[Federal Register Volume 75, Number 176 (Monday, September 13, 2010)]
[Notices]
[Pages 55605-55610]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22688]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-350P]
Assessment of Annual Needs for the List I Chemicals Ephedrine,
Pseudoephedrine, and Phenylpropanolamine for 2011: Proposed
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed annual assessment of needs for 2011.
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SUMMARY: This notice proposes the initial year 2011 Assessment of
Annual Needs for certain List I chemicals in accordance with the Combat
Methamphetamine Epidemic Act (CMEA) of 2005. The CMEA requires DEA to
establish production quotas and import quotas for ephedrine,
pseudoephedrine, and phenylpropanolamine. The CMEA places additional
regulatory controls upon the manufacture, distribution, importation,
and exportation of the three List I chemicals.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before October 13, 2010.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-350P'' 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, 8701 Morrissette Drive, Springfield,
Virginia 22152, 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, Virginia 22152. Comments may be
directly sent to DEA electronically by sending an electronic message to
[email protected]. However, persons wishing to request a
hearing should note that such requests must be written and manually
signed; requests for a hearing will not be accepted via electronic
means. 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,
8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: (202)
307-7183.
SUPPLEMENTARY INFORMATION: Section 713 of the CMEA of 2005 (Title VII
of Pub. L. 109-177) (CMEA) amended Sec. 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
[[Page 55606]]
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. 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
schedules 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 proposed 2011 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 to meet the estimated
medical, scientific, research, and industrial needs of the United
States; lawful export requirements; and the establishment and
maintenance of reserve stocks.
As of June 25, 2010, the DEA has received a total of 99
applications for 2011 import, procurement and manufacturing quotas for
ephedrine, pseudoephedrine, and phenylpropanolamine. As a comparison,
for the 2010 quota year, DEA has received 204 applications for import,
procurement, and manufacturing quotas. DEA calculated the 2011
Assessment of Annual Needs for the List I chemicals using the
calculation methodology described in both the 2009 and 2010 Assessment
of Annual Needs (74 FR 32954 and 74 FR 60294, respectively). These
calculations take into account the criteria that DEA is required to
consider in accordance with 21 U.S.C. 826 and its implementing
regulations (21 CFR 1315.11).
In finalizing the assessments for these List I chemicals, DEA will
consider the information contained in additional applications for 2011
import, manufacturing and procurement quotas from DEA registered
manufacturers and importers that DEA receives after the date of
drafting this notice, June 25, 2010, as well as the comments that DEA
receives in response to this proposal. DEA registered manufacturers and
importers are reminded that pursuant to 21 CFR 1315.22, 1315.32(e) and
1315.34(d) applications for import and procurement quotas are due by
April 1 and that applications for manufacturing quotas are due by May 1
of the year preceding the year for which the quota is to be applied.
DEA encourages registrants to submit their quota applications by the
regulatory due dates to ensure their requirements are considered.
Underlying Data and DEA's Analysis
In determining the proposed 2011 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 (2011), 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 in 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 Data
Ephedrine (for Sale) Data for 2011 Assessment of Annual Needs
[Kilograms]
------------------------------------------------------------------------
2011
Ephedrine 2008 2009 2010 request
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Sales* (DEA 250)............ 2,159 2,136 2,416 2,867
Imports** (DEA 488)......... 49 0 87 104
Export Declarations (DEA 18 64 52 n/a
486).......................
Inventory* (DEA 250)........ 723 497 315 n/a
IMS*** (NSP)................ 1,460 1,401 n/a n/a
------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement
quotas (DEA 250).
** Reported imports from applications for 2011 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to
December 2009, Retail and Non-Retail Channels, Data Extracted June 25,
2010.
[[Page 55607]]
Ephedrine Analysis
DEA calculated the proposed 2011 Assessment of Annual Needs for
ephedrine using the calculation developed to determine the 2009
Assessment of Annual Needs. This calculation considers the criteria
defined in 21 U.S.C. 826: estimated medical, scientific, research, and
industrial needs of the United States; lawful export requirements; and
the establishment and maintenance of reserve stocks.
