Department of
lawfully sold over the counter without
MD 20993–0002, 301–796–8930. To Justice.
a prescription. This authority has been
confirm that this change of address and ACTION: Final rule. delegated to the Administrator of DEA
telephone number has occurred, please
SUMMARY: Under this Final Rule, the
and redelegated to the Deputy Assistant
see our Web site at www.fda.gov/
Drug Enforcement Administration Administrator of the Office of Diversion
CombinationProducts/default.htm.
(DEA) is updating the Table of Excluded Control pursuant to 28 CFR 0.100 and
SUPPLEMENTARY INFORMATION: FDA is title 28, part 0, appendix to subpart R,
amending its regulations in 21 CFR part Nonnarcotic Products found in 21 CFR
1308.22 to include the Nasal 7(g), respectively.
3 to reflect a change in the address and Such exclusions apply only to
telephone number for OCP. Publication Decongestant Inhaler/Vapor Inhaler
nonnarcotic products and are only
of this document constitutes final action (containing 50 mg Levmetamfetamine)
granted following suitable application to
on this change under the Administrative manufactured by Classic
the DEA per the provisions of 21 CFR
Procedure Act (5 U.S.C. 553). Notice Pharmaceuticals, LLC and marketed
1308.21. The current Table of Excluded
and public procedures are unnecessary under various private labels (to include
Nonnarcotic Products found in 21 CFR
because FDA is merely updating the ‘‘Premier Value’’ and ‘‘Kroger’’
1308.22 lists those products that have
nonsubstantive content. labels). This nonnarcotic drug product,
been granted excluded status.
which may be lawfully sold over the Pursuant to the application process of
List of Subjects in 21 CFR Part 3 counter without a prescription under
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21 CFR 1308.21, DEA received
Administrative practice and the Federal Food, Drug, and Cosmetic application for exclusion from Classic
procedure, Biologics, Combination Act, is excluded from provisions of the Pharmaceuticals, LLC, the manufacturer
products, Drugs, Medical devices. Controlled Substances Act (CSA) of a Nasal Decongestant Inhaler/Vapor
■ Therefore, under the Federal Food,
pursuant to 21 U.S.C. 811(g)(1). Inhaler which contains the schedule II
Drug, and Cosmetic Act and under DATES: This rulemaking shall become controlled substance
authority delegated to the Commissioner effective on March 23, 2010. Levmetamfetamine. This inhaler is sold
of Food and Drugs, 21 CFR part 3 is FOR FURTHER INFORMATION CONTACT: over the counter under various private
amended as follows: Christine A. Sannerud, PhD, Chief, Drug labels (such as the ‘‘Premier Value’’ label
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