Exemption of Chemical Mixtures; Correction, 294-295 [05-57]
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Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Rules and Regulations
§ 1304.26 Additional recordkeeping
requirements applicable to drug products
containing gamma-hydroxybutyric acid.
In addition to the recordkeeping
requirements for dispensers and
researchers provided in § 1304.22,
practitioners dispensing gammahydroxybutyric acid that is
manufactured or distributed in
accordance with an application under
section 505 of the Federal Food, Drug,
and Cosmetic Act must maintain and
make available for inspection and
copying by the Attorney General, all of
the following information for each
prescription:
(a) Name of the prescribing
practitioner.
(b) Prescribing practitioner’s Federal
and State registration numbers, with the
expiration dates of these registrations.
(c) Verification that the prescribing
practitioner possesses the appropriate
registration to prescribe this controlled
substance.
(d) Patient’s name and address.
(e) Patient’s insurance provider, if
available.
I 4. Section 1304.33 is amended by
revising paragraph (c) and the
introductory text of paragraph (d)(1) to
read as follows:
§ 1304.33
Reports to ARCOS.
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(c) Persons reporting. For controlled
substances in Schedules I, II, narcotic
controlled substances in Schedule III,
and gamma-hydroxybutyric acid drug
product controlled substances in
Schedule III, each person who is
registered to manufacture in bulk or
dosage form, or to package, repackage,
label or relabel, and each person who is
registered to distribute, including each
person who is registered to reverse
distribute, shall report acquisition/
distribution transactions. In addition to
reporting acquisition/distribution
transactions, each person who is
registered to manufacture controlled
substances in bulk or dosage form shall
report manufacturing transactions on
controlled substances in Schedules I
and II, each narcotic controlled
substance listed in Schedules III, IV,
and V, gamma-hydroxybutyric acid drug
product controlled substances in
Schedule III, and on each psychotropic
controlled substance listed in Schedules
III and IV as identified in paragraph (d)
of this section.
(d) Substances covered. (1)
Manufacturing and acquisition/
distribution transaction reports shall
include data on each controlled
substance listed in Schedules I and II,
on each narcotic controlled substance
listed in Schedule III (but not on any
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15:29 Jan 03, 2005
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material, compound, mixture or
preparation containing a quantity of a
substance having a stimulant effect on
the central nervous system, which
material, compound, mixture or
preparation is listed in Schedule III or
on any narcotic controlled substance
listed in Schedule V), and on gammahydroxybutyric acid drug products
listed in Schedule III. Additionally,
reports on manufacturing transactions
shall include the following psychotropic
controlled substances listed in
Schedules III and IV:
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PART 1306—PRESCRIPTIONS
5. The authority citation for part 1306
continues to read as follows:
I
Authority: 21 U.S.C. 821, 829, 871(b)
unless otherwise noted.
6. Section 1306.05 is amended by
revising paragraph (a) to read as follows:
I
§ 1306.05 Manner of issuance of
prescriptions.
(a) All prescriptions for controlled
substances shall be dated as of, and
signed on, the day when issued and
shall bear the full name and address of
the patient, the drug name, strength,
dosage form, quantity prescribed,
directions for use and the name, address
and registration number of the
practitioner. Where a prescription is for
gamma-hydroxybutyric acid, the
practitioner shall note on the face of the
prescription the medical need of the
patient for the prescription. A
practitioner may sign a prescription in
the same manner as he would sign a
check or legal document (e.g., J.H. Smith
or John H. Smith). Where an oral order
is not permitted, prescriptions shall be
written with ink or indelible pencil or
typewriter and shall be manually signed
by the practitioner. The prescriptions
may be prepared by the secretary or
agent for the signature of a practitioner,
but the prescribing practitioner is
responsible in case the prescription
does not conform in all essential
respects to the law and regulations. A
corresponding liability rests upon the
pharmacist, including a pharmacist
employed by a central fill pharmacy,
who fills a prescription not prepared in
the form prescribed by DEA regulations.
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PART 1310—RECORDS AND
REPORTS OF LISTED CHEMICALS
AND CERTAIN MACHINES
7. The authority citation for part 1310
is revised to read as follows:
I
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Authority: 21 U.S.C. 802, 827(h), 830,
871(b) 890.
8. Section 1310.03 is amended by
revising paragraph (c) to read as follows:
I
§ 1310.03 Persons required to keep
records and file reports.
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(c) Each regulated person who
engages in a transaction with a
nonregulated person or who engages in
an export transaction that involves
ephedrine, pseudoephedrine,
phenylpropanolamine, or gammahydroxybutyric acid, including drug
products containing these chemicals,
and uses or attempts to use the Postal
Service or any private or commercial
carrier must file monthly reports of each
such transaction as specified in
§ 1310.05 of this part.
