Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations 10671 

Alternative Methods of Compliance 

(AMOCs) 

(j)(1) The Manager, Seattle Aircraft 

Certification Office, FAA, has the authority to 

approve AMOCs for this AD, if requested 

using the procedures found in 14 CFR 39.19. 

Send information to ATTN: Marcia Smith, 

Aerospace Engineer, Cabin Safety and 

Environmental Systems Branch, ANM–150S, 

FAA, Seattle Aircraft Certification Office, 

1601 Lind Avenue SW., Renton, Washington 

98057–3356; telephone (425) 917–6484; fax 

(425) 917–6590. Or, e-mail information to 9- 

ANM-Seattle-ACO-AMOC-Requests@faa.gov. 

(2) To request a different method of 

compliance or a different compliance time 

for this AD, follow the procedures in 14 CFR 

39.19. Before using any approved AMOC on 

any airplane to which the AMOC applies, 

notify your principal maintenance inspector 

(PMI) or principal avionics inspector (PAI), 

as appropriate, or lacking a principal 

inspector, your local Flight Standards District 

Office. The AMOC approval letter must 

specifically reference this AD. 

Material Incorporated by Reference 

(k) You must use Boeing Service Bulletin 

747–25A3368, Revision 2, dated June 12, 

2008, to do the actions required by this AD, 

unless the AD specifies otherwise. 

(1) The Director of the Federal Register 

approved the incorporation by reference of 

this service information under 5 U.S.C. 

552(a) and 1 CFR part 51. 

(2) For service information identified in 

this AD, contact Boeing Commercial 

Airplanes, Attention: Data & Services 

Management, P.O. Box 3707, MC 2H–65, 

Seattle, Washington 98124–2207; telephone 

206–544–5000, extension 1; fax 206–766– 

5680; e-mail me.boecom@boeing.com; 

Internet https://www.myboeingfleet.com. 

(3) You may review copies of the service 

information at the FAA, Transport Airplane 

Directorate, 1601 Lind Avenue, SW., Renton, 

Washington. For information on the 

availability of this material at the FAA, call 

425–227–1221 or 425–227–1152. 

(4) You may also review copies of the 

service information that is incorporated by 

reference at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, call 202–741–6030, or go 

to: http://www.archives.gov/federal_register/ 

code_of_federal_regulations/ 

ibr_locations.html. 

Issued in Renton, Washington, on February 

25, 2010. 

Jeffrey E. Duven, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service. 

[FR Doc. 2010–4650 Filed 3–8–10; 8:45 am] 

BILLING CODE 4910–13–P 

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 


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10672 Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations 

multiple formats. By consolidating this 

information into a table within the CFR, 

DEA will be able to rapidly respond 

should mailing addresses change due to 

facility relocation, special mail handling 

procedures, or other circumstances. 

With publication of this Final Rule, 

all entries citing DEA mailing addresses 

will be removed and replaced with 

language directing interested persons to 

the Table of DEA Mailing Addresses 

found at 21 CFR 1321.01. 

Information Affected by the Removal of 

Addresses 

As noted previously, the current CFR 

contains numerous addresses specific to 

applications, forms, and other 

information to be physically mailed to 

DEA. Below are two tables. The first 

table lists the CFR section which 

previously contained a mailing address, 

the subject, and the corresponding DEA 

office that is responsible for that 

activity. The second table provides the 

mailing address information that will be 

provided in 21 CFR 1321.01. 

TABLE 1—MAILING ADDRESSES REFERENCED IN THE CFR 

CFR Section Subject DEA Office 

1301.03 ...................... Procedures information request (controlled substances registration) ................. DEA Registration Section. 

1301.13(e)(2) ............. Request DEA Forms 224, 225, and 363 ............................................................. DEA Registration Section. 

1301.14(a) ................. Controlled substances registration application submission ................................. DEA Registration Section. 

1301.18(c) .................. Research project controlled substance increase request .................................... DEA Registration Section. 

1301.51 ...................... Controlled substances registration modification request ..................................... DEA Registration Section. 

1301.52(b) ................. Controlled substances registration transfer request ............................................ DEA Registration Section. 

1301.52(c) .................. Controlled substances registration return for cancellation .................................. DEA Office of Diversion Control. 

