[Federal Register Volume 75, Number 45 (Tuesday, March 9, 2010)]
[Rules and Regulations]
[Pages 10671-10687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-4714]


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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 submitted for filing 
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. The appropriate registration fee and any 
required attachments must accompany the application.
* * * * *


0
35. Section 1309.61 is revised to read as follows:


Sec.  1309.61  Modification in registration.

    Any registrant may apply to modify his or her registration to 
authorize the 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 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 List I chemicals to be added to his registration 
or the new name or address and shall be signed in accordance with Sec.  
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.


0
36. Section 1309.71 is amended by revising paragraph (c) as follows:


Sec.  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 Sec.  1321.01 of this chapter for the current mailing 
address.

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES

0
37. The authority citation for Part 1310 continues to read as follows:

    Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.


0
38. Section 1310.05 is amended by revising paragraphs (c), (d), (e)(1), 
and (e)(2) to read as follows:


Sec.  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 Sec.  1321.01 of 
this 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 Sec.  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 Sec.  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 Sec. Sec.  1300.02(b)(28)(i)(D) or 1300.02(b)(28)(i)(E) except as 
set forth in Sec.  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 Sec.  1310.06(h) and such information is

[[Page 10681]]

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 Sec.  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 Sec.  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 Sec.  1321.01 of this chapter 
for the current mailing address.
* * * * *


0
39. Section 1310.06 is amended by revising paragraphs (d), (g), and 
(h)(5) to read as follows:


Sec.  1310.06  Content of records and reports.

* * * * *
    (d) A suggested format for the reports is provided below:

Supplier:

Registration Number----------------------------------------------------
Name-------------------------------------------------------------------
Business Address-------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Business Phone---------------------------------------------------------

Purchaser:

Registration Number----------------------------------------------------
Name-------------------------------------------------------------------
Business Address-------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Business Phone---------------------------------------------------------
Identification---------------------------------------------------------

Shipping Address (if different than purchaser Address):

Street-----------------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Date of Shipment-------------------------------------------------------
Name of Listed Chemical(s)---------------------------------------------
Quantity and Form of Packaging-----------------------------------------

Description of Machine:

Make-------------------------------------------------------------------
Model------------------------------------------------------------------
Serial <greek-i>-------------------------------------------------------
Method of Transfer-----------------------------------------------------

If Loss or Disappearance:

Date of Loss-----------------------------------------------------------
Type of Loss-----------------------------------------------------------
Description of Circumstances-------------------------------------------
* * * * *
    (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 Sec.  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 Sec. Sec.  
1300.02(b)(28)(i)(D) or 1300.02(b)(28)(i)(E) during the preceding 
calendar year.
* * * * *


0
40. Section 1310.13 is amended by revising paragraph (b) to read as 
follows:


Sec.  1310.13  Exemption of chemical mixtures; application.

* * * * *
    (b) Any manufacturer seeking an exemption for a chemical mixture, 
not exempt under Sec.  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 
Sec.  1321.01 of this chapter for the current mailing address.
* * * * *


0
41. Section 1310.21 is amended by revising the introductory text of 
paragraph (b) to read as follows:


Sec.  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 Sec.  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

0
42. The authority citation for Part 1312 continues to read as follows:

    Authority:  21 U.S.C. 952, 953, 954, 957, 958.


0
43. Section 1312.12 is amended by revising paragraph (a) to read as 
follows:


Sec.  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 Sec.  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

[[Page 10682]]

thereof. The application shall also include the following:
* * * * *


0
44. Section 1312.16 is amended by revising paragraph (b) to read as 
follows:


Sec.  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 Sec.  1321.01 of this chapter for the current mailing address.


0
45. Section 1312.18 is amended by revising paragraph (b) to read as 
follows:


Sec.  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 Sec.  1312.19. See the Table of DEA 
Mailing Addresses in Sec.  1321.01 of this chapter for the current 
mailing address.
* * * * *


0
46. Section 1312.19 is amended by revising paragraph (b) to read as 
follows:


Sec.  1312.19  Distribution of import declaration.

