[Federal Register Volume 75, Number 243 (Monday, December 20, 2010)]
[Notices]
[Pages 79412-79417]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31848]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-326F]
Final Revised Assessment of Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2010
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of Final Assessment of Annual Needs for 2010.
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SUMMARY: This notice establishes the Final Revised 2010 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.
DATES: Effective Date: December 20, 2010.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug & Chemical Evaluation Section, Drug Enforcement Administration
(DEA), Springfield, Virginia 22152, Telephone: (202) 307-7183.
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) (21 U.S.C. 826) 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, 715 of CMEA amended 21 U.S.C. 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
* * * may be so imported under such regulations as the Attorney
General shall prescribe.
* * * * *
(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.
Editor's 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 2010 Assessment of Annual Needs represents those quantities of
ephedrine, pseudoephedrine, and phenylpropanolamine which may be
manufactured domestically and/or imported into the United States in
2010 to provide adequate supplies of each chemical for: The estimated
medical, scientific, research, and industrial needs of the United
States; lawful export requirements; and the establishment and
maintenance of reserve stocks.
On June 28, 2010, a notice entitled, ``Proposed Revised Assessment
of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine,
and Phenylpropanolamine for 2010'' was published in the Federal
Register (75 FR 36684). This notice proposed the revised 2010
Assessment of Annual Needs for ephedrine (for sale), ephedrine (for
conversion), pseudoephedrine (for sale), phenylpropanolamine (for sale)
and phenylpropanolamine (for conversion).
[[Page 79413]]
All interested persons were invited to comment on or object to the
proposed assessments on or before July 28, 2010.
Comments Received
DEA did not receive any comments to the Assessment of Annual Needs
for ephedrine (for sale), ephedrine (for conversion), pseudoephedrine
(for sale), phenylpropanolamine (for sale) and phenylpropanolamine (for
conversion). DEA is finalizing the assessments for these List I
chemicals based on information contained in applications for 2010
import, manufacturing and procurement quotas provided by DEA registered
importers and manufacturers, including those quota applications that
DEA received between the drafting of the June 28th notice and the
drafting of this notice on August 10, 2010. DEA is providing the data
used in developing the established assessments for each of the listed
chemicals.
Underlying Data and DEA's Analysis
In determining the 2010 assessments, DEA has considered the total
net disposals (i.e. sales) of the List I chemicals for the current and
preceding two years, actual and estimated inventories, projected demand
(2010), industrial use, and export requirements from data provided by
DEA registered manufacturers and importers in procurement quota
applications (DEA 250), from manufacturing quota applications (DEA
189), and from import quota applications (DEA 488).\1\
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\1\ Applications and instructions for procurement, import and
manufacturing quotas can be found at http://www.deadiversion.usdoj.gov/quotas/quota_apps.htm.
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DEA further considered trends as derived from information provided
in applications for import, manufacturing, and procurement quotas and
in import and export declarations. DEA notes that the inventory,
acquisitions (purchases) and disposition (sales) data provided by DEA
registered manufacturers and importers reflects the most current
information available.
Ephedrine (for Sale) Data
Ephedrine (for Sale) Data for 2010 Assessment of Annual Needs
[Kilograms]
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2010
Ephedrine 2007 2008 2009 Request
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Sales * (DEA 250)........................................... 2,698 2,507 2,650 3,289
Imports ** (DEA 488)........................................ 9,595 1,690 2,139 2,431
Export Declarations (DEA 486)............................... 168 18 64 n/a
Inventory * (DEA 250)....................................... 1,373 626 191 n/a
IMS *** (NSP)............................................... 1,236 1,460 1,401 n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10,
2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
Channels, Data Extracted August 10, 2010.
Ephedrine (for Sale) Analysis
DEA previously has established the 2010 assessment of annual needs
for ephedrine (for sale) at 3,600 kg (74 FR 60298).
As noted above, DEA developed the revisions to the 2010 assessment
of annual needs for ephedrine (for sale) using the same calculation and
methodology that DEA used to determine the 2009 and 2010 assessment of
annual needs.
