Chemical Mixtures; Temporary Waiver of Import/Export Requirements, 5925-5926 [05-2212]
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Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Rules and Regulations
(ii) In the case of a customer who does
not qualify as an ‘‘institutional
customer’’ as defined in § 1.3(g) of this
chapter, an introducing broker must
obtain the customer’s prior consent
through a signed acknowledgment,
which may be accomplished in
accordance with § 1.55(d) of this
chapter.
*
*
*
*
*
Dated: January 27, 2005.
By the Commission.
Jean A. Webb,
Secretary of the Commission.
[FR Doc. 05–1906 Filed 2–3–05; 8:45 am]
BILLING CODE 6351–01–M
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1310 and 1313
[Docket No. DEA–137N]
RIN 1117–AA31
Chemical Mixtures; Temporary Waiver
of Import/Export Requirements
Drug Enforcement
Administration (DEA), Justice.
ACTION: Temporary waiver of import/
export requirements.
AGENCY:
SUMMARY: On December 15, 2004, the
Drug Enforcement Administration
(DEA) published a final rule that
implemented regulations pertaining to
chemical mixtures that contain any of
27 listed chemicals regulated under the
Controlled Substances Act (21 U.S.C.
801 et seq.). That rulemaking became
effective on January 14, 2005.
Following publication of the final
rule, certain segments of the chemical
industry expressed concerns to DEA
regarding difficulty in fully complying
with DEA import/export notification
requirements as specified in 21 CFR part
1313 by this deadline. Therefore, in
order to avoid interruption of legitimate
import/export distributions, DEA is
providing a waiver of the import/export
reporting requirements as specified in
21 CFR part 1313 until May 14, 2005.
As such, regulated persons will
temporarily not be required to submit
advance notification for import, export
and transshipment transactions for
chemical mixtures regulated solely due
to the presence of these 27 listed
chemicals until May 14, 2005. This
temporary waiver applies only to
import, export and transshipment
notification requirements; all other
chemical control requirements set forth
in the final rulemaking published on
VerDate jul<14>2003
14:01 Feb 03, 2005
Jkt 205001
December 15, 2004, shall remain in full
force and effect.
DATES: Effective February 4, 2005. The
new deadline for providing import,
export and transshipment notification
for regulated chemical mixtures
containing these 27 listed chemicals
will be May 14, 2005.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, Ph.D., Chief,
Drug & Chemical Evaluation Section,
Office of Diversion Control, Drug
Enforcement Administration,
Washington, DC 20537, telephone (202)
307–7183
SUPPLEMENTARY INFORMATION: On
December 15, 2004, the Drug
Enforcement Administration (DEA)
published a final rule (69 FR 74957) that
implemented regulations pertaining to
chemical mixtures that contain any of
27 listed chemicals regulated under the
Controlled Substances Act (CSA). That
rulemaking became effective on January
14, 2005.
Following publication of the final rule
concerns were raised by various
segments of the chemical industry
regarding their difficulty in fully
complying with DEA import/export
notification requirements as specified in
21 CFR part 1313 by this deadline. DEA
received correspondence from two
national chemical associations and from
one major chemical producer.
Additionally, DEA received verbal
communication from industry that
expressed concerns regarding the large
number of potentially affected mixtures
and the difficulty industry was having
in meeting deadlines for submitting
import/export notification. After
carefully considering the concerns
expressed by industry, DEA has decided
to postpone the implementation of the
import/export notification requirements
as specified in 21 CFR part 1313 until
May 14, 2005. This temporary waiver
shall apply only to chemical mixtures
which became regulated under the
December 15, 2004 final rule (69 FR
74957).
While the submission of import,
export and transshipment information
to DEA is an important provision in
countering the potential diversion of
these materials, this temporary waiver is
being provided to allow industry ample
time to ensure their full compliance
with CSA import/export regulatory
requirements as specified in 21 CFR part
1313. As such, DEA will be temporarily
waiving the requirement for regulated
persons to submit advance notification
for import, export and transshipment
transactions for chemical mixtures
which are regulated solely due to the
presence of the 27 listed chemicals
PO 00000
Frm 00011
Fmt 4700
Sfmt 4700
5925
which were the subject of the December
15, 2004 final rule. This temporary
waiver applies only to import, export
and transshipment notification
requirements. All other chemical
control requirements set forth in the
final rulemaking published on
December 15, 2004 (69 FR 74957) shall
remain in full force and effect.
The new deadline for providing
import, export and transshipment
notification for regulated chemical
mixtures containing these 27 listed
chemicals will be May 14, 2005.
