Information on Foreign Chain of Distribution for Ephedrine, Pseudoephedrine, and Phenylpropanolamine, 16793-16797 [E8-6357]
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jlentini on PROD1PC65 with PROPOSALS
Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Proposed Rules
Deadhorse Airport area would be
established by this action. The proposed
airspace is sufficient in size to contain
aircraft executing the instrument
procedures at the Deadhorse Airport,
Deadhorse, AK.
The area would be depicted on
aeronautical charts for pilot reference.
The coordinates for this airspace docket
are based on North American Datum 83.
The Class E airspace areas designated as
surface areas are published in paragraph
6002 of FAA Order 7400.9R, Airspace
Designations and Reporting Points,
signed August 15, 2007, and effective
September 15, 2007, which is
incorporated by reference in 14 CFR
71.1. The Class E airspace areas
designated as 700/1200 foot transition
areas are published in paragraph 6005
in FAA Order 7400.9R, Airspace
Designations and Reporting Points,
signed August 15, 2007, and effective
September 15, 2007, which is
incorporated by reference in 14 CFR
71.1. The Class E airspace designations
listed in this document would be
published subsequently in the Order.
The FAA has determined that this
proposed regulation only involves an
established body of technical
regulations for which frequent and
routine amendments are necessary to
keep them operationally current. It,
therefore —(1) is not a ‘‘significant
regulatory action’’ under Executive
Order 12866; (2) is not a ‘‘significant
rule’’ under DOT Regulatory Policies
and Procedures (44 FR 11034; February
26, 1979); and (3) does not warrant
preparation of a regulatory evaluation as
the anticipated impact is so minimal.
Since this is a routine matter that will
only affect air traffic procedures and air
navigation, it is certified that this rule,
when promulgated, will not have a
significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the United States Code.
Subtitle 1, Section 106 describes the
authority of the FAA Administrator.
Subtitle VII, Aviation Programs,
describes in more detail the scope of the
agency’s authority.
This rulemaking is promulgated
under the authority described in
Subtitle VII, Part A, Subpart 1, Section
40103, Sovereignty and use of airspace.
Under that section, the FAA is charged
with prescribing regulations to ensure
the safe and efficient use of the
navigable airspace. This regulation is
within the scope of that authority
because it proposes to create Class E
airspace sufficient in size to contain
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aircraft executing instrument
procedures at the Deadhorse Airport,
AK, and represents the FAA’s
continuing effort to safely and
efficiently use the navigable airspace.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Proposed Amendment
In consideration of the foregoing, the
Federal Aviation Administration
proposes to amend 14 CFR part 71 as
follows:
16793
Issued in Anchorage, AK, on March 20,
2008.
Michael A. Tarr,
Acting Manager, Alaska Flight Services
Information Area Group.
[FR Doc. E8–6597 Filed 3–28–08; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1313
[Docket No. DEA–295P]
PART 71—DESIGNATION OF CLASS A,
CLASS B, CLASS C, CLASS D, AND
CLASS E AIRSPACE AREAS;
AIRWAYS; ROUTES; AND REPORTING
POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of Federal Aviation
Administration Order 7400.9R, Airspace
Designations and Reporting Points,
signed August 15, 2007, and effective
September 15, 2007, is to be amended
as follows:
*
*
*
*
*
Paragraph 6002 Class E Airspace
Designated as Surface Areas.
*
*
*
*
*
AAL AK E2 Deadhorse, AK [Revised]
Deadhorse, Deadhorse Airport, AK
(Lat. 70°11′41″ N., long. 148°27′55″ W.)
Within a 4.1-mile radius of the Deadhorse
Airport, and within 2.4 miles either side of
the 035° (T)/ 058°(M) bearing from the
Deadhorse Airport extending from the 2.4mile radius to 7.0 miles northeast of the
Deadhorse Airport. This Class E airspace area
is effective during the specific dates and
times established in advance by a Notice to
Airmen. The effective date and time will
thereafter be continuously published in the
Airport/Facility Directory.
*
*
*
*
*
Paragraph 6005 Class E Airspace Extending
Upward from 700 Feet or More Above the
Surface of the Earth.
*
*
*
*
*
AAL AK E5 Deadhorse, AK [Revised]
Deadhorse, Deadhorse Airport, AK
(Lat. 70°11′41″ N., long. 148°27′55″ W.)
That airspace extending upward from 700
feet above the surface within a 7.0-mile
radius of the Deadhorse Airport; and that
airspace extending upward from 1,200 ft.
above the surface within a 72-mile radius of
the Deadhorse Airport.
*
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*
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RIN 1117–AB07
Information on Foreign Chain of
Distribution for Ephedrine,
Pseudoephedrine, and
Phenylpropanolamine
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
SUMMARY: The Combat
Methamphetamine Epidemic Act of
2005 (CMEA), which was enacted on
March 9, 2006, requires DEA to collect
from importers of ephedrine,
pseudoephedrine, and
phenylpropanolamine all information
known to the importer on the foreign
chain of distribution of the chemical
from the manufacturer to the importer.
DEA is proposing to amend its
regulations to incorporate the
requirement for this information into
the import declaration.
DATES: Written comments must be
postmarked, and electronic comments
must be sent, on or before May 30, 2008.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–295’’ on all written and
electronic correspondence. Written
comments being sent via regular mail
should be sent to the Deputy Assistant
Administrator, Office of Diversion
Control, Drug Enforcement
Administration, Washington, DC 20537,
Attention: DEA Federal Register
Representative/ODL. Written comments
sent via express mail should be sent to
DEA Headquarters, Attention: DEA
Federal Register Representative/ODL,
8701 Morrissette Drive, Springfield, VA
22152. Comments may be directly sent
to DEA electronically by sending an
electronic message to:
dea.diversion.policy@usdoj.gov.
