[Federal Register Volume 77, Number 138 (Wednesday, July 18, 2012)]
[Notices]
[Pages 42333-42334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-17522]


-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. DEA-353]


Proposed Adjustment of the Assessment of Annual Needs for the 
List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine 
for 2012

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice with request for comments.

-----------------------------------------------------------------------

SUMMARY: This notice proposes to adjust the 2012 assessment of annual 
needs for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine.

DATES: Electronic comments must be submitted and written comments must 
be postmarked on or before August 17, 2012. Commenters should be aware 
that the electronic Federal Docket Management System will not accept 
comments after midnight Eastern Time on the last day of the comment 
period.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-353'' on all electronic and written correspondence. 
DEA encourages all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that 
site. An electronic copy of this document is also available at the 
http://www.regulations.gov Web site for easy reference. Paper comments 
that duplicate the electronic submission are not necessary as all 
comments submitted to www.regulations.gov will be posted for public 
review and are part of the official docket record. Should you, however, 
wish to submit written comments via regular or express mail, they 
should be sent to the Drug Enforcement Administration, Attention: DEA 
Federal Register Representative/ODL, 8701 Morrissette Drive, 
Springfield, VA 22152.

FOR FURTHER INFORMATION CONTACT: John W. Partridge, Chief, Liaison and 
Policy Section, Drug Enforcement Administration, 8701 Morrissette 
Drive, Springfield, VA 22152, Telephone: (202) 307-4654.

SUPPLEMENTARY INFORMATION: 

Posting of Public Comments

    Please note that all comments received are considered part of the 
public record and made available for public inspection online at http://www.regulations.gov and in the DEA's public docket. Such information 
includes personal identifying information (such as your name, address, 
etc.) voluntarily submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted, 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the FOR FURTHER INFORMATION CONTACT paragraph.

Background

    On December 12, 2011, DEA established the assessment of annual 
needs for 2012 for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine, pursuant to 21 U.S.C. 826(a) and 21 CFR 1315.11 
(76 FR 77252). That Notice indicated that DEA would adjust the 
assessment of annual needs at a later date, if necessary, as provided 
in 21 CFR 1315.13.
    DEA now proposes to adjust the established assessment of annual 
needs for 2012 for the list I chemicals ephedrine, pseudoephedrine, and 
phenylpropanolamine. In proposing the adjustment, DEA has taken into 
account the criteria that DEA is required to consider in accordance 
with 21 CFR 1315.13. DEA proposes the adjustment of the assessment of 
annual needs for 2012 by considering: (1) Changes in demand, changes in 
the national rate of net disposal, and changes in the rate of net 
disposal by the registrants holding individual manufacturing or import 
quotas for the chemical; (2) whether any increased demand or changes in 
the national and/or individual rates of net disposal are temporary, 
short term, or long term; (3) whether any increased demand can be met 
through existing inventories, increased individual manufacturing 
quotas, or increased importation without increasing the assessment of 
annual needs; (4) whether any decreased demand will result in excessive 
inventory accumulation by all persons registered to handle the 
particular chemical; and (5) other factors affecting the medical, 
scientific, research, industrial, and importation needs in the United 
States, lawful export requirements, and reserve stocks, as the 
Administrator finds relevant.
    Other factors that DEA considered include trends as derived from 
information provided in applications for import, manufacturing, and 
procurement quotas and in import and export declarations. The 
inventory, acquisition (purchases), and disposition (sales) data as 
provided by DEA registered manufacturers and importers reflects the 
most current information available to DEA at the time of publication of 
this Notice.

Analysis

    In determining whether to propose adjustments to the 2012 
assessment of annual needs, DEA considered the total net disposals 
(i.e., sales) of the list I

[[Page 42334]]

