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Federal Register / Vol. 72, No.

67 / Monday, April 9, 2007 / Rules and Regulations 17401

(7) Any other pertinent information making of the designation by the compliance of their components with
with respect to the accidental radiation manufacturer at the place and time the applicable provisions of §§ 1020.30
occurrence. where it is made, and the persons or through 1020.33.
* * * * * person signing the designation shall * * * * *
■ 22. In § 1002.50, paragraph (c)(3) is
certify that it is so made. The
Dated: March 28, 2007.
designation must disclose the
revised to read as follows: Jeffrey Shuren,
manufacturer’s full legal name and the
§ 1002.50 Special exemptions. name(s) under which the manufacturer Assistant Commissioner for Policy.
conducts the business, if applicable, the [FR Doc. E7–6290 Filed 4–6–07; 8:45 am]
* * * * *
(c) * * * principal place of business, and mailing BILLING CODE 4160–01–S

(3) Such conditions as are deemed address. If any of the products of the
necessary to protect the public health manufacturer do not bear his legal
and safety. Copies of exemptions shall name, the designation must identify the DEPARTMENT OF JUSTICE
be available upon request from the marks, trade names, or other
Center for Devices and Radiological designations of origin which these Drug Enforcement Administration
Health, Office of Communication, products bear. The designation must
Education, and Radiation Programs provide that it will remain in effect until 21 CFR Parts 1300 and 1313
(HFZ–240), 9200 Corporate Blvd., withdrawn or replaced by the [Docket No. DEA–292I]
Rockville, MD 20850. manufacturer and shall bear a
declaration of acceptance duly signed RIN 1117–AB06
* * * * * by the designated agent. The full legal
name and mailing address of the agent Implementation of the Combat
PART 1005—IMPORTATION OF Methamphetamine Epidemic Act of
ELECTRONIC PRODUCTS must be stated. Until rejected by the
Secretary, designations are binding on 2005; Notice of Transfers Following
the manufacturer even when not in Importation or Exportation
■ 23. The authority section for part 1005
continues to read as follows: compliance with all the requirements of AGENCY: Drug Enforcement
this section. The designated agent may Administration (DEA), Justice.
Authority: 42 U.S.C. 263d, 263h.
not assign performance of his function
■ 24. Section 1005.11 is revised to read ACTION: Interim Final Rule with Request
under the designation to another.
as follows: for Comment.
* * * * *
§ 1005.11 Payment for samples. SUMMARY: This regulation implements
PART 1020—PERFORMANCE section 716 of the Combat
The Department of Health and Human STANDARDS FOR IONIZING
Services will pay for all import samples Methamphetamine Epidemic Act
RADIATION EMITTING PRODUCTS (CMEA) of 2005 (21 U.S.C. 971 as
of electronic products rendered
unsalable as a result of testing, or will amended), which was enacted on March
■ 26. The authority section for part 1020
pay the reasonable costs of repackaging 9, 2006. DEA is amending its regulations
continues to read as follows:
such samples for sale, if the samples are to require additional reporting for
Authority: 21 U.S.C. 351, 352, 360e–360j, import, export, and international
found to be in compliance with the 360gg–360ss, 371, 381.
requirements of the Radiation Control transactions involving all List I and List
■ 27. In § 1020.30, paragraph (c) is II chemicals. This rule implements
for Health and Safety Act of 1968. revised to read as follows:
Billing for reimbursement shall be made section 716 of the CMEA which extends
by the owner or consignee to the Center § 1020.30 Diagnostic x-ray systems and current reporting requirements for
for Devices and Radiological Health their major components. importations, exportations, and
(HFZ–204), 9200 Corporate Blvd., * * * * * international transactions involving List
Rockville, MD 20857. Payment for (c) Manufacturers’ responsibility. I and List II chemicals.
samples will not be made if the sample Manufacturers of products subject to DATES: This rule is effective May 9,
is found to be in violation of the Act, §§ 1020.30 through 1020.33 shall certify 2007. Written comments must be
even though subsequently brought into that each of their products meet all postmarked, and electronic comments
compliance pursuant to terms specified applicable requirements when installed must be sent, on or before May 9, 2007.
in a notice of permission issued under into a diagnostic x-ray system according ADDRESSES: To ensure proper handling
§ 1005.22. to instructions. This certification shall of comments, please reference ‘‘Docket
■ 25. In § 1005.25, paragraph (b) is be made under the format specified in No. DEA–292’’ on all written and
revised to read as follows: § 1010.2 of this chapter. Manufacturers electronic correspondence. Written
may certify a combination of two or comments being sent via regular mail
§ 1005.25 Service of process on more components if they obtain prior should be sent to the Deputy Assistant
manufacturers. authorization in writing from the Administrator, Office of Diversion
* * * * * Director of the Office of Control, Drug Enforcement
(b) A manufacturer designating an Communication, Education, and Administration, Washington, DC 20537,
agent must address the designation to Radiation Programs of the Center for Attention: DEA Federal Register
the Center for Devices and Radiological Devices and Radiological Health. Representative/ODL. Written comments
Health (HFZ–240), 9200 Corporate Manufacturers shall not be held sent via express mail should be sent to
Blvd., Rockville, MD 20850. It must be responsible for noncompliance of their DEA Headquarters, Attention: DEA
in writing and dated; all signatures must products if that noncompliance is due Federal Register Representative/ODL,
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be in ink. The designation must be made solely to the improper installation or 2401 Jefferson-Davis Highway,
in the legal form required to make it assembly of that product by another Alexandria, VA 22301. Comments may
valid and binding on the manufacturer person; however, manufacturers are be directly sent to DEA electronically by
under the laws, corporate bylaws, or responsible for providing assembly sending an electronic message to
other requirements governing the instructions adequate to assure dea.diversion.policy@usdoj.gov.