1301.71(d) ................. Controlled substances security system compliance review ................................ DEA Regulatory Section. 

1303.12(b) ................. Application for controlled substances procurement quota (DEA Form 250) filing and request.DEA Drug & Chemical Evaluation Section. 

1303.12(d) ................. Controlled substances quota adjustment request ............................................... DEA Drug & Chemical Evaluation Section. 

1303.22 ...................... Application for individual manufacturing quota (DEA Form 189) filing and request for schedule I or II controlled substances.DEA Drug & Chemical Evaluation Section. 

1304.04(d) ................. ARCOS separate central reporting identifier request .......................................... DEA ARCOS Unit. 

1304.31(a) ................. Manufacturers importing narcotic raw material report submission ...................... DEA Drug & Chemical Evaluation Section. 

1304.32(a) ................. Manufacturers importing coca leaves report submission .................................... DEA Drug & Chemical Evaluation Section. 

1304.33(a) ................. Reports to ARCOS ............................................................................................... DEA ARCOS Unit. 

1307.03 ...................... Exception request filing ........................................................................................ DEA Office of Diversion Control. 

1307.22 ...................... Disposal of controlled substances by the Administration delivery application .... DEA Office of Diversion Control. 

1308.21(a) ................. Exclusion of nonnarcotic substance .................................................................... DEA Office of Diversion Control. 

1308.23(b) ................. Exemption for chemical preparations .................................................................. DEA Office of Diversion Control. 

1308.24(d) ................. Exempt narcotic chemical preparations importer/exporter reporting ................... DEA Drug & Chemical Evaluation Section. 

1308.24(i) ................... Exempted chemical preparations listing .............................................................. DEA Drug & Chemical Evaluation Section. 

1308.25(a) ................. Exclusion of veterinary anabolic steroid implant product application .................. DEA Office of Diversion Control. 

1308.26(a) ................. Excluded veterinary anabolic steroid implant products listing ............................. DEA Drug & Chemical Evaluation Section. 

1308.31(a) ................. Exemption of a nonnarcotic prescription product application .............................. DEA Office of Diversion Control. 

1308.32 ...................... Exempted prescription products listing ................................................................ DEA Drug & Chemical Evaluation Section. 

1308.33(b) ................. Exemption of certain anabolic steroid products application ................................ DEA Office of Diversion Control. 

1308.34 ...................... Exempted anabolic steroid products listing ......................................................... DEA Drug & Chemical Evaluation Section. 

1308.43(b) ................. Petition to initiate proceedings for rulemaking ..................................................... DEA Administrator. 

1309.03 ...................... List I chemicals registration procedures information request .............................. DEA Registration Section. 

1309.32(c) .................. Request DEA Form 510 ....................................................................................... DEA Registration Section. 

1309.33(a) ................. List I chemicals registration application submission ............................................ DEA Registration Section. 

1309.61 ...................... List I chemicals registration modification request ................................................ DEA Registration Section. 

1309.71(c) .................. List I chemicals security system compliance review ........................................... DEA Regulatory Section. 

1310.05(c) .................. Importer/exporter of tableting or encapsulation machines reporting ................... DEA Import/Export Unit. 

1310.05(d) ................. Bulk manufacturer of listed chemicals reporting .................................................. DEA Drug & Chemical Evaluation Section. 

1310.05(e)(1) ............. Reporting by persons required to keep records and file reports regarding List I 

chemicals.

DEA Import/Export Unit. 

1310.05(e)(2) ............. Request to submit List I chemicals reports in electronic form ............................ DEA Import/Export Unit. 

1310.06(g) ................. Report of declared exports of machines refused, rejected, or returned ............. DEA Import/Export Unit. 

1310.13(b) ................. Exemption for chemical preparations .................................................................. DEA Office of Diversion Control. 

1310.21(b) ................. Sale by Federal departments or agencies of chemicals which could be used to 

manufacture controlled substances certification request.

DEA Office of Diversion Control. 

1312.12(a) ................. Application for import permit (DEA Form 357) .................................................... DEA Import/Export Unit. 

1312.16(b) ................. Return unused import permits ............................................................................. DEA Import/Export Unit. 

1312.18(b) ................. Import declaration (DEA Form 236) submission ................................................. DEA Import/Export Unit. 

