Proposed Revised Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008, 35410-35412 [E8-14108]
Download as PDF
<![CDATA[
35410
Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Notices
DEPARTMENT OF JUSTICE
General, Environment and Natural
Resources Division, and either emailed
to pubcomment-ees.enrd@usdoj.gov or
mailed to P.O. Box 7611, U.S.
Department of Justice, Washington, DC
20044–7611, and should refer to United
States v. John Woodhams, D.J. Ref. 90–
11–3–09038.
The Decree may be examined at the
Office of the United States Attorney,
District of North Dakota, 655 First
Avenue North, Suite 250, Fargo, ND
58102–4932, and at U.S. EPA Region 8,
1595 Wynkoop St., Denver, CO 80202–
1129. During the public comment
period, the Decree, may also be
examined on the following Department
of Justice Web site, https://
www.usdoj.gov/enrd/
Consent_Decrees.html. A copy of the
Decree may also be obtained by mail
from the Consent Decree Library, P.O.
Box 7611, U.S. Department of Justice,
Washington, D.C. 20044–7611 or by
faxing or e-mailing a request to Tonia
Fleetwood (tonia.fleetwood@usdoj.gov),
fax no. (202) 514–0097, phone
confirmation number (202) 514–1547. In
requesting a copy from the Consent
Decree Library, please enclose a check
in the amount of $6.25 (25 cents per
page reproduction cost) payable to the
U.S. Treasury or, if by email or fax,
forward a check in that amount to the
Consent Decree Library at the stated
address.
Notice of Lodging of Consent Decree
Under the Comprehensive
Environmental Response,
Compensation, and Liability Act
Robert D. Brook,
Assistant Chief, Environmental Enforcement
Section, Environment and Natural Resources
Division.
[FR Doc. E8–14056 Filed 6–20–08; 8:45 am]
filed on time and was accompanied by
all the rentals due since the date the
lease terminated under the law.
FOR FURTHER INFORMATION CONTACT:
Bureau of Land Management, Pamela J.
Lewis, Chief, Branch of Fluid Minerals
Adjudication, at (307) 775–6176.
SUPPLEMENTARY INFORMATION: The lessee
has agreed to the amended lease terms
for rentals and royalties at rates of
$10.00 per acre, or fraction thereof, per
year and 162⁄3 percent, respectively. The
lessee has paid the required $500
administrative fee and $163 to
reimburse the Department for the cost of
this Federal Register notice. The lessee
has met all the requirements for
reinstatement of the lease as set out in
Sections 31(d) and (e) of the Mineral
Lands Leasing Act of 1920 (30 U.S.C.
188), and the Bureau of Land
Management is proposing to reinstate
lease WYW173501 effective December
1, 2007, under the original terms and
conditions of the lease and the
increased rental and royalty rates cited
above. BLM has not issued a valid lease
affecting the lands.
Pamela J. Lewis,
Chief, Branch of Fluid Minerals Adjudication.
[FR Doc. E8–14155 Filed 6–20–08; 8:45 am]
mmaher on PROD1PC70 with NOTICES
BILLING CODE 4310–22–P
Notice is hereby given that on June
17, 2008, a proposed Consent Decree
(‘‘Decree’’) in United States v. John
Woodhams, Civil Action No. 3:07–CV–
0074–RRE–KKK was lodged with the
United States District Court for the
District of North Dakota.
The Decree resolves the United States’
claims under Section 107 of the
Comprehensive Environmental
Response, Compensation, and Liability
Act, 42 U.S.C. 9607, for reimbursement
of response costs incurred in connection
with the release or threatened release of
hazardous substances at the Camelot
Cleaners Site in West Fargo, North
Dakota (‘‘Site’’). The Decree requires
Defendant to pay $300,000 to the United
States for response costs and assign to
the United States all potential rights to
insurance claim proceeds relating to the
Site.
The Department of Justice will receive
for a period of thirty (30) days from the
date of this publication comments
relating to the Decree. Comments should
be addressed to the Assistant Attorney
VerDate Aug<31>2005
01:51 Jun 21, 2008
Jkt 214001
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Notice of Lodging of Settlement
Agreement; Comprehensive
Environmental Response,
Compensation, and Liability Act
Notice is hereby given that, for a
period of 30 days, the United States will
receive public comments on a proposed
Consent Decree in United States v.
Dravo Corporation (Civil Action No.
8:04–CV–356), which was lodged with
the United States District Court for the
District of Nebraska on June 16, 2008.
The Complaint alleges that Dravo is
civilly liable for violations under
Section 107(a) of the Comprehensive
Environmental Response,
Compensation, and Liability Act of
1980, as amended (‘‘CERCLA’’), 42
U.S.C. 9607(a). The Complaint seeks the
recovery of response costs incurred and
to be incurred by the United States as
a result of releases or threatened
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
releases of hazardous substances at or
from the Hastings Naval Ammunition
Depot Subsite of the Hastings Ground
Water Contamination Site, located in
Hastings, Adams County, Nebraska.
