2011-23499. Proposed Adjustment of the Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2011

AGENCY:

Drug Enforcement Administration (DEA), Department of Justice.

ACTION:

Notice with request for comments.

SUMMARY:

This notice proposes to adjust the 2011 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 October 14, 2011. 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-350R” 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 http://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:

Christine A. Sannerud, Ph.D., Chief, UN Reporting and Quota Section, Drug Enforcement Administration, 8701 Morrissette Drive, Springfield, Virginia 22152, Telephone: [phone].

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” paragraph.

Background

On December 20, 2010, DEA established the assessment of annual needs for 2011 for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine, pursuant to 21 U.S.C. 826(a) and 21 CFR 1315.11 (75 FR 79407). 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 assessments of annual needs for 2011 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 2011 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 2011 assessment of annual needs, DEA 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 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 provided by DEA registered manufacturers and importers reflects the most current information available. In developing the proposed 2011 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 April 18, 2011, DEA registered manufacturers of dosage form products containing pseudoephedrine requested the authority to purchase 249,634 kg of pseudoephedrine. DEA registered manufacturers of pseudoephedrine reported sales totaling approximately 202,779 kg in 2009 and 216,724 kg in 2010; this represents a seven percent increase in sales reported by these firms from 2009 to 2010. 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 21, 2010. Based on the updated information provided to DEA as of April 18, 2011, DEA is proposing to increase the 2011 assessment of annual needs for pseudoephedrine (for sale) from 280,000 kg to 299,000 kg.

As of April 18, 2011, DEA registered manufacturers of phenylpropanolamine (for conversion) requested authority to purchase a total of 24,953 kg of phenylpropanolamine for the manufacture of amphetamine. DEA registered manufacturers of phenylpropanolamine reported sales of phenylpropanolamine totaling approximately 11,486 kg in 2009 and 17,086 kg in 2010; this represents a 33 percent increase in sales reported by these firms from 2009 to 2010. In 2011, DEA registered manufacturers reported sales of 21,008 kg for 2011; when compared to 2009 this represents a 45 percent increase in sales reported by these firms. DEA notes that in 2011 there were significant increased sales of phenylpropanolamine (for conversion) for the manufacture of amphetamine. DEA believes that current reported 2011 sales of phenylpropanolamine (for conversion) supplied by DEA registered manufacturers best represent the legitimate need for phenylpropanolamine (for conversion). There were no reported exports of phenylpropanolamine (for conversion). DEA has not received any requests to synthesize phenylpropanolamine in 2011. Based on the information provided to DEA, DEA is proposing to increase the 2011 assessment of annual needs for phenylpropanolamine (for conversion) from 21,800 kg to 29,500 kg.

As of April 18, 2011, the data provided to DEA for review of ephedrine (for sale), phenylpropanolamine (for sale), and ephedrine (for conversion) demonstrated no significant changes in demand or net disposals. Thus, DEA has determined that the assessment of annual needs for these chemicals—ephedrine (for sale), phenylpropanolamine (for sale), and ephedrine (for conversion)—shall remain unchanged.

The Administrator, therefore, proposes the following adjustment of the 2011 assessment of annual needs for the List I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine:

List I chemicals	2011 Assessment of annual needs	Proposed adjustment to the 2011 assessment of annual needs
Ephedrine (for sale)	4,200 kg	No Change.
Phenylpropanolamine (for sale)	5,300 kg	No Change.
Pseudoephedrine (for sale)	280,000 kg	299,000 kg.
Phenylpropanolamine (for conversion)	21,800 kg	29,500 kg.
Ephedrine (for conversion)	18,600 kg	No Change.

In finalizing the adjustment of the 2011 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: August 31, 2011.

Michele M. Leonhart,

Administrator.