Provisions of December 15, 2004 Final
Rule (69 FR 74957) Which Do Not
Change
For any person distributing,
importing, or exporting any amount of
a regulated mixture containing a List I
chemical, the CSA requires that person
to obtain a DEA registration. DEA
recognizes that it is not possible for
persons who are subject to the
registration requirement to immediately
complete and submit an application for
registration and for DEA to immediately
issue registrations for those activities.
Therefore, in order to allow continued
legitimate commerce in regulated
mixtures, the December 15, 2004 final
rule established a temporary exemption
from the registration requirement (in 21
CFR 1310.09) for persons desiring to
engage in activities with regulated
mixtures that are subject to registration
requirements, provided that DEA
receives a properly completed
application for registration or an
application for exemption (pursuant to
21 CFR 1310.13) for their chemical
mixture(s) on or before February 14,
2005. The temporary exemption from
registration for such persons will remain
in effect until DEA takes final action on
their application(s).
Any person whose application for
exemption is subsequently rejected by
DEA must obtain a registration with
DEA. A temporary exemption from the
registration requirement will also be
provided for these persons, if DEA
receives a properly completed
application for registration on or before
30 days following the date of official
DEA notification that the application for
exemption has not been approved. The
deadline for submission of an
application for registration, or an
application for exemption, remains
February 14, 2005 in order to obtain the
temporary exemption from registration.
None of the temporary exemptions
discussed in this rulemaking suspend
applicable federal criminal laws relating
to the regulated mixtures, nor does it
supersede state or local laws or
regulations. All handlers of a regulated
E:\FR\FM\04FER1.SGM
04FER1
5926
Federal Register / Vol. 70, No. 23 / Friday, February 4, 2005 / Rules and Regulations
mixture must comply with applicable
state and local requirements in addition
to the CSA regulatory controls.
Dated: January 28, 2005.
William J. Walker,
Deputy Assistant Administrator, Office of
Diversion Control.
[FR Doc. 05–2212 Filed 2–3–05; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AK94
Payment for Non-VA Physician and
Other Health Care Professional
Services Associated With Either
Outpatient or Inpatient Care Provided
at Non-VA Facilities
Department of Veterans Affairs.
Final rule.
AGENCY:
ACTION:
SUMMARY: This final rule amends the
Department of Veterans Affairs (VA)
medical regulations concerning
payment for non-VA health care
professional services that are associated
with either outpatient or inpatient care
provided to eligible VA beneficiaries at
non-VA facilities. Currently, the
medical regulations require all VA
facilities to reimburse for non-VA health
care professional services based upon
the Centers for Medicare and Medicaid
Services (CMS) physician fee schedule
in effect at the time the services are
provided. However, if the standard
payment methodology is implemented
in Alaska, VA payments will be
significantly less than the usual and
customary charges for the state. This
may limit VA patient access to non-VA
health care. Since a large portion of VA
health care provided in Alaska is
obtained from non-VA sources, this
could negatively impact the quality of
care provided veterans living in that
state. This rule establishes an Alaskaspecific payment methodology for
inpatient and outpatient non-VA health
care professional services within that
state. The rule ensures that amounts
paid to health care providers represent
the local cost to furnish a service, while
continuing to achieve program cost
reductions.
DATES: Effective Date: This rule shall
become effective on March 7, 2005.
Applicability Date: This rule shall be
applicable to all claims for payment for
services rendered on or after April 1,
2005.
FOR FURTHER INFORMATION CONTACT:
Susan Schmetzer, Chief, Policy &
VerDate jul<14>2003
14:01 Feb 03, 2005
Jkt 205001
Compliance Division, Health
Administration Center, Department of
Veterans Affairs, P.O. Box 65020,
Denver, CO 80206, telephone 303–331–
7552. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: In a
document published in the Federal
Register on July 29, 2003 (68 FR 44507)
we proposed to amend VA’s medical
regulations at 38 CFR part 17 to provide
for the payment of non-VA physician
services in Alaska that are associated
with either outpatient or inpatient care
provided to eligible VA beneficiaries at
non-VA facilities. We provided a 60-day
comment period that ended on
September 29, 2003. We received one
comment, in which the commenter
suggested that VA adopt the Official
Alaska Workers’ Compensation Medical
Fee Schedule as a basis for such
payments. No changes are made based
on this comment, as adoption of the
Official Alaska Workers’ Compensation
Medical Fee Schedule would not
achieve the dual goal of ensuring that
the amounts paid to health care
providers better represent the local cost
to furnish a service, while continuing to
achieve program cost reductions.