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17402 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations

Comments may also be sent this rule became effective on March 9, transactions of List I and List II
electronically through http:// 2006. An agency may find good cause to chemicals. Importers, exporters, brokers,
www.regulations.gov using the exempt a rule from certain provisions of and traders are now required to notify
electronic comment form provided on the Administrative Procedure Act (APA) DEA, before the transaction is to take
that site. An electronic copy of this (5 U.S.C. 553), including Notice of place, of certain information regarding
document is also available at the http:// Proposed Rulemaking and the their downstream customers. If the
www.regulations.gov Web site. DEA will opportunity for public comment, if it is person to whom the chemical is being
accept attachments to electronic determined to be unnecessary, transferred is not a regular customer, the
comments in Microsoft Word, impracticable, or contrary to the public importer, exporter, broker, or trader
WordPerfect, Adobe PDF, or Excel file interest. The requirements of the CMEA must notify DEA no later than 15 days
formats only. DEA will not accept any of 2005 included in this rulemaking before the transaction is to take place;
file formats other than those specifically were set out in such detail as to be self- upon receipt, DEA will have 15 days to
listed here. implementing. Therefore the changes in review the notification. Specifically, the
FOR FURTHER INFORMATION CONTACT: this rulemaking provide conforming United States importer or exporter must
Mark W. Caverly, Chief, Liaison and amendments to make the language of provide the name and address of each
Policy Section, Office of Diversion the regulations consistent with that of person to whom the listed chemicals
Control, Drug Enforcement the law. DEA has no authority to revise will be transferred, and the name and
Administration, Washington, DC 20537 the changes and is simply quantity of the listed chemicals to be
at (202) 307–7297. implementing, and making its transferred, including package
regulations conform to, the statute. information. This person is referred to
SUPPLEMENTARY INFORMATION:
as the ‘‘transferee’’ of the United States
Combat Methamphetamine Epidemic
DEA’s Legal Authority importer or exporter. The spot market
Act of 2005
DEA implements the Comprehensive reporting requirements also apply, to a
The portion of the CMEA being limited extent, to United States brokers
Drug Abuse Prevention and Control Act implemented in this rulemaking and traders that arrange international
of 1970, often referred to as the addresses the importation, exportation, transactions (i.e., transactions between
Controlled Substances Act (CSA) and and international transactions of all List customers in two foreign countries).
Controlled Substances Import and I and List II chemicals. Section 716 of For a United States exporter, the
Export Act (21 U.S.C. 801 et seq.), as the CMEA (21 U.S.C. 971 as amended) transferee is the foreign importer. Thus,
amended. DEA publishes the closes a loophole in the current this aspect of the new requirement does
implementing regulations for this regulatory system for imports, exports, not represent a change for United States
statute in Title 21 of the Code of Federal and international transactions of listed exporters, who have previously notified
Regulations (CFR), Parts 1300 to end. chemicals used in the illicit DEA of information on their purchasers.
These regulations are designed to ensure manufacture of controlled substances. For a United States broker or trader, the
that there is a sufficient supply of Prior to enactment of the CMEA, a transferee is the foreign customer
controlled substances for legitimate company that wanted to import or purchasing the listed chemicals. Again,
medical purposes and to deter the export any List I or List II chemical was this requirement is not a change for
diversion of controlled substances to required to either: (1) Notify the brokers and traders, who have
illegal purposes. The CSA mandates that Department of Justice 15 days in previously notified DEA of information
DEA establish a closed system of control advance of the import or export; or (2) on their purchasers.
for manufacturing, distributing, and be a company that previously imported The requirement is, however, a
dispensing controlled substances. Any or exported a listed chemical and that change for United States importers. For
person who manufactures, distributes, was proposing to import from or export a United States importer, the
dispenses, imports, exports, or conducts the chemicals to a customer with whom ‘‘transferee’’ is the person to whom the
research or chemical analysis with the company had previously dealt. (See importer transfers the listed chemicals—
controlled substances must register with 21 U.S.C. 971(a), (b)) the downstream customer. Until the
DEA (unless exempt) and comply with A problem can arise, however, when CMEA, importers were required to
the applicable requirements for the the sale that the importer or exporter provide information regarding their
activity. The CSA as amended also originally planned falls through. When suppliers, but not regarding the parties
requires DEA to regulate the this happens, the importer or exporter purchasing the chemicals in the United
manufacture and distribution of must quickly find a new buyer for the States. Under the CMEA, importers will
chemicals that may be used to chemicals on what is called the ‘‘spot have to list both the foreign supplier
manufacture controlled substances. market’’—a wholesale market. Sellers and each United States customer for the
Listed chemicals that are classified as are often under presure to find a buyer imported chemical.
List I chemicals are important to the in a short amount of time, meaning that The provision of customer
manufacture of controlled substances. they may be tempted to entertain bids information by the importer provides
Those classified as List II chemicals may from companies without a strong record DEA with an opportunity to evaluate the
be used to manufacture controlled of preventing diversion. More transaction. DEA will have 15 days from
substances. importantly, DEA is not made aware of, the time the customer information is
On March 9, 2006, the President and has no opportunity to review, such submitted to review the transaction and
signed the CMEA of 2005, which is Title transactions in advance in order to determine whether it may be diverted to
VII of the USA PATRIOT Improvement suspend them if there is a danger of the clandestine manufacture of a
and Reauthorization Act of 2005 (Pub. diversion to the clandestine controlled substance. If DEA determines
L. 109–177). DEA is promulgating this manufacture of a controlled substance. that the transaction does not pose an
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rule as an interim final rule rather than Section 716 of the CMEA extends the unacceptable risk of diversion, DEA will
a proposed rule because the changes current reporting requirements—as well take no action. The importer will thus
being made merely codify statutory as the current exemption for regular be granted regular importer status for
provisions. Much of the statute is self- importers and regular customers—to transactions involving the specific
implementing; the changes discussed in post-import and post-export chemical to be imported to the specific