As of June 25, 2010, DEA registered manufacturers of dosage form
products containing ephedrine requested the authority to purchase a
total of 2,867 kg ephedrine (for sale) in 2011. DEA registered
manufacturers of ephedrine reported sales totaling approximately 2,136
kg in 2009 and 2,416 kg in 2010; this represents a 12 percent increase
in sales reported by these firms from 2009 to 2010. Additionally,
exports of ephedrine products from the United States as reported on
export declarations (DEA 486) totaled 64 kg in 2009 and 52 kg in 2010;
this represents a 19 percent decrease from levels observed in 2009. The
average of the 2009 and 2010 exports of ephedrine products is
approximately 58 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 2010 sales figure reported by
manufacturers (2,416 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. In considering
the manufacturer's reported sales, DEA thus believes that 2,416 kg
fairly represents the U.S. sales of ephedrine for 2011 and that 58 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 2010 year end inventory as reported by DEA registrants in
determining the inventory allowance.
DEA calculated the ephedrine (for sale) assessment by the following
methodology:
2010 sales + reserve stock + export requirement - existing inventory
= AAN 2,416 + (50%*2,416) + 58 - 315 = 3,367 kg ephedrine (for sale)
for 2011.
This calculation suggests that DEA's Assessment of Annual Needs for
ephedrine should be proposed to be 3,400 kg. Accordingly, DEA is
proposing the 2011 Assessment of Annual Needs for ephedrine (for sale)
at 3,400 kg.
Phenylpropanolamine (for Sale) Data
Phenylpropanolamine (for Sale) Data for 2011 Assessment of Annual Needs
[Kilograms]
------------------------------------------------------------------------
Phenylpropanolamine (for 2011
sale) 2008 2009 2010 request
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Sales* (DEA 250)............ 4,252 4,350 4,374 5,638
Imports** (DEA 488)......... 105 1,503 1,582 1,596
Export Declarations (DEA 0 3 0 n/a
486).......................
Inventory* (DEA 250)........ 2,054 2,318 1,951 n/a
------------------------------------------------------------------------
* Reported sales and inventory from applications for 2011 procurement
quotas (DEA 250) received as of June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488)
received as of June 25, 2010.
Phenylpropanolamine (for Sale) Analysis
DEA utilized the same general methodology and calculation to
establish the assessment for phenylpropanolamine (for sale) as was
described for the assessment of ephedrine (for sale), above.
As of June 25, 2010, DEA registered manufacturers of dosage form
products containing phenylpropanolamine requested the authority to
purchase 5,638 kg phenylpropanolamine (for sale) in 2011. DEA
registered manufacturers of phenylpropanolamine reported sales totaling
approximately 4,350 kg in 2009 and 4,374 kg in 2010; this represents a
0.5 percent increase in sales reported by these firms from 2009 to
2010. Additionally, exports of phenylpropanolamine products from the
U.S. as reported on export declarations (DEA 486) totaled 3 kg in 2009
and 0 kg in 2010; this represents a 3 kg decrease from levels observed
in 2009. The average of the 2009 and 2010 exports of
phenylpropanolamine products is approximately 2 kg. DEA thus believes
that 4,374 kg fairly represents the U.S. sales of phenylpropanolamine
for 2011 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 these
channels and is therefore not included.
DEA calculated the phenylpropanolamine (for sale) assessment by the
following methodology:
2010 sales + reserve stock + export requirement - existing inventory
= AAN
4,374 + (50%*4,374) + 2 - 1,951 = 4,612 kg phenylpropanolamine (for
sale) for 2011.
This calculation suggests that DEA's 2011 Assessment of Annual
Needs for phenylpropanolamine (for sale) should be proposed at 4,700
kg. Accordingly, DEA is proposing the 2011 Assessment of Annual Needs
for phenylpropanolamine (for sale) at 4,700 kg.
Pseudoephedrine (for Sale) Data
Pseudoephedrine (for Sale) Data for 2011 Assessment of Annual Needs
[Kilograms]
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2011
Pseudoephedrine (for sale) 2008 2009 2010 request
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Sales * (DEA 250)........................................... 169,992 145,853 148,934 181,219
[[Page 55608]]
Sales * (DEA 189)........................................... 64,781 7,321 5,550 0
Imports ** (DEA 488)........................................ 10,872 39,168 44,030 74,012
Export Declarations (DEA 486)............................... 47,199 35,264 8,480 n/a
Inventory * (DEA 250)....................................... 97,026 72,070 55,323 n/a
IMS *** (NSP)............................................... 149,232 140,784 n/a n/a
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* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250).