A number of technical changes of a
non-substantive nature have been made
in this final rule. The proposed rule
described the title of this rule as
Payment for Non-VA Physician Services
Associated with Either Outpatient or
Inpatient Care Provided at Non-VA
Facilities. The use of the phrase ‘‘nonVA physician,’’ both in the title of 38
CFR 17.56 and throughout the
regulation, is imprecise, as the rule
applies to all non-VA physician and
other health care professional services
associated with outpatient or inpatient
care provided at non-VA facilities. In
order to reconcile the terminology used
in this rule with common practice in
VA, the phrase ‘‘non-VA physician’’
will be replaced with ‘‘non-VA health
care professional services.’’
Additionally, the language was clarified
to state the rates payable are based on
the geographic location of where the
services were rendered.
The proposed rule stated that VA
would rely on Current Procedural
Terminology (CPT) codes utilized by
Centers for Medicare and Medicaid
Services (CMS) to pay for these non-VA
services. The reference to CPT codes
was too restrictive, as CMS uses other
national coding sets for health care
professional services. Therefore, the
references to CPT codes were removed.
The final rule refers generally to the use
of national standard code sets.
The proposed rule referenced Fiscal
Year (FY) 2002 as the base year for
PO 00000
Frm 00012
Fmt 4700
Sfmt 4700
determining various costs. In light of the
passage of time since publication of the
proposed rule, and in order to reflect the
most up-to-date data, this reference has
been changed to FY 2003 throughout the
final rule.
The proposed rule stated that for
services that VA did not have occasion
to pay for in Alaska in FY 2002, and for
services represented by CPT codes
established after FY 2002, VA will take
the Centers for Medicare and Medicaid
Services’ rate for each unpaid code and
multiply it times the average percentage
paid by VA in Alaska for Centers for
Medicare and Medicaid Services-like
codes. Applying this rule only to
services that VA had no occasion to pay
during the previous Fiscal Year was
unnecessarily narrow and would limit
VA’s ability to accurately gauge a
reasonable payment. It is also
inconsistent with other provisions of
this rule, which require a minimum of
eight occurrences. Therefore, the final
rule has been revised to apply this rule
to services that VA provided less than
eight times in Alaska during the
previous Fiscal Year. Clarification was
also made that this rule would be
applicable to unit-based codes as the VA
moved from a single payment per code
irrespective of units to unit-based
payment in FY 2004, and development
of a fee schedule that is not unit-based
would be inconsistent and inaccurate.
The proposed rule stated that VA
would increase the amounts on the VA
Fee Schedule for Alaska annually in
accordance with annual inflation rate
adjustments published by CMS. The VA
will use the national Medicare
Economic Index (MEI) for that purpose.
The MEI measures inflation in
physician practice cost and general
wage levels. The VA will not make
modifications to the MEI based on
regional factors because doing so would
not achieve the dual goal of ensuring
that the amounts paid to health care
providers represent the local cost to
furnish a service, while continuing to
achieve program cost reductions.
Administrative Procedure Act
The modifications in this final rule
are logical and reasonable outgrowths of
the proposed changes set forth in the
proposed rule and are intended to
clarify the intent of the proposed rule.
Based on the rationales set forth in the
proposed rule and those contained in
this document, we are adopting the
provisions of the proposed rule as a
final rule with the modifications
described above.
E:\FR\FM\04FER1.SGM
04FER1
]]>Agencies
[Federal Register Volume 70, Number 23 (Friday, February 4, 2005)]
[Rules and Regulations]
[Pages 5925-5926]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-2212]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1310 and 1313
[Docket No. DEA-137N]
RIN 1117-AA31
Chemical Mixtures; Temporary Waiver of Import/Export Requirements
AGENCY: Drug Enforcement Administration (DEA), Justice.
ACTION: Temporary waiver of import/export requirements.
-----------------------------------------------------------------------
SUMMARY: On December 15, 2004, the Drug Enforcement Administration
(DEA) published a final rule that implemented regulations pertaining to
chemical mixtures that contain any of 27 listed chemicals regulated
under the Controlled Substances Act (21 U.S.C. 801 et seq.). That
rulemaking became effective on January 14, 2005.