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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 17403

customer. The transferee—the addition, even if an importer or exporter controlled substance, DEA may
downstream customer—will be granted did not have to file an initial disqualify the regular customer status of
regular customer status for imports of notification—either because he is a the transferee and suspend the
the specified chemical by the specified regular importer selling to a regular shipment. See 21 CFR 1313.26(d).
importer. DEA must review each import customer, or an exporter selling to a Finally, within 30 days after the
transaction based not only on the regular customer—if the newly arranged importation, exportation, or
chemical to be imported, but also on the spot market sale is to a new customer international transaction is completed,
transferee to whom the chemical will be (i.e., not a ‘‘regular customer’’), the the importer, exporter, broker, or trader
transferred. importer or exporter must file an must send DEA a return declaration
If, after submission of the initial DEA advance notice 15 days prior to containing information regarding the
Form 486, Import/Export Declaration, transferring the chemical to the new transaction, including the name of the
the importer, exporter, broker, or trader customer. As is the case under existing transferee, date the import or export and
will not be transferring the listed law, a suspension can be appealed any subsequent transfer occurred, the
chemical to the person initially named through an administrative hearing. (See name of the chemical transferred, the
on the DEA Form 486, or if the importer 21 U.S.C. 971(c)(2)) actual quantity transferred, the
or exporter will be transferring a greater If, however, the new proposed container, and any other information
quantity than originally indicated on the purchaser qualifies as a ‘‘regular that DEA may specify. This is a new
DEA Form 486, then the importer, customer’’ under existing law, the requirement for United States importers,
exporter, broker, or trader must file an importer or exporter is not required to exporters, brokers, and traders. For
amended DEA Form 486 reporting the file a second advance notice 15 days importers, a single return declaration
change. This is a new requirement for prior to the transfer of the listed may include the information for both
both United States importers and chemical. Rather, notice must be filed the importation and distribution. If the
exporters, as well as brokers and traders. on or before the date of the transfer. importer has not distributed all
This amendment must provide the name Note that the second notice may occur chemicals imported by the end of the
of the new prospective customer and/or after importation or exportation. initial 30-day period, the importer must
the greater quantity of the listed (Brokers and traders are required to file supplemental return declarations no
chemical to be transferred. The report all regulated international later than 30 days from the date of any
requirement to notify DEA of a change transactions.) further distribution, until the
in the transferee or an increase in the If DEA determines that a listed distribution or other disposition of all
quantity of the chemical to be chemical shipment handled by a regular chemicals imported under the import
transferred applies to amended DEA importer or a regular customer notification or any update are accounted
Forms 486 in the same manner that it (including a regular customer who is for. In addition, if an importer, exporter,
applies to original submissions. substituted for the original customer broker, or trader files a DEA Form 486,
Thus, if an importer, exporter, broker, listed on the original advance but the transfer covered fails to take
or trader is required to file an initial notification) may be diverted to the place (e.g., the import or export is
advance notice with DEA 15 days before clandestine manufacture of a controlled canceled prior to shipment), the person
the transaction is to take place, and the substance, DEA may disqualify the must file an amended DEA Form 486 to
originally planned sale falls through, the regular importer or regular customer notify DEA of the cancellation. These
importer, exporter, broker, or trader is status of such importer or customer and additional filings will ensure that DEA
required to file a second advance notice may suspend the shipment. If the has an accurate record of importations,
with DEA, identifying the new proposed importer or customer (including a new exportations, and international
purchaser. DEA will again have 15 days proposed customer) is not a regular transactions.
to review the new transaction and importer or customer, then DEA may
determine whether it may be diverted to suspend the shipment, since there Summary of Changes Made by This
the clandestine manufacture of a would be no regular importer or regular Interim Final Rule
controlled substance. In the case of a customer status to disqualify. The The table below provides a
transaction reported by a broker or procedures are set forth in the new comparison of the previous
trader, DEA cannot suspend the regulatory text at 21 CFR 1313.16(d). requirements regarding imports,
transaction, but could alert authorities Similarly, in the case of an export of a exports, and international transactions
in the foreign country involved in the listed chemical that may be diverted to with the new requirements of the
transaction of the risk of diversion. In the clandestine manufacture of a CMEA:

TABLE 1.—COMPARISON OF PREVIOUS AND NEW REQUIREMENTS


Requirement Previous rule New rule

Notify DEA prior to import/export/international transactions ........................................................................................... Yes ................. Yes.


Identify source of imports/international transactions ....................................................................................................... Yes ................. Yes.
Identify transferees of exports/international transactions ............................................................................................... Yes ................. Yes.
Identify transferees (downstream customers) of imports ................................................................................................ No ................... Yes.
Notify DEA of change in transferees of exports and international transactions prior to transaction ............................. No ................... Yes.
Notify DEA of change in transferees (downstream customers) of imports prior to transaction ..................................... No ................... Yes.
Notify DEA of increase in chemical quantity transferred for exports and international transactions prior to trans- No ................... Yes.
action.
Notify DEA of increase in chemical quantity transferred for import transactions prior to transaction ........................... No ................... Yes.
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File return declaration when imports/exports and international transactions are distributed ......................................... No ................... Yes.
File subsequent return declaration if entire quantity of import not distributed within 30 days of importation ................ No ................... Yes.

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17404 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations

Specific Changes Made by This Interim Section 1313.13, contents of import has not been revised or amended since
Final Rule declaration, is amended by requiring the its inception in 1989. Thus, this form
In this interim final rule, DEA is importer to provide information has not kept pace with subsequent
incorporating the provisions of section regarding the person or persons to legislation including the Domestic
716 of the CMEA into Title 21 of the whom the importer intends to transfer Chemical Diversion Control Act of 1993,
Code of Federal Regulations. Specific the chemical. the Comprehensive Methamphetamine
Section 1313.16 is added to specify Control Act of 1996, and the
changes are discussed below.
requirements regarding transfers after Methamphetamine Anti-Proliferation
Certain definitions relating to listed
importation, Section 1313.26 is added to Act of 2000. Therefore, some of the
chemicals in section 1300.02 are being
specify requirements regarding transfers changes DEA is making to this form are
revised or amended. The definition of
after exportation, and Section 1313.32 is not directly related to the CMEA.
‘‘established business relationship’’ is
amended to specify requirements for However, these changes are necessary
being revised to remove language
brokers and traders regarding for ease of use and clarity of the form.
regarding foreign customers; this
international transactions. These Changes being made include the
definition is now a general definition
requirements specify what the U.S. following:
relating to any business relationship,
either import or export. Further, parts of
importer, the U.S. exporter, or the U.S. • Changing the title of the form to:
broker or trader must do if an originally ‘‘Import/Export Declaration for List I
this definition are moved to new planned sale falls through and the
Section 1313.05, requirements of an and List II Chemicals’’ to more
importer or exporter arranges a accurately characterize the use of the
established business relationship. The subsequent spot market sale, as
definition of ‘‘established record as an form.
explained earlier in the preamble. For • Adding a check box for
importer’’ is being revised by moving brokers and traders, the situation is ‘‘international transaction’’ in addition
certain information into new Section somewhat more complicated because to existing fields for ‘‘import’’ and
1313.08. Finally, the definition of the broker or trader does not control the ‘‘export.’’
‘‘regular customer’’ is being revised to sale. If a transaction is not completed, • Adding fields for DEA registration
update the cross reference. the broker or trader could be asked to number and company identifier, if
As noted previously, Section 1313.05 find another buyer for the chemical or applicable.
is added to specify requirements of an the broker or trader may not be involved • Adding a field for the foreign
established business relationship. in arranging the subsequent sale. If the permit number, if applicable.
Information in this section was broker or trader arranges a subsequent • Adding check boxes for the type of
previously found in the definition of sale to replace the previously arranged submission of the form: ‘‘original,’’
‘‘established business relationship.’’ transaction, this transaction is a new ‘‘amended,’’ and ‘‘withdrawn.’’
As noted previously, Section 1313.08 transaction and must be reported as • Adding fields for the actual date
is added to specify requirements for such; a return declaration must be filed and quantity imported.
establishing a record as an importer. when the transaction is completed. • Adding fields for reporting by
Information in this section was Sections 1313.17(a), 1313.27(a), and importers of the person to whom the
previously found in the definition of 1313.35(a) are added to specify the listed chemical will be transferred, the
‘‘established record as an importer.’’ requirement that within 30 days of the downstream customer, per requirements
Section 1313.15(a) is being amended to completion of a transaction, the of the CMEA.
update the cross reference accordingly. importer, exporter, broker, or trader • Adding fields regarding return
Section 1313.12, requirement of must send DEA a return declaration declaration by importers and exporters.
authorization to import, is amended by containing information regarding the • Removing the certification by the
revising paragraph (c) to add the transaction, including the name of the Customs District Director; this
requirement that, to qualify for a waiver transferee, date the import, export, or certification is now the responsibility of
of the 15 day advance notice, not only international transaction and any the importer or exporter as part of the
does the importer have to be known to subsequent transfer occurred, the name return declaration.
DEA as a regular importer, but also that of the chemical transferred, the actual • Eliminating a number of fields,
the customer must meet the quantity transferred, the container, and including: gross weight of chemicals
requirements in Section 1313.05 to be any other information that DEA may imported/exported; intermediate
regarded as a regular customer. The specify. carriers; address of intermediate
effect of this new requirement is that, Sections 1313.17(b), 1313.27(b), and consignees.
effective May 9, 2007, all persons 1313.35(b) are added to specify the • Reorganizing layout for clarity.
previously granted regular importer requirement that if an importation,
status will be required to provide Implementation of This Rule
exportation, or international transaction
advance notification of imports with reported on a DEA Form 486 fails to be Effective May 9, 2007, all United
information regarding transferees, even completed, the importer, exporter, States importers and exporters of List I
for customers that they did business broker, or trader must file an and List II chemicals must use the
with in the past. This advance amendment to the Form 486 to notify revised DEA Form 486 to notify DEA of
notification will provide DEA the DEA. their imports and exports. This revised
opportunity to review and approve the form will be available on the Diversion
customer as a regular customer (see the Revision of DEA Form 486: Import/ Control Program Web site, http://
new definition in Section 1300.02 and Export Declaration for Precursor and www.deadiversion.usdoj.gov.
the requirements in new Section Essential Chemicals Effective May 9, 2007, all persons
1313.05). If the 15-day notification To comply with the changes made to previously granted regular importer
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period elapses without DEA taking the Controlled Substances Act by the status will no longer hold that status.
action, then that importer is granted Combat Methamphetamine Epidemic Every import of a List I and List II
regular importer status for all imports of Act of 2005, DEA is revising the existing chemical must be reported to DEA not
that particular chemical intended for the DEA Form 486, Import/Export later than 15 days prior to the proposed
specified customer. Declaration. DEA notes that this form importation. This report must include

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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 17405

