[Federal Register Volume 71, Number 202 (Thursday, October 19, 2006)]
[Notices]
[Pages 61801-61803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-17526]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-300P]
Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2007: Proposed
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed year 2007 assessment of annual needs.
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SUMMARY: This notice proposes initial year 2007 assessment of annual
needs for certain List I chemicals in accordance with the Combat
Methamphetamine Epidemic Act of 2005 (CMEA), enacted on March 9, 2006.
The Act required DEA to establish production quotas and import quotas
for ephedrine, pseudoephedrine, and phenylpropanolamine. This effort
was done in order to prevent the illicit use of these three chemicals
in the clandestine manufacture of methamphetamine. The enactment of the
CMEA places additional regulatory controls upon the manufacture,
distribution, importation and exportation of the three List I
chemicals.
DATES: Comments or objections must be received on or before December 4,
2006.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-300P'' 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, 2401 Jefferson Davis Highway, Alexandria,
VA 22301. Comments may be directly sent to DEA electronically by
sending an electronic message to dea.diversion.policy@usdoj.gov. DEA
will accept attachments to electronic comments in Microsoft Word,
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept
any file format other than those specifically listed here.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, by e-mail, ode@dea.usdoj.gov or by fax, (202)
353-1263.
SUPPLEMENTARY INFORMATION: Section 713 of the Combat Methamphetamine
Epidemic Act of 2005 (Title VII of Pub. L. 109-177) (CMEA) amended
section 306 of the Controlled Substances Act (CSA) (Title 21 United
States Code (U.S.C.) Sec. 826 ``Production quotas for controlled
substances'') by adding ephedrine, pseudoephedrine, and
phenylpropanolamine to existing language to read as follows: ``The
Attorney General shall determine the total quantity and establish
production quotas for each basic class of controlled substance in
schedules I and II and for ephedrine, pseudoephedrine, and
phenylpropanolamine to be manufactured each calendar year to provide
for the estimated medical, scientific, research, and industrial needs
of the United States, for lawful export requirements, and for the
establishment and maintenance of reserve stocks.'' Further, Sec. 715
of CMEA amended 21 U.S.C. Sec. 952 ``Importation of controlled
substances'' by adding the same List I chemicals to the existing
language in paragraph (a), and by adding a new paragraph (d) to read as
follows:
(a) Controlled substances in schedule I or II and narcotic drugs
in schedule III, IV, or V; exceptions:
It shall be unlawful to import into the customs territory of the
United States from any place outside thereof (but within the United
States), or to import into the United States from any place outside
thereof, any controlled substance in schedule I or II of subchapter
I of this chapter, or any narcotic drug in schedule III, IV, or V of
subchapter I of this chapter, or ephedrine, pseudoephedrine, and
phenylpropanolamine, except that--
(1) such amounts of crude opium, poppy straw, concentrate of
poppy straw, and coca leaves, and of ephedrine, pseudoephedrine, and
phenylpropanolamine, as the Attorney General finds to be necessary
to provide for medical, scientific, or other legitimate purposes,
and * * *
(d)(1) With respect to a registrant under section 958 who is
authorized under subsection (a)(1) to import ephedrine,
pseudoephedrine, or phenylpropanolamine, at any time during the year
the registrant may apply for an increase in the amount of such
chemical that the registrant is authorized to import, and the
Attorney General may approve the application if the Attorney General
determines that the approval is necessary to provide for medical,
scientific, or other legitimate purposes regarding the chemical.
Note: This excerpt of the amendment is published for the
convenience of the reader. The official text is published at 21
U.S.C. 952(a) and (d)(1).
The responsibility for establishing the assessment of annual needs
has been delegated to the Administrator of the DEA by Sec. 0.100 of
Title 28 of the Code of Federal Regulations. The Administrator, in
turn, has redelegated this function to the Deputy Administrator,
pursuant to the Code of Federal Regulations Title 28 Sec. 0.104.