Under the settlement, Dravo
Corporation has agreed to pay to the
United States one million one hundred
sixty-one thousand dollars
($1,161,000.00) for the recovery of these
response costs.
Comments should be addressed to the
Assistant Attorney General,
Environment and Natural Resources
Division, and may be submitted to: P.O.
Box 7611, U.S. Department of Justice,
Washington, DC 20044–7611, or via
e-mail to
pubcomment-ees.enrd@usdoj.gov, and
should refer to United States v. Dravo
Corporation, D.J. Ref. 90–11–2–1260/2.
The Consent Decree may be examined
at the Office of the United States
Attorney. District of Nebraska, 1620
Dodge Street, Suite 1400, Omaha, NE
68102–1506. During the public
comment period the Dravo Consent
Decree may also be examined on the
following Department of Justice Web
site: https://www.usdoj.gov/enrd/
Consent_Decrees.html. A copy of the
Dravo Consent Decree also may be
obtained by mail from the Consent
Decree Library, P.O. Box 7611, U.S.
Department of Justice, Washington, DC
20044–7611 or by faxing or e-mailing a
request to Tonia Fleetwood
(tonia.fleetwood@usdoj.gov), fax no.
(202) 514–0097, phone confirmation
number (202) 514–1547. In requesting a
copy from the Consent Decree Library,
please enclose a check in the amount of
$4.25 (25 cents per page reproduction
cost) payable to the U.S. Treasury.
Maureen M. Katz,
Assistant Section Chief, Environmental
Enforcement Section, Environment and
Natural Resources Division.
[FR Doc. E8–14041 Filed 6–20–08; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–306R]
Proposed Revised Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2008
Drug Enforcement
Administration (DEA), Justice.
ACTION: Notice of proposed revised 2008
assessment of annual needs for the list
I chemicals ephedrine,
AGENCY:
E:\FR\FM\23JNN1.SGM
23JNN1
35411
Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Notices
pseudoephedrine, and
phenylpropanolamine.
SUMMARY: This notice proposes revised
2008 assessment of annual needs for the
List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine.
Written comments must be
postmarked, and electronic comments
must be sent, on or before July 23, 2008.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–306R’’ 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, VA
22152. Comments may be directly sent
to DEA electronically by sending an
electronic message to
dea.diversion.policy@usdoj.gov.
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, Ph.D., Chief,
Drug and Chemical Evaluation Section,
Drug Enforcement Administration,
Washington, DC 20537, 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
DATES:
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, and
*
*
*
*
*
(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).
On December 27, 2007, a notice was
published in the Federal Register which
established the assessment of annual
needs for the List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine (72 FR 73361).
Pursuant to 21 CFR 1315, the Deputy
Administrator of the DEA will, in early
2008, adjust the assessment of annual
needs and individual importing and
manufacturing quotas allocated for the
year based upon 2007 year-end
inventory and 2007 disposition data
supplied by quota recipients for
ephedrine, pseudoephedrine, and
phenylpropanolamine, and other
information available to the DEA.
The proposed revised 2008
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 for: The estimated medical,
scientific, research, and industrial needs
of the United States; lawful export
requirements; and the establishment
and maintenance of reserve stocks.
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
2008 assessment of annual needs for the
List I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine for 2008,
expressed in grams of anhydrous base:
Previously
established
initial 2008
assessment/
(kg)
List I chemicals
mmaher on PROD1PC70 with NOTICES
Ephedrine (for sale) .................................................................................................................................................
Ephedrine (for conversion) ......................................................................................................................................
Pseudoephedrine (for sale) .....................................................................................................................................
Phenylpropanolamine (for sale) ...............................................................................................................................
Phenylpropanolamine (for conversion) ....................................................................................................................
All interested persons are invited to
submit their comments in writing or
electronically regarding this proposal
VerDate Aug<31>2005
01:51 Jun 21, 2008
Jkt 214001
following the procedures in the
section of this document. A
person may object to or comment on the
ADDRESSES
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
11,500
128,760
511,100
5,545
85,470
Proposed
revised 2008
assessment/
(kg)
11,500
128,760
511,100
5,545
85,470
proposal relating to any of the abovementioned substances without filing
comments or objections regarding the
E:\FR\FM\23JNN1.SGM
23JNN1
35412
Federal Register / Vol. 73, No. 121 / Monday, June 23, 2008 / Notices
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.
mmaher on PROD1PC70 with NOTICES
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
VerDate Aug<31>2005
01:51 Jun 21, 2008
Jkt 214001
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 foreignbased companies in domestic and
export markets.
Dated: June 6, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8–14108 Filed 6–20–08; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Occupational Safety and Health
Administration
[Docket No. OSHA–2008–0020]
Slings; Extension of the Office of
Management and Budget’s (OMB)
Approval of Information Collection
(Paperwork) Requirements
Occupational Safety and Health
Administration (OSHA), Labor.
ACTION: Request for public comment.
