[Federal Register: December 27, 2007 (Volume 72, Number 247)]
[Notices]
[Page 73370-73372]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27de07-89]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-307E]
Controlled Substances: Established Initial Aggregate Production
Quotas for 2008
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of aggregate production quotas for 2008.
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SUMMARY: This notice establishes initial 2008 aggregate production
quotas for controlled substances in schedules I and II of the
Controlled Substances Act (CSA).
EFFECTIVE DATE: December 27, 2007.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug & Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, Telephone: (202) 307-7183.
SUPPLEMENTARY INFORMATION: Section 306 of the CSA (21 U.S.C. 826)
requires that the Attorney General establish aggregate production
quotas for each basic class of controlled substance listed in schedules
I and II. This responsibility has been delegated to the Administrator
of the DEA by 28 CFR 0.100. The Administrator, in turn, has redelegated
this function to the Deputy Administrator, pursuant to 28 CFR 0.104.
The 2008 aggregate production quotas represent those quantities of
controlled substances that may be produced in the United States in 2008
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 (21 U.S.C. 826(a) and 21 CFR 1303.11).
These quotas do not include imports of controlled substances for use in
industrial processes.
On August 24, 2007, a notice of the proposed initial 2008 aggregate
production quotas for certain controlled substances in schedules I and
II was published in the Federal Register (72 FR 48683). All interested
persons were invited to comment on or object to these proposed
aggregate production quotas on or before September 14, 2007.
Seven responses were received resulting in comments on a total of
17 schedule I and II controlled substances within the published comment
period. The commenters stated that the proposed aggregate production
quotas for 14-hydroxymorphinone, alfentanil, amphetamine (for
conversion), codeine (for sale), fentanyl, gamma hydroxybutyric acid,
hydromorphone, lisdexamfetamine, marihuana, methadone, methylphenidate,
noroxymorphone (for conversion), oxycodone, oxymorphone, sufentanil,
tetrahydrocannabinols and thebaine were insufficient 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. The DEA has determined that 14-
hydroxymorphinone is considered a morphine derivative controlled under
the morphine basic drug class code and therefore the comment received
for 14-hydroxymorphinone was treated as a comment for morphine.
One commenter stated that, ``one or more manufacturers are
preparing to receive Food and Drug Administration (FDA) approvals for
generic version of Marinol. Generic versions of the drug, however, will
not be approved for all of the indications for which FDA has found
Marinol safe and effective. As a consequence, those newly approved
generic versions should not be prescribed and distributed for all of
the same indications as Marinol.'' The commenter further stated that if
one of the generic Marinol manufacturers seeks an ``upwardly adjusted
quota'' beyond that which is necessary for the medical requirements of
the United States, then this would be contrary to the DEA's obligations
under the Controlled Substances Act. For these reasons, the commenter
requested a hearing regarding the aggregate production quota for
tetrahydrocannabinols. The commenter believes that the approval of
generic versions of Marinol will lead to an inappropriate increase in
the ``medical use'' estimate for tetrahydrocannabinols in the United
States. This is only one of the factors that DEA must consider when
establishing the aggregate production quota. DEA must also consider the
industrial and research requirements of the United States, lawful
export requirements, and reserve stock requirements.
DEA notes it first established a 312,500 gram aggregate production
quota for tetrahydrocannabinols in 2005 (70 FR 120, January 3, 2005).
At that time, the increase from the proposed value of 211,000 grams was
primarily due to an increase in the research and development efforts of
DEA registered manufacturers, which included generic drug development
efforts, increased drug requirements necessary to develop new
indications of currently marketed drug products, and the development of
novel drug delivery systems containing tetrahydrocannabinols. These
research efforts continue today. Additionally, the FDA, which provides
DEA with estimates of medical use of controlled substances each year,
advised DEA that the medical use of Marinol is expected to grow by
approximately 8.8 percent from 2006 to 2009. Export and industrial
requirements are minimal and thus inconsequential to DEA's final
analysis.
Pursuant to 21 CFR 1303.11(c), the DEA has determined that a
hearing is not required in this matter. DEA has fully considered the
comments received in connection with the hearing request within the
context of the applications for manufacturing and procurement quotas
received from DEA registered manufacturers and information provided by
the FDA, and concludes that the amount proposed is sufficient 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. Therefore, DEA is
establishing the 2008 aggregate production quota for
tetrahydrocannabinols at the proposed value of 312,500 grams.
