Changes to and Consolidation of DEA Mailing Addresses, 10671-10687 [2010-4714]
Download as PDF
<![CDATA[
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
Alternative Methods of Compliance
(AMOCs)
DEPARTMENT OF JUSTICE
(j)(1) The Manager, Seattle Aircraft
Certification Office, FAA, has the authority to
approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19.
Send information to ATTN: Marcia Smith,
Aerospace Engineer, Cabin Safety and
Environmental Systems Branch, ANM–150S,
FAA, Seattle Aircraft Certification Office,
1601 Lind Avenue SW., Renton, Washington
98057–3356; telephone (425) 917–6484; fax
(425) 917–6590. Or, e-mail information to 9ANM-Seattle-ACO-AMOC-Requests@faa.gov.
(2) To request a different method of
compliance or a different compliance time
for this AD, follow the procedures in 14 CFR
39.19. Before using any approved AMOC on
any airplane to which the AMOC applies,
notify your principal maintenance inspector
(PMI) or principal avionics inspector (PAI),
as appropriate, or lacking a principal
inspector, your local Flight Standards District
Office. The AMOC approval letter must
specifically reference this AD.
Drug Enforcement Administration
Material Incorporated by Reference
sroberts on DSKD5P82C1PROD with RULES
(k) You must use Boeing Service Bulletin
747–25A3368, Revision 2, dated June 12,
2008, to do the actions required by this AD,
unless the AD specifies otherwise.
(1) The Director of the Federal Register
approved the incorporation by reference of
this service information under 5 U.S.C.
552(a) and 1 CFR part 51.
(2) For service information identified in
this AD, contact Boeing Commercial
Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H–65,
Seattle, Washington 98124–2207; telephone
206–544–5000, extension 1; fax 206–766–
5680; e-mail me.boecom@boeing.com;
Internet https://www.myboeingfleet.com.
(3) You may review copies of the service
information at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton,
Washington. For information on the
availability of this material at the FAA, call
425–227–1221 or 425–227–1152.
(4) You may also review copies of the
service information that is incorporated by
reference at the National Archives and
Records Administration (NARA). For
information on the availability of this
material at NARA, call 202–741–6030, or go
to: https://www.archives.gov/federal_register/
code_of_federal_regulations/
ibr_locations.html.
Issued in Renton, Washington, on February
25, 2010.
Jeffrey E. Duven,
Acting Manager, Transport Airplane
Directorate, Aircraft Certification Service.
[FR Doc. 2010–4650 Filed 3–8–10; 8:45 am]
BILLING CODE 4910–13–P
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
21 CFR Parts 1301, 1303, 1304, 1307,
1308, 1309, 1310, 1312, 1313, 1314,
1315, 1316, 1321
[Docket No. DEA–312F]
RIN 1117–AB19
Changes to and Consolidation of DEA
Mailing Addresses
AGENCY: Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
SUMMARY: DEA is amending Title 21 of
the Code of Federal Regulations (CFR) to
update and consolidate existing mailing
addresses. Mailing addresses are being
removed from the individual sections in
which they currently appear and are
being consolidated into one table in a
new part 1321. DEA is making this
change to the CFR to ensure registrants
have the most current and accurate
information, reduce administrative
costs, and facilitate future address
changes. A statement directing persons
to the Table of DEA Mailing Addresses
within the CFR is being provided in
place of specific mailing addresses.
DATES: Effective Date: This rule is
effective March 9, 2010.
FOR FURTHER INFORMATION CONTACT:
Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152, Telephone (202)
307–7297.
SUPPLEMENTARY INFORMATION:
DEA’s Legal Authority
DEA implements the Comprehensive
Drug Abuse Prevention and Control Act
of 1970, often referred to as the
Controlled Substances Act (CSA) and
Controlled Substances Import and
Export Act (21 U.S.C. 801–971), as
amended. DEA publishes the
implementing regulations for these
statutes in Title 21 of the Code of
Federal Regulations (CFR), parts 1300 to
end. These regulations are designed to
ensure that there is a sufficient supply
of controlled substances for legitimate
medical purposes and to deter the
diversion of controlled substances to
illegal purposes.
Controlled substances are drugs and
other substances that have a potential
for abuse and psychological and
physical dependence; these include
substances classified as opioids,
stimulants, depressants, hallucinogens,
PO 00000
Frm 00039
Fmt 4700
Sfmt 4700
10671
anabolic steroids, and drugs that are
immediate precursors of these classes of
substances. The CSA mandates that
DEA establish a closed system of control
for manufacturing, distributing, and
dispensing controlled substances. Any
person who manufactures, distributes,
dispenses, imports, exports, or conducts
research or chemical analysis with
controlled substances must register with
DEA (unless exempt) and comply with
the applicable requirements for the
activity.
The CSA, as amended, also requires
DEA to regulate the manufacture,
distribution, importation, and
exportation of chemicals that may be
used to manufacture controlled
substances. Listed chemicals that are
classified as List I chemicals are
important to the manufacture of
controlled substances. Those classified
as List II chemicals may be used to
manufacture controlled substances.
Registrants are also required to provide
other reports and information to DEA on
an ongoing basis in compliance with a
variety of statutory and regulatory
obligations.
Background
Currently, 21 CFR parts 1300 to end
contain numerous office names and
mailing addresses to which specific
forms and other information are to be
sent. However, oftentimes these mailing
addresses and office names are not
consistent and many are no longer
accurate. DEA became aware of this
internal inconsistency when it
determined that, to improve agency
management and efficiency, its
Washington, DC, addresses would be
moved to other locations. As DEA
reviewed the number of addresses
contained in 21 CFR, it became clear
that a significant administrative burden
would be involved in updating these
addresses. DEA recognized that this
administrative burden could potentially
not be a one-time occurrence; that is, it
is quite possible that DEA might move
some of its mailing addresses in the
future, necessitating further revisions to
the CFR.
For registrants to have the most
current mailing addresses to which
applications, forms, and other materials
are to be sent, DEA believes directing
registrants and other interested persons
to a single location within the CFR is
the most practical way to convey
current mailing address information. To
address this, DEA is establishing a new
part 1321 in the CFR that will contain
the Table of DEA Mailing Addresses.
Providing this information in the table
format in the CFR allows for easy
retrieval of necessary information in
E:\FR\FM\09MRR1.SGM
09MRR1
10672
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
multiple formats. By consolidating this
information into a table within the CFR,
DEA will be able to rapidly respond
should mailing addresses change due to
facility relocation, special mail handling
procedures, or other circumstances.
With publication of this Final Rule,
all entries citing DEA mailing addresses
will be removed and replaced with
language directing interested persons to
the Table of DEA Mailing Addresses
found at 21 CFR 1321.01.
Information Affected by the Removal of
Addresses
As noted previously, the current CFR
contains numerous addresses specific to
applications, forms, and other
information to be physically mailed to
DEA. Below are two tables. The first
table lists the CFR section which
previously contained a mailing address,
the subject, and the corresponding DEA
office that is responsible for that
activity. The second table provides the
mailing address information that will be
provided in 21 CFR 1321.01.
TABLE 1—MAILING ADDRESSES REFERENCED IN THE CFR
CFR Section
Subject
1301.03 ......................
1301.13(e)(2) .............
1301.14(a) .................
1301.18(c) ..................
1301.51 ......................
1301.52(b) .................
1301.52(c) ..................
1301.71(d) .................
1303.12(b) .................
Procedures information request (controlled substances registration) .................
Request DEA Forms 224, 225, and 363 .............................................................
Controlled substances registration application submission .................................
Research project controlled substance increase request ....................................
Controlled substances registration modification request .....................................
Controlled substances registration transfer request ............................................
Controlled substances registration return for cancellation ..................................
Controlled substances security system compliance review ................................
Application for controlled substances procurement quota (DEA Form 250) filing and request.
Controlled substances quota adjustment request ...............................................
1303.12(d) .................
1303.22 ......................
DEA Office
1304.04(d) .................
1304.31(a) .................
Application for individual manufacturing quota (DEA Form 189) filing and request for schedule I or II controlled substances.
ARCOS separate central reporting identifier request ..........................................
Manufacturers importing narcotic raw material report submission ......................
1304.32(a) .................
Manufacturers importing coca leaves report submission ....................................
1304.33(a) .................
1307.03 ......................
1307.22 ......................
1308.21(a) .................
1308.23(b) .................
1308.24(d) .................
Reports to ARCOS ...............................................................................................
Exception request filing ........................................................................................
Disposal of controlled substances by the Administration delivery application ....
Exclusion of nonnarcotic substance ....................................................................
Exemption for chemical preparations ..................................................................
Exempt narcotic chemical preparations importer/exporter reporting ...................
1308.24(i) ...................
Exempted chemical preparations listing ..............................................................
1308.25(a) .................
1308.26(a) .................
Exclusion of veterinary anabolic steroid implant product application ..................
Excluded veterinary anabolic steroid implant products listing .............................
1308.31(a) .................
1308.32 ......................
Exemption of a nonnarcotic prescription product application ..............................
Exempted prescription products listing ................................................................
1308.33(b) .................
1308.34 ......................
Exemption of certain anabolic steroid products application ................................
Exempted anabolic steroid products listing .........................................................
1308.43(b) .................
1309.03 ......................
1309.32(c) ..................
1309.33(a) .................
1309.61 ......................
1309.71(c) ..................
1310.05(c) ..................
1310.05(d) .................
Petition to initiate proceedings for rulemaking .....................................................
List I chemicals registration procedures information request ..............................
Request DEA Form 510 .......................................................................................
List I chemicals registration application submission ............................................
List I chemicals registration modification request ................................................
List I chemicals security system compliance review ...........................................
Importer/exporter of tableting or encapsulation machines reporting ...................
Bulk manufacturer of listed chemicals reporting ..................................................
1310.05(e)(1) .............
Reporting by persons required to keep records and file reports regarding List I
chemicals.
Request to submit List I chemicals reports in electronic form ............................
Report of declared exports of machines refused, rejected, or returned .............
Exemption for chemical preparations ..................................................................
Sale by Federal departments or agencies of chemicals which could be used to
manufacture controlled substances certification request.
Application for import permit (DEA Form 357) ....................................................
Return unused import permits .............................................................................
Import declaration (DEA Form 236) submission .................................................
DEA Form 236 copy 4 .........................................................................................
Application for export permit (DEA Form 161) ....................................................
Request for return of unacceptable or undeliverable exported controlled substances..
DEA Form 161 copy 2 .........................................................................................
sroberts on DSKD5P82C1PROD with RULES
1310.05(e)(2) .............
1310.06(g) .................
1310.13(b) .................
1310.21(b) .................
1312.12(a) .................
1312.16(b) .................
1312.18(b) .................
1312.19(b) .................
1312.22(a) .................
1312.22(d)(8) .............
1312.24(a) .................
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
PO 00000
Frm 00040
Fmt 4700
Sfmt 4700
E:\FR\FM\09MRR1.SGM
DEA Registration Section.
DEA Registration Section.
DEA Registration Section.
DEA Registration Section.
DEA Registration Section.
DEA Registration Section.
DEA Office of Diversion Control.
DEA Regulatory Section.
DEA Drug & Chemical Evaluation
tion.
DEA Drug & Chemical Evaluation
tion.
DEA Drug & Chemical Evaluation
tion.
DEA ARCOS Unit.
DEA Drug & Chemical Evaluation
tion.
DEA Drug & Chemical Evaluation
tion.
DEA ARCOS Unit.
DEA Office of Diversion Control.
DEA Office of Diversion Control.
DEA Office of Diversion Control.
DEA Office of Diversion Control.
DEA Drug & Chemical Evaluation
tion.
DEA Drug & Chemical Evaluation
tion.
DEA Office of Diversion Control.
DEA Drug & Chemical Evaluation
tion.
DEA Office of Diversion Control.
DEA Drug & Chemical Evaluation
tion.
DEA Office of Diversion Control.
DEA Drug & Chemical Evaluation
tion.
DEA Administrator.
DEA Registration Section.
DEA Registration Section.
DEA Registration Section.
DEA Registration Section.
DEA Regulatory Section.
DEA Import/Export Unit.
DEA Drug & Chemical Evaluation
tion.
DEA Import/Export Unit.
DEA
DEA
DEA
DEA
Import/Export Unit.
Import/Export Unit.
Office of Diversion Control.
Office of Diversion Control.
DEA
DEA
DEA
DEA
DEA
DEA
Import/Export
Import/Export
Import/Export
Import/Export
Import/Export
Import/Export
Unit.
Unit.
Unit.
Unit.
Unit.
Unit
DEA Import/Export Unit.
09MRR1
SecSecSecSecSec-
SecSecSecSecSec-
Sec-
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
10673
TABLE 1—MAILING ADDRESSES REFERENCED IN THE CFR—Continued
CFR Section
Subject
1312.27(a) .................
1312.27(b)(5)(iv) ........
1312.28(d) .................
1312.31(b) .................
1312.32(a) .................
Special controlled substances export invoice (DEA Form 236) filing .................
Request for reexport ............................................................................................
Distribution of special controlled substances invoice (DEA Form 236) copy 4 ..
Controlled substances transshipment permit application ....................................
Advanced notice of importation for transshipment or transfer of controlled substances.
Authorization to import listed chemicals (DEA Form 486) ..................................
Quarterly reports for listed chemicals importation ...............................................
Authorization to export listed chemicals (DEA Form 486) ..................................
Quarterly reports for listed chemicals exportation ...............................................
Written notice of declared exports of listed chemicals refused, rejected or undeliverable.
Advanced notice of importation for transshipment or transfer of listed chemicals.
International transaction authorization (DEA Form 486) .....................................
Reports for mail-order sales ................................................................................
Request to submit mail-order sales reports in electronic form ............................
Application for individual manufacturing quota for ephedrine, pseudoephedrine,
phenylpropanolamine (DEA Form 189) filing and request.
Application for procurement quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 250) filing and request.
Procurement quota adjustment request for ephedrine, pseudoephedrine, phenylpropanolamine.
Application for import quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 488) request and filing.
Request import quota increase for ephedrine, pseudoephedrine, or phenylpropanolamine.
Petition for grant of confidentiality for research subjects ....................................
Petition for exemption from prosecution for researchers ....................................
Hearings documentation filing ..............................................................................
Inspection of record .............................................................................................
Request for hearing .............................................................................................
Notice of appearance ...........................................................................................
1313.12(b)
1313.12(e)
1313.21(b)
1313.21(e)
1313.22(e)
.................
.................
.................
.................
.................
1313.31(b) .................
1313.32(b)(1) .............
1314.110(a)(1) ...........
1314.110(a)(2) ...........
1315.22 ......................
1315.32(e) .................
1315.32(g) .................
1315.34(d) .................
1315.36(b) .................
1316.23(b) .................
1316.24(b) .................
1316.45 ......................
1316.46(a) .................
1316.47(a) .................
1316.48 ......................
DEA Office
DEA
DEA
DEA
DEA
DEA
Import/Export
Import/Export
Import/Export
Import/Export
Import/Export
Unit.
Unit.
Unit.
Unit.
Unit.
DEA
DEA
DEA
DEA
DEA
Import/Export
Import/Export
Import/Export
Import/Export
Import/Export
Unit.
Unit.
Unit.
Unit.
Unit.
DEA Import/Export Unit.
DEA Import/Export Unit.
DEA Import/Export Unit.
DEA Import/Export Unit.
DEA Drug & Chemical Evaluation Section.
DEA Drug & Chemical Evaluation Section.
DEA Drug & Chemical Evaluation Section.
DEA Drug & Chemical Evaluation Section.
DEA Drug & Chemical Evaluation Section.
DEA Administrator.
DEA Administrator.
DEA Hearing Clerk.
DEA Hearing Clerk.
DEA Federal Register Representative.
DEA Administrator.
TABLE 2—TABLE OF DEA MAILING ADDRESSES
Code of Federal Regulations Section—Topic
DEA Mailing address
DEA Administrator
1308.43(b)—Petition to initiate proceedings for rulemaking ...........................................................
1316.23(b)—Petition for grant of confidentiality for research subjects.
1316.24(b)—Petition for exemption from prosecution for researchers.
1316.48—Notice of appearance.
Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield,
VA 22152.
DEA Office of Diversion Control
1301.52(c)—Controlled substances registration return for cancellation .........................................
1307.03—Exception request filing.
1307.22—Disposal of controlled substances by the Administration delivery application.
1308.21(a)—Exclusion of nonnarcotic substance.
1308.23(b)—Exemption for chemical preparations.
1308.25(a)—Exclusion of veterinary anabolic steroid implant product application.
1308.31(a)—Exemption of a nonnarcotic prescription product application.
1308.33(b)—Exemption of certain anabolic steroid products application.