Following publication of the final rule, certain segments of the
chemical industry expressed concerns to DEA regarding difficulty in
fully complying with DEA import/export notification requirements as
specified in 21 CFR part 1313 by this deadline. Therefore, in order to
avoid interruption of legitimate import/export distributions, DEA is
providing a waiver of the import/export reporting requirements as
specified in 21 CFR part 1313 until May 14, 2005. As such, regulated
persons will temporarily not be required to submit advance notification
for import, export and transshipment transactions for chemical mixtures
regulated solely due to the presence of these 27 listed chemicals until
May 14, 2005. This temporary waiver applies only to import, export and
transshipment notification requirements; all other chemical control
requirements set forth in the final rulemaking published on December
15, 2004, shall remain in full force and effect.
DATES: Effective February 4, 2005. The new deadline for providing
import, export and transshipment notification for regulated chemical
mixtures containing these 27 listed chemicals will be May 14, 2005.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, Ph.D., Chief,
Drug & Chemical Evaluation Section, Office of Diversion Control, Drug
Enforcement Administration, Washington, DC 20537, telephone (202) 307-
7183
SUPPLEMENTARY INFORMATION: On December 15, 2004, the Drug Enforcement
Administration (DEA) published a final rule (69 FR 74957) that
implemented regulations pertaining to chemical mixtures that contain
any of 27 listed chemicals regulated under the Controlled Substances
Act (CSA). That rulemaking became effective on January 14, 2005.
Following publication of the final rule concerns were raised by
various segments of the chemical industry regarding their difficulty in
fully complying with DEA import/export notification requirements as
specified in 21 CFR part 1313 by this deadline. DEA received
correspondence from two national chemical associations and from one
major chemical producer. Additionally, DEA received verbal
communication from industry that expressed concerns regarding the large
number of potentially affected mixtures and the difficulty industry was
having in meeting deadlines for submitting import/export notification.
After carefully considering the concerns expressed by industry, DEA has
decided to postpone the implementation of the import/export
notification requirements as specified in 21 CFR part 1313 until May
14, 2005. This temporary waiver shall apply only to chemical mixtures
which became regulated under the December 15, 2004 final rule (69 FR
74957).
While the submission of import, export and transshipment
information to DEA is an important provision in countering the
potential diversion of these materials, this temporary waiver is being
provided to allow industry ample time to ensure their full compliance
with CSA import/export regulatory requirements as specified in 21 CFR
part 1313. As such, DEA will be temporarily waiving the requirement for
regulated persons to submit advance notification for import, export and
transshipment transactions for chemical mixtures which are regulated
solely due to the presence of the 27 listed chemicals which were the
subject of the December 15, 2004 final rule. This temporary waiver
applies only to import, export and transshipment notification
requirements. All other chemical control requirements set forth in the
final rulemaking published on December 15, 2004 (69 FR 74957) shall
remain in full force and effect.
The new deadline for providing import, export and transshipment
notification for regulated chemical mixtures containing these 27 listed
chemicals will be May 14, 2005.
Provisions of December 15, 2004 Final Rule (69 FR 74957) Which Do Not
Change
For any person distributing, importing, or exporting any amount of
a regulated mixture containing a List I chemical, the CSA requires that
person to obtain a DEA registration. DEA recognizes that it is not
possible for persons who are subject to the registration requirement to
immediately complete and submit an application for registration and for
DEA to immediately issue registrations for those activities. Therefore,
in order to allow continued legitimate commerce in regulated mixtures,
the December 15, 2004 final rule established a temporary exemption from
the registration requirement (in 21 CFR 1310.09) for persons desiring
to engage in activities with regulated mixtures that are subject to
registration requirements, provided that DEA receives a properly
completed application for registration or an application for exemption
(pursuant to 21 CFR 1310.13) for their chemical mixture(s) on or before
February 14, 2005. The temporary exemption from registration for such
persons will remain in effect until DEA takes final action on their
application(s).
Any person whose application for exemption is subsequently rejected
by DEA must obtain a registration with DEA. A temporary exemption from
the registration requirement will also be provided for these persons,
if DEA receives a properly completed application for registration on or
before 30 days following the date of official DEA notification that the
application for exemption has not been approved. The deadline for
submission of an application for registration, or an application for
exemption, remains February 14, 2005 in order to obtain the temporary
exemption from registration.
None of the temporary exemptions discussed in this rulemaking
suspend applicable federal criminal laws relating to the regulated
mixtures, nor does it supersede state or local laws or regulations. All
handlers of a regulated
[[Page 5926]]
mixture must comply with applicable state and local requirements in
addition to the CSA regulatory controls.
Dated: January 28, 2005.
William J. Walker,
Deputy Assistant Administrator, Office of Diversion Control.
[FR Doc. 05-2212 Filed 2-3-05; 8:45 am]
BILLING CODE 4410-09-P