1312.19(b) ................. DEA Form 236 copy 4 ......................................................................................... DEA Import/Export Unit. 

1312.22(a) ................. Application for export permit (DEA Form 161) .................................................... DEA Import/Export Unit. 

1312.22(d)(8) ............. Request for return of unacceptable or undeliverable exported controlled substances..DEA Import/Export Unit 

1312.24(a) ................. DEA Form 161 copy 2 ......................................................................................... DEA Import/Export Unit. 


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TABLE 1—MAILING ADDRESSES REFERENCED IN THE CFR—Continued 

CFR Section Subject DEA Office 

1312.27(a) ................. Special controlled substances export invoice (DEA Form 236) filing ................. DEA Import/Export Unit. 

1312.27(b)(5)(iv) ........ Request for reexport ............................................................................................ DEA Import/Export Unit. 

1312.28(d) ................. Distribution of special controlled substances invoice (DEA Form 236) copy 4 .. DEA Import/Export Unit.

1312.31(b) ................. Controlled substances transshipment permit application .................................... DEA Import/Export Unit. 

1312.32(a) ................. Advanced notice of importation for transshipment or transfer of controlled substances.DEA Import/Export Unit. 

1313.12(b) ................. Authorization to import listed chemicals (DEA Form 486) .................................. DEA Import/Export Unit. 

1313.12(e) ................. Quarterly reports for listed chemicals importation ............................................... DEA Import/Export Unit. 

1313.21(b) ................. Authorization to export listed chemicals (DEA Form 486) .................................. DEA Import/Export Unit. 

1313.21(e) ................. Quarterly reports for listed chemicals exportation ............................................... DEA Import/Export Unit. 

1313.22(e) ................. Written notice of declared exports of listed chemicals refused, rejected or undeliverable.DEA Import/Export Unit. 

1313.31(b) ................. Advanced notice of importation for transshipment or transfer of listed chemicals.DEA Import/Export Unit. 

1313.32(b)(1) ............. International transaction authorization (DEA Form 486) ..................................... DEA Import/Export Unit. 

1314.110(a)(1) ........... Reports for mail-order sales ................................................................................ DEA Import/Export Unit. 

1314.110(a)(2) ........... Request to submit mail-order sales reports in electronic form ............................ DEA Import/Export Unit. 

1315.22 ...................... Application for individual manufacturing quota for ephedrine, pseudoephedrine, 

phenylpropanolamine (DEA Form 189) filing and request.

DEA Drug & Chemical Evaluation Section. 

1315.32(e) ................. Application for procurement quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 250) filing and request.DEA Drug & Chemical Evaluation Section. 

1315.32(g) ................. Procurement quota adjustment request for ephedrine, pseudoephedrine, phenylpropanolamine.DEA Drug & Chemical Evaluation Section. 

1315.34(d) ................. Application for import quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 488) request and filing.DEA Drug & Chemical Evaluation Section. 

1315.36(b) ................. Request import quota increase for ephedrine, pseudoephedrine, or phenylpropanolamine.DEA Drug & Chemical Evaluation Section. 

1316.23(b) ................. Petition for grant of confidentiality for research subjects .................................... DEA Administrator. 

1316.24(b) ................. Petition for exemption from prosecution for researchers .................................... DEA Administrator. 

1316.45 ...................... Hearings documentation filing .............................................................................. DEA Hearing 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 proceedings for rulemaking ...........................................................

1316.23(b)—Petition for grant of confidentiality for research subjects. 

1316.24(b)—Petition for exemption from prosecution for researchers. 

Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, 

VA 22152. 

1316.48—Notice of appearance. 

DEA Office of Diversion Control 

1301.52(c)—Controlled substances registration return for cancellation .........................................

1307.03—Exception request filing. 

1307.22—Disposal of controlled substances by the Administration delivery application. 

Drug Enforcement Administration, Attn: Office 

of Diversion Control/OD, 8701 Morrissette 

Drive, 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 review for controlled substances ..................................

1309.71(c)—Security system compliance review for List I chemicals. 

Drug Enforcement Administration, Attn: Regulatory Section/ODG, 8701 Morrissette Drive, 

Springfield, VA 22152. 

DEA Import/Export Unit 

1310.05(c)—Importer/exporter of tableting or encapsulation machines reporting ..........................