1310.13(b)—Exemption for chemical preparations.
1310.21(b)—Sale by Federal departments or agencies of chemicals which could be used to
manufacture controlled substances certification request.
Drug Enforcement Administration, Attn: Office
of Diversion Control/OD, 8701 Morrissette
Drive, Springfield, VA 22152.
DEA Regulatory Section
sroberts on DSKD5P82C1PROD with RULES
1301.71(d)—Security system compliance review for controlled substances ..................................
1309.71(c)—Security system compliance review for List I chemicals.
Drug Enforcement Administration, Attn: Regulatory Section/ODG, 8701 Morrissette Drive,
Springfield, VA 22152.
DEA Import/Export Unit
1310.05(c)—Importer/exporter of tableting or encapsulation machines reporting ..........................
1310.05(e)(1)—Reporting by persons required to keep records and file reports regarding List I
chemicals.
1310.05(e)(2)—Request to submit List I chemicals reports in electronic form.
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
PO 00000
Frm 00041
Fmt 4700
Sfmt 4700
Drug Enforcement Administration, Attn: Import/
Export Unit/ODGI, 8701 Morrissette Drive,
Springfield, VA 22152.
E:\FR\FM\09MRR1.SGM
09MRR1
10674
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
TABLE 2—TABLE OF DEA MAILING ADDRESSES—Continued
Code of Federal Regulations Section—Topic
DEA Mailing address
1310.06(g)—Report of declared exports of machines refused, rejected, or returned.
1312.12(a)—Application for import permit (DEA Form 357).
1312.16(b)—Return unused import permits.
1312.18(b)—Import declaration (DEA Form 236) submission.
1312.19(b)—DEA Form 236 copy 4 filing.
1312.22(a)—Application for export permit (DEA Form 161).
1312.22(d)(8)—Request for return of unacceptable or undeliverable exported controlled substances.
1312.24(a)—DEA Form 161 copy 2 filing.
1312.27(a)—Special controlled substances export invoice (DEA Form 236) filing.
1312.27(b)(5)(iv)—Request for reexport.
1312.28(d)—Distribution of special controlled substances invoice (DEA Form 236) copy 4.
1312.31(b)—Controlled substances transshipment permit application.
1312.32(a)—Advanced notice of importation for transshipment or transfer of controlled substances.
1313.12(b)—Authorization to import listed chemicals (DEA Form 486).
1313.12(e)—Quarterly reports of listed chemicals importation.
1313.21(b)—Authorization to export listed chemicals (DEA Form 486).
1313.21(e)—Quarterly reports of listed chemicals exportation.
1313.22(e)—Written notice of declared exports of listed chemicals refused, rejected or undeliverable.
1313.31(b)—Advanced notice of importation for transshipment or transfer of listed chemicals.
1313.32(b)(1)—International transaction authorization (DEA Form 486).
1314.110(a)(1)—Reports for mail-order sales.
1314.110(a)(2)—Request to submit mail-order sales reports in electronic form.
DEA Drug & Chemical Evaluation Section
1303.12(b)—Application for controlled substances procurement quota (DEA Form 250) filing
and request.
1303.12(d)—Controlled substances quota adjustment request.
1303.22—Application for individual manufacturing quota (DEA Form 189) filing and request for
schedule I or II controlled substances.
1304.31(a)—Manufacturers importing narcotic raw material report submission.
1304.32(a)—Manufacturers importing coca leaves report submission.
1308.24(d)—Exempt narcotic chemical preparations importer/exporter reporting.
1308.24(i)—Exempted chemical preparations listing.
1308.26(a)—Excluded veterinary anabolic steroid implant products listing.
1308.32—Exempted prescription products listing.
1308.34—Exempted anabolic steroid products listing.
1310.05(d)—Bulk manufacturer of listed chemicals reporting.
1315.22—Application for individual manufacturing quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 189) filing and request.
1315.32(e)—Application for procurement quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 250) filing and request.
1315.32(g)—Procurement quota adjustment request for ephedrine, pseudoephedrine, phenylpropanolamine.
1315.34(d)—Application for import quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 488) request and filing.
1315.36(b)—Request import quota increase for ephedrine, pseudoephedrine, or phenylpropanolamine.
Drug Enforcement Administration, Attn: Drug &
Chemical Evaluation Section/ODE, 8701
Morrissette Drive, Springfield, VA 22152.
DEA ARCOS Unit
1304.04(d)—ARCOS separate central reporting identifier request ................................................
1304.33(a)—Reports to ARCOS.
Drug
Enforcement
Administration,
Attn:
ARCOS Unit/ODPT, P.O. Box 2520, Springfield, VA 22152–2520, OR Drug Enforcement Administration, Attn: ARCOS Unit/
ODPT, 8701 Morrissette Drive, Springfield,
VA 22152.
sroberts on DSKD5P82C1PROD with RULES
DEA Registration Section
1301.03—Procedures information request (controlled substances registration) ............................
1301.13(e)(2)—Request DEA Forms 224, 225, and 363.
1301.14(a)—Controlled substances registration application submission.
1301.18(c)—Research project controlled substance increase request.
1301.51—Controlled substances registration modification request.
1301.52(b)—Controlled substances registration transfer request.
1309.03—List I chemicals registration procedures information request.
1309.32(c)—Request DEA Form 510.
1309.33(a)—List I chemicals registration application submission.
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
Drug Enforcement Administration, Attn: Registration Section/ODR P.O. Box 2639,
Springfield, VA 22152–2639.
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
10675
TABLE 2—TABLE OF DEA MAILING ADDRESSES—Continued
Code of Federal Regulations Section—Topic
DEA Mailing address
1309.61—List I chemicals registration modification request.
DEA Hearing Clerk
1316.45—Hearings documentation filing ........................................................................................
1316.46(a)—Inspection of record.
Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, VA 22152.
DEA Federal Register Representative
1316.47(a)—Request for hearing ....................................................................................................
DEA is removing address references
for the two information collections
specifically listed in the regulations (21
CFR 1310.06(d) and 1313.24(e)), as the
information was provided
inconsistently. Persons are encouraged
to submit comments regarding
information collections as each specific
collection is renewed. Notices regarding
such renewal are published in the
Federal Register, seek public comment,
and provide the address to be used
when submitting those comments.
Technical Corrections
While preparing this rule, DEA
became aware of inaccurate section
citations in 21 CFR 1310.05(d) and 21
CFR 1310.06(h)(5). Those paragraphs
referenced 21 CFR 1310.01(f)(1)(iv) and
21 CFR 1310.01(f)(1)(v) which had
previously been redesignated as 21 CFR
1300.02(b)(28)(i)(D) and 21 CFR
1300.02(b)(28)(i)(E), respectively. DEA
is correcting these inaccurate citations
in this rule.
Regulatory Certifications
sroberts on DSKD5P82C1PROD with RULES
Administrative Procedure Act (5 U.S.C.
553)
An agency may find good cause to
exempt a rule from certain provisions of
the Administrative Procedure Act (5
U.S.C. 553), including notice of
proposed rulemaking and the
opportunity for public comment, if it is
determined to be unnecessary,
impracticable, or contrary to the public
interest. This rule updates existing
mailing addresses and consolidates
those addresses into a new part in 21
CFR. By consolidating this information,
DEA will be able to rapidly respond
should mailing addresses change due to
facility relocation, special mail handling
procedures, or other circumstances. As
this Final Rule only updates existing
mailing addresses and consolidates
those addresses (some of which were
outdated), DEA finds it unnecessary and
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
impracticable to permit public notice
and comment. Therefore, DEA is
publishing this document as a final rule.
Further, as the changes of address have
occurred and it is administratively
burdensome for DEA to continue to
support previous mailing addresses, and
since a delay in the effective date of this
regulation could impede the timely
receipt of required reports by DEA from
the regulated industry and cause further
confusion, DEA finds there is good
cause to make this final rule effective
immediately upon publication.
Regulatory Flexibility Act
The Deputy Administrator hereby
certifies that this rulemaking has been
drafted in accordance with the
Regulatory Flexibility Act (5 U.S.C.
601–612), has reviewed this regulation,
and by approving it certifies that this
regulation will not have a significant
economic impact on a substantial
number of small entities. This final rule
merely changes DEA mailing addresses,
permitting industry to report to DEA in
a timely manner.
Executive Order 12866
The Deputy Administrator further
certifies that this rulemaking has been
drafted in accordance with the
principles in Executive Order 12866
Section 1(b). DEA has determined that
this is not a significant regulatory
action. Therefore, this action has not
been reviewed by the Office of
Management and Budget.
Executive Order 12988
This regulation meets the applicable
standards set forth in Sections 3(a) and
3(b)(2) of Executive Order 12988 Civil
Justice Reform.
Executive Order 13132
This rulemaking does not preempt or
modify any provision of state law; nor
does it impose enforcement
responsibilities on any state; nor does it
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
Drug Enforcement Administration, Attn: Federal
Register
Representative/ODL,
8701
Morrissette Drive, Springfield, VA 22152.
diminish the power of any state to
enforce its own laws. Accordingly, this
rulemaking does not have federalism
implications warranting the application
of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $120,000,000 or more
(adjusted for inflation) in any one year,
and will not significantly or uniquely
affect small governments. Therefore, no
actions were deemed necessary under
the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as
defined by Section 804 of the Small
Business Regulatory Enforcement
Fairness Act of 1996 (Congressional
Review Act). This rule will not result in
an annual effect on the economy of
$100,000,000 or more; a major increase
in costs or prices; or significant adverse
effects on competition, employment,
investment, productivity, innovation, or
on the ability of United States-based
companies to compete with foreignbased companies in domestic and
export markets.
List of Subjects
21 CFR Part 1301
Administrative practice and
procedure, Drug traffic control, Security
measures.
21 CFR Part 1303
Administrative practice and
procedure, Drug traffic control.
21 CFR Part 1304
Drug traffic control, Reporting and
recordkeeping requirements.
21 CFR Part 1307
Drug traffic control.
E:\FR\FM\09MRR1.SGM
09MRR1
10676
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
21 CFR Part 1308
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
21 CFR Part 1309
Administrative practice and
procedure, Drug traffic control, Exports,
Imports, Security measures.
21 CFR Part 1310
Drug traffic control, Exports, Imports,
Reporting and recordkeeping
requirements.
21 CFR Part 1312
Administrative practice and
procedure, Drug traffic control, Exports,
Imports, Reporting and recordkeeping
requirements.
21 CFR Part 1313
Administrative practice and
procedure, Drug traffic control, Exports,
Imports, Reporting and recordkeeping
requirements.
21 CFR Part 1314
Drug traffic control, Reporting and
recordkeeping requirements.
1. The authority citation for Part 1301
continues to read as follows:
sroberts on DSKD5P82C1PROD with RULES
2. Section 1301.03 is revised to read
as follows:
§ 1301.03 Information; special
instructions.
Information regarding procedures
under these rules and instructions
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
§ 1301.51
*
*
*
*
(e) * * *
(2) DEA Forms 224, 225, and 363 may
be obtained at any area office of the
Administration or by writing to the
Registration Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
4. Section 1301.14 is amended by
revising paragraph (a) to read as follows:
■
5. Section 1301.18 is amended by
revising paragraph (c) to read as follows:
PART 1301—REGISTRATION OF
MANUFACTURERS, DISTRIBUTORS,
AND DISPENSERS OF CONTROLLED
SUBSTANCES
■
*
■
21 CFR Part 1321
Administrative practice and
procedure, Drug traffic control,
Reporting and recordkeeping
requirements.
■ For the reasons set out above, 21 CFR
Chapter II is amended as follows:
Authority: 21 U.S.C. 821, 822, 823, 824,
831, 871(b), 875, 877, 886a, 951, 952, 953,
956, 957, 958.
■
(a) All applications for registration
shall be submitted for filing to the
Registration Unit, Drug Enforcement
Administration. The appropriate
registration fee and any required
attachments must accompany the
application. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
21 CFR Part 1316
Administrative practice and
procedure, Authority delegations
(Government agencies), Drug traffic
control, Research, Seizures and
forfeitures.
Administration together with the
Administration comments. The Food
and Drug Administration shall approve
or deny the request as an amendment to
the protocol and so notify the registrant.
Approval of the letter by the Food and
Drug Administration shall authorize the
registrant to use the additional quantity
of the controlled substance in the
research project.
*
*
*
*
*
§ 1301.13 Application for registration; time
for application; expiration date; registration
for independent activities; application
forms, fees, contents and signature;
coincident activities.
§ 1301.14 Filing of application; acceptance
for filing; defective applications.
21 CFR Part 1315
Administrative practice and
procedure, Chemicals, Drug traffic
control, Imports, Reporting and
recordkeeping requirements.
■
supplementing these rules will be
furnished upon request by writing to the
Registration Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
■ 3. Section 1301.13 is amended by
revising paragraph (e)(2) to read as
follows:
§ 1301.18
Research protocols.
*
*
*
*
*
(c) In the event that the registrant
desires to increase the quantity of a
controlled substance used for an
approved research project, he/she shall
submit a request to the Registration
Unit, Drug Enforcement Administration,
by registered mail, return receipt
requested. See the Table of DEA Mailing
Addresses in § 1321.01 of this chapter
for the current mailing address. The
request shall contain the following
information: DEA registration number;
name of the controlled substance or
substances and the quantity of each
authorized in the approved protocol;
and the additional quantity of each
desired. Upon return of the receipt, the
registrant shall be authorized to
purchase the additional quantity of the
controlled substance or substances
specified in the request. The
Administration shall review the letter
and forward it to the Food and Drug
PO 00000
Frm 00044
Fmt 4700
Sfmt 4700
6. Section 1301.51 is revised to read
as follows:
Modification in registration.
Any registrant may apply to modify
his/her registration to authorize the
handling of additional controlled
substances or to change his/her name or
address, by submitting a letter of request
to the Registration Unit, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. The letter shall contain
the registrant’s name, address, and
registration number as printed on the
certificate of registration, and the
substances and/or schedules to be
added to his/her registration or the new
name or address and shall be signed in
accordance with § 1301.13(j). If the
registrant is seeking to handle
additional controlled substances listed
in Schedule I for the purpose of research
or instructional activities, he/she shall
attach three copies of a research
protocol describing each research
project involving the additional
substances, or two copies of a statement
describing the nature, extent, and
duration of such instructional activities,
as appropriate. No fee shall be required
to be paid for the modification. The
request for modification shall be
handled in the same manner as an
application for registration. If the
modification in registration is approved,
the Administrator shall issue a new
certificate of registration (DEA Form
223) to the registrant, who shall
maintain it with the old certificate of
registration until expiration.
7. Section 1301.52 is amended by
revising paragraphs (b) and (c) to read
as follows:
■
§ 1301.52 Termination of registration;
transfer of registration; distribution upon
discontinuance of business.
*
*
*
*
*
(b) No registration or any authority
conferred thereby shall be assigned or
otherwise transferred except upon such
conditions as the Administration may
specifically designate and then only
pursuant to written consent. Any person
seeking authority to transfer a
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
registration shall submit a written
request, providing full details regarding
the proposed transfer of registration, to
the Deputy Assistant Administrator,
Office of Diversion Control, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
(c) Any registrant desiring to
discontinue business activities
altogether or with respect to controlled
substances (without transferring such
business activities to another person)
shall return for cancellation his/her
certificate of registration, and any
unexecuted order forms in his/her
possession, to the Registration Unit,
Drug Enforcement Administration. See
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. Any controlled
substances in his/her possession may be
disposed of in accordance with
§ 1307.21 of this chapter.
*
*
*
*
*
8. Section 1301.71 is amended by
revising paragraph (d) to read as
follows:
■
§ 1301.71
Security requirements generally.
*
*
*
*
*
(d) Any registrant or applicant
desiring to determine whether a
proposed security system substantially
complies with, or is the structural
equivalent of, the requirements set forth
in §§ 1301.72–1301.76 may submit any
plans, blueprints, sketches or other
materials regarding the proposed
security system either to the Special
Agent in Charge in the region in which
the system will be used, or to the
Regulatory Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
PART 1303—QUOTAS
9. The authority citation for Part 1303
continues to read as follows:
■
Authority: 21 U.S.C. 821, 826, 871(b).
10. Section 1303.12 is amended by
revising paragraphs (b) and (d) to read
as follows:
■
§ 1303.12
Procurement quotas.
sroberts on DSKD5P82C1PROD with RULES
*
*
*
*
*
(b) Any person who is registered to
manufacture controlled substances
listed in any schedule and who desires
to use during the next calendar year any
basic class of controlled substances
listed in Schedule I or II (except raw
opium being imported by the registrant
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
pursuant to an import permit) for
purposes of manufacturing, shall apply
on DEA Form 250 for a procurement
quota for such basic class. A separate
application must be made for each basic
class desired to be procured or used.