The proposed year 2007 assessment of annual needs represents those
quantities of ephedrine, pseudoephedrine, and phenylpropanolamine which
may be manufactured domestically and/or imported into the United States
to provide adequate supplies of each substance for: The estimated
medical, scientific, research, and industrial needs of the United
States; lawful export requirements; and the establishment and
maintenance of reserve stocks.
Calculation of the Assessment: Medical Needs of the United States for
Ephedrine and Pseudoephedrine
Since the manufacture and importation of ephedrine,
pseudoephedrine, and phenylpropanolamine have not been previously
regulated through the establishment of an assessment of annual needs,
the Drug Enforcement Administration obtained assistance from a private
independent contractor, IMS Health Government Solutions (IMS), to
develop the proposed initial estimate of the medical needs of the
United States of ephedrine and pseudoephedrine.
IMS' estimates of medical needs for ephedrine and pseudoephedrine
were derived from 2005 data that the company routinely collects and
offers to customers in order to understand the pharmaceutical market.
For this analysis, IMS utilized the following types of data: (1) Sales
to retail establishments (including pharmacies), (2) sales by retail
establishments to patients, and (3) medical insurance claims. IMS'
estimates of medical needs were intended to encompass only those
products containing either ephedrine or pseudoephedrine, whether
requiring a
[[Page 61802]]
prescription or available over-the-counter (OTC). Its estimates of use
encompassed those products containing ephedrine and pseudoephedrine
which are lawfully marketed under the Food, Drug and Cosmetic Act.
Although no direct estimates for the assessment of annual needs are
currently available, IMS utilized information from a variety of data
sources to develop three independent measures (as described in the next
paragraph). After each of the three independent measures were
calculated for ephedrine and pseudoephedrine, IMS then took a weighted
average of the three individual estimates in order to derive its final
estimate which was then considered by DEA. The weighted average was
determined based on IMS' confidence in each individual estimate such
that estimates with less confidence were given less weight.
The first estimate was based upon product sales to retail outlets,
from IMS' National Sales Perspective (NSP) service. This estimate was
supplemented with information from: IMS' Drug Distribution Database
(DDD) and National Prescription Audit (NPA), ACNielsen's Scantrack (ST)
and Homescan (HS) services. The second estimate was based upon product
sales to customers, from NPA, ST, and HS services, supplemented with
information from DDD and NSP services. The third estimate was based
upon patient prescription claims data from IMS' ReferencePoint (RP)
database, supplemented with information from United States Census
Bureau population estimates and IMS' National Disease and Therapeutic
Index (NDTI), NSP, DDD, ST, and HS services. A copy of the IMS report
may be obtained from DEA Diversion Web site at: http://
www.deadiversion.usdoj.gov.
Based on the IMS report, DEA concluded that 3,800 kg of ephedrine
and 350,700 kg of pseudoephedrine were required to meet the medical
needs of the United States.
Calculation of the Assessment: Medical Needs of the United States for
Phenylpropanolamine
DEA did not request that IMS determine the medical needs for
phenylpropanolamine. In November 2000, the Food and Drug Administration
(FDA) issued a public health warning for phenylpropanolamine and
requested that all drug companies discontinue marketing products
containing phenylpropanolamine due to the drug's association with risk
for hemorrhagic stroke. In response to the FDA's warning, many
companies voluntarily reformulated their products to exclude
phenylpropanolamine. Subsequently, on December 22, 2005, FDA published
a Notice of Proposed Rulemaking (70 FR 75988) to reclassify all over-
the-counter nasal decongestants and weight control drug products
containing phenylpropanolamine preparations from their previously
proposed monograph status (Category 1) to nonmonograph (Category II).
FDA concluded that drug products containing phenylpropanolamine cannot
be generally recognized as safe and should no longer be available for
over-the-counter use in humans. Therefore, for purposes of calculating
the medical needs of the United States for phenylpropanolamine, DEA
considered the drug's use in veterinary products only.
DEA obtained from the FDA a list of all companies that manufacture
veterinary products containing phenylpropanolamine. DEA contacted each
company and requested information relating to sales of their
phenylpropanolamine-containing products. Based on this review, DEA
concluded that 4,354 kg were required to meet the medical needs of the
United States.