1310.05(e)(1)—Reporting by persons required to keep records and file reports regarding List I 

chemicals. 

1310.05(e)(2)—Request to submit List I chemicals reports in electronic form. 

Drug Enforcement Administration, Attn: Import/ 

Export Unit/ODGI, 8701 Morrissette Drive, 

Springfield, VA 22152. 


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TABLE 2—TABLE OF DEA MAILING ADDRESSES—Continued 

Code of Federal Regulations Section—Topic DEA Mailing address 

1310.06(g)—Report of declared exports of machines refused, rejected, or returned. 

1312.12(a)—Application for import permit (DEA Form 357). 

1312.16(b)—Return unused import permits. 

1312.18(b)—Import declaration (DEA Form 236) submission. 

1312.19(b)—DEA Form 236 copy 4 filing. 

1312.22(a)—Application for export permit (DEA Form 161). 

1312.22(d)(8)—Request for return of unacceptable or undeliverable exported controlled substances. 

1312.24(a)—DEA Form 161 copy 2 filing. 

1312.27(a)—Special controlled substances export invoice (DEA Form 236) filing. 

1312.27(b)(5)(iv)—Request for reexport. 

1312.28(d)—Distribution of special controlled substances invoice (DEA Form 236) copy 4. 

1312.31(b)—Controlled substances transshipment permit application. 

1312.32(a)—Advanced notice of importation for transshipment or transfer of controlled substances. 

1313.12(b)—Authorization to import listed chemicals (DEA Form 486). 

1313.12(e)—Quarterly reports of listed chemicals importation. 

1313.21(b)—Authorization to export listed chemicals (DEA Form 486). 

1313.21(e)—Quarterly reports of listed chemicals exportation. 

1313.22(e)—Written notice of declared exports of listed chemicals refused, rejected or undeliverable. 

1313.31(b)—Advanced notice of importation for transshipment or transfer of listed chemicals. 

1313.32(b)(1)—International transaction authorization (DEA Form 486). 

1314.110(a)(1)—Reports for mail-order sales. 

1314.110(a)(2)—Request to submit mail-order sales reports in electronic form. 

DEA Drug & Chemical Evaluation Section 

1303.12(b)—Application for controlled substances procurement quota (DEA Form 250) filing 

and request.

1303.12(d)—Controlled substances quota adjustment request. 

1303.22—Application for individual manufacturing quota (DEA Form 189) filing and request for 

schedule I or II controlled substances. 

Drug Enforcement Administration, Attn: Drug & 

Chemical Evaluation Section/ODE, 8701 

Morrissette Drive, Springfield, VA 22152. 

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 reporting identifier request ................................................

1304.33(a)—Reports to ARCOS. 

Drug Enforcement Administration, Attn: 

ARCOS Unit/ODPT, P.O. Box 2520, Springfield, VA 22152–2520, OR Drug Enforcement Administration, Attn: ARCOS Unit/ 

ODPT, 8701 Morrissette Drive, Springfield, 

VA 22152. 

DEA Registration Section 

1301.03—Procedures information request (controlled substances registration) ............................

1301.13(e)(2)—Request DEA Forms 224, 225, and 363. 

1301.14(a)—Controlled substances registration application submission. 

Drug Enforcement Administration, Attn: Registration Section/ODR P.O. Box 2639, 

Springfield, VA 22152–2639. 

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. 


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TABLE 2—TABLE OF DEA MAILING ADDRESSES—Continued 

Code of Federal Regulations Section—Topic DEA Mailing address 

1309.61—List I chemicals registration modification request. 

DEA Hearing Clerk 

1316.45—Hearings documentation filing ........................................................................................

1316.46(a)—Inspection of record. 

Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, VA 22152. 

DEA Federal Register Representative 

1316.47(a)—Request for hearing .................................................................................................... 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 foreignbased companies in domestic and 

export markets. 

List of Subjects 

21 CFR Part 1301 

Administrative practice and 

procedure, Drug traffic control, Security 

measures. 

21 CFR Part 1303 

Administrative practice and 

procedure, Drug traffic control. 

21 CFR Part 1304 

Drug traffic control, Reporting and 

recordkeeping requirements. 

21 CFR Part 1307 

Drug traffic control. 


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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. 

■ 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 

■ 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. 