The applicant shall state whether he
intends to manufacture the basic class
himself or purchase it from another
manufacturer. The applicant shall state
separately each purpose for which the
basic class is desired, the quantity
desired for that purpose during the next
calendar year, and the quantities used
and estimated to be used, if any, for that
purpose during the current and
preceding 2 calendar years. If the
purpose is to manufacture the basic
class into dosage form, the applicant
shall state the official name, common or
usual name, chemical name, or brand
name of that form. If the purpose is to
manufacture another substance, the
applicant shall state the official name,
common or usual name, chemical name,
or brand name of the substance, and, if
a controlled substance listed in any
schedule, the schedule number and
Administration Controlled Substances
Code Number, as set forth in part 1308
of this chapter, of the substance. If the
purpose is to manufacture another basic
class of controlled substance listed in
Schedule I or II, the applicant shall also
state the quantity of the other basic class
which the applicant has applied to
manufacture pursuant to § 1303.22 and
the quantity of the first basic class
necessary to manufacture a specified
unit of the second basic class. DEA
Form 250 shall be filed on or before
April 1 of the year preceding the
calendar year for which the
procurement quota is being applied.
Copies of DEA Form 250 may be
obtained from, and shall be filed with,
the Drug and Chemical Evaluation
Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
(d) Any person to whom a
procurement quota has been issued may
at any time request an adjustment in the
quota by applying to the Administrator
with a statement showing the need for
the adjustment. Such application shall
be filed with the Drug & Chemical
Evaluation Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
The Administrator shall increase or
decrease the procurement quota of such
person if and to the extent that he finds,
after considering the factors enumerated
in paragraph (c) of this section and any
PO 00000
Frm 00045
Fmt 4700
Sfmt 4700
10677
occurrences since the issuance of the
procurement quota, that the need
justifies an adjustment.
*
*
*
*
*
11. Section 1303.22 is amended by
revising the introductory text to read as
follows:
■
§ 1303.22 Procedure for applying for
individual manufacturing quotas.
Any person who is registered to
manufacture any basic class of
controlled substance listed in Schedule
I or II and who desires to manufacture
a quantity of such class shall apply on
DEA Form 189 for a manufacturing
quota for such quantity of such class.
Copies of DEA Form 189 may be
obtained from, and shall be filed (on or
before May 1 of the year preceding the
calendar year for which the
manufacturing quota is being applied)
with, the Drug & Chemical Evaluation
Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
A separate application must be made for
each basic class desired to be
manufactured. The applicant shall state:
*
*
*
*
*
PART 1304—RECORDS AND
REPORTS OF REGISTRANTS
12. The authority citation for Part
1304 continues to read as follows:
■
Authority: 21 U.S.C. 821, 827, 831, 871(b),
958(e), 965, unless otherwise noted.
13. Section 1304.04 is amended by
revising paragraph (d) to read as
follows:
■
§ 1304.04 Maintenance of records and
inventories.
*
*
*
*
*
(d) ARCOS participants who desire
authorization to report from other than
their registered locations must obtain a
separate central reporting identifier.
Request for central reporting identifiers
will be submitted to the ARCOS Unit.
See the Table of DEA Mailing Addresses
in § 1321.01 of this chapter for the
current mailing address.
*
*
*
*
*
■ 14. Section 1304.31 is amended by
revising paragraph (a) to read as follows:
§ 1304.31 Reports from manufacturers
importing narcotic raw material.
(a) Every manufacturer which imports
or manufactures from narcotic raw
material (opium, poppy straw, and
concentrate of poppy straw) shall
submit information which accounts for
the importation and for all
manufacturing operations performed
E:\FR\FM\09MRR1.SGM
09MRR1
10678
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
between importation and the production
in bulk or finished marketable products,
standardized in accordance with the
U.S. Pharmacopeia, National Formulary
or other recognized medical standards.
Reports shall be signed by the
authorized official and submitted
quarterly on company letterhead to the
Drug and Chemical Evaluation Section,
Drug Enforcement Administration, on or
before the 15th day of the month
immediately following the period for
which it is submitted. See the Table of
DEA Mailing Addresses in § 1321.01 of
this chapter for the current mailing
address.
*
*
*
*
*
15. Section 1304.32 is amended by
revising paragraph (a) to read as follows:
■
§ 1304.32 Reports of manufacturers
importing coca leaves.
(a) Every manufacturer importing or
manufacturing from raw coca leaves
shall submit information accounting for
the importation and for all
manufacturing operations performed
between the importation and the
manufacture of bulk or finished
products standardized in accordance
with U.S. Pharmacopoeia, National
Formulary, or other recognized
standards. The reports shall be
submitted quarterly on company
letterhead to the Drug and Chemical
Evaluation Section, Drug Enforcement
Administration, on or before the 15th
day of the month immediately following
the period for which it is submitted. See
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
16. Section 1304.33 is amended by
revising paragraph (a) to read as follows:
■
§ 1304.33
Reports to ARCOS.
(a) Reports generally. All reports
required by this section shall be filed
with the ARCOS Unit on DEA Form
333, or on media which contains the
data required by DEA Form 333 and
which is acceptable to the ARCOS Unit.
See the Table of DEA Mailing Addresses
in § 1321.01 of this chapter for the
current mailing address.
*
*
*
*
*
sroberts on DSKD5P82C1PROD with RULES
PART 1307—MISCELLANEOUS
17. The authority citation for Part
1307 continues to read as follows:
■
Authority: 21 U.S.C. 821, 822(d), 871(b),
unless otherwise noted.
18. Section 1307.03 is revised to read
as follows:
■
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
§ 1307.03
Exceptions to regulations.
Any person may apply for an
exception to the application of any
provision of this chapter by filing a
written request with the Office of
Diversion Control, Drug Enforcement
Administration, stating the reasons for
such exception. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
The Administrator may grant an
exception in his discretion, but in no
case shall he/she be required to grant an
exception to any person which is
otherwise required by law or the
regulations cited in this section.
■ 19. Section 1307.22 is revised to read
as follows:
§ 1307.22 Disposal of controlled
substances by the Administration.
Any controlled substance delivered to
the Administration under § 1307.21 or
forfeited pursuant to section 511 of the
Act (21 U.S.C. 881) may be delivered to
any department, bureau, or other agency
of the United States or of any State upon
proper application addressed to the
Office of Diversion Control, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. The application shall
show the name, address, and official
title of the person or agency to whom
the controlled drugs are to be delivered,
including the name and quantity of the
substances desired and the purpose for
which intended. The delivery of such
controlled drugs shall be ordered by the
Administrator, if, in his opinion, there
exists a medical or scientific need
therefor.
PART 1308—SCHEDULES OF
CONTROLLED SUBSTANCES
20. The authority citation for part
1308 continues to read as follows:
■
Authority: 21 U.S.C. 811, 812, 871(b),
unless otherwise noted.
21. Section 1308.21 is amended by
revising paragraph (a) to read as follows:
■
§ 1308.21 Application for exclusion of a
nonnarcotic substance.
(a) Any person seeking to have any
nonnarcotic drug that may, under the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 301), be lawfully sold over
the counter without a prescription,
excluded from any schedule, pursuant
to section 201(g)(1) of the Act (21 U.S.C.
811(g)(1)), may apply to the Office of
Diversion Control, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
PO 00000
Frm 00046
Fmt 4700
Sfmt 4700
22. Section 1308.23 is amended by
revising paragraph (b) to read as follows:
■
§ 1308.23 Exemption of certain chemical
preparations; application.
*
*
*
*
*
(b) Any person seeking to have any
preparation or mixture containing a
controlled substance and one or more
noncontrolled substances exempted
from the application of all or any part
of the Act, pursuant to paragraph (a) of
this section, may apply to the Office of
Diversion Control, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
23. Section 1308.24 is amended by
revising paragraphs (d) and (i) to read as
follows:
■
§ 1308.24
Exempt chemical preparations.
*
*
*
*
*
(d) Records and reports: Any person
who manufactures an exempt chemical
preparation or mixture must keep
complete and accurate records and file
all reports required under part 1304 of
this chapter regarding all controlled
substances being used in the
manufacturing process until the
preparation or mixture is in the form
described in paragraph (i) of this
section. In lieu of records and reports
required under part 1304 of this chapter
regarding exempt chemical
preparations, the manufacturer need
only record the name, address, and
registration number, if any, of each
person to whom the manufacturer
distributes any exempt chemical
preparation. Each importer or exporter
of an exempt narcotic chemical
preparation must submit a semiannual
report of the total quantity of each
substance imported or exported in each
calendar half-year within 30 days of the
close of the period to the Drug and
Chemical Evaluation Section, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. Any other person who
handles an exempt chemical
preparation after it is in the form
described in paragraph (i) of this section
is not required to maintain records or
file reports.
*
*
*
*
*
(i) A listing of exempt chemical
preparations may be obtained by
submitting a written request to the Drug
and Chemical Evaluation Section, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
24. Section 1308.25 is amended by
revising paragraph (a) to read as follows:
■
§ 1308.25 Exclusion of a veterinary
anabolic steroid implant product;
application.
(a) Any person seeking to have any
anabolic steroid product, which is
expressly intended for administration
through implants to cattle or other
nonhuman species and which has been
approved by the Secretary of Health and
Human Services for such
administration, identified as being
excluded from any schedule, pursuant
to section 102(41)(B)(i) of the Act (21
U.S.C. 802(41)(B)(i)), may apply to the
Office of Diversion Control, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
■ 25. Section 1308.26 is amended by
revising paragraph (a) to read as follows:
§ 1308.26 Excluded veterinary anabolic
steroid implant products.
(a) Products containing an anabolic
steroid, that are expressly intended for
administration through implants to
cattle or other nonhuman species and
which have been approved by the
Secretary of Health and Human Services
for such administration are excluded
from all schedules pursuant to section
102(41)(B)(i) of the Act (21 U.S.C.
802(41)(B)(i)). A listing of the excluded
products may be obtained by submitting
a written request to the Drug and
Chemical Evaluation Section, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
26. Section 1308.31 is amended by
revising paragraph (a) to read as follows:
■
sroberts on DSKD5P82C1PROD with RULES
§ 1308.31 Application for exemption of a
nonnarcotic prescription product.
(a) Any person seeking to have any
compound, mixture, or preparation
containing any nonnarcotic controlled
substance listed in § 1308.12(e), or in
§ 1308.13(b) or (c), or in § 1308.14, or in
§ 1308.15, exempted from application of
all or any part of the Act pursuant to
section 201(g)(3)(A), of the Act (21
U.S.C. 811(g)(3)(A)) may apply to the
Office of Diversion Control, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
■ 27. Section 1308.32 is revised to read
as follows:
§ 1308.32
Exempted prescription products.
The compounds, mixtures, or
preparations that contain a nonnarcotic
controlled substance listed in
§ 1308.12(e) or in § 1308.13(b) or (c) or
in § 1308.14 or in § 1308.15 listed in the
Table of Exempted Prescription
Products have been exempted by the
Administrator from the application of
sections 302 through 305, 307 through
309, and 1002 through 1004 of the Act
(21 U.S.C. 822–825, 827–829, and 952–
954) and §§ 1301.13, 1301.22, and
§§ 1301.71 through 1301.76 of this
chapter for administrative purposes
only. An exception to the above is that
those products containing butalbital
shall not be exempt from the
requirement of 21 U.S.C. 952–954
concerning importation, exportation,
transshipment and in-transit shipment
of controlled substances. Any deviation
from the quantitative composition of
any of the listed drugs shall require a
petition of exemption in order for the
product to be exempted. A listing of the
Exempted Prescription Products may be
obtained by submitting a written request
to the Drug and Chemical Evaluation
Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
10679
through 1004 of the Act (21 U.S.C. 822–
829 and 952–954) and §§ 1301.13,
1301.22, and 1301.71 through 1301.76
of this chapter for administrative
purposes only may be obtained by
submitting a written request to the Drug
and Chemical Evaluation Section, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
30. Section 1308.43 is amended by
revising paragraph (b) to read as follows:
■
§ 1308.43 Initiation of proceedings for
rulemaking.
*
*
*
*
*
(b) Petitions shall be submitted in
quintuplicate to the Administrator. See
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. Petitions shall be in the
following form:
llllllllll (Date)
Administrator, Drug Enforcement
Administration llllll (Mailing
Address)
*
Dear Sir: The undersigned
llllllll hereby petitions the
Administrator to initiate proceedings for
the issuance (amendment or repeal) of a
rule or regulation pursuant to section
201 of the Controlled Substances Act.
Attached hereto and constituting a
part of this petition are the following:
(A) The proposed rule in the form
proposed by the petitioner. (If the
petitioner seeks the amendment or
repeal of an existing rule, the existing
rule, together with a reference to the
section in the Code of Federal
Regulations where it appears, should be
included.)
(B) A statement of the grounds which
the petitioner relies for the issuance
(amendment or repeal) of the rule. (Such
grounds shall include a reasonably
concise statement of the facts relied
upon by the petitioner, including a
summary of any relevant medical or
scientific evidence known to the
petitioner.)
All notices to be sent regarding this
petition should be addressed to:
29. Section 1308.34 is revised to read
as follows:
llllllllll (Name)
28. Section 1308.33 is amended by
revising paragraph (b) to read as follows:
■
§ 1308.33 Exemption of certain anabolic
steroid products; application.
*
*
*
*
(b) Any person seeking to have any
compound, mixture, or preparation
containing an anabolic steroid as
defined in part 1300 of this chapter
exempted from the application of all or
any part of the Act, pursuant to
paragraph (a) of this section, may apply
to the Office of Diversion Control, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
■
§ 1308.34 Exempt anabolic steroid
products.
The list of compounds, mixtures, or
preparations that contain an anabolic
steroid that have been exempted by the
Administrator from application of
sections 302 through 309 and 1002
PO 00000
Frm 00047
Fmt 4700
Sfmt 4700
llllllllll (Street Address)
llllllllll (City and State)
Respectfully yours,
llllllllll (Signature of
petitioner)
*
*
*
*
*
E:\FR\FM\09MRR1.SGM
09MRR1
10680
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
PART 1309—REGISTRATION OF
MANUFACTURERS, DISTRIBUTORS,
IMPORTERS, AND EXPORTERS OF
LIST I CHEMICALS
31. The authority citation for Part
1309 continues to read as follows:
■
Authority: 21 U.S.C. 821, 822, 823, 824,
830, 871(b), 875, 877, 886a, 958.
32. Section 1309.03 is revised to read
as follows:
■
§ 1309.03 Information; special
instructions.
Information regarding procedures
under these rules and instructions
supplementing these rules will be
furnished upon request by writing to the
Registration Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
33. Section 1309.32 is amended by
revising paragraph (c) to read as follows:
■
§ 1309.32 Application forms; contents;
signature.
*
*
*
*
(c) DEA Form 510 may be obtained at
any divisional office of the
Administration or by writing to the
Registration Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
DEA Form 510a will be mailed to each
List I chemical registrant approximately
60 days before the expiration date of his
or her registration; if any registered
person does not receive such forms
within 45 days before the expiration
date of the registration, notice must be
promptly given of such fact and DEA
Form 510a must be requested by writing
to the Registration Section of the
Administration at the foregoing address.
*
*
*
*
*
34. Section 1309.33 is amended by
revising paragraph (a) to read as follows:
■
sroberts on DSKD5P82C1PROD with RULES
Filing of application; joint filings.
(a) All applications for registration
shall be submitted for filing to the
Registration Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
The appropriate registration fee and any
required attachments must accompany
the application.
*
*
*
*
*
35. Section 1309.61 is revised to read
as follows:
■
§ 1309.61
Modification in registration.
Any registrant may apply to modify
his or her registration to authorize the
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
36. Section 1309.71 is amended by
revising paragraph (c) as follows:
■
*
§ 1309.33
handling of additional List I chemicals
or to change his or her name or address,
by submitting a letter of request to the
Registration Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
The letter shall contain the registrant’s
name, address, and registration number
as printed on the certificate of
registration, and the List I chemicals to
be added to his registration or the new
name or address and shall be signed in
accordance with § 1309.32(g). No fee
shall be required to be paid for the
modification. The request for
modification shall be handled in the
same manner as an application for
registration. If the modification in
registration is approved, the
Administrator shall issue a new
certificate of registration (DEA Form
511) to the registrant, who shall
maintain it with the old certificate of
registration until expiration.
§ 1309.71
General security requirements.
*
*
*
*
*
(c) Any registrant or applicant
desiring to determine whether a
proposed system of security controls
and procedures is adequate may submit
materials and plans regarding the
proposed security controls and
procedures either to the Special Agent
in Charge in the region in which the
security controls and procedures will be
used, or to the Regulatory Section, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
PART 1310—RECORDS AND
REPORTS OF LISTED CHEMICALS
AND CERTAIN MACHINES
37. The authority citation for Part
1310 continues to read as follows:
■
Authority: 21 U.S.C. 802, 827(h), 830,
871(b), 890.