** Reported imports from applications for 2011 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2008 to December 2009, Retail. and Non-Retail
Channels, Data Extracted June 25, 2010.
Pseudoephedrine (for Sale) Analysis
DEA utilized the same general methodology and calculations to
establish the assessment for pseudoephedrine (for sale) as were
described for the assessment of ephedrine (for sale), above.
As of June 25, 2010, DEA registered manufacturers of dosage form
products containing pseudoephedrine requested the authority to purchase
181,219 kg pseudoephedrine. DEA registered manufacturers of
pseudoephedrine reported sales totaling approximately 145,853 kg in
2009 and 148,934 kg in 2010; this represents a 2 percent increase in
sales reported by these firms from 2009 to 2010. During the same period
exports of pseudoephedrine products from the U.S. as reported on export
declarations (DEA 486) totaled 35,264 kg in 2009 and 8,480 kg in 2010;
this represents a 76 percent decrease from levels observed in 2009. The
average of the 2009 and 2010 exports is 21,872 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 145,008 kg. DEA thus believes that
148,934 kg of sales reported by manufacturers fairly represents the
U.S. sales of pseudoephedrine for 2011 and that 21,872 kg fairly
represents the export requirements of pseudoephedrine.
DEA calculated the pseudoephedrine (for sale) assessment by the
following methodology:
2010 sales + reserve stock + export requirement - existing inventory
= AAN
148,934 + (50%*148,934) + 21,872 - 55,323 = 189,950 kg
pseudoephedrine (for sale) for 2011
This calculation suggests that DEA's 2011 Assessment of Annual
Needs for pseudoephedrine (for sale) should be proposed at 190,000 kg.
Accordingly, DEA is proposing the 2011 Assessment of Annual Needs for
pseudoephedrine (for sale) at 190,000 kg.
Phenylpropanolamine (for Conversion) Data
Phenylpropanolamine (for Conversion) Data for 2011 Assessment of Annual Needs
[Kilograms]
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2011
Phenylpropanolamine (for conversion) 2008 2009 2010 request
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Sales * (DEA 250)........................................... 3,120 4,415 5,855 12,200
Imports ** (DEA 488)........................................ 105 1,503 1,582 1,500
Export Declarations (DEA 486)............................... 0 0 0 n/a
Inventory * (DEA 250)....................................... 875 503 713 n/a
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* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) received as of June 25,
2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.
Phenylpropanolamine (for Conversion) Analysis
As of June 25, 2010, DEA registered manufacturers of
phenylpropanolamine (for conversion) requested the authority to
purchase a total of 12,200 kg phenylpropanolamine for the manufacture
of amphetamine. DEA registered manufacturers of phenylpropanolamine
reported sales of phenylpropanolamine totaling approximately 4,415 kg
in 2009 and 5,855 kg in 2010; this represents a 26 percent increase in
sales reported by these firms from 2009 to 2010. There were no reported
exports of phenylpropanolamine (for conversion). DEA has not received
any requests to synthesize phenylpropanolamine in 2011. DEA has
concluded that the 2010 sales of phenylpropanolamine (for conversion),
5,855 kg, fairly represents U.S. requirements for 2011 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) assessment
for the manufacture of amphetamine as follows:
(2010 sales) + reserve stock + export requirement - inventory = AAN
(5,855) + (50%*5,855) + 0 - 713 = 8,070 kg PPA (for conversion) for
2011
[[Page 55609]]
This calculation suggests that DEA's 2011 Assessment of Annual
Needs for phenylpropanolamine (for conversion) should be proposed at
8,100 kg. Accordingly, DEA is proposing the 2011 Assessment of Annual
Needs for phenylpropanolamine (for conversion) at 8,100 kg.