Comments may also be sent
electronically through https://
www.regulations.gov using the
electronic comment form provided on
that site. An electronic copy of this
document is also available at the
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16794
Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Proposed Rules
https://www.regulations.gov Web site.
DEA will accept attachments to
electronic comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file
formats only. DEA will not accept any
file formats other than those specifically
listed here.
Posting of Public Comments: Please
note that all comments received are
considered part of the public record and
made available for public inspection
online at https://www.regulations.gov
and in the Drug Enforcement
Administration’s public docket. Such
information includes personal
identifying information (such as your
name, address, etc.) voluntarily
submitted by the commenter.
If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all the personal identifying information
you do not want posted online or made
available in the public docket in the first
paragraph of your comment and identify
what information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be posted online or made
available in the public docket.
Personal identifying information and
confidential business information
identified and located as set forth above
will be redacted and the comment, in
redacted form, will be posted online and
placed in the Drug Enforcement
Administration’s public docket file. If
you wish to inspect the agency’s public
docket file in person by appointment,
please see the FOR FURTHER INFORMATION
CONTACT paragraph.
jlentini on PROD1PC65 with PROPOSALS
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, Washington DC 20537
at (202) 307–7297.
SUPPLEMENTARY INFORMATION:
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DEA’s Legal Authority
DEA implements the Comprehensive
Drug Abuse Prevention and Control Act
of 1970, often referred to as the
Controlled Substances Act (CSA) and
the Controlled Substances Import and
Export Act (21 U.S.C. 801–971), as
amended. DEA publishes the
implementing regulations for these
statutes in title 21 of the Code of Federal
Regulations (CFR), parts 1300 to 1399.
These regulations are designed to ensure
that there is a sufficient supply of
controlled substances for legitimate
medical, scientific, research, and
industrial purposes and to deter the
diversion of controlled substances to
illegal purposes. The CSA mandates that
DEA establish a closed system of control
for manufacturing, distributing, and
dispensing controlled substances. Any
person who manufactures, distributes,
dispenses, imports, exports, or conducts
research or chemical analysis with
controlled substances must register with
DEA (unless exempt) and comply with
the applicable requirements for the
activity. The CSA as amended also
requires DEA to regulate the
manufacture, distribution, import, and
export of chemicals that may be used to
manufacture controlled substances
illegally. Listed chemicals that are
classified as List I chemicals are
important to the manufacture of
controlled substances. Those classified
as List II chemicals may be used to
manufacture controlled substances.
On March 9, 2006, the President
signed the Combat Methamphetamine
Epidemic Act of 2005 (CMEA), which is
title VII of the USA PATRIOT
Improvement and Reauthorization Act
of 2005 (Pub. L. 109–177). The changes
proposed here are needed to implement
the statutory provisions. The statute is
self-implementing; the provisions
related to information to be collected at
the importation of ephedrine,
pseudoephedrine, and
phenylpropanolamine became effective
on March 9, 2006. The changes
proposed in this rulemaking provide
conforming amendments to make the
language of the regulations consistent
with that of the statute. DEA must
implement the statute and is simply
conforming its regulations to, and
implementing, the statute.
Import Declaration Requirements
Under existing DEA regulations (21
CFR part 1313), importers of listed
chemicals are required to provide DEA
with advance notification of imports
unless the importer has met the
requirements as a regular importer of
the listed chemical; for regular
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importers, the notification must be filed
by the date of importation. In the
importation declaration (DEA Form
486), the importer must provide
information on the chemical (name, size
and weight of the container, number of
containers, total weight of chemical),
importation (date, foreign port of
shipment, United States port of entry)
and the foreign supplier (name, address,
contact information).
CMEA imposes several new
requirements on imports of listed
chemicals. CMEA amended 21 U.S.C.
971, ‘‘Notification, suspension of
shipment, and penalties with respect to
importation and exportation of listed
chemicals’’, to require DEA to collect
information regarding persons to whom
the United States importer, exporter,
broker, or trader transfers the listed
chemical, actual quantities shipped, and
the date the shipment occurred. If the
person to whom the listed chemical is
to be transferred is not a regular
customer of the United States importer
or exporter, then the importer or
exporter must notify DEA no later than
15 days before the transaction is to take
place. Further, if the person to whom
the chemical is to be transferred changes
subsequent to initial notification of
DEA, or if the amount of the chemical
to be transferred increases, the importer
or exporter shall update the notice to
DEA to identify the most recent
prospective transferee or the most recent
quantity or both (as the case may be)
and may not transfer the listed chemical
until after the expiration of the 15-day
period beginning on the date on which
the update is submitted to DEA, except
that such 15-day restriction does not
apply if the prospective transferee
identified in the update is a regular
customer. These changes apply to all
listed chemicals. On April 9, 2007, DEA
published an Interim Final Rule with
Request for Comment codifying these
provisions (72 FR 17401). Subsequently,
due to requests from the regulated
industry, DEA temporarily stayed
certain provisions of that rule (72 FR
28601, May 22, 2007). That Interim
Final Rule became effective June 8,
2007.