As of August 10, 2010, DEA registered manufacturers of dosage form
products containing ephedrine requested the authority to purchase a
total of 3,289 kg ephedrine (for sale) in 2010. DEA registered
manufacturers of ephedrine reported sales totaling approximately 2,507
kg in 2008 and 2,650 kg in 2009; this represents a 5 percent increase
in sales reported by these firms from 2008 to 2009. Additionally,
exports of ephedrine products from the United States as reported on
export declarations (DEA 486) totaled 18 kg in 2008 and 64 kg in 2009;
this represents a 72 percent increase from levels observed in 2008. The
average of the 2008 and 2009 exports of ephedrine products is
approximately 41 kg. DEA also considered information on trends in the
national rate of net disposals from sales data provided by IMS Health's
NSP database. IMS NSP data reported the average sales volume of
ephedrine for the calendar years 2008 and 2009 to be approximately
1,431 kg. DEA notes that the 2009 sales figure reported by
manufacturers (2,650 kg) is higher than the average sales reported by
IMS for the previous two years (1,431 kg). This is expected because a
manufacturer's reported sales include quantities which are necessary to
provide reserve stocks for distributors and retailers. DEA, in
considering the manufacturer's reported sales, thus believes that 2,650
kg fairly represents the United States sales of ephedrine for 2010 and
that 41 kg fairly represents the export requirements of ephedrine.
For the establishment and maintenance of reserve stocks, DEA notes
that 21 CFR 1315.24 allows for an inventory allowance (reserve stock)
of 50 percent of a manufacturer's estimated sales. DEA also considered
the estimated 2009 year end inventory as reported by DEA registrants in
determining the inventory allowance.
DEA calculated the proposed revised ephedrine (for sale) assessment
as follows:
2009 sales + reserve stock + export requirement-existing inventory
= AAN
2,650 + (50%*2,650) + 41-191 = 3,825 kg ephedrine (for sale) for
2010
This calculation suggests that DEA's assessment of annual needs for
ephedrine should be 3,900 kg. DEA notes that its June 28, 2010, notice
proposed to increase the ephedrine assessment to 4,100 kg. That
proposal was based on information received as of March 10, 2010. Since
that time DEA has received revised manufacture production data, i.e.,
sales and inventory information decreasing the reported sales of
ephedrine for 2009. After calculating the ephedrine (for sale)
assessment using the most current data--that reported by DEA registered
manufactures as of August 10, 2010--DEA concludes that the proposed
revised assessment of 4,100 kg would have been unnecessarily high.
Accordingly, DEA is increasing the 2010 assessment of annual needs for
ephedrine (for sale) from 3,600 kg to 3,900 kg.
Phenylpropanolamine (for Sale) data
[[Page 79414]]
Phenylpropanolamine (for Sale) Data for 2010 Assessment of Annual Needs
[Kilograms]
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2010
Phenylpropanolamine (for sale) 2007 2008 2009 Request
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Sales* (DEA 250)............................................ 4,158 4,528 5,355 7,480
Imports** (DEA 488)......................................... 5,787 3,425 6,626 7,271
Export Declarations (DEA 486)............................... 1,002 0 3 n/a
Inventory* (DEA 250)........................................ 3,642 2,470 645 n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10,
2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
Phenylpropanolamine (for Sale) Analysis
DEA previously has established the 2010 assessment of annual needs
for phenylpropanolamine (for sale) at 6,400 kg (74 FR 60298).
As noted above, DEA utilized the same general methodology and
calculation to develop the proposed revised assessment for
phenylpropanolamine (for sale) that DEA used to determine the 2009 and
2010 assessment of annual needs.
As of August 10, 2010, DEA registered manufacturers of dosage form
products containing phenylpropanolamine requested the authority to
purchase 7,480 kg phenylpropanolamine (for sale) in 2010. DEA
registered manufacturers of phenylpropanolamine reported sales totaling
approximately 4,528 kg in 2008 and 5,355 kg in 2009; this represents a
15.5% increase in sales reported by these firms from 2008 to 2009.
Additionally, exports of phenylpropanolamine products from the United
States as reported on export declarations (DEA 486) totaled 0 kg in
2008 and 3 kg in 2009; this represents a 3 kg increase from levels
observed in 2008. The average of the 2008 and 2009 exports of
phenylpropanolamine products is approximately 2 kg. DEA thus believes
that 5,355 kg fairly represents the United States sales of
phenylpropanolamine for 2010 and that 2 kg fairly represents the export
requirements of phenylpropanolamine. DEA notes that phenylpropanolamine
is sold primarily as a veterinary product for the treatment for canine
incontinence and is not approved for human consumption. IMS Health's
NSP data does not capture sales of phenylpropanolamine to veterinary
channels and is, therefore, not included.
