Federal RegisterVol. 75_ No. 55T

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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,
                                                   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
                                                   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
                                                                                                           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).
                                                   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
                                                                                                           Drug Enforcement Administration                       Administrator of the Office of Diversion
                                                                                                           (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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