CMEA added a new paragraph (h) to
21 U.S.C. 971 that applies specifically to
the importation of ephedrine,
pseudoephedrine, and
phenylpropanolamine. In paragraph
(h)(1), the Act states that the import
declaration ‘‘shall include all
information known to the importer on
the chain of distribution of such
chemical from the manufacturer to the
importer.’’ Paragraphs 971(h)(2) and (3)
state that the Attorney General may ask
foreign manufacturers and distributors
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jlentini on PROD1PC65 with PROPOSALS
to provide information known to them
on distribution of the chemical,
including sales. If the foreign
manufacturer or distributor refuses to
cooperate, the Attorney General may
issue an order prohibiting the
importation of the three chemicals if the
foreign manufacturer or distributor is
part of the chain of distribution. Not
later than 60 days prior to issuing the
order, the Attorney General must
publish in the Federal Register a notice
of intent to issue the order. Imports
handled by the foreign distributor may
not be restricted during the 60-day
period. In the Conference Report (H.R.
109–333), Congress stated that the
‘‘provision will assist U.S. law
enforcement agencies to better track
where meth precursors come from, and
how they get to the U.S. At present, very
little information exists about the
international ‘chain of distribution’ for
these chemicals, hindering effective
controls.’’
DEA is proposing to add a new
paragraph (d) to 21 CFR 1313.13,
Contents of import declaration, to state
that importers of ephedrine,
pseudoephedrine, and
phenylpropanolamine must provide
information known to them on the chain
of distribution from the manufacturer to
the importer. DEA is also proposing to
add a new 21 CFR 1313.42 to cover the
provisions of paragraphs (h)(2) and (3)
on orders to prohibit imports from
foreign manufacturers and distributors
who refuse to cooperate with requests
for information.
Revision of DEA Form 486: Import/
Export Declaration for List I and List II
Chemicals
To comply with the changes made to
the Controlled Substances Act by the
Combat Methamphetamine Epidemic
Act of 2005, DEA is proposing to
establish a new DEA Form 486A to be
used by persons importing ephedrine,
pseudoephedrine, or
phenylpropanolamine, or drug products
containing ephedrine, pseudoephedrine,
or phenylpropanolamine. This new
form responds to the requirement
regarding the foreign chain of
distribution discussed above, as well as
to requirements implemented regarding
import quotas for ephedrine,
pseudoephedrine, and
phenylpropanolamine. In a separate
rulemaking, ‘‘Import and Production
Quotas for Certain List I Chemicals’’
[Docket No. DEA–293, RIN 1117–AB08]
(72 FR 37439, July 10, 2007), DEA
implemented the import quota
provisions of CMEA. Importers of
ephedrine, pseudoephedrine, and
phenylpropanolamine will be required
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to provide information about their
individual import quota on the DEA
Form 486A so that DEA may determine
whether the importer has enough quota
remaining to import the quantity
requested.
Thus, in addition to the fields
currently present on the DEA Form 486,
the DEA Form 486A contains the
following fields:
• Name and address of foreign
distributor (if applicable).
• Import quota, including: quota for
current year; quota used to date for
current year; and, amount of quota
remaining.
Once the new DEA Form 486A is
implemented, DEA will make both the
DEA Form 486 and the DEA Form 486A
fully interactive forms. That is, these
forms would be able to be completed
and submitted electronically. Currently,
forms can be completed electronically,
but must be printed and sent to DEA via
facsimile. DEA notes that the
availability of a fully interactive form
has been long sought by the regulated
industry.
Implementation of this Rule
Effective 30 days after publication of
a Final Rule implementing these
regulations in the Federal Register, all
United States importers of the List I
chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine would be
required to use the new DEA Form 486A
‘‘Importation of the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine’’ to notify DEA of
their imports.
Regulatory Certifications
Regulatory Flexibility Act
The Acting Administrator hereby
certifies that this rulemaking has been
drafted in accordance with the
provisions of the Regulatory Flexibility
Act (5 U.S.C. 601–612). This rule is
necessary to comply with statutory
mandates which require that notices of
importation for imports of the List I
chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine provide to
DEA all information known to the
importer on the foreign chain of
distribution of the chemical. As noted
above, changes to the forms also
respond to provisions regarding import
quotas, requiring that importers note on
the form the amount of quota issued and
available for each chemical. Without
these changes, DEA will be unable to
comply with statutory mandates and
will not be able to fully administer the
system of import and production quotas
mandated for ephedrine,
pseudoephedrine, and
phenylpropanolamine.
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16795
DEA notes that the statute requires
importers to provide only information
that is known to them; the burden
associated with providing names on the
foreign chain of distribution will be
minimal. This rule does not impose any
new costs. DEA notes that, prior to this
rule, importers of ephedrine,
pseudoephedrine, and
phenylpropanolamine were required to
complete a DEA Form 486 to import
these List I chemicals. Only the
information on the form has changed.
Therefore, this rule will not have a
significant economic impact on a
substantial number of small entities.
Executive Order 12866
The Acting Administrator further
certifies that this rulemaking has been
drafted in accordance with the
principles in Executive Order 12866
1(b). It has been determined that this is
‘‘a significant regulatory action.’’
Therefore, this action has been reviewed
by the Office of Management and
Budget. As discussed above, this action
is codifying statutory provisions and
involves no agency discretion. This
statutory change imposes minimal costs
on importers; they simply have to file a
form with DEA in advance of
transactions that includes information
that is known to them. They are not
required to conduct research to obtain
information. DEA notes that the
requirement to complete the form is
already present in DEA regulations. This
rule merely requires that importers of
these three List I chemicals provide
information known to them regarding
the foreign chain of distribution of the
chemicals.