Calculation of the Assessment: Industrial Needs, Export and Inventory
Requirements
After DEA considered the medical needs for ephedrine,
pseudoephedrine and phenylpropanolamine (veterinary products), it then
considered: (1) Industrial needs of the United States, (2) lawful
export requirements, and (3) maintenance of reserve stocks to determine
the assessment of annual needs for ephedrine, pseudoephedrine, and
phenylpropanolamine.
In consideration of the industrial needs of the United States for
these three chemicals, DEA considered the use of ephedrine for the
domestic manufacture of pseudoephedrine in 2005 and the amount of
phenylpropanolamine used for the domestic manufacture of amphetamine in
2005.
In consideration of the requirements for lawful export purposes for
these three chemicals, DEA considered total 2005 exports as provided on
the DEA-Form 486 entitled ``Import/Export Declaration--Precursors and
Essential Chemicals.'' Exports reported on the DEA-486 were as follows:
------------------------------------------------------------------------
2005 export
List I chemicals quantity (kg)
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Ephedrine............................................... 2,540
Pseudoephedrine......................................... 90,260
Phenylpropanolamine..................................... 320
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In consideration of the amounts required for the maintenance of
reserve stocks, DEA considered 20% of the estimated medical and
industrial requirements.
Based on this information, the Deputy Administrator hereby proposes
that the year 2007 assessment of annual needs for the following List I
chemicals, expressed in kilograms of anhydrous base or acid, be
established as follows:
------------------------------------------------------------------------
Proposed
year 2007
List I chemicals quotas
(kg)
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Ephedrine (for sale)........................................ 7,100 kg
Ephedrine (for conversion).................................. 128,760 kg
Pseudoephedrine (for sale).................................. 511,100 kg
Phenylpropanolamine (for sale).............................. 5,545 kg
Phenylpropanolamine (for conversion)........................ 6,240 kg
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Ephedrine (for conversion) refers to the industrial use of
ephedrine, i.e., that which will be converted to pseudoephedrine.
Phenylpropanolamine (for conversion) refers to the industrial use of
phenylpropanolamine, i.e., that which will be converted to amphetamine
by the pharmaceutical industry. The ``for sale'' quotas refer to the
amount of ephedrine, pseudoephedrine, and phenylpropanolamine used for
purposes outside of the above-mentioned conversions.
All interested persons are invited to submit their comments in
writing or electronically regarding this proposal following the
procedures in the ADDRESSES section of this document. A person may
object to or comment on the proposal relating to any of the above-
mentioned chemicals without filing comments or objections regarding the
others. If a person believes that one or more of these issues warrant a
hearing, the individual should so state and summarize the reasons for
this belief.
In the event that comments or objections to this proposal raise one
or more issues which the Deputy Administrator finds warrant a hearing,
the Deputy Administrator shall order a public hearing by notice in the
Federal Register, summarizing the issues to be heard and setting the
time for the hearing.
The Office of Management and Budget has determined that notices of
quotas are not subject to centralized review under Executive Order
12866.
[[Page 61803]]
This action 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 action does not have any federalism implications
warranting the application of Executive Order 13132.
The Deputy Administrator hereby certifies that this action will
have no significant impact upon small entities whose interests must be
considered under the Regulatory Flexibility Act, 5 U.S.C. 601 et seq.
The establishment of quotas for ephedrine, pseudoephedrine, and
phenylpropanolamine is mandated by law. The quotas are necessary to
provide for the estimated medical, scientific, research and industrial
needs of the United States, for export requirements and the
establishment and maintenance of reserve stocks. While quotas are of
primary importance to large manufacturers, their impact upon small
entities is neither negative nor beneficial. Accordingly, the Deputy
Administrator has determined that this action does not require a
regulatory flexibility analysis.
This action meets the applicable standards set forth in Sec. Sec.
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
This action will not result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of
$118,000,000 or more 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.
This action is not a major rule as defined by Sec. 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This action 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.
Dated: October 13, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-17526 Filed 10-18-06; 8:45 am]
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