Ephedrine (for Conversion) Data
Ephedrine (for Conversion) Data for 2011 Assessment of Annual Needs
[Kilograms]
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2011
Ephedrine (for conversion) 2008 2009 2010 request
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Sales * (DEA 250)........................................... 64,665 9,316 6,057 287
Imports ** (DEA 488)........................................ 0 0 0 0
Inventory * (DEA 250)....................................... 233 99 152 n/a
APQ Methamphetamine ***..................................... 3,130 3,130 3,130 n/a
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* Reported sales and inventory from applications for 2011 procurement quotas (DEA 250) and manufacturing quotas
(DEA 189) received as of June 25, 2010.
** Reported imports from applications for 2011 import quotas (DEA 488) received as of June 25, 2010.
*** Methamphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
Ephedrine (for Conversion) Analysis
As of June 25, 2010, DEA registered manufacturers of ephedrine (for
conversion) requested the authority to purchase a total of 287 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 Aggregate Production Quota (APQ) for methamphetamine. DEA
determined that the estimated sale of pseudoephedrine, as referenced in
the proposed Assessment of Annual Needs (AAN) 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.
DEA calculated the ephedrine (for conversion) assessment by the
following methodology:
methamphetamine requirement + pseudoephedrine requirement = AAN
DEA calculated the ephedrine (for conversion) requirement for the
manufacture of methamphetamine as follows:
(2010 APQ methamphetamine/39 percent yield) + reserve stock -
inventory = ephedrine (for manufacture of methamphetamine)
(3,130/39 percent yield) + 50 percent*(3,130/39 percent yield) - 152
= 11,887 kg
The calculation for the ephedrine (for conversion) requirement
for the manufacture of pseudoephedrine leads to a result of 6,703
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, the assessment
for ephedrine was determined by the sum total of the ephedrine (for
conversion) requirements as described by the following methodology:
methamphetamine requirement + pseudoephedrine requirement = AAN 11,887
+ 6,703 = 18,590 kg ephedrine (for conversion) for 2011
This calculation suggests that DEA's 2011 Assessment of Annual
Needs for ephedrine (for conversion) should be proposed at 18,600 kg.
Accordingly, DEA is proposing the 2011 Assessment of Annual Needs for
ephedrine (for conversion) at 18,600 kg.
Conclusion
In finalizing the 2011 assessments for these List I chemicals, DEA
will use the methodology and calculations presented above. The numbers
used in the calculations may be adjusted upwards or downwards based on
the additional applications for 2011 import, manufacturing and
procurement quotas received after June 25, 2010. DEA urges registered
importers and manufacturers to submit applications for 2011 import,
manufacturing and procurement quota so that DEA may include information
from those applications when finalizing these assessments in accordance
with 21 CFR 1315.
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
proposes the following 2011 Assessment of Annual Needs for the List I
chemicals ephedrine, pseudoephedrine, and phenylpropanolamine for 2011,
expressed in kilograms of anhydrous base:
------------------------------------------------------------------------
Proposed year
2011
List I chemicals assessment of
annual needs
(kg)
------------------------------------------------------------------------
Ephedrine (for sale).................................... 3,400
Phenylpropanolamine (for sale).......................... 4,700
Pseudoephedrine (for sale).............................. 190,000
Phenylpropanolamine (for conversion).................... 8,100
Ephedrine (for conversion).............................. 18,600
------------------------------------------------------------------------
Ephedrine (for conversion) refers to the industrial use of
ephedrine, i.e., that which will be converted to another basic drug
class such as pseudoephedrine or methamphetamine used for the
manufacture of prescription weight loss drug. Phenylpropanolamine (for
conversion) refers to the industrial use of phenylpropanolamine, i.e.,
that which will be converted to another basic drug class such as
amphetamine for the manufacture of drug products. The ``for sale''
assessments refer to the amount of ephedrine, pseudoephedrine, and
phenylpropanolamine intended for ultimate use in products containing
these List I chemicals.
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
[[Page 55610]]
proposal relating to any of the above-mentioned substances 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.
Persons wishing to request a hearing should note that such requests
must be written and manually signed; requests for a hearing will not be
accepted via electronic means. 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 as per 21
CFR 1315.13(e).
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 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: August 27, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-22688 Filed 9-10-10; 8:45 am]
BILLING CODE 4410-09-P