PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE,
AND PHENYLPROPANOLAMINE - Subpart B--Assessment of Annual Needs
This page includes changes
to the Code of Federal Regulations since April 1, 2007. View
Key.
Sec. 1315.11 Assessment of annual needs.
(a) The Administrator shall determine the total quantity of ephedrine,
pseudoephedrine, and phenylpropanolamine, including drug products containing
ephedrine, pseudoephedrine, and phenylpropanolamine, necessary to be
manufactured and imported during the following 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.
(b) In making his determinations, the Administrator shall consider the
following factors:
(1) Total net disposal of the chemical by all manufacturers and importers
during the current and 2 preceding years;
(2) Trends in the national rate of net disposal of each chemical;
(3) Total actual (or estimated) inventories of the chemical and of all
substances manufactured from the chemical, and trends in inventory
accumulation;
(4) Projected demand for each chemical as indicated by procurement and
import quotas requested pursuant to Sec. 1315.32; and
(5) Other factors affecting medical, scientific, research, and industrial
needs in the United States, lawful export requirements, and the establishment
and maintenance of reserve stocks, as the Administrator finds relevant,
including changes in the currently accepted medical use in treatment with the
chemicals or the substances which are manufactured from them, the economic and
physical availability of raw materials for use in manufacturing and for
inventory purposes, yield and stability problems, potential disruptions to
production (including possible labor strikes), and recent unforeseen
emergencies such as floods and fires.
(c) The Administrator shall, on or before May 1 of each year, publish in
the Federal Register, general notice of an assessment of annual needs for
ephedrine, pseudoephedrine, and phenylpropanolamine determined by him under
this section. A notice of the publication shall be mailed simultaneously to
each person registered to manufacture or import the chemical.
(d) The Administrator shall permit any interested person to file written
comments on or objections to the proposed assessment of annual needs and shall
designate in the notice the time during which the filings may be made.
(e) The Administrator may, but is not required to, hold a public hearing on
one or more issues raised by the comments and objections filed with him. In
the event the Administrator decides to hold such a hearing, he shall publish a
notice of the hearing in the Federal Register. The notice shall summarize the
issues to be heard and set the time for the hearing, which shall not be less
than 30 days after the date of publication of the notice.
(f) After consideration of any comments or objections, or after a hearing
if one is ordered by the Administrator, the Administrator shall issue and
publish in the Federal Register the final order determining the assessment of
annual needs for the chemicals. The order shall include the findings of fact
and conclusions of law upon which the order is based. The order shall specify
the date on which it shall take effect. A notice of the publication shall be
mailed simultaneously to each person registered as a manufacturer or importer
of the chemical.
Sec. 1315.13 Adjustments of the assessment of annual needs.
(a) The Administrator may at any time increase or reduce the assessment of
annual needs for ephedrine, pseudoephedrine, or phenylpropanolamine that has
been previously fixed pursuant to Sec. 1315.11.
(b) In determining to adjust the assessment of annual needs, the
Administrator shall consider the following factors:
(1) Changes in the demand for that chemical, changes in the national rate
of net disposal of the chemical, and changes in the rate of net disposal of
the chemical by registrants holding individual manufacturing or import quotas
for that chemical;
(2) Whether any increased demand for that chemical, the national and/or
changes in individual rates of net disposal of that chemical are temporary,
short term, or long term;
(3) Whether any increased demand for that chemical can be met through
existing inventories, increased individual manufacturing quotas, or increased
importation, without increasing the assessment of annual needs, taking into
account production delays and the probability that other individual
manufacturing quotas may be suspended pursuant to Sec. 1315.24(b);
(4) Whether any decreased demand for that chemical will result in excessive
inventory accumulation by all persons registered to handle that chemical
(including manufacturers, distributors, importers, and exporters),
notwithstanding the possibility that individual manufacturing quotas may be
suspended pursuant to Sec. 1315.24(b) or abandoned pursuant to Sec. 1315.27;
(5) Other factors affecting medical, scientific, research, industrial, and
importation needs in the United States, lawful export requirements, and
reserve stocks, as the Administrator finds relevant, including changes in the
currently accepted medical use in treatment with the chemical or the
substances that are manufactured from it, the economic and physical
availability of raw materials for use in manufacturing and for inventory
purposes, yield and stability problems, potential disruptions to production
(including possible labor strikes), and recent unforeseen emergencies such as
floods and fires.
(c) In the event that the Administrator determines to increase or reduce
the assessment of annual needs for a chemical, the Administrator shall publish
in the Federal Register general notice of an adjustment in the assessment of
annual needs for that chemical as determined under this section. A notice of
the publication shall be mailed simultaneously to each person registered as a
manufacturer or importer of the chemical.
(d) The Administrator shall permit any interested person to file written
comments on or objections to the proposal and shall designate in the notice
the time during which such filings may be made.
(e) The Administrator may, but is not required to, hold a public hearing on
one or more issues raised by the comments and objections filed with him. In
the event the Administrator decides to hold such a hearing, he shall publish a
notice of the hearing in the Federal Register. The notice shall summarize the
issues to be heard and set the time for the hearing, which shall not be less
than 10 days after the date of publication of the notice.
(f) After consideration of any comments or objections, or after a hearing
if one is ordered by the Administrator, the Administrator shall issue and
publish in the Federal Register the final order determining the assessment of
annual needs for the chemical. The order shall include the
findings of fact and conclusions of law upon which the order is based. The
order shall specify the date on which it shall take effect. A notice of the
publication shall be mailed simultaneously to each person registered as a
manufacturer or importer of the chemical.
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