AGENCY:
SUMMARY: OSHA solicits comments
concerning its proposal to extend OMB
approval of the information collection
requirements contained in the Standard
on Slings (29 CFR 1910.184). The
collection of information (paperwork)
provisions of the Standard specify
affixing identification tags or markings
on slings, developing and maintaining
inspection records, and retaining proof
testing certificates.
DATES: Comments must be submitted
(postmarked, sent, or received) by
August 22, 2008.
ADDRESSES: Electronically: You may
submit comments and attachments
electronically at https://
www.regulations.gov, which is the
Federal eRulemaking Portal. Follow the
instructions online for submitting
comments.
Facsimile: If your comments,
including attachments, are not longer
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
than 10 pages, you may fax them to the
OSHA Docket Office at (202) 693–1648.
Mail, hand delivery, express mail,
messenger, or courier service: When
using this method, you must submit
three copies of your comments and
attachments to the OSHA Docket Office,
Docket No. OSHA–2008–0020, U.S.
Department of Labor, Occupational
Safety and Health Administration,
Room N–2625, 200 Constitution
Avenue, NW., Washington, DC 20210.
Deliveries (hand, express mail,
messenger, and courier service) are
accepted during the Department of
Labor’s and Docket Office’s normal
business hours, 8:15 a.m. to 4:45 p.m.,
e.t.
Instructions: All submissions must
include the Agency name and OSHA
docket number for the ICR (OSHA–
2008–0020). All comments, including
any personal information you provide,
are placed in the public docket without
change, and may be made available
online at https://www.regulations.gov.
For further information on submitting
comments see the ‘‘Public
Participation’’ heading in the section of
this notice titled SUPPLEMENTARY
INFORMATION.
Docket: To read or download
comments or other material in the
docket, go to https://www.regulations.gov
or the OSHA Docket Office at the
address above. All documents in the
docket (including this Federal Register
notice) are listed in the https://
www.regulations.gov index; however,
some information(e.g., copyrighted
material) is not publicly available to
read or download through the Web site.
All submissions, including copyrighted
material, are available for inspection
and copying at the OSHA Docket Office.
You may also contact Theda Kenney at
the address below to obtain a copy of
the ICR.
FOR FURTHER INFORMATION CONTACT:
Theda Kenney or Todd Owen,
Directorate of Standards and Guidance,
OSHA, U.S. Department of Labor,
RoomN–3609, 200 Constitution Avenue,
NW., Washington, DC 20210; telephone
(202) 693–2222.
SUPPLEMENTARY INFORMATION:
I. Background
The Department of Labor, as part of its
continuing effort to reduce paperwork
and respondent (i.e., employer) burden,
conducts a preclearance consultation
program to provide the public with an
opportunity to comment on proposed
and continuing information collection
requirements in accordance with the
Paperwork Reduction Act of 1995 (44
U.S.C. 3506(c)(2)(A)). This program
E:\FR\FM\23JNN1.SGM
23JNN1
]]>Agencies
[Federal Register Volume 73, Number 121 (Monday, June 23, 2008)]
[Notices]
[Pages 35410-35412]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-14108]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA-306R]
Proposed Revised Assessment of Annual Needs for the List I
Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2008
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Notice of proposed revised 2008 assessment of annual needs for
the list I chemicals ephedrine,
[[Page 35411]]
pseudoephedrine, and phenylpropanolamine.
-----------------------------------------------------------------------
SUMMARY: This notice proposes revised 2008 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 23, 2008.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-306R'' 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, VA
22152. Comments may be directly sent to DEA electronically by sending
an electronic message to dea.diversion.policy@usdoj.gov. 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, Ph.D., Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, 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,
and
* * * * *
(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).
On December 27, 2007, a notice was published in the Federal
Register which established the assessment of annual needs for the List
I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine (72 FR
73361). Pursuant to 21 CFR 1315, the Deputy Administrator of the DEA
will, in early 2008, adjust the assessment of annual needs and
individual importing and manufacturing quotas allocated for the year
based upon 2007 year-end inventory and 2007 disposition data supplied
by quota recipients for ephedrine, pseudoephedrine, and
phenylpropanolamine, and other information available to the DEA.
The proposed revised 2008 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 for: The
estimated medical, scientific, research, and industrial needs of the
United States; lawful export requirements; and the establishment and
maintenance of reserve stocks.
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 2008 assessment of annual needs for the
List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine
for 2008, expressed in grams of anhydrous base:
------------------------------------------------------------------------
Previously
established Proposed
List I chemicals initial 2008 revised 2008
assessment/ assessment/
(kg) (kg)
------------------------------------------------------------------------
Ephedrine (for sale).................... 11,500 11,500
Ephedrine (for conversion).............. 128,760 128,760
Pseudoephedrine (for sale).............. 511,100 511,100
Phenylpropanolamine (for sale).......... 5,545 5,545
Phenylpropanolamine (for conversion).... 85,470 85,470
------------------------------------------------------------------------
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
[[Page 35412]]
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: June 6, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-14108 Filed 6-20-08; 8:45 am]
BILLING CODE 4410-09-P