38. Section 1310.05 is amended by
revising paragraphs (c), (d), (e)(1), and
(e)(2) to read as follows:
■
§ 1310.05
Reports.
*
*
*
*
*
(c) Each regulated person who
imports or exports a tableting machine,
or encapsulation machine, shall file a
report (not a 486) of such importation or
exportation with the Import/Export
Unit, Drug Enforcement Administration,
on or before the date of importation or
exportation. See the Table of DEA
Mailing Addresses in § 1321.01 of this
PO 00000
Frm 00048
Fmt 4700
Sfmt 4700
chapter for the current mailing address.
In order to facilitate the importation or
exportation of any tableting machine or
encapsulating machine and implement
the purpose of the Act, regulated
persons may wish to report to the
Administration as far in advance as
possible. A copy of the report may be
transmitted directly to the Drug
Enforcement Administration through
electronic facsimile media. Any
tableting machine or encapsulating
machine may be imported or exported if
that machine is needed for medical,
commercial, scientific, or other
legitimate uses. However, an
importation or exportation of a tableting
machine or encapsulating machine may
not be completed with a person whose
description or identifying characteristic
has previously been furnished to the
regulated person by the Administration
unless the transaction is approved by
the Administration.
(d) Each regulated bulk manufacturer
of a listed chemical shall submit
manufacturing, inventory and use data
on an annual basis as set forth in
§ 1310.06(h). This data shall be
submitted annually to the Drug and
Chemical Evaluation Section, Drug
Enforcement Administration, on or
before the 15th day of March of the year
immediately following the calendar year
for which submitted. See the Table of
DEA Mailing Addresses in § 1321.01 of
this chapter for the current mailing
address. A business entity which
manufactures a listed chemical may
elect to report separately by individual
location or report as an aggregate
amount for the entire business entity
provided that they inform the DEA of
which method they will use. This
reporting requirement does not apply to
drug or other products which are
exempted under §§ 1300.02(b)(28)(i)(D)
or 1300.02(b)(28)(i)(E) except as set forth
in § 1310.06(h)(5). Bulk manufacturers
that produce a listed chemical solely for
internal consumption shall not be
required to report for that listed
chemical. For purposes of these
reporting requirements, internal
consumption shall consist of any
quantity of a listed chemical otherwise
not available for further resale or
distribution. Internal consumption shall
include (but not be limited to) quantities
used for quality control testing,
quantities consumed in-house or
production losses. Internal consumption
does not include the quantities of a
listed chemical consumed in the
production of exempted products. If an
existing standard industry report
contains the information required in
§ 1310.06(h) and such information is
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
separate or readily retrievable from the
report, that report may be submitted in
satisfaction of this requirement. Each
report shall be submitted to the DEA
under company letterhead and signed
by an appropriate, responsible official.
For purposes of this paragraph only, the
term regulated bulk manufacturer of a
listed chemical means a person who
manufactures a listed chemical by
means of chemical synthesis or by
extraction from other substances. The
term bulk manufacturer does not
include persons whose sole activity
consists of the repackaging or relabeling
of listed chemical products or the
manufacture of drug dosage form
products which contain a listed
chemical.
(e) * * *
(1) Submit a written report,
containing the information set forth in
§ 1310.06(i) of this part, on or before the
15th day of each month following the
month in which the distributions took
place. The report shall be submitted
under company letterhead, signed by
the person authorized to sign the
registration application forms on behalf
of the registrant, to the Import/Export
Unit, Drug Enforcement Administration
(see the Table of DEA Mailing
Addresses in § 1321.01 of this chapter
for the current mailing address); or
(2) Upon request to and approval by
the Administration, submit the report in
electronic form, either via computer
disk or direct electronic data
transmission, in such form as the
Administration shall direct. Requests to
submit reports in electronic form should
be submitted to the Import/Export Unit,
Drug Enforcement Administration. See
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
39. Section 1310.06 is amended by
revising paragraphs (d), (g), and (h)(5) to
read as follows:
■
§ 1310.06
Content of records and reports.
*
sroberts on DSKD5P82C1PROD with RULES
City llllllllllllllll
State llllllllllllllll
Zip llllllllllllllll
Business Phone lllllllllll
Identification llllllllllll
Shipping Address (if different than
purchaser Address):
Street lllllllllllllll
City llllllllllllllll
State llllllllllllllll
Zip llllllllllllllll
Date of Shipment llllllllll
Name of Listed Chemical(s) lllll
Quantity and Form of Packaging lll
Description of Machine:
Make lllllllllllllll
Model lllllllllllllll
Serial # llllllllllllll
Method of Transfer lllllllll
If Loss or Disappearance:
Date of Loss llllllllllll
Type of Loss llllllllllll
Description of Circumstances llll
*
*
*
*
*
(g) Declared exports of machines
which are refused, rejected, or otherwise
deemed undeliverable may be returned
to the U.S. exporter of record. A brief
written report outlining the
circumstances must be sent to the
Import/Export Unit, Drug Enforcement
Administration, following the return
within a reasonable time. See the Table
of DEA Mailing Addresses in § 1321.01
of this chapter for the current mailing
address. This provision does not apply
to shipments that have cleared foreign
customs, been delivered, and accepted
by the foreign consignee. Returns to
third parties in the United States will be
regarded as imports.
(h) * * *
(5) The aggregate quantity of each
listed chemical manufactured which
becomes a component of a product
exempted from §§ 1300.02(b)(28)(i)(D)
or 1300.02(b)(28)(i)(E) during the
preceding calendar year.
*
*
*
*
*
*
*
*
*
(d) A suggested format for the reports
is provided below:
Supplier:
Registration Number llllllll
Name lllllllllllllll
Business Address llllllllll
City llllllllllllllll
State llllllllllllllll
Zip llllllllllllllll
Business Phone lllllllllll
Purchaser:
Registration Number llllllll
Name lllllllllllllll
Business Address llllllllll
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
40. Section 1310.13 is amended by
revising paragraph (b) to read as follows:
■
§ 1310.13 Exemption of chemical mixtures;
application.
*
*
*
*
*
(b) Any manufacturer seeking an
exemption for a chemical mixture, not
exempt under § 1310.12, from the
application of all or any part of the Act,
may apply to the Office of Diversion
Control, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
PO 00000
Frm 00049
Fmt 4700
Sfmt 4700
10681
41. Section 1310.21 is amended by
revising the introductory text of
paragraph (b) to read as follows:
■
§ 1310.21 Sale by Federal departments or
agencies of chemicals which could be used
to manufacture controlled substances.
*
*
*
*
*
(b) A Federal department or agency
must request certification by submitting
a written request to the Administrator,
Drug Enforcement Administration. See
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. A request for
certification may be transmitted directly
to the Office of Diversion Control, Drug
Enforcement Administration, through
electronic facsimile media. A request for
certification must be submitted no later
than fifteen calendar days before the
proposed sale is to take place. In order
to facilitate the sale of chemicals from
Federal departments’ or agencies’
stocks, Federal departments or agencies
may wish to submit requests as far in
advance of the fifteen calendar days as
possible. The written notification of the
proposed sale must include:
*
*
*
*
*
PART 1312—IMPORTATION AND
EXPORTATION OF CONTROLLED
SUBSTANCES
42. The authority citation for Part
1312 continues to read as follows:
■
Authority: 21 U.S.C. 952, 953, 954, 957,
958.
43. Section 1312.12 is amended by
revising paragraph (a) to read as follows:
■
§ 1312.12
Application for import permit.
(a) An application for a permit to
import controlled substances shall be
made on DEA Form 357. DEA Form 357
may be obtained from, and shall be filed
with, the Import/Export Unit, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. Each application shall
show the date of execution; the
registration number of the importer; a
detailed description of each controlled
substance to be imported including the
drug name, dosage form, National Drug
Code (NDC) number, the Administration
Controlled Substance Code Number as
set forth in part 1308 of this chapter, the
number and size of packages or
containers, the name and quantity of the
controlled substance contained in any
finished dosage units, and the net
quantity of any controlled substance
(expressed in anhydrous acid, base or
alkaloid) given in kilograms or parts
E:\FR\FM\09MRR1.SGM
09MRR1
10682
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
thereof. The application shall also
include the following:
*
*
*
*
*
44. Section 1312.16 is amended by
revising paragraph (b) to read as follows:
■
§ 1312.16 Cancellation of permit;
expiration date.
*
*
*
*
*
(b) An import permit shall not be
valid after the date specified therein,
and in no event shall the date be
subsequent to 6 months after the date
the permit is issued. Any unused import
permit shall be returned for cancellation
by the registrant to the Import/Export
Unit, Drug Enforcement Administration.
See the Table of DEA Mailing Addresses
in § 1321.01 of this chapter for the
current mailing address.
45. Section 1312.18 is amended by
revising paragraph (b) to read as follows:
■
§ 1312.18
Contents of import declaration.
*
*
*
*
*
(b) Any person registered or
authorized to import and desiring to
import any non-narcotic controlled
substance in Schedules III, IV, or V
which is not subject to the requirement
of an import permit as described in
paragraph (a) of this section, must
furnish a controlled substances import
declaration on DEA Form 236 to the
Import/Export Unit, Drug Enforcement
Administration, not later than 15
calendar days prior to the proposed date
of importation and distribute four
copies of same as hereinafter directed in
§ 1312.19. See the Table of DEA Mailing
Addresses in § 1321.01 of this chapter
for the current mailing address.
*
*
*
*
*
46. Section 1312.19 is amended by
revising paragraph (b) to read as follows:
■
§ 1312.19 Distribution of import
declaration.
*
*
*
*
*
(b) Copy 4 shall be forwarded, within
the time limit required in § 1312.18,
directly to the Import/Export Unit, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
47. Section 1312.22 is amended by
revising paragraphs (a) and (d)(8) to read
as follows:
sroberts on DSKD5P82C1PROD with RULES
■
§ 1312.22
Application for export permit.
(a) An application for a permit to
export controlled substances shall be
made on DEA Form 161, and an
application for a permit to reexport
controlled substances shall be made on
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
DEA Form 161R. Forms may be
obtained from, and shall be filed with,
the Import/Export Unit, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. Each application shall
show the exporter’s name, address, and
registration number; a detailed
description of each controlled substance
desired to be exported including the
drug name, dosage form, National Drug
Code (NDC) number (in accordance with
Food and Drug Administration
regulations), the Administration
Controlled Substance Code Number as
set forth in Part 1308 of this chapter, the
number and size of packages or
containers, the name and quantity of the
controlled substance contained in any
finished dosage units, and the quantity
of any controlled substance (expressed
in anhydrous acid, base, or alkaloid)
given in kilograms or parts thereof. The
application shall include the name,
address, and business of the consignee,
foreign port of entry, the port of
exportation, the approximate date of
exportation, the name of the exporting
carrier or vessel (if known, or if
unknown it should be stated whether
shipment will be made by express,
freight, or otherwise, exports of
controlled substances by mail being
prohibited), the date and number, if any,
of the supporting foreign import license
or permit accompanying the
application, and the authority by whom
such foreign license or permit was
issued. The application shall also
contain an affidavit that the packages
are labeled in conformance with
obligations of the United States under
international treaties, conventions, or
protocols in effect on May 1, 1971. The
affidavit shall further state that to the
best of affiant’s knowledge and belief,
the controlled substances therein are to
be applied exclusively to medical or
scientific uses within the country to
which exported, will not be reexported
therefrom and that there is an actual
need for the controlled substance for
medical or scientific uses within such
country, unless the application is
submitted for reexport in accordance
with paragraphs (c) and (d) of this
section. In the case of exportation of
crude cocaine, the affidavit may state
that to the best of affiant’s knowledge
and belief, the controlled substances
will be processed within the country to
which exported, either for medical or
scientific use within that country or for
reexportation in accordance with the
laws of that country to another for
medical or scientific use within that
country. The application shall be signed
PO 00000
Frm 00050
Fmt 4700
Sfmt 4700
and dated by the exporter and shall
contain the address from which the
substances will be shipped for
exportation.
*
*
*
*
*
(d) * * *
(8) Shipments that have been
exported from the United States and are
refused by the consignee in either the
first or second country, or are otherwise
unacceptable or undeliverable, may be
returned to the registered exporter in the
United States upon authorization of the
Administration. In these circumstances,
the exporter in the United States shall
file a written request for the return of
the controlled substances to the United
States with a brief summary of the facts
that warrant the return, along with a
completed DEA Form 357, Application
for Import Permit, with the Import/
Export Unit, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
The Administration will evaluate the
request after considering all the facts as
well as the exporter’s registration status
with the Administration. If the exporter
provides sufficient documentation, the
Administration will issue an import
permit for the return of these drugs, and
the exporter can then obtain an export
permit from the country of original
importation. The substance may be
returned to the United States only after
affirmative authorization is issued in
writing by the Administration.
*
*
*
*
*
48. Section 1312.24 is amended by
revising paragraph (a) to read as follows:
■
§ 1312.24
permit.
Distribution of copies of export
*
*
*
*
*
(a) The original, duplicate, and
triplicate copies (Copy 1, Copy 2, and
Copy 3) shall be transmitted by the
Administration to the exporter who will
retain the triplicate copy (Copy 3) as his
record of authority for the exportation.
The exporter shall present to the District
Director of the U.S. Customs Service at
the port of export and at the time of
shipment, the original and duplicate
copies (Copy 1 and Copy 2). After
endorsing the port of export on the
reverse side of the original and
duplicate copies (Copy 1 and Copy 2)
the District Director shall forward the
endorsed original copy (Copy 1) with
the shipment, and return the endorsed
duplicate copy (Copy 2) to the Import/
Export Unit, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
49. Section 1312.27 is amended by
revising paragraphs (a) and (b)(5)(iv) to
read as follows:
■
§ 1312.27 Contents of special controlled
substances invoice.
(a) A person registered or authorized
to export any non-narcotic controlled
substance listed in Schedule III, IV, or
V, which is not subject to the
requirement of an export permit
pursuant to § 1312.23 (b) or (c), or any
person registered or authorized to
export any controlled substance in
Schedule V, must furnish a special
controlled substances export invoice on
DEA Form 236 to the Import/Export
Unit, Drug Enforcement Administration,
not less than 15 calendar days prior to
the proposed date of exportation, and
distribute four copies of same as
hereinafter directed in § 1312.28 of this
part. See the Table of DEA Mailing
Addresses in § 1321.01 of this chapter
for the current mailing address.
(b) * * *
(5) * * *
(iv) Shipments which have been
exported from the United States and are
refused by the consignee in the country
of destination, or are otherwise
unacceptable or undeliverable, may be
returned to the registered exporter in the
United States upon authorization of the
Drug Enforcement Administration. In
this circumstance, the exporter in the
United States shall file a written request
for reexport, along with a completed
DEA Form 236, Import Declaration with
the Import/Export Unit, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. A brief summary of the
facts that warrant the return of the
substance to the United States along
with an authorization from the country
of export will be included with the
request. DEA will evaluate the request
after considering all the facts as well as
the exporter’s registration status with
DEA. The substance may be returned to
the United States only after affirmative
authorization is issued in writing by
DEA.
*
*
*
*
*
■ 50. Section 1312.28 is amended by
revising paragraph (d) to read as
follows:
sroberts on DSKD5P82C1PROD with RULES
§ 1312.28 Distribution of special controlled
substances invoice.
*
*
*
*
*
(d) Copy 4 shall be forwarded, within
the time limit required in § 1312.27 of
this part, directly to the Import/Export
Unit, Drug Enforcement Administration.
The documentation required by
§ 1312.27(b)(4) of this part must be
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
attached to this copy. See the Table of
DEA Mailing Addresses in § 1321.01 of
this chapter for the current mailing
address.
*
*
*
*
*
■ 51. Section 1312.31 is amended by
revising the introductory text of
paragraph (b) to read as follows:
§ 1312.31 Schedule I: Application for prior
written approval.
*
*
*
*
*
(b) An application for a transshipment
permit must be submitted to the Import/
Export Unit, Drug Enforcement
Administration, at least 30 days, or in
the case of an emergency as soon as
practicable, prior to the expected date of
importation, transfer or transshipment.
See the Table of DEA Mailing Addresses
in § 1321.01 of this chapter for the
current mailing address. Each
application shall contain the following:
*
*
*
*
*
■ 52. Section 1312.32 is amended by
revising paragraph (a) to read as follows:
§ 1312.32
notice.