* * * * *
    (b) Copy 4 shall be forwarded, within the time limit required in 
Sec.  1312.18, directly to the Import/Export Unit, Drug Enforcement 
Administration. See the Table of DEA Mailing Addresses in Sec.  1321.01 
of this chapter for the current mailing address.
* * * * *


0
47. Section 1312.22 is amended by revising paragraphs (a) and (d)(8) to 
read as follows:


Sec.  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 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 Sec.  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 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 Sec.  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.
* * * * *


0
48. Section 1312.24 is amended by revising paragraph (a) to read as 
follows:


Sec.  1312.24  Distribution of copies of export permit.

* * * * *
    (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 Sec.  1321.01 of this chapter for the current mailing 
address.
* * * * *


[[Page 10683]]



0
49. Section 1312.27 is amended by revising paragraphs (a) and 
(b)(5)(iv) to read as follows:


Sec.  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 Sec.  
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 Sec.  1312.28 of this part. 
See the Table of DEA Mailing Addresses in Sec.  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 Sec.  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.
* * * * *

0
50. Section 1312.28 is amended by revising paragraph (d) to read as 
follows:


Sec.  1312.28  Distribution of special controlled substances invoice.

* * * * *
    (d) Copy 4 shall be forwarded, within the time limit required in 
Sec.  1312.27 of this part, directly to the Import/Export Unit, Drug 
Enforcement Administration. The documentation required by Sec.  
1312.27(b)(4) of this part must be attached to this copy. See the Table 
of DEA Mailing Addresses in Sec.  1321.01 of this chapter for the 
current mailing address.
* * * * *

0
51. Section 1312.31 is amended by revising the introductory text of 
paragraph (b) to read as follows:


Sec.  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 Sec.  1321.01 of this chapter for the 
current mailing address. Each application shall contain the following:
* * * * *

0
52. Section 1312.32 is amended by revising paragraph (a) to read as 
follows:


Sec.  1312.32  Schedules II, III, IV: Advance notice.

    (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 Sec.  1321.01 of this chapter for the 
current mailing address.
* * * * *

PART 1313--IMPORTATION AND EXPORTATION OF LIST I AND LIST II 
CHEMICALS

0
53. The authority citation for part 1313 continues to read as follows:

    Authority:  21 U.S.C. 802, 830, 871(b), 971.


0
54. Section 1313.12 is amended by revising paragraph (b) and the 
introductory text of paragraph (e) to read as follows:


Sec.  1313.12  Requirement of authorization to import.

* * * * *
    (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 Sec.  
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 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 Sec.  1321.01 of this chapter for the 
current mailing address. The report shall contain the following 
information regarding each individual importation:
* * * * *

0
55. Section 1313.21 is amended by revising paragraph (b) and the 
introductory text of paragraph (e) to read as follows:


Sec.  1313.21  Requirement of authorization to export.

* * * * *
    (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 Sec.  
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 Sec.  1321.01 of this chapter for the 
current mailing address. The report shall contain the following 
information regarding each individual exportation:
* * * * *

0
56. Section 1313.22 is amended by revising paragraph (e) to read as 
follows:


Sec.  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

[[Page 10684]]

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 Sec.  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.

0
57. Section 1313.24 is amended by revising paragraph (e) to read as 
follows:


Sec.  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.

0
58. Section 1313.31 is amended by revising the introductory text of 
paragraph (b) to read as follows:


Sec.  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 
Sec.  1321.01 of this chapter for the current mailing address. The 
written notification (not a DEA Form 486) shall contain the following 
information:
* * * * *

0
59. Section 1313.32 is amended by revising paragraph (b)(1) to read as 
follows:


Sec.  1313.32  Requirement of authorization for international 
transactions

* * * * *
    (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 Sec.  1321.01 of this chapter for the current mailing 
address.
* * * * *

PART 1314--RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS

0
60. The authority citation for part 1314 continues to read as follows:

    Authority:  21 U.S.C. 802, 830, 842, 871(b), 875, 877.