Paperwork Reduction Act
DEA is proposing to revise an existing
information collection by establishing a
new form for the reporting of imports of
the List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine. Specifically,
DEA is creating new DEA Form 486A,
‘‘Import Declaration for Ephedrine,
Pseudoephedrine, and
Phenylpropanolamine’’. This form
permits the reporting of any information
known to the United States importer
regarding the foreign chain of
distribution of the List I chemical(s).
Specifically, DEA estimates that 30
respondents will import ephedrine,
pseudoephedrine, and
phenylpropanolamine annually. These
persons will conduct 350 individual
importations, necessitating the
submission of 350 forms. Because of the
additional information required on the
DEA Form 486A, DEA estimates that
this form will take 20 minutes to
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Federal Register / Vol. 73, No. 62 / Monday, March 31, 2008 / Proposed Rules
Overview of Information Collection
1117–0023
(1) Type of Information Collection:
Revision of an existing collection.
(2) Title of the Form/Collection:
Import/Export Declaration for List I and
List II Chemicals.
(3) Agency form number, if any, and
the applicable component of the
Department of Justice sponsoring the
collection:
Form Number: DEA Form 486 and
DEA Form 486A. Office of Diversion
Control, Drug Enforcement
Administration, U.S. Department of
Justice.
(4) Affected public who will be asked
or required to respond, as well as a brief
abstract:
Primary: Business or other for-profit.
Other: None.
Abstract: Persons importing,
exporting, and conducting international
transactions with List I and List II
chemicals must notify DEA of those
transactions in advance of their
occurrence, including information
regarding the person(s) to whom the
chemical will be transferred and the
quantity to be transferred. Persons must
also provide return declarations,
confirming the date of the importation
and transfer, and the amounts of the
chemical transferred. For the List I
chemicals ephedrine, pseudoephedrine,
and phenylpropanolamine, importers
must report all information known to
them on the chain of distribution of the
chemical from the manufacturer to the
importer. This information is used to
prevent shipments not intended for
legitimate purposes.
(5) An estimate of the total number of
respondents and the amount of time
estimated for an average respondent to
respond:
Number of
respondents
complete, as opposed to the DEA Form
486, which DEA estimates takes 15
minutes to complete. DEA notes here
that the completion of the DEA Form
486A will be in lieu of the currentlyrequired completion of the DEA Form
486. Therefore, while the number of
responses remains constant, the hour
burden increases due to the greater time
associated with the DEA Form 486A.
The net increase for this collection is 13
hours annually.
The Department of Justice, Drug
Enforcement Administration, has
submitted the following information
collection request to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with review procedures of the
Paperwork Reduction Act of 1995. The
proposed information collection is
published to obtain comments from the
public and affected agencies.
All comments, suggestions, or
questions regarding additional
information, to include obtaining a copy
of the proposed information collection
instrument with instructions, should be
directed to Mark W. Caverly, Chief,
Liaison and Policy Section, Office of
Diversion Control, Drug Enforcement
Administration, Washington, DC 20537.
Written comments and suggestions
from the public and affected agencies
concerning the collection of information
are encouraged. Your comments on the
information collection-related aspects of
Average time
per response
this rule should address one or more of
the following four points:
(1) Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
(2) Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and
clarity of the information to be
collected; and
(4) Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses.
Number of
responses
Total
(in hours)
Form 486 (export) ..........................................
Form 486 (Export Return Declaration) ..........
Form 486 (import) ..........................................
Form 486 (import return declaration)* ...........
Form 486A (import) ........................................
Form 486A (import return declaration)* .........
Form 486 (international transaction) ..............
Form 486 (international transaction return
declaration.
Quarterly reports for imports of acetone, 2butanone, and toluene.
239
239
230
230
30
30
9
9
7,997
7,997
2000
2200
350
385
111
111
0.2 hour (12 minutes) ....................................
0.08 hour (5 minutes) ....................................
0.25 hour (15 minutes) ..................................
0.08 hour (5 minutes) ....................................
0.33 hour (20 minutes) ..................................
0.08 hour (5 minutes) ....................................
0.2 hour (12 minutes) ....................................
0.08 hour (5 minutes) ....................................
1,599.4
666.4
500
183.3
116.7
32.1
22.2
9.25
110
440
0.5 hour (30 minutes) ....................................
220
Total ........................................................
239
........................
........................................................................
3,349.35
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* 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
burden (in hours) associated with the
collection: DEA estimates that this
collection will take 3,350 hours
annually.
If additional information is required,
contact Lynn Bryant, Department
Clearance Officer, Information
Management and Security Staff, Justice
Management Division, Department of
Justice, Patrick Henry Building, Suite
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1600, 601 D Street, NW., Washington,
DC 20530.
Executive Order 12988
This regulation meets the applicable
standards set forth in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil
Justice Reform.
Executive Order 13132
This rulemaking does not preempt or
modify any provision of state law; nor
does it impose enforcement
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responsibilities on any state; nor does it
diminish the power of any state to
enforce its own laws. Accordingly, this
rulemaking does not have federalism
implications warranting the application
of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $120,000,000 or more
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(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as
defined by section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This rule will not result in
an annual effect on the economy of
$100,000,000 or more; a major increase
in costs or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
List of Subjects in 21 CFR Part 1313
Administrative practice and
procedure, Drug traffic control, Exports,
Imports, Reporting and recordkeeping
requirements.