the name of the person to whom the rules. The APA also provides, however, statutory change imposes minimal costs
chemical is proposed to be transferred that agencies can be excepted from these on United States importers, exporters,
and the amount of the chemical requirements when ‘‘the agency for good brokers, and traders; they simply have
proposed to be transferred. DEA will cause finds (and incorporates the to file a form with DEA in advance of
evaluate each proposed importation finding and a brief statement of reasons spot market transactions. They must
based not only on the chemical to be therefor in the rules issued) that notice also provide a return declaration after
imported but on the transferee and public procedure thereon are the import or export has occurred.
information supplied by the importer as impracticable, unnecessary, or contrary
to the public interest.’’ (5 U.S.C. Paperwork Reduction Act
well. This process will allow for the
establishment of regular customer status 553(b)(B). As discussed previously, the DEA is
by transferees of United States DEA has concluded that ‘‘good cause’’ revising an information collection by
importers, and for establishment of exists to promulgate this rule as an revising the information collected on
regular importer status by importers interim final rule rather than a proposed DEA Form 486: Import/Export
importing a specific listed chemical rule because the mandates of the CMEA Declaration for List I and List II
intended for sale to a specific customer. were set forth in such detail as to be Chemicals [OMB information collection
Effective May 9, 2007, all persons self-implementing. The changes 1117–0023]. Those changes have been
importing and exporting List I and List announced in this interim final rule discussed above, and are necessary for
II chemicals must provide the above render DEA’s regulations consistent DEA to implement the provisions of the
discussed return declarations to DEA. with the new provisions of the CMEA. CMEA of 2005.
Since DEA is without authority to revise The Department of Justice, DEA, has
Note Regarding Importation of the this rule based on public comments, submitted the following information
List I Chemicals Ephedrine, DEA finds that notice and opportunity collection request to the OMB for review
Pseudoephedrine, and for comment are unnecessary and and clearance in accordance with
Phenylpropanolamine impracticable under the APA (5 U.S.C. review procedures of the Paperwork
This rulemaking addresses all List I 553(b)(B)). Reduction Act of 1995. The information
and List II chemicals. While ephedrine, DEA is cognizant of the fact that collection is published to obtain
pseudoephedrine, and exceptions to the APA’s notice and comments from the public and affected
phenylpropanolamine are List I comment procedures are to be agencies.
chemicals and are covered by these ‘‘narrowly construed and only All comments and suggestions, or
regulations, other provisions of section reluctantly countenanced.’’ American questions regarding additional
721 of the CMEA require the reporting Federation of Government Employees v. information, to include obtaining a copy
of certain information regarding the Block, 655 F2d 1153, 1156 (D.C. Cir. of the information collection instrument
foreign chain of distribution of these 1981) (quoting New Jersey Department with instructions, should be directed to
three List I chemicals. Other provisions of Environmental Protection v. EPA, 626 Mark W. Caverly, Chief, Liaison and
of the CMEA require that these three F2d 1038, 1045 (D.C. Cir. 1980)). Based Policy Section, Office of Diversion
List I chemicals be imported only if on the detailed requirements set forth in Control, Drug Enforcement
there is a medical, scientific, or other the CMEA which give no discretion in Administration, Washington, DC 20537.
legitimate purpose for these chemicals. their implementation, however, DEA Written comments and suggestions
DEA is addressing these provisions in a finds that the invocation of the ‘‘good from the public and affected agencies
separate rulemaking. Persons importing cause’’ exception, and the issuance of concerning the collection of information
ephedrine, pseudoephedrine, and this rule as an interim final rule, is are encouraged. Your comments on the
phenylpropanolamine are required to justified. information collection-related aspects of
comply with the provisions of this rule this rule should address one or more of
Regulatory Flexibility Act
until such time as the rulemaking the following four points:
regarding provision of information The Deputy Administrator hereby (1) Evaluate whether the proposed
about the foreign chain of distribution is certifies that this rulemaking has been collection of information is necessary
promulgated. At that time, persons drafted in accordance with the for the proper performance of the
importing these three List I chemicals Regulatory Flexibility Act (RFA) (5 functions of the agency, including
will then be subject to those additional U.S.C. 605(b)). The RFA applies to rules whether the information will have
requirements. that are subject to notice and comment. practical utility;
Further, since the CMEA requires that Because this rule is simply codifying (2) Evaluate the accuracy of the
these three List I chemicals be imported statutory provisions, DEA has agency’s estimate of the burden of the
only if there is a medical, scientific, or determined, as explained above, that proposed collection of information,
other legitimate purpose for these public notice and comment are not including the validity of the
chemicals, DEA must establish import necessary. Consequently, the RFA does methodology and assumptions used;
not apply. (3) Enhance the quality, utility, and
quotas for ephedrine, pseudoephedrine,
clarity of the information to be
and phenylpropanolamine. DEA is Executive Order 12866
collected; and
addressing these provisions in separate The Deputy Administrator further (4) Minimize the burden of the
rulemakings. certifies that this rulemaking has been collection of information on those who
Regulatory Certifications drafted in accordance with the are to respond, including through the
principles in Executive Order 12866 use of appropriate automated,
Administrative Procedure Act (5 U.S.C. § 1(b). It has been determined that this electronic, mechanical, or other
553) is ‘‘a significant regulatory action.’’ technological collection techniques or
rwilkins on PROD1PC63 with RULES

The Administrative Procedure Act Therefore, this action has been reviewed other forms of information technology,
(APA) generally requires agencies to by the Office of Management and e.g., permitting electronic submission of
publish a notice of proposed rulemaking Budget (OMB). As discussed above, this responses.
and allow for a period of public action is codifying statutory provisions Overview of this information
comment prior to implementing new and involves no agency discretion. This collection:

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(1) Type of Information Collection: (4) Affected public who will be asked quantity to be transferred. For
revision of an existing collection. or required to respond, as well as a brief importations, persons must also provide
(2) Title of the Form/Collection: abstract: return declarations, confirming the date
Import/Export Declaration for List I and Primary: business or other for-profit. of the importation and transfer, and the
List II Chemicals. Other: none. amounts of the chemical transferred.
(3) Agency form number, if any, and Abstract: Persons importing, This information is used to prevent
the applicable component of the exporting, and conducting international shipments not intended for legitimate
Department of Justice sponsoring the transactions with List I and List II purposes.
collection: chemicals must notify DEA of those
(5) An estimate of the total number of
Form Number: DEA Form 486. transactions in advance of their
respondents and the amount of time
Office of Diversion Control, Drug occurrence, including information
Enforcement Administration, U.S. regarding the person(s) to whom the estimated for an average respondent to
Department of Justice. chemical will be transferred and the respond:

Number of Number of Average time Total hours


respondents responses per response

Form 486 (export) .......................................................................................... 225 7,917 0.2 hour 1,583.4 hours.
(12 minutes)
Form 486 (export return declaration) ............................................................. 225 7,917 0.08 hour 659.75 hours.
(5 minutes)
Form 486 (import) .......................................................................................... 216 2,278 0.25 hour 569.5 hours.
(15 minutes)
Form 486 (import return declaration)* ............................................................ 216 2,506 0.08 hour 208.8 hours.
(5 minutes)
Form 486 (international transaction) .............................................................. 9 111 0.2 hour 22.2 hours.
(12 minutes)
Form 486 (international transaction return declaration) ................................. 9 111 0.08 hour 9.25 hours.
(5 minutes)
Quarterly reports for imports of acetone, 2-butanone, and toluene .............. 110 440 0.5 hour 220 hours.
(30 minutes)

Total ........................................................................................................ 225 ........................ ...................... 3,272.9 hours.


* DEA assumes 10% of all imports will not be transferred in the first thirty days and will necessitate submission of a subsequent return
declaration.

