[Federal Register Volume 72, Number 247 (Thursday, December 27, 2007)]
[Notices]
[Pages 73370-73372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25113]


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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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