For the reasons set out above, 21 CFR
part 1313 is proposed to be amended as
follows:
sales, the Administrator may issue an
order prohibiting the importation of the
chemical in any case where the
manufacturer or distributor is part of the
chain of distribution.
(b) Not later than 60 days prior to
issuing the order to prohibit
importation, the Administrator shall
publish in the Federal Register a notice
of intent to issue the order. During the
60 day period, imports from the foreign
manufacturer or distributor may not be
restricted under this section.
Dated: March 14, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8–6357 Filed 3–28–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Parts 1 and 301
[REG–119518–07]
RIN 1545–BG92
Travel Expenses of State Legislators
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking.
AGENCY:
PART 1313—IMPORTATION AND
EXPORTATION OF LIST I AND LIST II
CHEMICALS
1. The authority citation for part 1313
continues to read as follows:
Authority: 21 U.S.C. 802, 830, 871(b), 971.
2. Section 1313.13 is amended by
adding paragraph (d) to read as follows:
§ 1313.13
Contents of import declaration.
*
*
*
*
*
(d) Any regulated person importing
ephedrine, pseudoephedrine, or
phenylpropanolamine must submit, on
the import declaration, all information
known to the importer on the chain of
distribution of the chemical from the
manufacturer to the importer.
Ephedrine, pseudoephedrine, or
phenylpropanolamine include each of
the salts, optical isomers, and salts of
optical isomers of the chemical.
3. Section 1313.42 is added to read as
follows:
jlentini on PROD1PC65 with PROPOSALS
§ 1313.42 Prohibition of shipments from
certain foreign sources.
(a) If the Administrator determines
that a foreign manufacturer or
distributor of ephedrine,
pseudoephedrine, or
phenylpropanolamine has refused to
cooperate with a request by the
Administrator for information known to
the manufacturer or distributor on the
distribution of the chemical, including
VerDate Aug<31>2005
16:12 Mar 28, 2008
Jkt 214001
SUMMARY: This document contains
proposed regulations relating to travel
expenses of state legislators while away
from home. The regulations affect
eligible state legislators who make the
election under section 162(h) of the
Internal Revenue Code (Code). The
regulations are necessary to clarify the
amount of travel expenses that may be
deducted by a state legislator who
makes the election under section 162(h).
DATES: Written (paper or electronic)
comments or a request for a public
hearing must be received by June 30,
2008.
Send submissions to
CC:PA:LPD:PR (REG–119518–07), Room
5203, Internal Revenue Service, POB
7604, Ben Franklin Station, Washington,
DC 20044. Submissions may be handdelivered Monday through Friday
between the hours of 8 a.m. and 4 p.m.
to CC:PA:LPD:PR (REG–119518–07),
Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue,
NW., Washington, DC. Alternatively,
taxpayers may submit comments
electronically via the Federal
eRulemaking Portal at https://
www.regulations.gov (IRS REG–119518–
07).
FOR FURTHER INFORMATION CONTACT:
Concerning the proposed regulations, R.
ADDRESSES:
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
16797
Matthew Kelley, (202) 622–7900;
concerning submission of comments or
a request for a hearing, Kelly Banks,
(202) 622–7180 (not toll-free numbers).
SUPPLEMENTARY INFORMATION:
Paperwork Reduction Act
The collection of information
contained in this notice of proposed
rulemaking has been submitted to the
Office of Management and Budget for
review in accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. 3507(d)). Comments on the
collection of information should be sent
to the Office of Management and
Budget, Attn: Desk Officer for the
Department of the Treasury, Office of
Information and Regulatory Affairs,
Washington, DC 20503, with copies to
the Internal Revenue Service, Attn: IRS
Reports Clearance Officer,
SE:W:CAR:MP:T:T:SP, Washington, DC
20224. Comments on the collection of
information should be received by May
30, 2008. Comments are specifically
requested concerning:
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the IRS,
including whether the information will
have practical utility;
The accuracy of the estimated burden
associated with the proposed collection
of information;
How the quality, utility, and clarity of
the information to be collected may be
enhanced;
How the burden of complying with
the proposed collection of information
may be minimized, including through
the application of automated collection
techniques or other forms of information
technology; and
Estimates of capital or start-up costs
and costs of operation, maintenance,
and purchase of services to provide
information.
The collection of information in these
proposed regulations is in § 1.162–24(e).
This collection of information will help
the IRS determine if a taxpayer may
make an election under section 162(h).
The collection of information is
required to obtain a benefit.
The estimated burden is 30 minutes.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid control
number assigned by the Office of
Management and Budget.
Books or records relating to a
collection of information must be
retained as long as their contents may
become material in the administration
of any internal revenue law. Generally,
tax returns and return information are
E:\FR\FM\31MRP1.SGM
31MRP1
]]>Agencies
[Federal Register Volume 73, Number 62 (Monday, March 31, 2008)]
[Proposed Rules]
[Pages 16793-16797]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6357]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1313
[Docket No. DEA-295P]
RIN 1117-AB07
Information on Foreign Chain of Distribution for Ephedrine,
Pseudoephedrine, and Phenylpropanolamine
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which
was enacted on March 9, 2006, requires DEA to collect from importers of
ephedrine, pseudoephedrine, and phenylpropanolamine all information
known to the importer on the foreign chain of distribution of the
chemical from the manufacturer to the importer. DEA is proposing to
amend its regulations to incorporate the requirement for this
information into the import declaration.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before May 30, 2008.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-295'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/ODL. Written comments sent via express
mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA
22152. Comments may be directly sent to DEA electronically by sending
an electronic message to: dea.diversion.policy@usdoj.gov. Comments may
also be sent electronically through https://www.regulations.gov using
the electronic comment form provided on that site. An electronic copy
of this document is also available at the
[[Page 16794]]
https://www.regulations.gov Web site. DEA will accept attachments to
electronic comments in Microsoft Word, WordPerfect, Adobe PDF, or Excel
file formats only. DEA will not accept any file formats other than
those specifically listed here.