Dated: December 22, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. 05–56 Filed 1–3–05; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA–137f2]
RIN 1117–AA31
Exemption of Chemical Mixtures;
Correction
Drug Enforcement
Administration (DEA), Justice.
ACTION: Final rule with request for
comment; correction.
AGENCY:
SUMMARY: This document corrects the
Final Rule with request for comment
‘‘Exemption of Chemical Mixtures’’
[Docket No. DEA–137f2, RIN 1117–
AA31] which DEA published in the
Federal Register on Wednesday,
December 15, 2004 (69 FR 74957). The
Final Rule concerned the exemption of
certain chemical mixtures containing
listed chemicals from the provisions of
the Controlled Substances Act.
DATES: This correction is effective
January 14, 2005.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section,
Office of Diversion Control, Drug
Enforcement Administration,
Washington, DC 20537, Telephone (202)
307–7183
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 70, No. 2 / Tuesday, January 4, 2005 / Rules and Regulations
Background
On Wednesday, December 15, 2004,
DEA published a Final Rule with
request for comment entitled
‘‘Exemption of Chemical Mixtures’’ in
the Federal Register (69 FR 74957). The
aspect of the Final Rule subject to this
correction concerns the amendatory
instructions for 21 CFR 1310.04 in
which DEA indicated that ‘‘Section
1310.04 is to be amended by revising
paragraph (h) and adding new
paragraphs (i) and (j)’’. However, it was
not DEA’s intent to add new paragraphs
(i) and (j). DEA only intended to revise
paragraph (h). Therefore, to alleviate
any confusion which might arise
regarding these amendatory
instructions, DEA is correcting the
amendatory instructions for 21 CFR
1310.04. No substantive changes to 21
CFR 1310.04 are occurring in this
correction.
I Accordingly, the publication on
Wednesday, December 15, 2004 of the
Final Rule with request for comment
[Docket No. DEA–137f2, RIN 1117–
AA31], which was the subject of FR Doc.
04–27449, is corrected as follows:
PART 1310—[CORRECTED]
1. On page 74970, amendatory
instruction 2 is corrected to read as
follows: ‘‘2. Section 1310.04 is amended
by revising paragraph (h) to read as
follows:’’
I
Dated: December 27, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. 05–57 Filed 1–3–05; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE TREASURY
Internal Revenue Service
[TD 9172]
RIN 1545–BB12
Gross Estate; Election to Value on
Alternate Valuation Date
Internal Revenue Service (IRS),
Treasury.
ACTION: Final regulations.
AGENCY:
SUMMARY: This document contains final
regulations that amend § 20.2032–1(b) to
reflect the change made to section 2032
of the Internal Revenue Code by the
Deficit Reduction Act of 1984 and the
technical change to that section made by
the Tax Reform Act of 1986. In addition,
the final regulations remove temporary
15:29 Jan 03, 2005
Background
On December 24, 2003, proposed
regulations (REG–139845–02) were
published in the Federal Register (68
FR 74534). The proposed regulations
contained proposed amendments to the
Estate Tax Regulations (26 CFR part 20)
and the Procedure and Administration
Regulations (26 CFR part 301) relating to
the election under section 2032 to value
a decedent’s gross estate on the alternate
valuation date. The proposed
regulations reflected changes that were
made to section 2032 by the Deficit
Reduction Act of 1984, Public Law 98–
369 (98 Stat. 494). Written comments
were received on the proposed
regulations, and a public hearing was
held on June 3, 2004. The proposed
regulations, with certain changes in
response to the written and oral
comments, are adopted as final
regulations.
Summary of Comments and
Explanation of Provisions
26 CFR Parts 20 and 301
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regulation § 301.9100–6T(b) of the
Procedure and Administration
Regulations so that estates that fail to
make the alternate valuation election on
the last estate tax return filed before the
due date of the return, or on the first
estate tax return filed after the due date
of the return may request an extension
of time to make the election under the
provisions of §§ 301.9100–1 and
301.9100–3. The final regulations affect
estates that are required to file Form
706, United States Estate (and
Generation-Skipping Transfer) Tax
Return.
DATES: Effective Date: These regulations
are effective January 4, 2005.
Applicability Date: For dates of
applicability, see § 20.2032–1(h).
FOR FURTHER INFORMATION CONTACT:
Theresa M. Melchiorre at (202) 622–
7830 (not a toll-free number).