chemicals for the current and preceding two years, actual and estimated 
inventories, projected demand (2012), industrial use, and export 
requirements from updated data provided by DEA registered manufacturers 
and importers in procurement quota applications (DEA 250), 
manufacturing quota applications (DEA 189), import quota applications 
(DEA 488), declarations for import and export, and other information. 
Data considered included data submitted to DEA after the initial 
assessment of annual needs had been established. DEA notes that the 
inventory, acquisition (purchases), and disposition (sales) data proved 
by DEA registered manufacturers and importers reflects the most current 
information available. In developing the proposed 2012 revision, DEA 
has used the calculation methodology described previously in the 2010 
and 2011 assessment of annual needs (74 FR 60294 and 75 FR 79407, 
respectively).
    As of June 6, 2012, DEA registered manufacturers of dosage form 
products containing pseudoephedrine requested quota for 322,385 kg of 
pseudoephedrine. DEA registered manufacturers of pseudoephedrine 
reported sales totaling approximately 189,030 kg in 2010 and 268,669 kg 
in 2011; this represents a 30 percent increase in sales reported by 
these firms from 2010 to 2011. Additionally, DEA considered information 
on trends in the national rate of net disposals from sales data 
provided by IMS Health. The initial assessment of annual needs was 
based on data received by DEA as of October 17, 2011. Based on the 
updated information provided to DEA as of June 6, 2012, DEA is 
proposing to increase the 2011 assessment of annual needs for 
pseudoephedrine from 258,000 kg to 278,000 kg.
    As of June 6, 2012, DEA registered manufacturers of dosage form 
products containing ephedrine requested quota for 4,221 kg of ephedrine 
(for sale) in 2012. DEA registered manufacturers of ephedrine reported 
sales totaling approximately 1,598 kg in 2010 and 3,158 kg in 2011; 
this represents a 49 percent increase in sales reported by these firms 
from 2010 to 2011. Additionally, DEA considered information on trends 
in the national rate of net disposals from sales data provided by IMS 
Health. The initial assessment of annual needs was based on data 
received by DEA as of October 17, 2011. Based on the updated 
information provided to DEA as of June 6, 2012, DEA is proposing to 
increase the 2012 assessment of annual needs for ephedrine (for sale) 
from 4,000 kg to 4,300 kg.
    As of June 6, 2012, DEA registered manufacturers of 
phenylpropanolamine (for sale) requested quota for 7,763 kg of 
phenylpropanolamine (for sale). DEA registered manufacturers of 
phenylpropanolamine reported sales totaling approximately 4,790 kg in 
2010 and 5,289 kg in 2011; this represents a nine percent increase in 
sales reported by these firms from 2010 to 2011. DEA notes that 
phenylpropanolamine is sold primarily as a veterinary product 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 considered. The initial assessment of annual needs was 
based on data received by DEA as of October 17, 2011. DEA is proposing 
to increase the 2012 assessment of annual needs for phenylpropanolamine 
(for sale) from 5,200 kg to 5,800 kg.
    As of June 6, 2012, the data provided to DEA for review of 
phenylpropanolamine (for conversion) and ephedrine (for conversion) 
demonstrated no significant changes in demand or net disposals. DEA has 
thus determined that the assessment of annual needs for these 
chemicals--phenylpropanolamine (for conversion) and ephedrine (for 
conversion)--shall remain unchanged.
    The Administrator, therefore, proposes the following adjustment of 
the 2012 assessment of annual needs for the list I chemicals ephedrine, 
pseudoephedrine, and phenylpropanolamine as follows:

------------------------------------------------------------------------
                                                             Proposed
                                               2012        adjustment to
                                           assessment of     the 2012
            List I chemicals               annual needs    assessment of
                                               (kg)        annual needs
                                                               (kg)
------------------------------------------------------------------------
Ephedrine (for sale)....................           4,000           4,300
Phenylpropanolamine (for sale)..........           5,200           5,800
Pseudoephedrine.........................         258,000         278,000
Phenylpropanolamine (for conversion)....          26,200       No Change
Ephedrine (for conversion)..............          12,000       No Change
------------------------------------------------------------------------

    In finalizing the adjustment of the 2012 assessment of annual needs 
for ephedrine, pseudoephedrine, and phenylpropanolamine, DEA will 
consider any additional changes in demand, changes in the national rate 
of net disposal, or changes in the rate of net disposal by the 
registrants holding individual manufacturing or import quotas for the 
chemical, in accordance with 21 CFR Part 1315.

Comments

    Pursuant to 21 CFR 1315.13, any interested person may submit 
written comments on or objections to these proposed determinations. 
Based on comments received in response to this Notice, the 
Administrator may hold a public hearing on one or more issues raised. 
In the event the Administrator decides in her sole discretion to hold 
such a hearing, the Administrator will publish a notice of any such 
hearing in the Federal Register. After consideration of any comments 
and after a hearing, if one is held, the Administrator will publish in 
the Federal Register a Final Order determining any adjustment of the 
assessment of annual needs.

    Dated: July 13, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-17522 Filed 7-17-12; 8:45 am]
BILLING CODE 4410-09-P