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at https://www.regulations.gov and in the Drug
Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
If you want to submit personal identifying information (such as
your name, address, etc.) as part of your comment, but do not want it
to be posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket in the first paragraph of your comment and
identify what information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. If you wish
to inspect the agency's public docket file in person by appointment,
please see the FOR FURTHER INFORMATION CONTACT paragraph.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, Washington DC 20537 at (202) 307-7297.
SUPPLEMENTARY INFORMATION:
DEA's Legal Authority
DEA implements the Comprehensive Drug Abuse Prevention and Control
Act of 1970, often referred to as the Controlled Substances Act (CSA)
and the Controlled Substances Import and Export Act (21 U.S.C. 801-
971), as amended. DEA publishes the implementing regulations for these
statutes in title 21 of the Code of Federal Regulations (CFR), parts
1300 to 1399. These regulations are designed to ensure that there is a
sufficient supply of controlled substances for legitimate medical,
scientific, research, and industrial purposes and to deter the
diversion of controlled substances to illegal purposes. The CSA
mandates that DEA establish a closed system of control for
manufacturing, distributing, and dispensing controlled substances. Any
person who manufactures, distributes, dispenses, imports, exports, or
conducts research or chemical analysis with controlled substances must
register with DEA (unless exempt) and comply with the applicable
requirements for the activity. The CSA as amended also requires DEA to
regulate the manufacture, distribution, import, and export of chemicals
that may be used to manufacture controlled substances illegally. Listed
chemicals that are classified as List I chemicals are important to the
manufacture of controlled substances. Those classified as List II
chemicals may be used to manufacture controlled substances.
On March 9, 2006, the President signed the Combat Methamphetamine
Epidemic Act of 2005 (CMEA), which is title VII of the USA PATRIOT
Improvement and Reauthorization Act of 2005 (Pub. L. 109-177). The
changes proposed here are needed to implement the statutory provisions.
The statute is self-implementing; the provisions related to information
to be collected at the importation of ephedrine, pseudoephedrine, and
phenylpropanolamine became effective on March 9, 2006. The changes
proposed in this rulemaking provide conforming amendments to make the
language of the regulations consistent with that of the statute. DEA
must implement the statute and is simply conforming its regulations to,
and implementing, the statute.
Import Declaration Requirements
Under existing DEA regulations (21 CFR part 1313), importers of
listed chemicals are required to provide DEA with advance notification
of imports unless the importer has met the requirements as a regular
importer of the listed chemical; for regular importers, the
notification must be filed by the date of importation. In the
importation declaration (DEA Form 486), the importer must provide
information on the chemical (name, size and weight of the container,
number of containers, total weight of chemical), importation (date,
foreign port of shipment, United States port of entry) and the foreign
supplier (name, address, contact information).
CMEA imposes several new requirements on imports of listed
chemicals. CMEA amended 21 U.S.C. 971, ``Notification, suspension of
shipment, and penalties with respect to importation and exportation of
listed chemicals'', to require DEA to collect information regarding
persons to whom the United States importer, exporter, broker, or trader
transfers the listed chemical, actual quantities shipped, and the date
the shipment occurred. If the person to whom the listed chemical is to
be transferred is not a regular customer of the United States importer
or exporter, then the importer or exporter must notify DEA no later
than 15 days before the transaction is to take place. Further, if the
person to whom the chemical is to be transferred changes subsequent to
initial notification of DEA, or if the amount of the chemical to be
transferred increases, the importer or exporter shall update the notice
to DEA to identify the most recent prospective transferee or the most
recent quantity or both (as the case may be) and may not transfer the
listed chemical until after the expiration of the 15-day period
beginning on the date on which the update is submitted to DEA, except
that such 15-day restriction does not apply if the prospective
transferee identified in the update is a regular customer. These
changes apply to all listed chemicals. On April 9, 2007, DEA published
an Interim Final Rule with Request for Comment codifying these
provisions (72 FR 17401). Subsequently, due to requests from the
regulated industry, DEA temporarily stayed certain provisions of that
rule (72 FR 28601, May 22, 2007). That Interim Final Rule became
effective June 8, 2007.
CMEA added a new paragraph (h) to 21 U.S.C. 971 that applies
specifically to the importation of ephedrine, pseudoephedrine, and
phenylpropanolamine. In paragraph (h)(1), the Act states that the
import declaration ``shall include all information known to the
importer on the chain of distribution of such chemical from the
manufacturer to the importer.'' Paragraphs 971(h)(2) and (3) state that
the Attorney General may ask foreign manufacturers and distributors
[[Page 16795]]
to provide information known to them on distribution of the chemical,
including sales. If the foreign manufacturer or distributor refuses to
cooperate, the Attorney General may issue an order prohibiting the
importation of the three chemicals if the foreign manufacturer or
distributor is part of the chain of distribution. Not later than 60
days prior to issuing the order, the Attorney General must publish in
the Federal Register a notice of intent to issue the order. Imports
handled by the foreign distributor may not be restricted during the 60-
day period. In the Conference Report (H.R. 109-333), Congress stated
that the ``provision will assist U.S. law enforcement agencies to
better track where meth precursors come from, and how they get to the
U.S. At present, very little information exists about the international
`chain of distribution' for these chemicals, hindering effective
controls.''