(6) An estimate of the total public governments, in the aggregate, or by the Imports, Reporting and recordkeeping
burden (in hours) associated with the private sector, of $118,000,000 or more requirements.
collection: DEA estimates that this in any one year, and will not ■ For the reasons set out above, 21 CFR
collection will take 3,272.9 hours significantly or uniquely affect small parts 1300 and 1313 are amended as
annually. governments. Therefore, no actions were follows:
If additional information is required, deemed necessary under the provisions
contact: Lynn Bryant, Department of the Unfunded Mandates Reform Act PART 1300—DEFINITIONS
Clearance Officer, Information of 1995.
Management and Security Staff, Justice ■ 1. The authority citation for part 1300
Management Division, Department of Congressional Review Act
continues to read as follows:
Justice, Patrick Henry Building, Suite This rule is not a major rule as Authority: 21 U.S.C. 802, 871(b), 951,
1600, 601 D Street, NW., Washington, defined by § 804 of the Small Business 958(f).
DC 20530. Regulatory Enforcement Fairness Act of
Executive Order 12988 1996 (Congressional Review Act). This ■ 2. Section 1300.02 is amended by
rule will not result in an annual effect revising paragraphs (b)(12), (b)(13), and
This regulation meets the applicable
on the economy of $100,000,000 or (b)(25) to read as follows:
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil more; a major increase in costs or prices; § 1300.02 Definitions related to listed
Justice Reform. or significant adverse effects on chemicals.
competition, employment, investment,
Executive Order 13132 * * * * *
productivity, innovation, or on the
This rulemaking does not preempt or ability of United States-based (b) * * *
modify any provision of State law; nor companies to compete with foreign- (12) The term established business
does it impose enforcement based companies in domestic and relationship means the regulated person
responsibilities on any State; nor does it export markets. has imported or exported a listed
diminish the power of any State to chemical at least once within the past
List of Subjects
enforce its own laws. Accordingly, this six months, or twice within the past
rulemaking does not have federalism 21 CFR Part 1300 twelve months from or to a foreign
implications warranting the application manufacturer, distributor, or end user of
Chemicals, Drug traffic control.
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of Executive Order 13132. the chemical that has an established


21 CFR Part 1313 business with a fixed street address. A
Unfunded Mandates Reform Act of 1995 person or business that functions as a
This rule will not result in the Administrative practice and broker or intermediary is not a customer
expenditure by State, local, and tribal procedure, Drug traffic control, Exports, for purposes of this definition.

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Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations 17407

(13) The term established record as an relevant for determining whether a § 1313.15 Waiver of 15-day advance notice
importer means that the regulated customer is a regular customer. for regular importers.
person has imported a listed chemical at ■ 6. Section 1313.08 is added to read as (a) Each regulated person seeking
least once within the past six months, follows: designation as a ‘‘regular importer’’
or twice within the past twelve months shall provide, by certified mail return
from a foreign supplier. § 1313.08 Requirements for establishing a receipt requested, to the Administration
record as an importer. such information as is required under
* * * * *
(25) The term regular customer means To establish a record as an importer, § 1313.08 documenting their status as a
a person with whom the regulated the regulated person must provide the regular importer.
person has an established business Administrator with the following * * * * *
relationship for a specified listed information in accordance with the
■ 10. Section 1313.16 is added to read
chemical or chemicals that has been waiver of the 15-day advance notice
requirements of § 1313.15: as follows:
reported to the Administration subject
to the criteria established in part 1313 (a) The name, DEA registration § 1313.16 Transfers following importation.
of this chapter. number (where applicable), street
(a) In the case of a notice under
address, telephone number, and, where
* * * * * § 1313.12(a) submitted by a regulated
available, the facsimile number of the
person, if the transferee identified in the
PART 1313—IMPORTATION AND regulated person and of each foreign
notice is not a regular customer, the
EXPORTATION OF LIST I AND LIST II supplier; and
(b) The frequency and number of importer may not transfer the listed
CHEMICALS chemical until after the expiration of the
transactions occurring during the
preceding 12 month period. 15-day period beginning on the date on
■ 3. The authority citation for part 1313 which the notice is submitted to the
continues to read as follows: ■ 7. Section 1313.12 is amended by
Administration.
Authority: 21 U.S.C. 802, 830, 871(b), 971. revising paragraph (c) to read as follows: (b) After a notice under § 1313.12(a)
§ 1313.12 Requirement of authorization to or (d) is submitted to the
■ 4. The heading of part 1313 is revised
import. Administration, if circumstances change
to read as set forth above.
* * * * * and the importer will not be transferring
■ 5. Section 1313.05 is added to read as (c) The 15-day advance notification the listed chemical to the transferee
follows: requirement for listed chemical imports identified in the notice, or will be
may be waived for the following: transferring a greater quantity of the
§ 1313.05 Requirements for an established
(1) Any importation that meets both of chemical than specified in the notice,
business relationship.
the following requirements: the importer must update the notice to
To document that an importer or (i) The regulated person has satisfied identify the most recent prospective
exporter has an established business the requirements for reporting to the transferee or the most recent quantity or
relationship with a customer, the Administration as a regular importer of both (as the case may be) and may not
importer or exporter must provide the the listed chemicals. transfer the listed chemical until after
Administrator with the following (ii) The importer intends to transfer the expiration of the 15-day period
information in accordance with the the listed chemicals to a person who is beginning on the date on which the
waiver of 15-day advance notice a regular customer for the chemical, as update is submitted to the
requirements of § 1313.15 or § 1313.24: defined in § 1300.02 of this chapter. Administration, except that the 15-day
(a) The name and street address of the (2) A specific listed chemical, as set restriction does not apply if the
chemical importer or exporter and of forth in paragraph (f) of this section, for prospective transferee identified in the
each regular customer; which the Administrator determines
(b) The telephone number, contact update is a regular customer. The
that advance notification is not preceding sentence applies with respect
person, and where available, the
necessary for effective chemical to changing circumstances regarding a
facsimile number for the chemical
diversion control. transferee or quantity identified in an
importer or exporter and for each
regular customer; * * * * * update to the same extent and in the
(c) The nature of the regular ■ 8. Section 1313.13 is amended by same manner as the sentence applies
customer’s business (i.e., importer, revising paragraph (c)(4) and adding with respect to changing circumstances
exporter, distributor, manufacturer, paragraph (c)(5) to read as follows: regarding a transferee or quantity
etc.), and if known, the use to which the identified in the original notice under
§ 1313.13 Contents of import declaration. § 1313.12(a) or (d).
listed chemical or chemicals will be
applied; * * * * * (c) In the case of a transfer of a listed
(d) The duration of the business (c) * * * chemical that is subject to a 15-day
relationship; (4) The name, address, telephone restriction, the transferee involved shall,
(e) The frequency and number of number, telex number, and, where upon the expiration of the 15-day
transactions occurring during the available, the facsimile number of the period, be considered to qualify as a
preceding 12-month period; consigner in the foreign country of regular customer, unless the
(f) The amounts and the listed exportation; and Administration otherwise notifies the
chemical or chemicals involved in (5) The name, address, telephone importer involved in writing.
regulated transactions between the number, and where available, the (d) With respect to a transfer of a
chemical importer or exporter and facsimile number of the person or listed chemical with which a notice or
regular customer; persons to whom the importer intends update referred to in § 1313.12(a) or (d)
to transfer the listed chemical and the
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(g) The method of delivery (direct is concerned:


shipment or through a broker or quantity to be transferred to each (1) The Administration—
forwarding agent); and transferee. (i) May, in accordance with the same
(h) Other information that the ■ 9. Section 1313.15 is amended by procedures as apply under §§ 1313.51
chemical importer or exporter considers revising paragraph (a) to read as follows: through 1313.57, order the suspension

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17408 Federal Register / Vol. 72, No. 67 / Monday, April 9, 2007 / Rules and Regulations

of the transfer of the listed chemical by person, if the transferee identified in the (ii) May, for purposes of this
the importer involved, except for a notice, i.e., the foreign importer, is not paragraph (d), disqualify a regular
transfer to a regular customer, on the a regular customer, the regulated person customer on that ground.
ground that the chemical may be may not transfer the listed chemical (2) From and after the time when the
diverted to the clandestine manufacture until after the expiration of the 15-day Administration provides written notice
of a controlled substance (without period beginning on the date on which of the order under paragraph (d)(1)(i) of
regard to the form of the chemical that the notice is submitted to the this section (including a statement of
may be diverted, including the Administration. the legal and factual basis for the order)
diversion of a finished drug product to (b) After a notice under § 1313.21(a) is to the exporter, the exporter may not
be manufactured from bulk chemicals to submitted to the Administration, if carry out the transfer.
be transferred), subject to the circumstances change and the exporter (e) For purposes of this section:
Administration ordering the suspension will not be transferring the listed (1) The term transfer, with respect to
before the expiration of the 15-day chemical to the transferee identified in a listed chemical, includes the sale of
period with respect to the importation the notice, or will be transferring a the chemical.
(in any case in which such a period greater quantity of the chemical than (2) The term transferee means a
applies); and specified in the notice, the exporter person to whom an exporter transfers a
(ii) May, for purposes of this must update the notice to identify the listed chemical.
paragraph (d), disqualify a regular most recent prospective transferee or the ■ 13. Section 1313.27 is added to read
customer on that ground. most recent quantity or both (as the case as follows:
(2) From and after the time when the may be) and may not transfer the listed
Administration provides written notice chemical until after the expiration of the § 1313.27 Return declaration or
of the order under paragraph (d)(1)(i) of 15-day period beginning on the date on amendment to Form 486 for exports.
this section (including a statement of which the update is submitted to the (a) Within 30 days after a transaction
the legal and factual basis for the order) Administration, except that the 15-day is completed, the exporter must send to
to the importer, the importer may not restriction does not apply if the the Administration a return declaration
carry out the transfer. prospective transferee identified in the containing particulars of the transaction,
(e) For purposes of this section: update is a regular customer. The including the date, quantity, chemical,
(1) The term transfer, with respect to preceding sentence applies with respect container, name of transferees, and any
a listed chemical, includes the sale of to changing circumstances regarding a other information as the Administration
the chemical. transferee or quantity identified in an may specify.
(2) The term transferee means a update to the same extent and in the (b) If an exportation for which a Form
person to whom an importer transfers a same manner as the sentence applies 486 has been filed fails to take place, the
listed chemical. with respect to changing circumstances exporter must file an amended Form
■ 11. Section 1313.17 is added to read regarding a transferee or quantity 486 notifying the Administration that
as follows: identified in the original notice under the exportation did not occur.
§ 1313.17 Return declaration or paragraph (a) of this section. ■ 14. Section 1313.32 is amended by
amendment to Form 486 for imports. (c) In the case of a transfer of a listed adding paragraphs (d) and (e) to read as
(a) Within 30 days after a transaction chemical that is subject to a 15-day follows:
is completed, the importer must send to restriction, the transferee involved shall,
the Administration a return declaration upon the expiration of the 15-day § 1313.32 Requirement of authorization for
period, be considered to qualify as a international transactions.
containing particulars of the transaction,
including the date, quantity, chemical, regular customer, unless the * * * * *
container, name of transferees, and any Administration otherwise notifies the (d) After a notice under paragraph (a)
other information as the Administration exporter involved in writing. of this section is submitted to the
may specify. A single return declaration (d) With respect to a transfer of a Administration, if circumstances change
may include the particulars of both the listed chemical with which a notice or and the broker or trader will not be
importation and distribution. If the update referred to in § 1313.21(a) is transferring the listed chemical to the
importer has not distributed all concerned: transferee identified in the notice, or
chemicals imported by the end of the (1) The Administration— will be transferring a greater quantity of
initial 30-day period, the importer must (i) May, in accordance with the same the chemical than specified in the
file supplemental return declarations no procedures as apply under §§ 1313.51 notice, the broker or trader must update
later than 30 days from the date of any through 1313.57, order the suspension the notice to identify the most recent
further distribution, until the of the transfer of the listed chemical by prospective transferee or the most recent
distribution or other disposition of all the exporter involved, except for a quantity or both (as the case may be).
chemicals imported under the import transfer to a regular customer, on the The preceding sentence applies with
notification or any update are accounted ground that the chemical may be respect to changing circumstances
for. diverted to the clandestine manufacture regarding a transferee or quantity
(b) If an importation for which a Form of a controlled substance (without identified in an update to the same
486 has been filed fails to take place, the regard to the form of the chemical that extent and in the same manner as the
importer must file an amended Form may be diverted, including the sentence applies with respect to
486 notifying the Administration that diversion of a finished drug product to changing circumstances regarding a
the importation did not occur. be manufactured from bulk chemicals to transferee or quantity identified in the
■ 12. Section 1313.26 is added to read be transferred), subject to the original notice under paragraph (a) of
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as follows: Administration ordering the suspension this section.


before the expiration of the 15-day (e) For purposes of this section:
§ 1313.26 Transfers following exportation. period with respect to the exportation (1) The term transfer, with respect to
(a) In the case of a notice under (in any case in which such a period a listed chemical, includes the sale of
§ 1313.21(a) submitted by a regulated applies); and the chemical.