■ 2. Section 1301.03 is revised to read 

as follows: 

§ 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 § 1321.01 of this 

chapter for the current mailing address. 

■ 3. Section 1301.13 is amended by 

revising paragraph (e)(2) to read as 

follows: 

§ 1301.13 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 § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

■ 4. Section 1301.14 is amended by 

revising paragraph (a) to read as follows: 

§ 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 § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

■ 5. Section 1301.18 is amended by 

revising paragraph (c) to read as follows: 

§ 1301.18 Research protocols. 

* * * * * 

(c) In the event that the registrant 

desires to increase the quantity of a 

controlled substance used for an 

approved research project, he/she shall 

submit a request to the Registration 

Unit, Drug Enforcement Administration, 

by registered mail, return receipt 

requested. See the Table of DEA Mailing 

Addresses in § 1321.01 of this chapter 

for the current mailing address. The 

request shall contain the following 

information: DEA registration number; 

name of the controlled substance or 

substances and the quantity of each 

authorized in the approved protocol; 

and the additional quantity of each 

desired. Upon return of the receipt, the 

registrant shall be authorized to 

purchase the additional quantity of the 

controlled substance or substances 

specified in the request. The 

Administration shall review the letter 

and forward it to the Food and Drug 

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. 

* * * * * 

■ 6. Section 1301.51 is revised to read 

as follows: 

§ 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 

§ 1321.01 of this chapter for the current 

mailing address. The letter shall contain 

the registrant’s name, address, and 

registration number as printed on the 

certificate of registration, and the 

substances and/or schedules to be 

added to his/her registration or the new 

name or address and shall be signed in 

accordance with § 1301.13(j). If the 

registrant is seeking to handle 

additional controlled substances listed 

in Schedule I for the purpose of research 

or instructional activities, he/she shall 

attach three copies of a research 

protocol describing each research 

project involving the additional 

substances, or two copies of a statement 

describing the nature, extent, and 

duration of such instructional activities, 

as appropriate. No fee shall be required 

to be paid for the modification. The 

request for modification shall be 

handled in the same manner as an 

application for registration. If the 

modification in registration is approved, 

the Administrator shall issue a new 

certificate of registration (DEA Form 

223) to the registrant, who shall 

maintain it with the old certificate of 

registration until expiration. 

■ 7. Section 1301.52 is amended by 

revising paragraphs (b) and (c) to read 

as follows: 

§ 1301.52 Termination of registration; 

transfer of registration; distribution upon 

discontinuance of business. 

* * * * * 

(b) No registration or any authority 

conferred thereby shall be assigned or 

otherwise transferred except upon such 

conditions as the Administration may 

specifically designate and then only 

pursuant to written consent. Any person 

seeking authority to transfer a 


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registration shall submit a written 

request, providing full details regarding 

the proposed transfer of registration, to 

the Deputy Assistant Administrator, 

Office of Diversion Control, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

(c) Any registrant desiring to 

discontinue business activities 

altogether or with respect to controlled 

substances (without transferring such 

business activities to another person) 

shall return for cancellation his/her 

certificate of registration, and any 

unexecuted order forms in his/her 

possession, to the Registration Unit, 

Drug Enforcement Administration. See 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. Any controlled 

substances in his/her possession may be 

disposed of in accordance with 

§ 1307.21 of this chapter. 

* * * * * 

■ 8. Section 1301.71 is amended by 

revising paragraph (d) to read as 

follows: 

§ 1301.71 Security requirements generally. 

* * * * * 

(d) Any registrant or applicant 

desiring to determine whether a 

proposed security system substantially 

complies with, or is the structural 

equivalent of, the requirements set forth 

in §§ 1301.72–1301.76 may submit any 

plans, blueprints, sketches or other 

materials regarding the proposed 

security system either to the Special 

Agent in Charge in the region in which 

the system will be used, or to the 

Regulatory Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

PART 1303—QUOTAS 

■ 9. The authority citation for Part 1303 

continues to read as follows: 

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

■ 10. Section 1303.12 is amended by 

revising paragraphs (b) and (d) to read 

as follows: 

§ 1303.12 Procurement quotas. 

* * * * * 

(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 § 1303.22 and 

the quantity of the first basic class 

necessary to manufacture a specified 

unit of the second basic class. DEA 

Form 250 shall be filed on or before 

April 1 of the year preceding the 

calendar year for which the 

procurement quota is being applied. 