Schedules II, III, IV: Advance
(a) A controlled substance listed in
Schedules II, III, or IV may be imported
into the United States for
transshipment, or may be transferred or
transshipped within the United States
for immediate exportation, provided
that written notice is submitted to the
Import/Export Unit, Drug Enforcement
Administration, at least 15 days prior to
the expected date of importation,
transfer or transshipment. See the Table
of DEA Mailing Addresses in § 1321.01
of this chapter for the current mailing
address.
*
*
*
*
*
PART 1313—IMPORTATION AND
EXPORTATION OF LIST I AND LIST II
CHEMICALS
53. The authority citation for part
1313 continues to read as follows:
■
Authority: 21 U.S.C. 802, 830, 871(b), 971.
54. Section 1313.12 is amended by
revising paragraph (b) and the
introductory text of paragraph (e) to
read as follows:
■
§ 1313.12
import.
Requirement of authorization to
*
*
*
*
*
(b) A completed DEA Form 486 must
be received by the Import/Export Unit,
Drug Enforcement Administration, not
later than 15 days prior to the
importation. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
A copy of the completed DEA Form 486
PO 00000
Frm 00051
Fmt 4700
Sfmt 4700
10683
may be transmitted directly to the Drug
Enforcement Administration through
electronic facsimile media not later than
15 days prior to the importation.
*
*
*
*
*
(e) For importations where advance
notification is waived pursuant to
paragraph (c)(2) of this section no DEA
Form 486 is required; however, the
regulated person shall submit quarterly
reports to the Import/Export Unit, Drug
Enforcement Administration, no later
than the 15th day of the month
following the end of each quarter. See
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. The report shall
contain the following information
regarding each individual importation:
*
*
*
*
*
■ 55. Section 1313.21 is amended by
revising paragraph (b) and the
introductory text of paragraph (e) to
read as follows:
§ 1313.21
export.
Requirement of authorization to
*
*
*
*
*
(b) A completed DEA Form 486 must
be received by the Import/Export Unit,
Drug Enforcement Administration, not
later than 15 days prior to the
exportation. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
A copy of the completed DEA Form 486
may be transmitted directly to the Drug
Enforcement Administration through
electronic facsimile media not later than
15 days prior to the exportation.
*
*
*
*
*
(e) For exportations where advance
notification is waived pursuant to
paragraph (c)(2) of this section, no DEA
Form 486 is required; however, the
regulated person shall file quarterly
reports with the Import/Export Unit,
Drug Enforcement Administration, no
later than the 15th day of the month
following the end of each quarter. See
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. The report shall
contain the following information
regarding each individual exportation:
*
*
*
*
*
■ 56. Section 1313.22 is amended by
revising paragraph (e) to read as follows:
§ 1313.22
Contents of export declaration.
*
*
*
*
*
(e) Declared exports of listed
chemicals which are refused, rejected,
or otherwise deemed undeliverable may
be returned to the U.S. chemical
exporter of record. A brief written
notification (this does not require a DEA
Form 486) outlining the circumstances
E:\FR\FM\09MRR1.SGM
09MRR1
10684
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
must be sent to the Import/Export Unit,
Drug Enforcement Administration,
following the return within a reasonable
time. See the Table of DEA Mailing
Addresses in § 1321.01 of this chapter
for the current mailing address. This
provision does not apply to shipments
that have cleared foreign customs, been
delivered, and accepted by the foreign
consignee. Returns to third parties in
the United States will be regarded as
imports.
57. Section 1313.24 is amended by
revising paragraph (e) to read as follows:
■
§ 1313.24 Waiver of 15-day advance notice
for chemical exporters.
*
*
*
*
*
(e) The Administrator may notify any
chemical exporter that a regular
customer has been disqualified or that a
new customer for whom a notification
has been submitted is not to be accorded
the status of a regular customer. In the
event of a disqualification of an
established regular customer, the
chemical exporter will be notified in
writing of the reasons for such action.
58. Section 1313.31 is amended by
revising the introductory text of
paragraph (b) to read as follows:
■
§ 1313.31 Advance notice of importation
for transshipment or transfer.
*
*
*
*
*
(b) Advance notification must be
provided to the Import/Export Unit,
Drug Enforcement Administration, not
later than 15 days prior to the proposed
date the listed chemical will transship
or transfer through the United States.
See the Table of DEA Mailing Addresses
in § 1321.01 of this chapter for the
current mailing address. The written
notification (not a DEA Form 486) shall
contain the following information:
*
*
*
*
*
59. Section 1313.32 is amended by
revising paragraph (b)(1) to read as
follows:
■
sroberts on DSKD5P82C1PROD with RULES
*
*
*
*
(b)(1) A completed DEA Form 486
must be received by the Import/Export
Unit, Drug Enforcement Administration,
not later than 15 days prior to the
international transaction. See the Table
of DEA Mailing Addresses in § 1321.01
of this chapter for the current mailing
address.
*
*
*
*
*
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
60. The authority citation for part
1314 continues to read as follows:
■
Authority: 21 U.S.C. 802, 830, 842, 871(b),
875, 877.
61. Section 1314.110 is amended by
revising paragraphs (a)(1) and (a)(2) to
read as follows:
■
§ 1314.110
Reports for mail-order sales.
(a) * * *
(1) Submit a written report,
containing the information set forth in
paragraph (b) of this section, on or
before the 15th day of each month
following the month in which the
distributions took place. The report
must be submitted under company
letterhead, signed by the person
authorized to sign on behalf of the
regulated seller, to the Import/Export
Unit, Drug Enforcement Administration
(see the Table of DEA Mailing
Addresses in § 1321.01 of this chapter
for the current mailing address); or
(2) Upon request to and approval by
the Administration, submit the report in
electronic form, either via computer
disk or direct electronic data
transmission, in such form as the
Administration shall direct. Requests to
submit reports in electronic form should
be submitted to the Import/Export Unit,
Drug Enforcement Administration. See
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
PART 1315—IMPORTATION AND
PRODUCTION QUOTAS FOR
EPHEDRINE, PSEUDOEPHEDRINE,
AND PHENYLPROPANOLAMINE
62. The authority citation for part
1315 continues to read as follows:
■
Authority: 21 U.S.C. 802, 821, 826, 871(b),
952.
63. Section 1315.22 is amended by
revising the introductory text to read as
follows:
■
§ 1313.32 Requirement of authorization for
international transactions
*
PART 1314—RETAIL SALE OF
SCHEDULED LISTED CHEMICAL
PRODUCTS
§ 1315.22 Procedure for applying for
individual manufacturing quotas.
Any person who is registered to
manufacture ephedrine,
pseudoephedrine, or
phenylpropanolamine and who desires
to manufacture a quantity of the
chemical must apply on DEA Form 189
for a manufacturing quota for the
quantity of the chemical. Copies of DEA
Form 189 may be obtained from the
Office of Diversion Control Web site,
and must be filed (on or before April 1
PO 00000
Frm 00052
Fmt 4700
Sfmt 4700
of the year preceding the calendar year
for which the manufacturing quota is
being applied) with the Drug &
Chemical Evaluation Section, Drug
Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address. A separate application
must be made for each chemical desired
to be manufactured. The applicant must
state the following:
*
*
*
*
*
64. Section 1315.32 is amended by
revising paragraphs (e) and (g) to read as
follows:
■
§ 1315.32
Obtaining a procurement quota.
*
*
*
*
*
(e) DEA Form 250 must be filed on or
before April 1 of the year preceding the
calendar year for which the
procurement quota is being applied.
Copies of DEA Form 250 may be
obtained from the Office of Diversion
Control Web site, and must be filed with
the Drug & Chemical Evaluation
Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
(g) Any person to whom a
procurement quota has been issued may
at any time request an adjustment in the
quota by applying to the Administrator
with a statement showing the need for
the adjustment. The application must be
filed with the Drug & Chemical
Evaluation Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
The Administrator shall increase or
decrease the procurement quota of the
person if and to the extent that he finds,
after considering the factors enumerated
in paragraph (f) of this section and any
occurrences since the issuance of the
procurement quota, that the need
justifies an adjustment.
*
*
*
*
*
65. Section 1315.34 is amended by
revising paragraph (d) to read as
follows:
■
§ 1315.34
Obtaining an import quota.
*
*
*
*
*
(d) DEA Form 488 must be filed on or
before April 1 of the year preceding the
calendar year for which the import
quota is being applied. Copies of DEA
Form 488 may be obtained from the
Office of Diversion Control Web site,
and must be filed with the Drug &
Chemical Evaluation Section. See the
Table of DEA Mailing Addresses in
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
§ 1321.01 of this chapter for the current
mailing address.
*
*
*
*
*
■ 66. Section 1315.36 is amended by
revising paragraph (b) to read as follows:
§ 1315.36
Amending an import quota.
chapter for the current mailing address)
and shall contain the following:
*
*
*
*
*
■ 70. The authority citation for Subpart
D of part 1316 continues to read as
follows:
*
*
*
*
(b) Any person to whom an import
quota has been issued may at any time
request an increase in the quota quantity
by applying to the Administrator with a
statement showing the need for the
adjustment. The application must be
filed with the Drug & Chemical
Evaluation Section, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
The Administrator may increase the
import quota of the person if and to the
extent that he determines that the
approval is necessary to provide for
medical, scientific, or other legitimate
purposes regarding the chemical. The
Administrator shall specify a period of
time for which the approval is in effect
or shall provide that the approval is in
effect until the Administrator notifies
the applicant in writing that the
approval is terminated.
*
*
*
*
*
Authority: 21 U.S.C. 811, 812, 871(b), 875,
958(d), 965.
PART 1316—ADMINISTRATIVE
FUNCTIONS, PRACTICES, AND
PROCEDURES
(a) The record bearing on any
proceeding, except for material
described in subsection (b) of this
section, shall be available for inspection
and copying by any person entitled to
participate in such proceeding, during
office hours in the office of the Hearing
Clerk, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
*
*
*
*
*
*
67. The authority citation for Subpart
B of part 1316 continues to read as
follows:
■
Authority: 21 U.S.C. 830, 871(b).
68. Section 1316.23 is amended by
revising the introductory text of
paragraph (b) to read as follows:
■
§ 1316.23 Confidentiality of identity of
research subjects.
*
*
*
*
(b) All petitions for Grants of
Confidentiality shall be addressed to the
Administrator, Drug Enforcement
Administration (see the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address):
*
*
*
*
*
■ 69. Section 1316.24 is amended by
revising the introductory text of
paragraph (b) to read as follows:
sroberts on DSKD5P82C1PROD with RULES
§ 1316.24 Exemption from prosecution for
researchers.
*
*
*
*
(b) All petitions for Grants of
Exemption from Prosecution for the
Researcher shall be addressed to the
Administrator, Drug Enforcement
Administration, (see the Table of DEA
Mailing Addresses in § 1321.01 of this
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
§ 1316.45
Filings; address; hours.
Documents required or permitted to
be filed in, and correspondence relating
to, hearings governed by the regulations
in this chapter shall be filed with the
Hearing Clerk, Drug Enforcement
Administration. See the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address.
This office is open Monday through
Friday from 8:30 a.m. to 5 p.m. eastern
standard or daylight saving time,
whichever is effective in the District of
Columbia at the time, except on national
legal holidays. Documents shall be
dated and deemed filed upon receipt by
the Hearing Clerk.
72. Section 1316.46 is amended by
revising paragraph (a) to read as follows:
■
§ 1316.46
Inspection of record.
73. Section 1316.47 is amended by
revising paragraph (a) to read as follows:
■
*
*
71. Section 1316.45 is revised to read
as follows:
■
§ 1316.47
Request for hearing.
(a) Any person entitled to a hearing
and desiring a hearing shall, within the
period permitted for filing, file a request
for a hearing in the following form (see
the Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address):
llllllllll (Date)
Administrator, Drug Enforcement
Administration, Attention: DEA Federal
Register Representative.
Dear Sir: The undersigned
llllll (Name of person) hereby
requests a hearing in the matter of:
llllllll (Identification of the
proceeding).
(A) (State with particularity the
interest of the person in the proceeding.)
PO 00000
Frm 00053
Fmt 4700
Sfmt 4700
10685
(B) (State with particularity the
objections or issues, if any, concerning
which the person desires to be heard.)
(C) (State briefly the position of the
person with regard to the particular
objections or issues.)
All notices to be sent pursuant to the
proceeding should be addressed to:
llllllllll (Name)
llllllllll (Street address)
llllllllll (City and State)
Respectfully yours,
llllllllll (Signature of
person)
*
*
*
*
*
■ 74. Section 1316.48 is revised to read
as follows:
§ 1316.48
Notice of appearance.
Any person entitled to a hearing and
desiring to appear in any hearing, shall,
if he has not filed a request for hearing,
file within the time specified in the
notice of proposed rulemaking, a
written notice of appearance in the
following form (see the Table of DEA
Mailing Addresses in § 1321.01 of this
chapter for the current mailing address):
llllllllll (Date)
Administrator, Drug Enforcement
Administration
llllllllll (Mailing
Address), Attention: Federal Register
Representative
Dear Sir: Please take notice that
llllllll (Name of person) will
appear in the matter of:
llllllll (Identification of the
proceeding).
(A) (State with particularity the
interest of the person in the proceeding.)
(B) (State with particularity the
objections or issues, if any, concerning
which the person desires to be heard.)
(C) (State briefly the position of the
person with regard to the particular
objections or issues.)
All notices to be sent pursuant to this
appearance should be addressed to:
llllllllll (Name)
llllllllll (Street address)
llllllllll (City and State)
Respectfully yours,
llllllllll (Signature of
person)
■ 75. Part 1321 is added to 21 CFR
Chapter II to read as follows:
PART 1321—DEA MAILING
ADDRESSES
Sec.
1321.01
DEA mailing addresses.
Authority: 21 U.S.C. 871(b).
E:\FR\FM\09MRR1.SGM
09MRR1
10686
§ 1321.01
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
DEA mailing addresses.
The following table provides
information regarding mailing addresses
to be used when sending specified
correspondence to the Drug
Enforcement Administration.
TABLE OF DEA MAILING ADDRESSES
Code of Federal Regulations Section—Topic
DEA Mailing address
DEA Administrator
1308.43(b)—Petition to initiate proceedings for rulemaking ...........................................................
316.23(b)—Petition for grant of confidentiality for research subjects.
1316.24(b)—Petition for exemption from prosecution for researchers.
1316.48—Notice of appearance.
Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield,
VA 22152.
DEA Office of Diversion Control
1301.52(c)—Controlled substances registration return for cancellation .........................................
1307.03—Exception request filing.
1307.22—Disposal of controlled substances by the Administration delivery application.
1308.21(a)—Exclusion of nonnarcotic substance.
1308.23(b)—Exemption for chemical preparations.
1308.25(a)—Exclusion of veterinary anabolic steroid implant product application.
1308.31(a)—Exemption of a nonnarcotic prescription product application.
1308.33(b)—Exemption of certain anabolic steroid products application.
1310.13(b)—Exemption for chemical preparations.
1310.21(b)—Sale by Federal departments or agencies of chemicals which could be used to
manufacture controlled substances certification request.
Drug Enforcement Administration, Attn: Office
of Diversion Control/OD, 8701 Morrissette
Drive, Springfield, VA 22152.
DEA Regulatory Section
1301.71(d)—Security system compliance review for controlled substances ..................................
1309.71(c)—Security system compliance review for List I chemicals.
Drug Enforcement Administration, Attn: Regulatory Section/ODG, 8701 Morrissette Drive,
Springfield, VA 22152
DEA Import/Export Unit
1310.05(c)—Importer/exporter of tableting or encapsulation machines reporting ..........................
1310.05(e)(1)—Reporting by persons required to keep records and file reports regarding List I
chemicals.
1310.05(e)(2)—Request to submit List I chemicals reports in electronic form.
1310.06(g)—Report of declared exports of machines refused, rejected, or returned.
1312.12(a)—Application for import permit (DEA Form 357).
1312.16(b)—Return unused import permits.
1312.18(b)—Import declaration (DEA Form 236) submission.
1312.19(b)—DEA Form 236 copy 4 filing.
1312.22(a)—Application for export permit (DEA Form 161).
1312.22(d)(8)—Request for return of unacceptable or undeliverable exported controlled substances.
1312.24(a)—DEA Form 161 copy 2 filing.
1312.27(a)—Special controlled substances export invoice (DEA Form 236) filing.
1312.27(b)(5)(iv)—Request for reexport.
1312.28(d)—Distribution of special controlled substances invoice (DEA Form 236) copy 4.
1312.31(b)—Controlled substances transshipment permit application.
1312.32(a)—Advanced notice of importation for transshipment or transfer of controlled substances.
1313.12(b)—Authorization to import listed chemicals (DEA Form 486).
1313.12(e)—Quarterly reports of listed chemicals importation.
1313.21(b)—Authorization to export listed chemicals (DEA Form 486).