DEA is proposing to add a new paragraph (d) to 21 CFR 1313.13,
Contents of import declaration, to state that importers of ephedrine,
pseudoephedrine, and phenylpropanolamine must provide information known
to them on the chain of distribution from the manufacturer to the
importer. DEA is also proposing to add a new 21 CFR 1313.42 to cover
the provisions of paragraphs (h)(2) and (3) on orders to prohibit
imports from foreign manufacturers and distributors who refuse to
cooperate with requests for information.
Revision of DEA Form 486: Import/Export Declaration for List I and List
II Chemicals
To comply with the changes made to the Controlled Substances Act by
the Combat Methamphetamine Epidemic Act of 2005, DEA is proposing to
establish a new DEA Form 486A to be used by persons importing
ephedrine, pseudoephedrine, or phenylpropanolamine, or drug products
containing ephedrine, pseudoephedrine, or phenylpropanolamine. This new
form responds to the requirement regarding the foreign chain of
distribution discussed above, as well as to requirements implemented
regarding import quotas for ephedrine, pseudoephedrine, and
phenylpropanolamine. In a separate rulemaking, ``Import and Production
Quotas for Certain List I Chemicals'' [Docket No. DEA-293, RIN 1117-
AB08] (72 FR 37439, July 10, 2007), DEA implemented the import quota
provisions of CMEA. Importers of ephedrine, pseudoephedrine, and
phenylpropanolamine will be required to provide information about their
individual import quota on the DEA Form 486A so that DEA may determine
whether the importer has enough quota remaining to import the quantity
requested.
Thus, in addition to the fields currently present on the DEA Form
486, the DEA Form 486A contains the following fields:
Name and address of foreign distributor (if applicable).
Import quota, including: quota for current year; quota
used to date for current year; and, amount of quota remaining.
Once the new DEA Form 486A is implemented, DEA will make both the
DEA Form 486 and the DEA Form 486A fully interactive forms. That is,
these forms would be able to be completed and submitted electronically.
Currently, forms can be completed electronically, but must be printed
and sent to DEA via facsimile. DEA notes that the availability of a
fully interactive form has been long sought by the regulated industry.
Implementation of this Rule
Effective 30 days after publication of a Final Rule implementing
these regulations in the Federal Register, all United States importers
of the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine would be required to use the new DEA Form 486A
``Importation of the List I Chemicals Ephedrine, Pseudoephedrine, and
Phenylpropanolamine'' to notify DEA of their imports.
Regulatory Certifications
Regulatory Flexibility Act
The Acting Administrator hereby certifies that this rulemaking has
been drafted in accordance with the provisions of the Regulatory
Flexibility Act (5 U.S.C. 601-612). This rule is necessary to comply
with statutory mandates which require that notices of importation for
imports of the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine provide to DEA all information known to the
importer on the foreign chain of distribution of the chemical. As noted
above, changes to the forms also respond to provisions regarding import
quotas, requiring that importers note on the form the amount of quota
issued and available for each chemical. Without these changes, DEA will
be unable to comply with statutory mandates and will not be able to
fully administer the system of import and production quotas mandated
for ephedrine, pseudoephedrine, and phenylpropanolamine.
DEA notes that the statute requires importers to provide only
information that is known to them; the burden associated with providing
names on the foreign chain of distribution will be minimal. This rule
does not impose any new costs. DEA notes that, prior to this rule,
importers of ephedrine, pseudoephedrine, and phenylpropanolamine were
required to complete a DEA Form 486 to import these List I chemicals.
Only the information on the form has changed. Therefore, this rule will
not have a significant economic impact on a substantial number of small
entities.
Executive Order 12866
The Acting Administrator further certifies that this rulemaking has
been drafted in accordance with the principles in Executive Order 12866
1(b). It has been determined that this is ``a significant regulatory
action.'' Therefore, this action has been reviewed by the Office of
Management and Budget. As discussed above, this action is codifying
statutory provisions and involves no agency discretion. This statutory
change imposes minimal costs on importers; they simply have to file a
form with DEA in advance of transactions that includes information that
is known to them. They are not required to conduct research to obtain
information. DEA notes that the requirement to complete the form is
already present in DEA regulations. This rule merely requires that
importers of these three List I chemicals provide information known to
them regarding the foreign chain of distribution of the chemicals.
Paperwork Reduction Act
DEA is proposing to revise an existing information collection by
establishing a new form for the reporting of imports of the List I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Specifically, DEA is creating new DEA Form 486A, ``Import Declaration
for Ephedrine, Pseudoephedrine, and Phenylpropanolamine''. This form
permits the reporting of any information known to the United States
importer regarding the foreign chain of distribution of the List I
chemical(s).
Specifically, DEA estimates that 30 respondents will import
ephedrine, pseudoephedrine, and phenylpropanolamine annually. These
persons will conduct 350 individual importations, necessitating the
submission of 350 forms. Because of the additional information required
on the DEA Form 486A, DEA estimates that this form will take 20 minutes
to
[[Page 16796]]
complete, as opposed to the DEA Form 486, which DEA estimates takes 15
minutes to complete. DEA notes here that the completion of the DEA Form
486A will be in lieu of the currently-required completion of the DEA
Form 486. Therefore, while the number of responses remains constant,
the hour burden increases due to the greater time associated with the
DEA Form 486A. The net increase for this collection is 13 hours
annually.