Copies of DEA Form 250 may be 

obtained from, and shall be filed with, 

the Drug and Chemical Evaluation 

Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

(d) Any person to whom a 

procurement quota has been issued may 

at any time request an adjustment in the 

quota by applying to the Administrator 

with a statement showing the need for 

the adjustment. Such application shall 

be filed with the Drug & Chemical 

Evaluation Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

The Administrator shall increase or 

decrease the procurement quota of such 

person if and to the extent that he finds, 

after considering the factors enumerated 

in paragraph (c) of this section and any 

occurrences since the issuance of the 

procurement quota, that the need 

justifies an adjustment. 

* * * * * 

■ 11. Section 1303.22 is amended by 

revising the introductory text to read as 

follows: 

§ 1303.22 Procedure for applying for 

individual manufacturing quotas. 

Any person who is registered to 

manufacture any basic class of 

controlled substance listed in Schedule 

I or II and who desires to manufacture 

a quantity of such class shall apply on 

DEA Form 189 for a manufacturing 

quota for such quantity of such class. 

Copies of DEA Form 189 may be 

obtained from, and shall be filed (on or 

before May 1 of the year preceding the 

calendar year for which the 

manufacturing quota is being applied) 

with, the Drug & Chemical Evaluation 

Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

A separate application must be made for 

each basic class desired to be 

manufactured. The applicant shall state: 

* * * * * 

PART 1304—RECORDS AND 

REPORTS OF REGISTRANTS 

■ 12. The authority citation for Part 

1304 continues to read as follows: 

Authority: 21 U.S.C. 821, 827, 831, 871(b), 

958(e), 965, unless otherwise noted. 

■ 13. Section 1304.04 is amended by 

revising paragraph (d) to read as 

follows: 

§ 1304.04 Maintenance of records and 

inventories. 

* * * * * 

(d) ARCOS participants who desire 

authorization to report from other than 

their registered locations must obtain a 

separate central reporting identifier. 

Request for central reporting identifiers 

will be submitted to the ARCOS Unit. 

See the Table of DEA Mailing Addresses 

in § 1321.01 of this chapter for the 

current mailing address. 

* * * * * 

■ 14. Section 1304.31 is amended by 

revising paragraph (a) to read as follows: 

§ 1304.31 Reports from manufacturers 

importing narcotic raw material. 

(a) Every manufacturer which imports 

or manufactures from narcotic raw 

material (opium, poppy straw, and 

concentrate of poppy straw) shall 

submit information which accounts for 

the importation and for all 

manufacturing operations performed 


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between importation and the production 

in bulk or finished marketable products, 

standardized in accordance with the 

U.S. Pharmacopeia, National Formulary 

or other recognized medical standards. 

Reports shall be signed by the 

authorized official and submitted 

quarterly on company letterhead to the 

Drug and Chemical Evaluation Section, 

Drug Enforcement Administration, on or 

before the 15th day of the month 

immediately following the period for 

which it is submitted. See the Table of 

DEA Mailing Addresses in § 1321.01 of 

this chapter for the current mailing 

address. 

* * * * * 

■ 15. Section 1304.32 is amended by 

revising paragraph (a) to read as follows: 

§ 1304.32 Reports of manufacturers 

importing coca leaves. 

(a) Every manufacturer importing or 

manufacturing from raw coca leaves 

shall submit information accounting for 

the importation and for all 

manufacturing operations performed 

between the importation and the 

manufacture of bulk or finished 

products standardized in accordance 

with U.S. Pharmacopoeia, National 

Formulary, or other recognized 

standards. The reports shall be 

submitted quarterly on company 

letterhead to the Drug and Chemical 

Evaluation Section, Drug Enforcement 

Administration, on or before the 15th 

day of the month immediately following 

the period for which it is submitted. See 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 16. Section 1304.33 is amended by 

revising paragraph (a) to read as follows: 

§ 1304.33 Reports to ARCOS. 

(a) Reports generally. All reports 

required by this section shall be filed 

with the ARCOS Unit on DEA Form 

333, or on media which contains the 

data required by DEA Form 333 and 

which is acceptable to the ARCOS Unit. 