1313.21(e)—Quarterly reports of listed chemicals exportation.
1313.22(e)—Written notice of declared exports of listed chemicals refused, rejected or undeliverable.
1313.31(b)—Advanced notice of importation for transshipment or transfer of listed chemicals.
1313.32(b)(1)—International transaction authorization (DEA Form 486).
1314.110(a)(1)—Reports for mail-order sales.
1314.110(a)(2)—Request to submit mail-order sales reports in electronic form.
Drug Enforcement Administration, Attn: Import/
Export Unit/ODGI, 8701 Morrissette Drive,
Springfield, VA 22152.
sroberts on DSKD5P82C1PROD with RULES
DEA Drug & Chemical Evaluation Section
1303.12(b)—Application for controlled substances procurement quota (DEA Form 250) filing
and request.
1303.12(d)—Controlled substances quota adjustment request.
1303.22—Application for individual manufacturing quota (DEA Form 189) filing and request for
schedule I or II controlled substances.
1304.31(a)—Manufacturers importing narcotic raw material report submission.
1304.32(a)—Manufacturers importing coca leaves report submission.
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
PO 00000
Frm 00054
Fmt 4700
Sfmt 4700
Drug Enforcement Administration, Attn: Drug &
Chemical Evaluation Section/ODE, 8701
Morrissette Drive, Springfield, VA 22152.
E:\FR\FM\09MRR1.SGM
09MRR1
Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations
10687
TABLE OF DEA MAILING ADDRESSES—Continued
Code of Federal Regulations Section—Topic
DEA Mailing address
1308.24(d)—Exempt narcotic chemical preparations importer/exporter reporting.
1308.24(i)—Exempted chemical preparations listing.
1308.26(a)—Excluded veterinary anabolic steroid implant products listing.
1308.32—Exempted prescription products listing.
1308.34—Exempted anabolic steroid products listing.
1310.05(d)—Bulk manufacturer of listed chemicals reporting.
1315.22—Application for individual manufacturing quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 189) filing and request.
1315.32(e)—Application for procurement quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 250) filing and request.
1315.32(g)—Procurement quota adjustment request for ephedrine, pseudoephedrine, phenylpropanolamine.
1315.34(d)—Application for import quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 488) request and filing.
1315.36(b)—Request import quota increase for ephedrine, pseudoephedrine, or phenylpropanolamine.
DEA ARCOS Unit
1304.04(d)—ARCOS separate central reporting identifier request ................................................
1304.33(a)—Reports to ARCOS.
Drug
Enforcement
Administration,
Attn:
ARCOS Unit/ODPT, P.O. Box 2520, Springfield, VA 22152–2520, OR Drug Enforcement Administration, Attn: ARCOS Unit,
8701 Morrissette Drive, Springfield, VA
22152.
DEA Registration Section
1301.03—Procedures information request (controlled substances registration) ............................
1301.13(e)(2)—Request DEA Forms 224, 225, and 363.
1301.14(a)—Controlled substances registration application submission.
1301.18(c)—Research project controlled substance increase request.
1301.51—Controlled substances registration modification request.
1301.52(b)—Controlled substances registration transfer request.
1309.03—List I chemicals registration procedures information request.
1309.32(c)—Request DEA Form 510.
1309.33(a)—List I chemicals registration application submission.
1309.61—List I chemicals registration modification request.
Drug Enforcement Administration, Attn: Registration Section/ODR P.O. Box 2639,
Springfield, VA 22152–2639.
DEA Hearing Clerk
1316.45—Hearings documentation filing ........................................................................................
1316.46(a)—Inspection of record.
Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, VA 22152.
DEA Federal Register Representative
1316.47(a)—Request for hearing ....................................................................................................
Drug Enforcement Administration, Attn: Federal
Register
Representative/ODL,
8701
Morrissette Drive, Springfield, VA 22152.
Dated: February 25, 2010.
Michele M. Leonhart,
Deputy Administrator.
SUMMARY: The Coast Guard published a
document in the Federal Register on
November 17, 2009, adding a section
and establishing regulated navigation
areas for bars along the coasts of Oregon
and Washington. That document
inadvertently failed to include an option
for mariners to use VHF–FM Channel 16
for notifying the Coast Guard, and also
contained typographical errors
improperly describing VHF–FM
Channel 16 and a position of latitude.
This document corrects the final
regulations.
DEPARTMENT OF HOMELAND
SECURITY
[FR Doc. 2010–4714 Filed 3–8–10; 8:45 am]
BILLING CODE 4410–09–P
Coast Guard
33 CFR Part 165
[Docket No. USCG–2008–1017]
sroberts on DSKD5P82C1PROD with RULES
RIN 1625–AA11
Regulated Navigation Areas; Bars
Along the Coasts of Oregon and
Washington; Correction
Coast Guard, DHS.
ACTION: Correcting amendment.
AGENCY:
VerDate Nov<24>2008
16:00 Mar 08, 2010
Jkt 220001
PO 00000
Frm 00055
Fmt 4700
Sfmt 4700
DATES:
Effective March 9, 2010.
FOR FURTHER INFORMATION CONTACT:
you have questions about this
E:\FR\FM\09MRR1.SGM
09MRR1
If
]]>Agencies
[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Rules and Regulations]
[Pages 10671-10687]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-4714]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301, 1303, 1304, 1307, 1308, 1309, 1310, 1312, 1313,
1314, 1315, 1316, 1321
[Docket No. DEA-312F]
RIN 1117-AB19
Changes to and Consolidation of DEA Mailing Addresses
AGENCY: Drug Enforcement Administration (DEA), Department of Justice.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: DEA is amending Title 21 of the Code of Federal Regulations
(CFR) to update and consolidate existing mailing addresses. Mailing
addresses are being removed from the individual sections in which they
currently appear and are being consolidated into one table in a new
part 1321. DEA is making this change to the CFR to ensure registrants
have the most current and accurate information, reduce administrative
costs, and facilitate future address changes. A statement directing
persons to the Table of DEA Mailing Addresses within the CFR is being
provided in place of specific mailing addresses.
DATES: Effective Date: This rule is effective March 9, 2010.
FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and
Policy Section, Office of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive, Springfield, VA 22152,
Telephone (202) 307-7297.
SUPPLEMENTARY INFORMATION:
DEA's Legal Authority
DEA implements the Comprehensive Drug Abuse Prevention and Control
Act of 1970, often referred to as the Controlled Substances Act (CSA)
and Controlled Substances Import and Export Act (21 U.S.C. 801-971), as
amended. DEA publishes the implementing regulations for these statutes
in Title 21 of the Code of Federal Regulations (CFR), parts 1300 to
end. These regulations are designed to ensure that there is a
sufficient supply of controlled substances for legitimate medical
purposes and to deter the diversion of controlled substances to illegal
purposes.
Controlled substances are drugs and other substances that have a
potential for abuse and psychological and physical dependence; these
include substances classified as opioids, stimulants, depressants,
hallucinogens, anabolic steroids, and drugs that are immediate
precursors of these classes of substances. The CSA mandates that DEA
establish a closed system of control for manufacturing, distributing,
and dispensing controlled substances. Any person who manufactures,
distributes, dispenses, imports, exports, or conducts research or
chemical analysis with controlled substances must register with DEA
(unless exempt) and comply with the applicable requirements for the
activity.
The CSA, as amended, also requires DEA to regulate the manufacture,
distribution, importation, and exportation of chemicals that may be
used to manufacture controlled substances. Listed chemicals that are
classified as List I chemicals are important to the manufacture of
controlled substances. Those classified as List II chemicals may be
used to manufacture controlled substances. Registrants are also
required to provide other reports and information to DEA on an ongoing
basis in compliance with a variety of statutory and regulatory
obligations.
Background
Currently, 21 CFR parts 1300 to end contain numerous office names
and mailing addresses to which specific forms and other information are
to be sent. However, oftentimes these mailing addresses and office
names are not consistent and many are no longer accurate. DEA became
aware of this internal inconsistency when it determined that, to
improve agency management and efficiency, its Washington, DC, addresses
would be moved to other locations. As DEA reviewed the number of
addresses contained in 21 CFR, it became clear that a significant
administrative burden would be involved in updating these addresses.
DEA recognized that this administrative burden could potentially not be
a one-time occurrence; that is, it is quite possible that DEA might
move some of its mailing addresses in the future, necessitating further
revisions to the CFR.
For registrants to have the most current mailing addresses to which
applications, forms, and other materials are to be sent, DEA believes
directing registrants and other interested persons to a single location
within the CFR is the most practical way to convey current mailing
address information. To address this, DEA is establishing a new part
1321 in the CFR that will contain the Table of DEA Mailing Addresses.
Providing this information in the table format in the CFR allows for
easy retrieval of necessary information in
[[Page 10672]]
multiple formats. By consolidating this information into a table within
the CFR, DEA will be able to rapidly respond should mailing addresses
change due to facility relocation, special mail handling procedures, or
other circumstances.
With publication of this Final Rule, all entries citing DEA mailing
addresses will be removed and replaced with language directing
interested persons to the Table of DEA Mailing Addresses found at 21
CFR 1321.01.
Information Affected by the Removal of Addresses
As noted previously, the current CFR contains numerous addresses
specific to applications, forms, and other information to be physically
mailed to DEA. Below are two tables. The first table lists the CFR
section which previously contained a mailing address, the subject, and
the corresponding DEA office that is responsible for that activity. The
second table provides the mailing address information that will be
provided in 21 CFR 1321.01.
Table 1--Mailing Addresses Referenced in the CFR
------------------------------------------------------------------------
CFR Section Subject DEA Office
------------------------------------------------------------------------
1301.03...................... Procedures information DEA Registration
request (controlled Section.
substances
registration).
1301.13(e)(2)................ Request DEA Forms 224, DEA Registration
225, and 363. Section.
1301.14(a)................... Controlled substances DEA Registration
registration Section.
application
submission.
1301.18(c)................... Research project DEA Registration
controlled substance Section.
increase request.
1301.51...................... Controlled substances DEA Registration
registration Section.
modification request.
1301.52(b)................... Controlled substances DEA Registration
registration transfer Section.
request.
1301.52(c)................... Controlled substances DEA Office of
registration return Diversion
for cancellation. Control.
1301.71(d)................... Controlled substances DEA Regulatory
security system Section.
compliance review.
1303.12(b)................... Application for DEA Drug &
controlled substances Chemical
procurement quota Evaluation
(DEA Form 250) filing Section.
and request.
1303.12(d)................... Controlled substances DEA Drug &
quota adjustment Chemical
request. Evaluation
Section.
1303.22...................... Application for DEA Drug &
individual Chemical
manufacturing quota Evaluation
(DEA Form 189) filing Section.
and request for
schedule I or II
controlled substances.
1304.04(d)................... ARCOS separate central DEA ARCOS Unit.
reporting identifier
request.
1304.31(a)................... Manufacturers DEA Drug &
importing narcotic Chemical
raw material report Evaluation
submission. Section.
1304.32(a)................... Manufacturers DEA Drug &
importing coca leaves Chemical
report submission. Evaluation
Section.
1304.33(a)................... Reports to ARCOS...... DEA ARCOS Unit.
1307.03...................... Exception request DEA Office of
filing. Diversion
Control.
1307.22...................... Disposal of controlled DEA Office of
substances by the Diversion
Administration Control.
delivery application.
1308.21(a)................... Exclusion of DEA Office of
nonnarcotic substance. Diversion
Control.
1308.23(b)................... Exemption for chemical DEA Office of
preparations. Diversion
Control.
1308.24(d)................... Exempt narcotic DEA Drug &
chemical preparations Chemical
importer/exporter Evaluation
reporting. Section.
1308.24(i)................... Exempted chemical DEA Drug &
preparations listing. Chemical
Evaluation
Section.
1308.25(a)................... Exclusion of DEA Office of
veterinary anabolic Diversion
steroid implant Control.
product application.
1308.26(a)................... Excluded veterinary DEA Drug &
anabolic steroid Chemical
implant products Evaluation
listing. Section.
1308.31(a)................... Exemption of a DEA Office of
nonnarcotic Diversion
prescription product Control.
application.
1308.32...................... Exempted prescription DEA Drug &
products listing. Chemical
Evaluation
Section.
1308.33(b)................... Exemption of certain DEA Office of
anabolic steroid Diversion
products application. Control.
1308.34...................... Exempted anabolic DEA Drug &
steroid products Chemical
listing. Evaluation
Section.
1308.43(b)................... Petition to initiate DEA
proceedings for Administrator.
rulemaking.
1309.03...................... List I chemicals DEA Registration
registration Section.
procedures
information request.
1309.32(c)................... Request DEA Form 510.. DEA Registration
Section.
1309.33(a)................... List I chemicals DEA Registration
registration Section.
application
submission.
1309.61...................... List I chemicals DEA Registration
registration Section.
modification request.
1309.71(c)................... List I chemicals DEA Regulatory
security system Section.
compliance review.
1310.05(c)................... Importer/exporter of DEA Import/Export
tableting or Unit.
encapsulation
machines reporting.
1310.05(d)................... Bulk manufacturer of DEA Drug &
listed chemicals Chemical
reporting. Evaluation
Section.
1310.05(e)(1)................ Reporting by persons DEA Import/Export
required to keep Unit.
records and file
reports regarding
List I chemicals.
1310.05(e)(2)................ Request to submit List DEA Import/Export
I chemicals reports Unit.
in electronic form.
1310.06(g)................... Report of declared DEA Import/Export
exports of machines Unit.
refused, rejected, or
returned.
1310.13(b)................... Exemption for chemical DEA Office of
preparations. Diversion
Control.
1310.21(b)................... Sale by Federal DEA Office of
departments or Diversion
agencies of chemicals Control.
which could be used
to manufacture
controlled substances
certification request.
1312.12(a)................... Application for import DEA Import/Export
permit (DEA Form 357). Unit.
1312.16(b)................... Return unused import DEA Import/Export
permits. Unit.
1312.18(b)................... Import declaration DEA Import/Export
(DEA Form 236) Unit.
submission.
1312.19(b)................... DEA Form 236 copy 4... DEA Import/Export
Unit.
1312.22(a)................... Application for export DEA Import/Export
permit (DEA Form 161). Unit.
1312.22(d)(8)................ Request for return of DEA Import/Export
unacceptable or Unit
undeliverable
exported controlled
substances..
1312.24(a)................... DEA Form 161 copy 2... DEA Import/Export
Unit.
[[Page 10673]]
1312.27(a)................... Special controlled DEA Import/Export
substances export Unit.
invoice (DEA Form
236) filing.
1312.27(b)(5)(iv)............ Request for reexport.. DEA Import/Export
Unit.
1312.28(d)................... Distribution of DEA Import/Export
special controlled Unit.
substances invoice
(DEA Form 236) copy 4.
1312.31(b)................... Controlled substances DEA Import/Export
transshipment permit Unit.
application.
1312.32(a)................... Advanced notice of DEA Import/Export
importation for Unit.
transshipment or
transfer of
controlled substances.
1313.12(b)................... Authorization to DEA Import/Export
import listed Unit.
chemicals (DEA Form
486).
1313.12(e)................... Quarterly reports for DEA Import/Export
listed chemicals Unit.
importation.
1313.21(b)................... Authorization to DEA Import/Export
export listed Unit.
chemicals (DEA Form
486).
1313.21(e)................... Quarterly reports for DEA Import/Export
listed chemicals Unit.
exportation.
1313.22(e)................... Written notice of DEA Import/Export
declared exports of Unit.
listed chemicals
refused, rejected or
undeliverable.
1313.31(b)................... Advanced notice of DEA Import/Export
importation for Unit.
transshipment or
transfer of listed
chemicals.
1313.32(b)(1)................ International DEA Import/Export
transaction Unit.
authorization (DEA
Form 486).
1314.110(a)(1)............... Reports for mail-order DEA Import/Export
sales. Unit.
1314.110(a)(2)............... Request to submit mail- DEA Import/Export
order sales reports Unit.
in electronic form.
1315.22...................... Application for DEA Drug &
individual Chemical
manufacturing quota Evaluation
for ephedrine, Section.
pseudoephedrine,
phenylpropanolamine
(DEA Form 189) filing
and request.
1315.32(e)................... Application for DEA Drug &
procurement quota for Chemical
ephedrine, Evaluation
pseudoephedrine, Section.
phenylpropanolamine
(DEA Form 250) filing
and request.
1315.32(g)................... Procurement quota DEA Drug &
adjustment request Chemical
for ephedrine, Evaluation
pseudoephedrine, Section.
phenylpropanolamine.
1315.34(d)................... Application for import DEA Drug &
quota for ephedrine, Chemical
pseudoephedrine, Evaluation
phenylpropanolamine Section.
(DEA Form 488)
request and filing.