0
61. Section 1314.110 is amended by revising paragraphs (a)(1) and 
(a)(2) to read as follows:


Sec.  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 Sec.  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 Sec.  1321.01 of this chapter 
for the current mailing address.
* * * * *

PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, 
PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE

0
62. The authority citation for part 1315 continues to read as follows:

    Authority:  21 U.S.C. 802, 821, 826, 871(b), 952.


0
63. Section 1315.22 is amended by revising the introductory text to 
read as follows:


Sec.  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 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 chemical desired to be manufactured. The 
applicant must state the following:
* * * * *

0
64. Section 1315.32 is amended by revising paragraphs (e) and (g) to 
read as follows:


Sec.  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 Sec.  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 Sec.  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.
* * * * *

0
65. Section 1315.34 is amended by revising paragraph (d) to read as 
follows:


Sec.  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

[[Page 10685]]

Sec.  1321.01 of this chapter for the current mailing address.
* * * * *

0
66. Section 1315.36 is amended by revising paragraph (b) to read as 
follows:


Sec.  1315.36  Amending an import quota.

* * * * *
    (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 Sec.  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.
* * * * *

PART 1316--ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES

0
67. The authority citation for Subpart B of part 1316 continues to read 
as follows:

    Authority:  21 U.S.C. 830, 871(b).


0
68. Section 1316.23 is amended by revising the introductory text of 
paragraph (b) to read as follows:


Sec.  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 Sec.  1321.01 of this chapter for the current 
mailing address):
* * * * *

0
69. Section 1316.24 is amended by revising the introductory text of 
paragraph (b) to read as follows:


Sec.  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 Sec.  
1321.01 of this chapter for the current mailing address) and shall 
contain the following:
* * * * *

0
70. The authority citation for Subpart D of part 1316 continues to read 
as follows:

    Authority:  21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.


0
71. Section 1316.45 is revised to read as follows:


Sec.  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 Sec.  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.


0
72. Section 1316.46 is amended by revising paragraph (a) to read as 
follows:


Sec.  1316.46  Inspection of record.

    (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 Sec.  1321.01 of this chapter for the current mailing address.
* * * * *


0
73. Section 1316.47 is amended by revising paragraph (a) to read as 
follows:


Sec.  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 Sec.  
1321.01 of this chapter for the current mailing address):

-------------------- (Date)


Administrator, Drug Enforcement Administration, Attention: DEA Federal 
Register Representative.

    Dear Sir: The undersigned ------------ (Name of person) hereby 
requests a hearing in the matter of: ---------------- (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 the proceeding should be 
addressed to:

-------------------- (Name)

-------------------- (Street address)

-------------------- (City and State)

    Respectfully yours,

-------------------- (Signature of person)
* * * * *

0
74. Section 1316.48 is revised to read as follows:


Sec.  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 Sec.  1321.01 of this chapter for the current 
mailing address):

-------------------- (Date)

Administrator, Drug Enforcement Administration

-------------------- (Mailing Address), Attention: Federal Register 
Representative

    Dear Sir: Please take notice that ---------------- (Name of person) 
will appear in the matter of: ---------------- (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:

-------------------- (Name)

-------------------- (Street address)

-------------------- (City and State)

    Respectfully yours,

-------------------- (Signature of person)

0
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).

[[Page 10686]]

Sec.  1321.01  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             Drug Enforcement
 proceedings for rulemaking.                  Administration, Attn:
316.23(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.
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,
                                              Springfield, VA 22152.
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.

[[Page 10687]]

 
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, 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.
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.
------------------------------------------------------------------------


    Dated: February 25, 2010.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 2010-4714 Filed 3-8-10; 8:45 am]
BILLING CODE 4410-09-P