DEA calculated the proposed revised phenylpropanolamine (for sale)
assessment by the following methodology:
2009 sales + reserve stock + export requirement - existing
inventory = AAN
5,355 + (50%*5,355) + 2 - 645 = 7,390 kg phenylpropanolamine (for
sale) for 2010
This calculation suggests that DEA's 2010 Assessment of Annual
Needs for phenylpropanolamine (for sale) should be 7,400 kg.
Accordingly, DEA is increasing the 2010 assessment of annual needs for
phenylpropanolamine (for sale) from 6,400 kg to 7,400 kg.
Pseudoephedrine (for Sale) Data
Pseudoephedrine (for Sale) Data for 2010 Assessment of Annual Needs
[Kilograms]
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2010
Pseudoephedrine (for sale) 2007 2008 2009 Request
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Sales * (DEA 250)........................................... 239,314 224,480 286,607 254,286
Sales * (DEA 189)........................................... 100,300 64,781 33,600 32,760
Imports ** (DEA 488)........................................ 231,683 170,614 274,492 261,528
Export Declarations (DEA 486)............................... 42,132 47,199 35,264 n/a
Inventory * (DEA 250)....................................... 136,039 121,374 68,100 n/a
IMS *** (NSP)............................................... 180,221 149,232 140,784 n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of August 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
Channels, Data Extracted August 10, 2010.
Pseudoephedrine (for Sale) Analysis
DEA previously has established the 2010 assessment of annual needs
for pseudoephedrine (for sale) at 404,000 kg (74 FR 60298).
As noted above, DEA utilized the same general methodology and
calculation to develop the proposed revised assessment for
pseudoephedrine (for sale) that DEA used to determine the 2009 and 2010
assessment of annual needs.
As of August 10, 2010, DEA registered manufacturers of dosage form
products containing pseudoephedrine requested the authority to purchase
254,286 kg pseudoephedrine. DEA registered manufacturers of
pseudoephedrine reported sales totaling approximately 224,480 kg in
2008 and 286,607 kg in 2009; this represents a 22 percent increase in
sales reported by these firms from 2008 to 2009. During the same period
exports of pseudoephedrine products from the United States as reported
on export declarations (DEA 486) totaled 47,199 kg in 2008 and 35,264
kg in 2009; this represents a 25 percent decrease from levels observed
in 2008. The average of the 2008 and 2009 exports is 41,232 kg.
Additionally, DEA considered information on trends in the national rate
of net disposals from sales data provided by IMS Health. IMS NSP data
reported the average retail sales volume of pseudoephedrine for the
calendar years 2008 and 2009 to be approximately 145,006 kg. DEA thus
believes that 286,607 kg of sales reported by manufacturers fairly
represents the United States sales of pseudoephedrine for 2010 and that
[[Page 79415]]
41,232 kg fairly represents the export requirements of pseudoephedrine.
DEA notes that manufacturer reported sales for 2009 (286,607 kg) are
higher than the average retail sales reported by IMS for the previous
two years (145,006 kg). This is expected because a manufacturer's
reported sales include quantities which are necessary to provide
reserve stocks for distributors and retailers.
DEA calculated the revised pseudoephedrine (for sale) assessment by
the following methodology:
2009 sales + reserve stock + export requirement - existing
inventory = AAN
286,607 + (50%*286,607) + 41,232 - 68,100 = 403,043 kg
pseudoephedrine (for sale) for 2010.
This calculation suggests that DEA's 2010 assessment of annual
needs for pseudoephedrine (for sale) should be 404,000 kg. DEA notes
that its June 28, 2010, notice proposed to increase the pseudoephedrine
assessment to 419,000 kg. That proposal was based on information
received as of March 10, 2010. Since that time DEA has received
additional request for quotas, revised manufacture production data,
i.e., sales and inventory information, requests for withdrawal of
quota, and request for adjustments to individual procurement quotas. As
a result of this additional information, the 2009 reported sales of
pseudoephedrine decreased from 287,756 kg to 286,607 kg and the
reported inventory increased from 54,173 kg to 68,001 kg. After
calculating the pseudoephedrine (for sale) assessment using the most
current data--that was reported by DEA registered manufactures as of
August 10, 2010--DEA concludes that the proposed revised assessment of
419,000 kg would have been unnecessarily high. Accordingly, DEA has
determined that the established 2010 AAN for pseudoephedrine of 404,000
kg is appropriate and requires no change.