1315.36(b)................... Request import quota DEA Drug &
increase for Chemical
ephedrine, Evaluation
pseudoephedrine, or Section.
phenylpropanolamine.
1316.23(b)................... Petition for grant of DEA
confidentiality for Administrator.
research subjects.
1316.24(b)................... Petition for exemption DEA
from prosecution for Administrator.
researchers.
1316.45...................... Hearings documentation DEA Hearing
filing. Clerk.
1316.46(a)................... Inspection of record.. DEA Hearing
Clerk.
1316.47(a)................... Request for hearing... DEA Federal
Register
Representative.
1316.48...................... Notice of appearance.. DEA
Administrator.
------------------------------------------------------------------------
Table 2--Table of DEA Mailing Addresses
------------------------------------------------------------------------
Code of Federal Regulations Section--Topic DEA Mailing address
------------------------------------------------------------------------
DEA Administrator
------------------------------------------------------------------------
1308.43(b)--Petition to initiate Drug Enforcement
proceedings for rulemaking. Administration, Attn:
1316.23(b)--Petition for grant of Administrator, 8701
confidentiality for research subjects.. Morrissette Drive,
1316.24(b)--Petition for exemption from Springfield, VA 22152.
prosecution for researchers..
1316.48--Notice of appearance.
------------------------------------------------------------------------
DEA Office of Diversion Control
------------------------------------------------------------------------
1301.52(c)--Controlled substances Drug Enforcement
registration return for cancellation. Administration, Attn:
1307.03--Exception request filing.......... Office of Diversion
1307.22--Disposal of controlled substances Control/OD, 8701
by the Administration delivery Morrissette Drive,
application.. Springfield, VA 22152.
1308.21(a)--Exclusion of nonnarcotic
substance.
1308.23(b)--Exemption for chemical
preparations.
1308.25(a)--Exclusion of veterinary
anabolic steroid implant product
application.
1308.31(a)--Exemption of a nonnarcotic
prescription product application.
1308.33(b)--Exemption of certain anabolic
steroid products application.
1310.13(b)--Exemption for chemical
preparations.
1310.21(b)--Sale by Federal departments or
agencies of chemicals which could be used
to manufacture controlled substances
certification request.
------------------------------------------------------------------------
DEA Regulatory Section
------------------------------------------------------------------------
1301.71(d)--Security system compliance Drug Enforcement
review for controlled substances. Administration, Attn:
1309.71(c)--Security system compliance Regulatory Section/ODG,
review for List I chemicals.. 8701 Morrissette Drive,
Springfield, VA 22152.
------------------------------------------------------------------------
DEA Import/Export Unit
------------------------------------------------------------------------
1310.05(c)--Importer/exporter of tableting Drug Enforcement
or encapsulation machines reporting. Administration, Attn:
1310.05(e)(1)--Reporting by persons Import/Export Unit/ODGI,
required to keep records and file reports 8701 Morrissette Drive,
regarding List I chemicals.. Springfield, VA 22152.
1310.05(e)(2)--Request to submit List I
chemicals reports in electronic form..
[[Page 10674]]
1310.06(g)--Report of declared exports of
machines refused, rejected, or returned.
1312.12(a)--Application for import permit
(DEA Form 357).
1312.16(b)--Return unused import permits.
1312.18(b)--Import declaration (DEA Form
236) submission.
1312.19(b)--DEA Form 236 copy 4 filing.
1312.22(a)--Application for export permit
(DEA Form 161).
1312.22(d)(8)--Request for return of
unacceptable or undeliverable exported
controlled substances.
1312.24(a)--DEA Form 161 copy 2 filing.
1312.27(a)--Special controlled substances
export invoice (DEA Form 236) filing.
1312.27(b)(5)(iv)--Request for reexport.
1312.28(d)--Distribution of special
controlled substances invoice (DEA Form
236) copy 4.
1312.31(b)--Controlled substances
transshipment permit application.
1312.32(a)--Advanced notice of importation
for transshipment or transfer of
controlled substances.
1313.12(b)--Authorization to import listed
chemicals (DEA Form 486).
1313.12(e)--Quarterly reports of listed
chemicals importation.
1313.21(b)--Authorization to export listed
chemicals (DEA Form 486).
1313.21(e)--Quarterly reports of listed
chemicals exportation.
1313.22(e)--Written notice of declared
exports of listed chemicals refused,
rejected or undeliverable.
1313.31(b)--Advanced notice of importation
for transshipment or transfer of listed
chemicals.
1313.32(b)(1)--International transaction
authorization (DEA Form 486).
1314.110(a)(1)--Reports for mail-order
sales.
1314.110(a)(2)--Request to submit mail-
order sales reports in electronic form.
------------------------------------------------------------------------
DEA Drug & Chemical Evaluation Section
------------------------------------------------------------------------
1303.12(b)--Application for controlled Drug Enforcement
substances procurement quota (DEA Form Administration, Attn: Drug
250) filing and request. & Chemical Evaluation
1303.12(d)--Controlled substances quota Section/ODE, 8701
adjustment request.. Morrissette Drive,
1303.22--Application for individual Springfield, VA 22152.
manufacturing quota (DEA Form 189) filing
and request for schedule I or II
controlled substances..
1304.31(a)--Manufacturers importing
narcotic raw material report submission.
1304.32(a)--Manufacturers importing coca
leaves report submission.
1308.24(d)--Exempt narcotic chemical
preparations importer/exporter reporting.
1308.24(i)--Exempted chemical preparations
listing.
1308.26(a)--Excluded veterinary anabolic
steroid implant products listing.
1308.32--Exempted prescription products
listing.
1308.34--Exempted anabolic steroid products
listing.
1310.05(d)--Bulk manufacturer of listed
chemicals reporting.
1315.22--Application for individual
manufacturing quota for ephedrine,
pseudoephedrine, phenylpropanolamine (DEA
Form 189) filing and request.
1315.32(e)--Application for procurement
quota for ephedrine, pseudoephedrine,
phenylpropanolamine (DEA Form 250) filing
and request.
1315.32(g)--Procurement quota adjustment
request for ephedrine, pseudoephedrine,
phenylpropanolamine.
1315.34(d)--Application for import quota
for ephedrine, pseudoephedrine,
phenylpropanolamine (DEA Form 488) request
and filing.
1315.36(b)--Request import quota increase
for ephedrine, pseudoephedrine, or
phenylpropanolamine.
------------------------------------------------------------------------
DEA ARCOS Unit
------------------------------------------------------------------------
1304.04(d)--ARCOS separate central Drug Enforcement
reporting identifier request. Administration, Attn:
1304.33(a)--Reports to ARCOS............... ARCOS Unit/ODPT, P.O. Box
2520, Springfield, VA
22152-2520, OR Drug
Enforcement
Administration, Attn:
ARCOS Unit/ODPT, 8701
Morrissette Drive,
Springfield, VA 22152.
------------------------------------------------------------------------
DEA Registration Section
------------------------------------------------------------------------
1301.03--Procedures information request Drug Enforcement
(controlled substances registration). Administration, Attn:
1301.13(e)(2)--Request DEA Forms 224, 225, Registration Section/ODR
and 363.. P.O. Box 2639,
1301.14(a)--Controlled substances Springfield, VA 22152-
registration application submission.. 2639.
1301.18(c)--Research project controlled
substance increase request.
1301.51--Controlled substances registration
modification request.
1301.52(b)--Controlled substances
registration transfer request.
1309.03--List I chemicals registration
procedures information request.
1309.32(c)--Request DEA Form 510.
1309.33(a)--List I chemicals registration
application submission.
[[Page 10675]]
1309.61--List I chemicals registration
modification request.
------------------------------------------------------------------------
DEA Hearing Clerk
------------------------------------------------------------------------
1316.45--Hearings documentation filing..... Drug Enforcement
1316.46(a)--Inspection of record........... Administration, Attn:
Hearing Clerk/LJ, 8701
Morrissette Drive,
Springfield, VA 22152.
------------------------------------------------------------------------
DEA Federal Register Representative
------------------------------------------------------------------------
1316.47(a)--Request for hearing............ Drug Enforcement
Administration, Attn:
Federal Register
Representative/ODL, 8701
Morrissette Drive,
Springfield, VA 22152.
------------------------------------------------------------------------
DEA is removing address references for the two information
collections specifically listed in the regulations (21 CFR 1310.06(d)
and 1313.24(e)), as the information was provided inconsistently.
Persons are encouraged to submit comments regarding information
collections as each specific collection is renewed. Notices regarding
such renewal are published in the Federal Register, seek public
comment, and provide the address to be used when submitting those
comments.
Technical Corrections
While preparing this rule, DEA became aware of inaccurate section
citations in 21 CFR 1310.05(d) and 21 CFR 1310.06(h)(5). Those
paragraphs referenced 21 CFR 1310.01(f)(1)(iv) and 21 CFR
1310.01(f)(1)(v) which had previously been redesignated as 21 CFR
1300.02(b)(28)(i)(D) and 21 CFR 1300.02(b)(28)(i)(E), respectively. DEA
is correcting these inaccurate citations in this rule.
Regulatory Certifications
Administrative Procedure Act (5 U.S.C. 553)
An agency may find good cause to exempt a rule from certain
provisions of the Administrative Procedure Act (5 U.S.C. 553),
including notice of proposed rulemaking and the opportunity for public
comment, if it is determined to be unnecessary, impracticable, or
contrary to the public interest. This rule updates existing mailing
addresses and consolidates those addresses into a new part in 21 CFR.
By consolidating this information, DEA will be able to rapidly respond
should mailing addresses change due to facility relocation, special
mail handling procedures, or other circumstances. As this Final Rule
only updates existing mailing addresses and consolidates those
addresses (some of which were outdated), DEA finds it unnecessary and
impracticable to permit public notice and comment. Therefore, DEA is
publishing this document as a final rule. Further, as the changes of
address have occurred and it is administratively burdensome for DEA to
continue to support previous mailing addresses, and since a delay in
the effective date of this regulation could impede the timely receipt
of required reports by DEA from the regulated industry and cause
further confusion, DEA finds there is good cause to make this final
rule effective immediately upon publication.
Regulatory Flexibility Act
The Deputy Administrator hereby certifies that this rulemaking has
been drafted in accordance with the Regulatory Flexibility Act (5
U.S.C. 601-612), has reviewed this regulation, and by approving it
certifies that this regulation will not have a significant economic
impact on a substantial number of small entities. This final rule
merely changes DEA mailing addresses, permitting industry to report to
DEA in a timely manner.
Executive Order 12866
The Deputy Administrator further certifies that this rulemaking has
been drafted in accordance with the principles in Executive Order 12866
Section 1(b). DEA has determined that this is not a significant
regulatory action. Therefore, this action has not been reviewed by the
Office of Management and Budget.
Executive Order 12988
This regulation meets the applicable standards set forth in
Sections 3(a) and 3(b)(2) of Executive Order 12988 Civil Justice
Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local, and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under the provisions of the Unfunded
Mandates Reform Act of 1995.
Congressional Review Act
This rule is not a major rule as defined by Section 804 of the
Small Business Regulatory Enforcement Fairness Act of 1996
(Congressional Review Act). This rule will not result in an annual
effect on the economy of $100,000,000 or more; a major increase in
costs or prices; or significant adverse effects on competition,
employment, investment, productivity, innovation, or on the ability of
United States-based companies to compete with foreign-based companies
in domestic and export markets.
List of Subjects
21 CFR Part 1301
Administrative practice and procedure, Drug traffic control,
Security measures.
21 CFR Part 1303
Administrative practice and procedure, Drug traffic control.
21 CFR Part 1304
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1307
Drug traffic control.
[[Page 10676]]
21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
21 CFR Part 1309
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Security measures.
21 CFR Part 1310
Drug traffic control, Exports, Imports, Reporting and recordkeeping
requirements.
21 CFR Part 1312
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
21 CFR Part 1313
Administrative practice and procedure, Drug traffic control,
Exports, Imports, Reporting and recordkeeping requirements.
21 CFR Part 1314
Drug traffic control, Reporting and recordkeeping requirements.
21 CFR Part 1315
Administrative practice and procedure, Chemicals, Drug traffic
control, Imports, Reporting and recordkeeping requirements.
21 CFR Part 1316
Administrative practice and procedure, Authority delegations
(Government agencies), Drug traffic control, Research, Seizures and
forfeitures.
21 CFR Part 1321
Administrative practice and procedure, Drug traffic control,
Reporting and recordkeeping requirements.
0
For the reasons set out above, 21 CFR Chapter II is amended as follows:
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND
DISPENSERS OF CONTROLLED SUBSTANCES
0
1. The authority citation for Part 1301 continues to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877,
886a, 951, 952, 953, 956, 957, 958.
0
2. Section 1301.03 is revised to read as follows:
Sec. 1301.03 Information; special instructions.
Information regarding procedures under these rules and instructions
supplementing these rules will be furnished upon request by writing to
the Registration Section, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
0
3. Section 1301.13 is amended by revising paragraph (e)(2) to read as
follows:
Sec. 1301.13 Application for registration; time for application;
expiration date; registration for independent activities; application
forms, fees, contents and signature; coincident activities.
* * * * *
(e) * * *
(2) DEA Forms 224, 225, and 363 may be obtained at any area office
of the Administration or by writing to the Registration Section, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address.
* * * * *
0
4. Section 1301.14 is amended by revising paragraph (a) to read as
follows:
Sec. 1301.14 Filing of application; acceptance for filing; defective
applications.
(a) All applications for registration shall be submitted for filing
to the Registration Unit, Drug Enforcement Administration. The
appropriate registration fee and any required attachments must
accompany the application. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address.
* * * * *
0
5. Section 1301.18 is amended by revising paragraph (c) to read as
follows:
Sec. 1301.18 Research protocols.
* * * * *
(c) In the event that the registrant desires to increase the
quantity of a controlled substance used for an approved research
project, he/she shall submit a request to the Registration Unit, Drug
Enforcement Administration, by registered mail, return receipt
requested. See the Table of DEA Mailing Addresses in Sec. 1321.01 of
this chapter for the current mailing address. The request shall contain
the following information: DEA registration number; name of the
controlled substance or substances and the quantity of each authorized
in the approved protocol; and the additional quantity of each desired.
Upon return of the receipt, the registrant shall be authorized to
purchase the additional quantity of the controlled substance or
substances specified in the request. The Administration shall review
the letter and forward it to the Food and Drug Administration together
with the Administration comments. The Food and Drug Administration
shall approve or deny the request as an amendment to the protocol and
so notify the registrant. Approval of the letter by the Food and Drug
Administration shall authorize the registrant to use the additional
quantity of the controlled substance in the research project.
* * * * *
0
6. Section 1301.51 is revised to read as follows:
Sec. 1301.51 Modification in registration.
Any registrant may apply to modify his/her registration to
authorize the handling of additional controlled substances or to change
his/her name or address, by submitting a letter of request to the
Registration Unit, Drug Enforcement Administration. See the Table of
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current
mailing address. The letter shall contain the registrant's name,
address, and registration number as printed on the certificate of
registration, and the substances and/or schedules to be added to his/
her registration or the new name or address and shall be signed in
accordance with Sec. 1301.13(j). If the registrant is seeking to
handle additional controlled substances listed in Schedule I for the
purpose of research or instructional activities, he/she shall attach
three copies of a research protocol describing each research project
involving the additional substances, or two copies of a statement
describing the nature, extent, and duration of such instructional
activities, as appropriate. No fee shall be required to be paid for the
modification. The request for modification shall be handled in the same
manner as an application for registration. If the modification in
registration is approved, the Administrator shall issue a new
certificate of registration (DEA Form 223) to the registrant, who shall
maintain it with the old certificate of registration until expiration.
0
7. Section 1301.52 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 1301.52 Termination of registration; transfer of registration;
distribution upon discontinuance of business.
* * * * *
(b) No registration or any authority conferred thereby shall be
assigned or otherwise transferred except upon such conditions as the
Administration may specifically designate and then only pursuant to
written consent. Any person seeking authority to transfer a
[[Page 10677]]
registration shall submit a written request, providing full details
regarding the proposed transfer of registration, to the Deputy
Assistant Administrator, Office of Diversion Control, Drug Enforcement
Administration. See the Table of DEA Mailing Addresses in Sec. 1321.01
of this chapter for the current mailing address.
(c) Any registrant desiring to discontinue business activities
altogether or with respect to controlled substances (without
transferring such business activities to another person) shall return
for cancellation his/her certificate of registration, and any
unexecuted order forms in his/her possession, to the Registration Unit,
Drug Enforcement Administration. See the Table of DEA Mailing Addresses
in Sec. 1321.01 of this chapter for the current mailing address. Any
controlled substances in his/her possession may be disposed of in
accordance with Sec. 1307.21 of this chapter.