DEA has taken into consideration the above comments along with the
relevant 2007 manufacturing quotas, current 2007 sales and inventories,
2008 export requirements, additional applications received, and
research and product development requirements. Based on this
information, the DEA has adjusted the initial aggregate production
quotas for alfentanil, levorphanol, noroxymorphone (for sale),
oxycodone (for conversion), and oxymorphone to meet the legitimate
needs of the United States. The DEA also adjusted the initial aggregate
production quota for hydrocodone due to known sales of hydrocodone
products to companies that sell hydrocodone illegally through the
Internet.
Regarding amphetamine (for conversion), codeine (for sale),
fentanyl, gamma hydroxybutyric acid, hydromorphone, lisdexamfetamine,
marihuana, methadone, methylphenidate, morphine, noroxymorphone (for
conversion), oxycodone, sufentanil,
[[Page 73371]]
tetrahydrocannabinols and thebaine, the DEA has determined that the
proposed initial 2008 aggregate production quotas are sufficient to
meet the current 2008 estimated medical, scientific, research and
industrial needs of the United States.
Pursuant to 21 CFR 1303, the Deputy Administrator of the DEA will,
in 2008, adjust aggregate production quotas and individual
manufacturing quotas allocated for the year based upon 2007 year-end
inventory and actual 2007 disposition data supplied by quota recipients
for each basic class of schedule I or II controlled substance.
Therefore, under the authority vested in the Attorney General by
Section 306 of the CSA (21 U.S.C. 826), and delegated to the
Administrator of the DEA by 28 CFR 0.100, and redelegated to the Deputy
Administrator pursuant to 28 CFR 0.104, the Deputy Administrator hereby
orders that the 2008 initial aggregate production quotas for the
following controlled substances, expressed in grams of anhydrous acid
or base, be established as follows:
------------------------------------------------------------------------
Established initial 2008
Basic class--Schedule I quotas
------------------------------------------------------------------------
2,5-Dimethoxyamphetamine................... 2 g
2,5-Dimethoxy-4-ethylamphetamine (DOET).... 2 g
2,5-Dimethoxy-4-(n)- 10 g
propylthiophenethylamine (2C-T-7).
3-Methylfentanyl........................... 2 g
3-Methylthiofentanyl....................... 2 g
3,4-Methylenedioxyamphetamine (MDA)........ 20 g
3,4-Methylenedioxy-N-ethylamphetamine 10 g
(MDEA).
3,4-Methylenedioxymethamphetamine (MDMA)... 22 g
3,4,5-Trimethoxyamphetamine................ 2 g
4-Bromo-2,5-dimethoxyamphetamine (DOB)..... 2 g
4-Bromo-2,5-dimethoxyphenethylamine (2-CB). 7 g
4-Methoxyamphetamine....................... 77 g
4-Methylaminorex........................... 2 g
4-Methyl-2,5-dimethoxyamphetamine (DOM).... 12 g
5-Methoxy-3,4-methylenedioxyamphetamine.... 2 g
5-Methoxy-N,N-diisopropyltryptamine........ 5 g
Acetyl-alpha-methylfentanyl................ 2 g
Acetyldihydrocodeine....................... 2 g
Acetylmethadol............................. 2 g
Allylprodine............................... 2 g
Alphacetylmethadol......................... 2 g
Alpha-ethyltryptamine...................... 2 g
Alphameprodine............................. 2 g
Alphamethadol.............................. 3 g
Alpha-methylfentanyl....................... 2 g
Alpha-methylthiofentanyl................... 2 g
Alpha-methyltryptamine..................... 5 g
Aminorex................................... 8 g
Benzylmorphine............................. 2 g
Betacetylmethadol.......................... 2 g
Beta-hydroxy-3-methylfentanyl.............. 2 g
Beta-hydroxyfentanyl....................... 2 g
Betameprodine.............................. 2 g
Betamethadol............................... 2 g
Betaprodine................................ 2 g
Bufotenine................................. 8 g
Cathinone.................................. 3 g
Codeine-N-oxide............................ 302 g
Diethyltryptamine.......................... 2 g
Difenoxin.................................. 50 g
Dihydromorphine............................ 2,549,000 g
Dimethyltryptamine......................... 3 g
Gamma-hydroxybutyric acid.................. 23,600,000 g
Heroin..................................... 5 g
Hydromorphinol............................. 3,000 g
Hydroxypethidine........................... 2 g
Ibogaine................................... 1 g
Lysergic acid diethylamide (LSD)........... 61 g
Marihuana.................................. 4,500,000 g
Mescaline.................................. 2 g
Methaqualone............................... 10 g
Methcathinone.............................. 4 g
Methyldihydromorphine...................... 2 g
Morphine-N-oxide........................... 310 g
N,N-Dimethylamphetamine.................... 7 g
N-Ethylamphetamine......................... 2 g
N-Hydroxy-3,4-methylenedioxyamphetamine.... 2 g