Phenylpropanolamine (for Conversion) Data
Phenylpropanolamine (for Conversion) Data for 2010 Assessment of Annual Needs
[Kilograms]
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2010
Phenylpropanolamine (for conversion) 2007 2008 2009 Request
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Sales * (DEA 250)........................................... 3,621 10,837 14,585 14,910
Imports ** (DEA 488)........................................ 8,250 12,019 11,373 28,408
Export Declarations (DEA 486)............................... 0 0 0 n/a
Inventory* (DEA 250)........................................ 3,581 5,537 4,104 n/a
APQ Amphetamine ***......................................... 22,000 22,000 24,500 23,500
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) received as of August 10,
2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
*** Amphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
Phenylpropanolamine (for Conversion) Analysis
DEA previously had established the 2010 assessment of annual needs
for phenylpropanolamine (for conversion) at 16,500 kg (74 FR 60298). As
noted above, DEA developed the proposed revisions to the 2010
assessment of annual needs for phenylpropanolamine (for conversion)
using the same calculation and methodology that DEA used to determine
the 2009 and 2010 assessment of annual needs.
As of August 10, 2010, DEA registered manufacturers of
phenylpropanolamine (for conversion) requested the authority to
purchase a total of 14,910 kg phenylpropanolamine for the manufacture
of amphetamine. DEA registered manufacturers of phenylpropanolamine
reported sales of phenylpropanolamine totaling approximately 10,837 kg
in 2008 and 14,585 kg in 2009; this represents a 26 percent increase in
sales reported by these firms from 2008 to 2009. There were no reported
exports of phenylpropanolamine (for conversion). DEA has not received
any requests to synthesize phenylpropanolamine in 2010. DEA has
concluded that the 2009 sales of phenylpropanolamine (for conversion),
14,585 kg fairly represents United States requirements for 2010 and
zero kg fairly represents the export requirements of
phenylpropanolamine (for conversion).
DEA believes that the data provided in procurement, manufacturing,
and import quota applications best represents the legitimate need for
phenylpropanolamine (for conversion). Phenylpropanolamine (for
conversion) is used for the manufacture of legitimate amphetamine
products, but DEA notes that most legitimate amphetamine is
manufactured by converting phenylacetone rather than
phenylpropanolamine, to amphetamine. Basing the phenylpropanolamine
(for conversion) calculation on the total Aggregate Production Quota
(APQ) for amphetamine, therefore, would inaccurately inflate the
phenylpropanolamine (for conversion) assessment.
DEA calculated the phenylpropanolamine (for conversion) needed for
the manufacture of amphetamine as follows:
(2009 sales) + reserve stock + export requirement - inventory = AAN
(14,585) + 50%*(14,585) + 0 - 4,104 = 17,774 kg PPA (for
conversion) for 2010
This calculation suggests that DEA's 2010 assessment of annual
needs for phenylpropanolamine (for conversion) should be 17,800 kg. DEA
notes that its June 28, 2010, notice proposed to increase the
phenylpropanolamine (for conversion) assessment to 18,200 kg. That
proposal was based on information received as of March 10, 2010. Since
that time DEA has received additional request for quotas, revised
manufacture production data, i.e., sales and inventory information, and
request for adjustments to individual procurement quotas. As a result
the 2009 reported inventory of phenylpropanolamine increased from 3,693
kg to 4,104 kg. After calculating the phenylpropanolamine (for
conversion) assessment using the most current data--that reported by
DEA registered manufactures as of August 10, 2010--DEA concludes that
the proposed revised assessment of 18,200 kg would have been
unnecessarily high. Accordingly, DEA is increasing the 2010 assessment
of annual needs for phenylpropanolamine (for conversion) from 16,500 kg
to 17,800 kg.
Ephedrine (for Conversion) Data
[[Page 79416]]
Ephedrine (for Conversion) Data for 2010 Assessment of Annual Needs
[Kilograms]
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2010
Ephedrine (for conversion) 2007 2008 2009 Request
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Sales * (DEA 250)........................................... 99,594 64,522 40,387 40,600
Imports ** (DEA 488)........................................ 99,594 64,128 39,897 40,204
Inventory * (DEA 250)....................................... 0 99 208 n/a
APQ Methamphetamine ***..................................... 3,130 3,130 3,130 3,130
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of August 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of August 10, 2010.
*** Methamphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
Ephedrine (for Conversion) Analysis
DEA previously has established the 2010 assessment of annual needs
for ephedrine (for conversion) at 75,000 kg (74 FR 60298). As noted
above, DEA developed the proposed revisions to the 2010 assessment of
annual needs for ephedrine (for conversion) using the same calculation
and methodology that DEA used to determine the 2009 and 2010 assessment
of annual needs.