* * * * *
0
8. Section 1301.71 is amended by revising paragraph (d) to read as
follows:
Sec. 1301.71 Security requirements generally.
* * * * *
(d) Any registrant or applicant desiring to determine whether a
proposed security system substantially complies with, or is the
structural equivalent of, the requirements set forth in Sec. Sec.
1301.72-1301.76 may submit any plans, blueprints, sketches or other
materials regarding the proposed security system either to the Special
Agent in Charge in the region in which the system will be used, or to
the Regulatory Section, Drug Enforcement Administration. See the Table
of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
* * * * *
PART 1303--QUOTAS
0
9. The authority citation for Part 1303 continues to read as follows:
Authority: 21 U.S.C. 821, 826, 871(b).
0
10. Section 1303.12 is amended by revising paragraphs (b) and (d) to
read as follows:
Sec. 1303.12 Procurement quotas.
* * * * *
(b) Any person who is registered to manufacture controlled
substances listed in any schedule and who desires to use during the
next calendar year any basic class of controlled substances listed in
Schedule I or II (except raw opium being imported by the registrant
pursuant to an import permit) for purposes of manufacturing, shall
apply on DEA Form 250 for a procurement quota for such basic class. A
separate application must be made for each basic class desired to be
procured or used. The applicant shall state whether he intends to
manufacture the basic class himself or purchase it from another
manufacturer. The applicant shall state separately each purpose for
which the basic class is desired, the quantity desired for that purpose
during the next calendar year, and the quantities used and estimated to
be used, if any, for that purpose during the current and preceding 2
calendar years. If the purpose is to manufacture the basic class into
dosage form, the applicant shall state the official name, common or
usual name, chemical name, or brand name of that form. If the purpose
is to manufacture another substance, the applicant shall state the
official name, common or usual name, chemical name, or brand name of
the substance, and, if a controlled substance listed in any schedule,
the schedule number and Administration Controlled Substances Code
Number, as set forth in part 1308 of this chapter, of the substance. If
the purpose is to manufacture another basic class of controlled
substance listed in Schedule I or II, the applicant shall also state
the quantity of the other basic class which the applicant has applied
to manufacture pursuant to Sec. 1303.22 and the quantity of the first
basic class necessary to manufacture a specified unit of the second
basic class. DEA Form 250 shall be filed on or before April 1 of the
year preceding the calendar year for which the procurement quota is
being applied. Copies of DEA Form 250 may be obtained from, and shall
be filed with, the Drug and Chemical Evaluation Section, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address.
* * * * *
(d) Any person to whom a procurement quota has been issued may at
any time request an adjustment in the quota by applying to the
Administrator with a statement showing the need for the adjustment.
Such application shall be filed with the Drug & Chemical Evaluation
Section, Drug Enforcement Administration. See the Table of DEA Mailing
Addresses in Sec. 1321.01 of this chapter for the current mailing
address. The Administrator shall increase or decrease the procurement
quota of such person if and to the extent that he finds, after
considering the factors enumerated in paragraph (c) of this section and
any occurrences since the issuance of the procurement quota, that the
need justifies an adjustment.
* * * * *
0
11. Section 1303.22 is amended by revising the introductory text to
read as follows:
Sec. 1303.22 Procedure for applying for individual manufacturing
quotas.
Any person who is registered to manufacture any basic class of
controlled substance listed in Schedule I or II and who desires to
manufacture a quantity of such class shall apply on DEA Form 189 for a
manufacturing quota for such quantity of such class. Copies of DEA Form
189 may be obtained from, and shall be filed (on or before May 1 of the
year preceding the calendar year for which the manufacturing quota is
being applied) with, the Drug & Chemical Evaluation Section, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address. A
separate application must be made for each basic class desired to be
manufactured. The applicant shall state:
* * * * *
PART 1304--RECORDS AND REPORTS OF REGISTRANTS
0
12. The authority citation for Part 1304 continues to read as follows:
Authority: 21 U.S.C. 821, 827, 831, 871(b), 958(e), 965, unless
otherwise noted.
0
13. Section 1304.04 is amended by revising paragraph (d) to read as
follows:
Sec. 1304.04 Maintenance of records and inventories.
* * * * *
(d) ARCOS participants who desire authorization to report from
other than their registered locations must obtain a separate central
reporting identifier. Request for central reporting identifiers will be
submitted to the ARCOS Unit. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address.
* * * * *
0
14. Section 1304.31 is amended by revising paragraph (a) to read as
follows:
Sec. 1304.31 Reports from manufacturers importing narcotic raw
material.
(a) Every manufacturer which imports or manufactures from narcotic
raw material (opium, poppy straw, and concentrate of poppy straw) shall
submit information which accounts for the importation and for all
manufacturing operations performed
[[Page 10678]]
between importation and the production in bulk or finished marketable
products, standardized in accordance with the U.S. Pharmacopeia,
National Formulary or other recognized medical standards. Reports shall
be signed by the authorized official and submitted quarterly on company
letterhead to the Drug and Chemical Evaluation Section, Drug
Enforcement Administration, on or before the 15th day of the month
immediately following the period for which it is submitted. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
* * * * *
0
15. Section 1304.32 is amended by revising paragraph (a) to read as
follows:
Sec. 1304.32 Reports of manufacturers importing coca leaves.
(a) Every manufacturer importing or manufacturing from raw coca
leaves shall submit information accounting for the importation and for
all manufacturing operations performed between the importation and the
manufacture of bulk or finished products standardized in accordance
with U.S. Pharmacopoeia, National Formulary, or other recognized
standards. The reports shall be submitted quarterly on company
letterhead to the Drug and Chemical Evaluation Section, Drug
Enforcement Administration, on or before the 15th day of the month
immediately following the period for which it is submitted. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
* * * * *
0
16. Section 1304.33 is amended by revising paragraph (a) to read as
follows:
Sec. 1304.33 Reports to ARCOS.
(a) Reports generally. All reports required by this section shall
be filed with the ARCOS Unit on DEA Form 333, or on media which
contains the data required by DEA Form 333 and which is acceptable to
the ARCOS Unit. See the Table of DEA Mailing Addresses in Sec. 1321.01
of this chapter for the current mailing address.
* * * * *
PART 1307--MISCELLANEOUS
0
17. The authority citation for Part 1307 continues to read as follows:
Authority: 21 U.S.C. 821, 822(d), 871(b), unless otherwise
noted.
0
18. Section 1307.03 is revised to read as follows:
Sec. 1307.03 Exceptions to regulations.
Any person may apply for an exception to the application of any
provision of this chapter by filing a written request with the Office
of Diversion Control, Drug Enforcement Administration, stating the
reasons for such exception. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address. The
Administrator may grant an exception in his discretion, but in no case
shall he/she be required to grant an exception to any person which is
otherwise required by law or the regulations cited in this section.
0
19. Section 1307.22 is revised to read as follows:
Sec. 1307.22 Disposal of controlled substances by the Administration.
Any controlled substance delivered to the Administration under
Sec. 1307.21 or forfeited pursuant to section 511 of the Act (21
U.S.C. 881) may be delivered to any department, bureau, or other agency
of the United States or of any State upon proper application addressed
to the Office of Diversion Control, Drug Enforcement Administration.
See the Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter
for the current mailing address. The application shall show the name,
address, and official title of the person or agency to whom the
controlled drugs are to be delivered, including the name and quantity
of the substances desired and the purpose for which intended. The
delivery of such controlled drugs shall be ordered by the
Administrator, if, in his opinion, there exists a medical or scientific
need therefor.
PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES
0
20. The authority citation for part 1308 continues to read as follows:
Authority: 21 U.S.C. 811, 812, 871(b), unless otherwise noted.
0
21. Section 1308.21 is amended by revising paragraph (a) to read as
follows:
Sec. 1308.21 Application for exclusion of a nonnarcotic substance.
(a) Any person seeking to have any nonnarcotic drug that may, under
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301), be lawfully
sold over the counter without a prescription, excluded from any
schedule, pursuant to section 201(g)(1) of the Act (21 U.S.C.
811(g)(1)), may apply to the Office of Diversion Control, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address.
* * * * *
0
22. Section 1308.23 is amended by revising paragraph (b) to read as
follows:
Sec. 1308.23 Exemption of certain chemical preparations; application.
* * * * *
(b) Any person seeking to have any preparation or mixture
containing a controlled substance and one or more noncontrolled
substances exempted from the application of all or any part of the Act,
pursuant to paragraph (a) of this section, may apply to the Office of
Diversion Control, Drug Enforcement Administration. See the Table of
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current
mailing address.
* * * * *
0
23. Section 1308.24 is amended by revising paragraphs (d) and (i) to
read as follows:
Sec. 1308.24 Exempt chemical preparations.
* * * * *
(d) Records and reports: Any person who manufactures an exempt
chemical preparation or mixture must keep complete and accurate records
and file all reports required under part 1304 of this chapter regarding
all controlled substances being used in the manufacturing process until
the preparation or mixture is in the form described in paragraph (i) of
this section. In lieu of records and reports required under part 1304
of this chapter regarding exempt chemical preparations, the
manufacturer need only record the name, address, and registration
number, if any, of each person to whom the manufacturer distributes any
exempt chemical preparation. Each importer or exporter of an exempt
narcotic chemical preparation must submit a semiannual report of the
total quantity of each substance imported or exported in each calendar
half-year within 30 days of the close of the period to the Drug and
Chemical Evaluation Section, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address. Any other person who handles an exempt
chemical preparation after it is in the form described in paragraph (i)
of this section is not required to maintain records or file reports.
* * * * *
(i) A listing of exempt chemical preparations may be obtained by
submitting a written request to the Drug and Chemical Evaluation
Section, Drug Enforcement Administration. See the Table of DEA Mailing
Addresses in
[[Page 10679]]
Sec. 1321.01 of this chapter for the current mailing address.
* * * * *
0
24. Section 1308.25 is amended by revising paragraph (a) to read as
follows:
Sec. 1308.25 Exclusion of a veterinary anabolic steroid implant
product; application.
(a) Any person seeking to have any anabolic steroid product, which
is expressly intended for administration through implants to cattle or
other nonhuman species and which has been approved by the Secretary of
Health and Human Services for such administration, identified as being
excluded from any schedule, pursuant to section 102(41)(B)(i) of the
Act (21 U.S.C. 802(41)(B)(i)), may apply to the Office of Diversion
Control, Drug Enforcement Administration. See the Table of DEA Mailing
Addresses in Sec. 1321.01 of this chapter for the current mailing
address.
* * * * *
0
25. Section 1308.26 is amended by revising paragraph (a) to read as
follows:
Sec. 1308.26 Excluded veterinary anabolic steroid implant products.
(a) Products containing an anabolic steroid, that are expressly
intended for administration through implants to cattle or other
nonhuman species and which have been approved by the Secretary of
Health and Human Services for such administration are excluded from all
schedules pursuant to section 102(41)(B)(i) of the Act (21 U.S.C.
802(41)(B)(i)). A listing of the excluded products may be obtained by
submitting a written request to the Drug and Chemical Evaluation
Section, Drug Enforcement Administration. See the Table of DEA Mailing
Addresses in Sec. 1321.01 of this chapter for the current mailing
address.
* * * * *
0
26. Section 1308.31 is amended by revising paragraph (a) to read as
follows:
Sec. 1308.31 Application for exemption of a nonnarcotic prescription
product.
(a) Any person seeking to have any compound, mixture, or
preparation containing any nonnarcotic controlled substance listed in
Sec. 1308.12(e), or in Sec. 1308.13(b) or (c), or in Sec. 1308.14,
or in Sec. 1308.15, exempted from application of all or any part of
the Act pursuant to section 201(g)(3)(A), of the Act (21 U.S.C.
811(g)(3)(A)) may apply to the Office of Diversion Control, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address.
* * * * *
0
27. Section 1308.32 is revised to read as follows:
Sec. 1308.32 Exempted prescription products.
The compounds, mixtures, or preparations that contain a nonnarcotic
controlled substance listed in Sec. 1308.12(e) or in Sec. 1308.13(b)
or (c) or in Sec. 1308.14 or in Sec. 1308.15 listed in the Table of
Exempted Prescription Products have been exempted by the Administrator
from the application of sections 302 through 305, 307 through 309, and
1002 through 1004 of the Act (21 U.S.C. 822-825, 827-829, and 952-954)
and Sec. Sec. 1301.13, 1301.22, and Sec. Sec. 1301.71 through 1301.76
of this chapter for administrative purposes only. An exception to the
above is that those products containing butalbital shall not be exempt
from the requirement of 21 U.S.C. 952-954 concerning importation,
exportation, transshipment and in-transit shipment of controlled
substances. Any deviation from the quantitative composition of any of
the listed drugs shall require a petition of exemption in order for the
product to be exempted. A listing of the Exempted Prescription Products
may be obtained by submitting a written request to the Drug and
Chemical Evaluation Section, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
0
28. Section 1308.33 is amended by revising paragraph (b) to read as
follows:
Sec. 1308.33 Exemption of certain anabolic steroid products;
application.
* * * * *
(b) Any person seeking to have any compound, mixture, or
preparation containing an anabolic steroid as defined in part 1300 of
this chapter exempted from the application of all or any part of the
Act, pursuant to paragraph (a) of this section, may apply to the Office
of Diversion Control, Drug Enforcement Administration. See the Table of
DEA Mailing Addresses in Sec. 1321.01 of this chapter for the current
mailing address.
* * * * *
0
29. Section 1308.34 is revised to read as follows:
Sec. 1308.34 Exempt anabolic steroid products.
The list of compounds, mixtures, or preparations that contain an
anabolic steroid that have been exempted by the Administrator from
application of sections 302 through 309 and 1002 through 1004 of the
Act (21 U.S.C. 822-829 and 952-954) and Sec. Sec. 1301.13, 1301.22,
and 1301.71 through 1301.76 of this chapter for administrative purposes
only may be obtained by submitting a written request to the Drug and
Chemical Evaluation Section, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
0
30. Section 1308.43 is amended by revising paragraph (b) to read as
follows:
Sec. 1308.43 Initiation of proceedings for rulemaking.
* * * * *
(b) Petitions shall be submitted in quintuplicate to the
Administrator. See the Table of DEA Mailing Addresses in Sec. 1321.01
of this chapter for the current mailing address. Petitions shall be in
the following form:
-------------------- (Date)
Administrator, Drug Enforcement Administration ------------ (Mailing
Address)
Dear Sir: The undersigned ---------------- hereby petitions the
Administrator to initiate proceedings for the issuance (amendment or
repeal) of a rule or regulation pursuant to section 201 of the
Controlled Substances Act.
Attached hereto and constituting a part of this petition are the
following:
(A) The proposed rule in the form proposed by the petitioner. (If
the petitioner seeks the amendment or repeal of an existing rule, the
existing rule, together with a reference to the section in the Code of
Federal Regulations where it appears, should be included.)
(B) A statement of the grounds which the petitioner relies for the
issuance (amendment or repeal) of the rule. (Such grounds shall include
a reasonably concise statement of the facts relied upon by the
petitioner, including a summary of any relevant medical or scientific
evidence known to the petitioner.)
All notices to be sent regarding this petition should be addressed
to:
-------------------- (Name)
-------------------- (Street Address)
-------------------- (City and State)
Respectfully yours,
-------------------- (Signature of petitioner)
* * * * *
[[Page 10680]]
PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS,
AND EXPORTERS OF LIST I CHEMICALS
0
31. The authority citation for Part 1309 continues to read as follows:
Authority: 21 U.S.C. 821, 822, 823, 824, 830, 871(b), 875, 877,
886a, 958.
0
32. Section 1309.03 is revised to read as follows:
Sec. 1309.03 Information; special instructions.
Information regarding procedures under these rules and instructions
supplementing these rules will be furnished upon request by writing to
the Registration Section, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in Sec. 1321.01 of this chapter for the
current mailing address.
0
33. Section 1309.32 is amended by revising paragraph (c) to read as
follows:
Sec. 1309.32 Application forms; contents; signature.
* * * * *
(c) DEA Form 510 may be obtained at any divisional office of the
Administration or by writing to the Registration Section, Drug
Enforcement Administration. See the Table of DEA Mailing Addresses in
Sec. 1321.01 of this chapter for the current mailing address. DEA Form
510a will be mailed to each List I chemical registrant approximately 60
days before the expiration date of his or her registration; if any
registered person does not receive such forms within 45 days before the
expiration date of the registration, notice must be promptly given of
such fact and DEA Form 510a must be requested by writing to the
Registration Section of the Administration at the foregoing address.
* * * * *
0
34. Section 1309.33 is amended by revising paragraph (a) to read as
follows:
Sec. 1309.33 Filing of application; joint filings.
(a) All applications for registration shall be su