Noracymethadol............................. 2 g
Norlevorphanol............................. 52 g
Normethadone............................... 2 g
Normorphine................................ 16 g
[[Page 73372]]
Para-fluorofentanyl........................ 2 g
Phenomorphan............................... 2 g
Pholcodine................................. 2 g
Psilocybin................................. 7 g
Psilocyn................................... 7 g
Tetrahydrocannabinols...................... 312,500 g
Thiofentanyl............................... 2 g
Trimeperidine.............................. 2 g
------------------------------------------------------------------------
------------------------------------------------------------------------
Established initial 2008
Basic class--Schedule II quotas
------------------------------------------------------------------------
1-Phenylcyclohexylamine................... 2 g
Alfentanil................................ 8,000 g
Alphaprodine.............................. 2 g
Amobarbital............................... 3 g
Amphetamine (for sale).................... 17,000,000 g
Amphetamine (for conversion).............. 5,000,000 g
Cocaine................................... 286,000 g
Codeine (for sale)........................ 39,605,000 g
Codeine (for conversion).................. 59,000,000 g
Dextropropoxyphene........................ 106,000,000 g
Dihydrocodeine............................ 1,200,000 g
Diphenoxylate............................. 828,000 g
Ecgonine.................................. 83,000 g
Ethylmorphine............................. 2 g
Fentanyl.................................. 1,428,000 g
Glutethimide.............................. 2 g
Hydrocodone (for sale).................... 45,200,000 g
Hydrocodone (for conversion).............. 1,500,000 g
Hydromorphone............................. 3,300,000 g
Isomethadone.............................. 2 g
Levo-alphacetylmethadol (LAAM)............ 3 g
Levomethorphan............................ 5 g
Levorphanol............................... 10,000 g
Lisdexamfetamine.......................... 6,200,000 g
Meperidine................................ 9,753,000 g
Metazocine................................ 1 g
Methadone (for sale)...................... 25,000,000 g
Methadone Intermediate.................... 26,000,000 g
Methamphetamine........................... 3,130,000 g
------------------------------------------------------------------------
[680,000 grams of levo-desoxyephedrine for use in a non-controlled, non-
prescription product; 2,405,000 grams for methamphetamine mostly for
conversion to a schedule III product; and 45,000 grams for
methamphetamine (for sale)]
------------------------------------------------------------------------
Methylphenidate........................... 50,000,000 g
Morphine (for sale)....................... 35,000,000 g
Morphine (for conversion)................. 100,000,000 g
Nabilone.................................. 3,002 g
Noroxymorphone (for sale)................. 10,000 g
Noroxymorphone (for conversion)........... 8,000,000 g
Opium..................................... 1,400,000 g
Oxycodone (for sale)...................... 70,000,000 g
Oxycodone (for conversion)................ 4,820,000 g
Oxymorphone............................... 2,400,000 g
Oxymorphone (for conversion).............. 11,000,000 g
Pentobarbital............................. 35,200,000 g
Phencyclidine............................. 2,021 g
Phenmetrazine............................. 2 g
Racemethorphan............................ 2 g
Remifentanil.............................. 3,000 g
Secobarbital.............................. 2 g
Sufentanil................................ 10,300 g
Thebaine.................................. 126,000,000 g
------------------------------------------------------------------------
The Deputy Administrator further orders that aggregate production
quotas for all other schedules I and II controlled substances included
in 21 CFR 1308.11 and 1308.12 be established at zero.
The Office of Management and Budget has determined that notices of
aggregate production quotas are not subject to centralized review under
Executive Order 12866.
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 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 aggregate production quotas for schedules I and II
controlled substances is mandated by law and by international treaty
obligations. 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 aggregate production 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 Sections
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
$120,000,000 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 Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996. 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: December 18, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-25113 Filed 12-26-07; 8:45 am]
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