SUPPLEMENTARY INFORMATION:
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Determination of Eligibility To Make the
Alternate Valuation Election
The proposed regulations provided
that the alternate valuation election may
be made only if the election results in
a decrease both in the value of the gross
estate and in the sum of the estate tax
and generation-skipping transfer tax
liability (reduced by credits allowable
against these taxes). One commentator
noted that it may not be possible to
determine whether the election will
reduce the sum of estate tax and
generation-skipping transfer tax if the
generation-skipping transfer tax will not
be imposed until a later time, as in the
case of a later taxable termination or
taxable distribution. In response to this
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295
comment, the final regulations provide
that the determination of whether there
has been a decrease in the sum of the
estate tax and generation-skipping
transfer tax liability (reduced by credits
allowable against these taxes) is made
with reference to the estate tax and
generation-skipping transfer tax payable
by reason of the decedent’s death.
Availability of Relief Under
§§ 301.9100–1 and 301.9100–3
In view of the 1-year limitation
imposed under section 2032(d)(2), the
proposed regulations provided that no
request for an extension of time to make
the alternate valuation election under
the provisions of §§ 301.9100–1 and
301.9100–3 will be granted if the
request is submitted to the IRS more
than 1 year after the due date of the
return of tax imposed by section 2001
(including extensions of time actually
granted). One commentator argued that
the 1-year limitation in section
2032(d)(2) applies only to late-filed
returns, and therefore should not limit
the availability of relief under
§§ 301.9100–1 and 301.9100–3 to make
a late alternate valuation election if the
taxpayer timely filed its return, but
failed to make the election on the
return. After considering the language
and intent of section 2032 and
§§ 301.9100–1 and 301.9100–3, the IRS
and Treasury Department have
determined that taxpayers may request
relief under §§ 301.9100–1 and
301.9100–3, even after the expiration of
the 1-year period, and that such relief
may be granted (subject to the
requirements of §§ 301.9100–1 and
301.9100–3) provided that the return of
tax is filed no later than 1 year after the
due date of the return (including
extensions of time actually granted).
This rule also will apply to requests
under §§ 301.9100–1 and 301.9100–3 for
an extension of time to make a
protective election under section 2032.
The IRS and Treasury Department
also have determined that taxpayers
should be permitted to apply for relief
under §§ 301.9100–1 and 301.9100–3 to
make a late election under section
2056A to be treated as a Qualified
Domestic Trust (QDOT). Like the
alternate valuation election of section
2032, no election under section 2056A
to be treated as a QDOT may be made
on a return that is filed more than 1 year
after the due date of the return
(including extensions of time actually
granted). Section 2056A(d). Thus,
taxpayers will be permitted to apply for
an extension of time under the
provisions of §§ 301.9100–1 and
301.9100–3 to make an election under
section 2056A(d), provided that the
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]]>Agencies
[Federal Register Volume 70, Number 2 (Tuesday, January 4, 2005)]
[Rules and Regulations]
[Pages 294-295]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-57]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1310
[Docket No. DEA-137f2]
RIN 1117-AA31
Exemption of Chemical Mixtures; Correction
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Final rule with request for comment; correction.
-----------------------------------------------------------------------
SUMMARY: This document corrects the Final Rule with request for comment
``Exemption of Chemical Mixtures'' [Docket No. DEA-137f2, RIN 1117-
AA31] which DEA published in the Federal Register on Wednesday,
December 15, 2004 (69 FR 74957). The Final Rule concerned the exemption
of certain chemical mixtures containing listed chemicals from the
provisions of the Controlled Substances Act.
DATES: This correction is effective January 14, 2005.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, Telephone (202) 307-
7183
SUPPLEMENTARY INFORMATION:
[[Page 295]]
Background
On Wednesday, December 15, 2004, DEA published a Final Rule with
request for comment entitled ``Exemption of Chemical Mixtures'' in the
Federal Register (69 FR 74957). The aspect of the Final Rule subject to
this correction concerns the amendatory instructions for 21 CFR 1310.04
in which DEA indicated that ``Section 1310.04 is to be amended by
revising paragraph (h) and adding new paragraphs (i) and (j)''.
However, it was not DEA's intent to add new paragraphs (i) and (j). DEA
only intended to revise paragraph (h). Therefore, to alleviate any
confusion which might arise regarding these amendatory instructions,
DEA is correcting the amendatory instructions for 21 CFR 1310.04. No
substantive changes to 21 CFR 1310.04 are occurring in this correction.
0
Accordingly, the publication on Wednesday, December 15, 2004 of the
Final Rule with request for comment [Docket No. DEA-137f2, RIN 1117-
AA31], which was the subject of FR Doc. 04-27449, is corrected as
follows:
PART 1310--[CORRECTED]
0
1. On page 74970, amendatory instruction 2 is corrected to read as
follows: ``2. Section 1310.04 is amended by revising paragraph (h) to
read as follows:''
Dated: December 27, 2004.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 05-57 Filed 1-3-05; 8:45 am]
BILLING CODE 4410-09-P
