[Federal Register Volume 75, Number 123 (Monday, June 28, 2010)]
[Notices]
[Pages 36684-36689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-15525]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-326R]
Proposed 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 proposed revised 2010 assessment of annual needs for
the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
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SUMMARY: This notice proposes revised 2010 assessment of annual needs
for the List I chemicals ephedrine, pseudoephedrine, and
phenylpropanolamine.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before July 28, 2010.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-326R'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Assistant Administrator, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Attention: DEA
Federal Register Representative/ODL. Written comments sent via express
mail should be sent to DEA Headquarters, Attention: DEA Federal
Register Representative/ODL, 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
[[Page 36685]]
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 Combat Methamphetamine
Epidemic Act of 2005 (CMEA) (Title VII of Pub. L. 109-177) 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, section 715 of the 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 (AAN) 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.
On November 20, 2009, DEA established the AAN for 2010 for the List
I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (74 FR
60294). That Notice indicated that the Deputy Administrator of the DEA
would adjust the AAN at a later date if necessary, as permitted by 21
CFR 1315.13.
DEA now proposes to revise the established assessments of annual
needs for 2010 for these List 1 chemicals. In developing the proposed
revisions, DEA has used the calculation methodology described in both
the 2009 and 2010 AAN (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 revised assessments for these List I chemicals,
DEA will consider the information contained in additional applications
for 2010 import, manufacturing and procurement quotas from DEA
registered manufacturers and importers that DEA receives after the date
of drafting this notice, March 10, 2010, as well as the comments that
DEA receives in response to this proposal.
Underlying Data and DEA's Analysis
In determining the proposed revisions to 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)........................................... 2,838 2,662 2,801 3,430
Imports ** (DEA 488)........................................ 9,595 1,690 2,165 2,268
Export Declarations (DEA 486)............................... 168 18 64 n/a
Inventory * (DEA 250)....................................... 1,428 626 191 n/a
IMS *** (NSP)............................................... 1,235 1,460 1,401 n/a
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* Reported sales and inventory from applications for 2010 procurement quotas (DEA 250).
** Reported imports from applications for 2010 import quotas (DEA 488).
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
Channels, Data Extracted March 10, 2010.
[[Page 36686]]
Ephedrine (for Sale) Analysis
DEA previously has established the 2010 AAN for ephedrine (for
sale) at 3,600 kg (74 FR 60298).
As noted above, DEA developed the proposed revisions to the 2010
AAN for ephedrine (for sale) using the same calculation and methodology
that DEA used to determine the 2009 and 2010 AAN.
As of March 10, 2010, DEA registered manufacturers of dosage form
products containing ephedrine requested the authority to purchase a
total of 3,430 kg ephedrine (for sale) in 2010. DEA registered
manufacturers of ephedrine reported sales totaling approximately 2,662
kg in 2008 and 2,801 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 (2,801 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 2,801
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
2,801 + (50%*2,801) + 41 - 191 = 4,052 kg ephedrine (for sale) for 2010
This calculation suggests that DEA's AAN for ephedrine should be
4,100 kg. Accordingly, DEA is proposing to increase the 2010 AAN for
ephedrine (for sale) from 3,600 kg to 4,100 kg.
Phenylpropanolamine (for Sale) data
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 6,799
Imports ** (DEA 488)........................................ 5,787 3,425 6,626 7,266
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 March 10,
2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
Phenylpropanolamine (for Sale) Analysis
DEA previously has established the 2010 AAN 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 AAN.
As of March 10, 2010, DEA registered manufacturers of dosage form
products containing phenylpropanolamine requested the authority to
purchase 6,799 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 proposing to increase the 2010 AAN 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)........................................... 239,121 223,813 287,756 239,646
Sales * (DEA 189)........................................... 100,300 64,781 33,600 32,760
Imports ** (DEA 488)........................................ 231,683 170,614 274,492 261,528
[[Page 36687]]
Export Declarations (DEA 486)............................... 42,132 47,199 35,264 n/a
Inventory * (DEA 250)....................................... 135,727 120,869 54,173 n/a
IMS *** (NSP)............................................... 180,221 149,227 140,269 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 March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** IMS Health, IMS National Sales PerspectivesTM, January 2007 to December 2009, Retail and Non-Retail
Channels, Data Extracted March 10, 2010.
Pseudoephedrine (for Sale) Analysis
DEA previously has established the 2010 AAN 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
AAN.
As of March 10, 2010, DEA registered manufacturers of dosage form
products containing pseudoephedrine requested the authority to purchase
239,646 kg pseudoephedrine. DEA registered manufacturers of
pseudoephedrine reported sales totaling approximately 223,813 kg in
2008 and 287,756 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 U.S. 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 144,748 kg. DEA thus believes that
287,756 kg of sales reported by manufacturers fairly represents the
U.S. sales of pseudoephedrine for 2010 and that 41,232 kg fairly
represents the export requirements of pseudoephedrine. DEA notes that
manufacturer reported sales for 2009 (287,756 kg) are higher than the
average retail sales reported by IMS for the previous two years
(144,748 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
287,756 + (50%*287,756) + 41,232 - 54,173 = 418,693 kg pseudoephedrine
(for sale) for 2010.