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(2) The term transferee means a Federal holidays. You may also find this contain complete supporting
person to whom an exporter transfers a docket on the Internet at http:// documentation and evidence which the
listed chemical. dms.dot.gov. appellant wishes to have considered.
■ 15. Section 1313.35 is added to read FOR FURTHER INFORMATION CONTACT: If Upon receipt of the appeal, the Area
as follows: you have questions on this rule, call Commander may direct a representative
Commander Michael Cunningham, to gather and submit documentation or
§ 1313.35 Return declaration or
Coast Guard, telephone 202–372–1129. other evidence which would be
amendment to Form 486 for international
transactions. If you have questions on viewing the necessary or helpful to a resolution of
docket, call Ms. Renee V. Wright, the appeal. A copy of this
(a) Within 30 days after a transaction
is completed, the broker or trader must Program Manager, Docket Operations, documentation and evidence is made
send to the Administration a return telephone 202–493–0402. available to the appellant. The appellant
declaration containing particulars of the SUPPLEMENTARY INFORMATION: Each year is afforded five working days from the
transaction, including the date, Title 33 of the Code of Federal date of receipt to submit rebuttal
quantity, chemical, container, name of Regulations is updated on July 1. On materials. Following submission of all
transferees, and any other information July 12, 2006, the Coast Guard materials, the Area Commander issues a
as the Administration may specify. published a final rule (USCG–2006– ruling, in writing, on the appeal. Prior
(b) If a transaction for which a Form 25150) to make technical, to issuing the ruling, the Area
486 has been filed fails to take place, the organizational, conforming amendments Commander may, as a matter of
broker or trader must file an amended and other editorial corrections discretion, allow oral presentation on
Form 486 notifying the Administration throughout Title 33. (71 FR 39206) Due the issues.
that the transaction did not occur. to a drafting error in the July 12th final
(d) Any person who receives an
rule the appeals process in § 160.7 is
Dated: March 30, 2007. unfavorable ruling on an appeal taken
now deficient. The July 12th final rule
Michele M. Leonhart, ascribes authorities not within the realm under paragraph (c) of this section, may
Deputy Administrator. of the Area Commander and does not appeal through the Area Commander to
[FR Doc. 07–1718 Filed 4–6–07; 8:45 am] clearly allow for an appeal of Area the Assistant Commandant for
BILLING CODE 4410–09–P Commander decisions to Coast Guard Prevention (formerly known as the
Headquarters. This correction document Assistant Commandant for Marine
makes corrections to the revisions in Safety, Security and Environmental
DEPARTMENT OF HOMELAND § 160.7 found in the July 12th final rule. Protection), U.S. Coast Guard,
SECURITY Washington, DC 20593. The appeal
List of Subjects in 33 CFR Part 160 must be in writing, except as allowed
Coast Guard Administrative practice and under paragraph (e) of this section. The
procedure, Harbors, Hazardous Area Commander forwards the appeal,
33 CFR Part 160 materials transportation, Marine safety, all the documents and evidence which
Navigation (water), Reporting and formed the record upon which the order
[USCG–2006–25150; Correction]
recordkeeping requirements, Vessels, or direction was issued or the ruling
RIN 1625–ZA08 Waterways. under paragraph (c) of this section was
■ Accordingly, 33 CFR part 160 is made, and any comments which might
Navigation and Navigable Waters; corrected by making the following be relevant, to the Assistant
Technical, Organizational, and correcting amendments:
Conforming Amendments Commandant for Prevention. A copy of
this documentation and evidence is
AGENCY: Coast Guard, DHS. PART 160—PORTS AND WATERWAYS made available to the appellant. The
SAFETY—GENERAL
ACTION: Final rule; correcting appellant is afforded five working days
amendments. ■ 1. The authority citation for part 160 from the date of receipt to submit
continues to read as follows: rebuttal materials to the Assistant
SUMMARY: This document contains a Commandant for Prevention. The
Authority: 33 U.S.C. 1223, 1231; 46 U.S.C.
correction to the section addressing decision of the Assistant Commandant
Chapter 701; Department of Homeland
appeals for orders issued pursuant to Security Delegation No. 0170.1. Subpart C is for Prevention is based upon the
the Coast Guard’s regulations also issued under the authority of 33 U.S.C. materials submitted, without oral
implementing the Ports and Waterways 1225 and 46 U.S.C. 3715. argument or presentation. The decision
Safety Act (USCG–2006–25150)
■ 2. Amend § 160.7 to revise paragraphs of the Assistant Commandant for
published on July 12, 2006, in the
(c) and (d) to read as follows: Prevention is issued in writing and
Federal Register (71 FR 39206).
constitutes final agency action.
DATES: This correction is effective April § 160.7 Appeals.
9, 2007. * * * * *
* * * * *
ADDRESSES: Comments and material (c) Any person directly affected by the Dated: March 27, 2007.
received from the public, as well as establishment of a safety zone or by an Stefan G. Venckus,
documents mentioned in this preamble order or direction issued by, or on Chief, Office of Regulations and
as being available in the docket, are part behalf of, a District Commander, or who Administrative Law, United States Coast
of docket USCG–2006–25150 and are receives an unfavorable ruling on an Guard.
available for inspection or copying at appeal taken under paragraph (b) of this [FR Doc. E7–6099 Filed 4–6–07; 8:45 am]
rwilkins on PROD1PC63 with RULES

the Docket Management Facility, U.S. section may appeal to the Area BILLING CODE 4910–15–P
Department of Transportation, room PL– Commander through the District
401, 400 Seventh Street SW., Commander. The appeal must be in
Washington, DC, between 9 a.m. and 5 writing, except as allowed under
p.m., Monday through Friday, except paragraph (e) of this section, and shall

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