The Department of Justice, Drug Enforcement Administration, has
submitted the following information collection request to the Office of
Management and Budget (OMB) for review and clearance in accordance with
review procedures of the Paperwork Reduction Act of 1995. The proposed
information collection is published to obtain comments from the public
and affected agencies.
All comments, suggestions, or questions regarding additional
information, to include obtaining a copy of the proposed information
collection instrument with instructions, should be directed to Mark W.
Caverly, Chief, Liaison and Policy Section, Office of Diversion
Control, Drug Enforcement Administration, Washington, DC 20537.
Written comments and suggestions from the public and affected
agencies concerning the collection of information are encouraged. Your
comments on the information collection-related aspects of this rule
should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to
be collected; and
(4) Minimize the burden of the collection of information on those
who are to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
Overview of Information Collection 1117-0023
(1) Type of Information Collection: Revision of an existing
collection.
(2) Title of the Form/Collection: Import/Export Declaration for
List I and List II Chemicals.
(3) Agency form number, if any, and the applicable component of the
Department of Justice sponsoring the collection:
Form Number: DEA Form 486 and DEA Form 486A. Office of Diversion
Control, Drug Enforcement Administration, U.S. Department of Justice.
(4) Affected public who will be asked or required to respond, as
well as a brief abstract:
Primary: Business or other for-profit.
Other: None.
Abstract: Persons importing, exporting, and conducting
international transactions with List I and List II chemicals must
notify DEA of those transactions in advance of their occurrence,
including information regarding the person(s) to whom the chemical will
be transferred and the quantity to be transferred. Persons must also
provide return declarations, confirming the date of the importation and
transfer, and the amounts of the chemical transferred. For the List I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine,
importers must report all information known to them on the chain of
distribution of the chemical from the manufacturer to the importer.
This information is used to prevent shipments not intended for
legitimate purposes.
(5) An estimate of the total number of respondents and the amount
of time estimated for an average respondent to respond:
----------------------------------------------------------------------------------------------------------------
Number of Number of Average time per Total (in
respondents responses response hours)
----------------------------------------------------------------------------------------------------------------
Form 486 (export)..................... 239 7,997 0.2 hour (12 minutes)... 1,599.4
Form 486 (Export Return Declaration).. 239 7,997 0.08 hour (5 minutes)... 666.4
Form 486 (import)..................... 230 2000 0.25 hour (15 minutes).. 500
Form 486 (import return 230 2200 0.08 hour (5 minutes)... 183.3
declaration)\*\.
Form 486A (import).................... 30 350 0.33 hour (20 minutes).. 116.7
Form 486A (import return 30 385 0.08 hour (5 minutes)... 32.1
declaration)\*\.
Form 486 (international transaction).. 9 111 0.2 hour (12 minutes)... 22.2
Form 486 (international transaction 9 111 0.08 hour (5 minutes)... 9.25
return declaration.
Quarterly reports for imports of 110 440 0.5 hour (30 minutes)... 220
acetone, 2-butanone, and toluene.
-------------------------------------------------------------------------
Total............................. 239 .............. ........................ 3,349.35
----------------------------------------------------------------------------------------------------------------
* 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 burden (in hours) associated
with the collection: DEA estimates that this collection will take 3,350
hours annually.
If additional information is required, contact Lynn Bryant,
Department Clearance Officer, Information Management and Security
Staff, Justice Management Division, Department of Justice, Patrick
Henry Building, Suite 1600, 601 D Street, NW., Washington, DC 20530.
Executive Order 12988
This regulation meets the applicable standards set forth in
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more
[[Page 16797]]
(adjusted for inflation) in any one year, and will not significantly or
uniquely affect small governments. Therefore, no actions were deemed
necessary under the provisions of the Unfunded Mandates Reform Act of
1995.
Congressional Review Act
This rule is not a major rule as defined by section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This rule will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
List of Subjects in 21 CFR Part 1313
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1313 is proposed to be
amended as follows:
PART 1313--IMPORTATION AND EXPORTATION OF LIST I AND LIST II
CHEMICALS
1. The authority citation for part 1313 continues to read as
follows:
Authority: 21 U.S.C. 802, 830, 871(b), 971.
2. Section 1313.13 is amended by adding paragraph (d) to read as
follows:
Sec. 1313.13 Contents of import declaration.
* * * * *
(d) Any regulated person importing ephedrine, pseudoephedrine, or
phenylpropanolamine must submit, on the import declaration, all
information known to the importer on the chain of distribution of the
chemical from the manufacturer to the importer. Ephedrine,
pseudoephedrine, or phenylpropanolamine include each of the salts,
optical isomers, and salts of optical isomers of the chemical.
3. Section 1313.42 is added to read as follows:
Sec. 1313.42 Prohibition of shipments from certain foreign sources.
(a) If the Administrator determines that a foreign manufacturer or
distributor of ephedrine, pseudoephedrine, or phenylpropanolamine has
refused to cooperate with a request by the Administrator for
information known to the manufacturer or distributor on the
distribution of the chemical, including sales, the Administrator may
issue an order prohibiting the importation of the chemical in any case
where the manufacturer or distributor is part of the chain of
distribution.
(b) Not later than 60 days prior to issuing the order to prohibit
importation, the Administrator shall publish in the Federal Register a
notice of intent to issue the order. During the 60 day period, imports
from the foreign manufacturer or distributor may not be restricted
under this section.
Dated: March 14, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-6357 Filed 3-28-08; 8:45 am]
BILLING CODE 4410-09-P