This calculation suggests that DEA's 2010 AAN for pseudoephedrine
(for sale) should be 419,000 kg. Accordingly, DEA is proposing to
increase the 2010 AAN for pseudoephedrine (for sale) from 404,000 kg to
419,000 kg.
Phenylpropanolamine (for Conversion) Data
Phenylpropanolamine (for conversion) 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)........................................... 3,621 10,837 14,585 19,142
Imports ** (DEA 488)........................................ 8,250 12,019 11,373 33,698
Export Declarations (DEA 486)............................... 0 0 0 n/a
Inventory * (DEA 250)....................................... 3,581 5,537 3,693 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 March 10,
2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 10, 2010.
*** Amphetamine Aggregate Production Quota History http://www.deadiversion.usdoj.gov/quotas/quota_history.pdf.
Phenylpropanolamine (for Conversion) Analysis
DEA previously has established the 2010 AAN for phenylpropanolamine
(for conversion) at 16,500 kg (74 FR 60298). As noted above, DEA
developed the proposed revisions to the 2010 AAN for
phenylpropanolamine (for conversion) using the same calculation and
methodology that DEA used to determine the 2009 and 2010 AAN.
As of March 10, 2010, DEA registered manufacturers of
phenylpropanolamine (for conversion) requested the authority to
purchase a total of 19,142 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 represent 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 U.S. requirements for 2010 and zero kg
fairly represents the export requirements of phenylpropanolamine (for
conversion).
Phenylpropanolamine (for conversion) is used for the manufacture of
legitimate amphetamine products. DEA notes, most legitimate amphetamine
is manufactured by the conversion of the schedule II controlled
substance phenylacetone to amphetamine, rather than the conversion of
phenylpropanolamine. DEA believes that the data provided in
procurement, manufacturing, and import quota applications best
represents the legitimate need for
[[Page 36688]]
phenylpropanolamine (for conversion) rather than total Aggregate
Production Quota (APQ) for amphetamine.
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 - 3,693 = 18,185 kg PPA (for conversion)
for 2010
This calculation suggests that DEA's 2010 AAN for
phenylpropanolamine (for conversion) should be 18,200 kg. Accordingly,
DEA is proposing to increase the 2010 AAN for phenylpropanolamine (for
conversion) from 16,500 kg to 18,200 kg.
Ephedrine (for Conversion) Data
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)........................................... 99,622 64,522 40,403 40,600
Imports ** (DEA 488)........................................ 99,594 64,128 39,897 40,000
Inventory * (DEA 250)....................................... 13 160 254 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 March 10, 2010.
** Reported imports from applications for 2010 import quotas (DEA 488) received as of March 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 AAN for ephedrine (for
conversion) at 75,000 kg (74 FR 60298). As noted above, DEA developed
the proposed revisions to the 2010 AAN for ephedrine (for conversion)
using the same calculation and methodology that DEA used to determine
the 2009 and 2010 AAN.
As of March 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 Aggregate Production Quota (APQ) for methamphetamine. DEA
determined that the estimated sales of pseudoephedrine, as referenced
in the 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.
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) - 254 = 11,785 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
11,785 + 63,157 = 74,942 kg ephedrine (for conversion) for 2010
This calculation suggests that DEA's 2010 AAN for ephedrine (for
conversion) should be 75,000 kg. Accordingly, DEA is proposing that the
2010 AAN for ephedrine (for conversion) remain unchanged at 75,000 kg.
Conclusion
In finalizing the revised 2010 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 2010 import,
manufacturing and procurement quotas received after March 10, 2010, in
accordance with 21 CFR part 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 revised 2010 AAN for the List I chemicals
ephedrine, pseudoephedrine, and phenylpropanolamine:
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Previously established
List I chemicals initial 2010 Proposed revised 2010
assessment assessment
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Ephedrine (for sale).......................................... 3,600 kg 4,100 kg
Phenylpropanolamine (for sale)................................ 6,400 kg 7,400 kg
Pseudoephedrine (for sale).................................... 404,000 kg 419,000 kg
Phenylpropanolamine (for conversion).......................... 16,500 kg 18,200 kg
Ephedrine (for conversion).................................... 75,000 kg No Change
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[[Page 36689]]
All interested persons are invited to submit their comments in
writing or electronically regarding this proposal following the
procedures in the Addresses section of this document. A person may
object to or comment on the proposal relating to any of the above-
mentioned 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 AAN 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
AAN 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: June 19, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-15525 Filed 6-25-10; 8:45 am]
BILLING CODE 4410-09-P