As of August 10, 2010, DEA registered manufacturers of ephedrine
(for conversion) requested the authority to purchase a total of 40,600
kg ephedrine (for conversion) for the manufacture of two substances:
methamphetamine and pseudoephedrine.
DEA considered the ephedrine (for conversion) requirements for the
manufacture of methamphetamine and pseudoephedrine. DEA has determined
that the established assessments for the manufacture of these two
substances are the best indicators of the need for ephedrine (for
conversion). The assessment of need for methamphetamine was determined
by DEA as the APQ for methamphetamine. DEA determined that the
estimated sales of pseudoephedrine by manufacturers, as referenced in
the assessment of annual needs for pseudoephedrine, represents the need
for pseudoephedrine. Reported sales of ephedrine (for conversion) are
included as reference to DEA's methodology.
DEA further considered the reported conversion yields of these
substances. DEA registered manufacturers reported a conversion yield of
39 percent for the synthesis of methamphetamine from ephedrine. DEA
cannot disclose the conversion yield for the synthesis of
pseudoephedrine because this information is proprietary to the one
manufacturer involved in this type of manufacturing.
Thus, DEA calculated the ephedrine (for conversion) requirement for
the manufacture of methamphetamine as follows:
(2009 APQ methamphetamine/39% yield) + reserve stock - inventory =
ephedrine (for manufacture of methamphetamine) (3,130/39% yield) +
50%*(3,130/39% yield) - 208 = 11,830 kg
The calculation for the ephedrine (for conversion) requirement for
the manufacture of pseudoephedrine leads to a result of 63,157 kg. DEA
cannot provide the details of the calculation because this would reveal
the conversion yield for the synthesis of pseudoephedrine, which is
proprietary to the one manufacturer involved in this type of
manufacturing.
Therefore, DEA determined the proposed revised assessment for
ephedrine (for conversion) by summing the amounts required for the
manufacture of methamphetamine and pseudoephedrine:
methamphetamine requirement + pseudoephedrine requirement = AAN
11,830 + 63,157 = 74,987 kg ephedrine (for conversion) for 2010
This calculation suggests that DEA's 2010 assessment of annual
needs for ephedrine (for conversion) should be 75,000 kg. Accordingly,
DEA is leaving the 2010 assessment of annual needs for ephedrine (for
conversion) unchanged at 75,000 kg.
DEA did not receive any comments on its Assessment of Annual Needs
for ephedrine (for sale), ephedrine (for conversion), pseudoephedrine
(for sale), phenylpropanolamine (for sale) and phenylpropanolamine (for
conversion). DEA is finalizing the assessments for these List I
chemicals based on information contained in additional applications for
2010 import, manufacturing and procurement quotas provided by DEA
registered importers and manufacturers whose quota applications were
received as of August 10, 2010.
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 Revised 2010 Assessment of Annual Needs for ephedrine,
pseudoephedrine, and phenylpropanolamine, expressed in kilograms of
anhydrous acid or base, be established as follows:
------------------------------------------------------------------------
Final 2010 assessment of
List I chemical annual needs
------------------------------------------------------------------------
Ephedrine (for sale)...................... 3,900 kg
Phenylpropanolamine (for sale)............ 7,400 kg
Pseudoephedrine (for sale)................ 404,000 kg
Phenylpropanolamine (for conversion)...... 17,800 kg
Ephedrine (for conversion)................ 75,000 kg
------------------------------------------------------------------------
Regulatory Certifications
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this action will not
have a significant economic impact upon small entities whose interests
must be considered under the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The establishment of the assessment of annual needs for ephedrine,
pseudoephedrine, and phenylpropanolamine is mandated by law. The
assessments are necessary to provide for the estimated medical,
scientific, research and industrial needs of the United States, for
lawful export requirements, and the establishment and maintenance of
reserve stocks. Accordingly, the Deputy Administrator has determined
that this action does not require a regulatory flexibility analysis.
Executive Order 12866
The Office of Management and Budget has determined that notices of
assessment of annual needs are not subject to centralized review under
Executive Order 12866.
Executive Order 13132
This action does not preempt or modify any provision of State law;
nor does it impose enforcement
[[Page 79417]]
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.
Executive Order 12988
This action meets the applicable standards set forth in Sections
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Unfunded Mandates Reform Act of 1995
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.
Congressional Review Act
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 13, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-31848 Filed 12-17-10; 8:45 am]
BILLING CODE 4410-09-P