See the Table of DEA Mailing Addresses 

in § 1321.01 of this chapter for the 

current mailing address. 

* * * * * 

PART 1307—MISCELLANEOUS 

■ 17. The authority citation for Part 

1307 continues to read as follows: 

Authority: 21 U.S.C. 821, 822(d), 871(b), 

unless otherwise noted. 

■ 18. Section 1307.03 is revised to read 

as follows: 

§ 1307.03 Exceptions to regulations. 

Any person may apply for an 

exception to the application of any 

provision of this chapter by filing a 

written request with the Office of 

Diversion Control, Drug Enforcement 

Administration, stating the reasons for 

such exception. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

The Administrator may grant an 

exception in his discretion, but in no 

case shall he/she be required to grant an 

exception to any person which is 

otherwise required by law or the 

regulations cited in this section. 

■ 19. Section 1307.22 is revised to read 

as follows: 

§ 1307.22 Disposal of controlled 

substances by the Administration. 

Any controlled substance delivered to 

the Administration under § 1307.21 or 

forfeited pursuant to section 511 of the 

Act (21 U.S.C. 881) may be delivered to 

any department, bureau, or other agency 

of the United States or of any State upon 

proper application addressed to the 

Office of Diversion Control, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. The application shall 

show the name, address, and official 

title of the person or agency to whom 

the controlled drugs are to be delivered, 

including the name and quantity of the 

substances desired and the purpose for 

which intended. The delivery of such 

controlled drugs shall be ordered by the 

Administrator, if, in his opinion, there 

exists a medical or scientific need 

therefor. 

PART 1308—SCHEDULES OF 

CONTROLLED SUBSTANCES 

■ 20. The authority citation for part 

1308 continues to read as follows: 

Authority: 21 U.S.C. 811, 812, 871(b), 

unless otherwise noted. 

■ 21. Section 1308.21 is amended by 

revising paragraph (a) to read as follows: 

§ 1308.21 Application for exclusion of a 

nonnarcotic substance. 

(a) Any person seeking to have any 

nonnarcotic drug that may, under the 

Federal Food, Drug, and Cosmetic Act 

(21 U.S.C. 301), be lawfully sold over 

the counter without a prescription, 

excluded from any schedule, pursuant 

to section 201(g)(1) of the Act (21 U.S.C. 

811(g)(1)), may apply to the Office of 

Diversion Control, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

■ 22. Section 1308.23 is amended by 

revising paragraph (b) to read as follows: 

§ 1308.23 Exemption of certain chemical 

preparations; application. 

* * * * * 

(b) Any person seeking to have any 

preparation or mixture containing a 

controlled substance and one or more 

noncontrolled substances exempted 

from the application of all or any part 

of the Act, pursuant to paragraph (a) of 

this section, may apply to the Office of 

Diversion Control, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

■ 23. Section 1308.24 is amended by 

revising paragraphs (d) and (i) to read as 

follows: 

§ 1308.24 Exempt chemical preparations. 

* * * * * 

(d) Records and reports: Any person 

who manufactures an exempt chemical 

preparation or mixture must keep 

complete and accurate records and file 

all reports required under part 1304 of 

this chapter regarding all controlled 

substances being used in the 

manufacturing process until the 

preparation or mixture is in the form 

described in paragraph (i) of this 

section. In lieu of records and reports 

required under part 1304 of this chapter 

regarding exempt chemical 

preparations, the manufacturer need 

only record the name, address, and 

registration number, if any, of each 

person to whom the manufacturer 

distributes any exempt chemical 

preparation. Each importer or exporter 

of an exempt narcotic chemical 

preparation must submit a semiannual 

report of the total quantity of each 

substance imported or exported in each 

calendar half-year within 30 days of the 

close of the period to the Drug and 

Chemical Evaluation Section, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. Any other person who 

handles an exempt chemical 

preparation after it is in the form 

described in paragraph (i) of this section 

is not required to maintain records or 

file reports. 

* * * * * 

(i) A listing of exempt chemical 

preparations may be obtained by 

submitting a written request to the Drug 

and Chemical Evaluation Section, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 


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§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 24. Section 1308.25 is amended by 

revising paragraph (a) to read as follows: 

§ 1308.25 Exclusion of a veterinary 

anabolic steroid implant product; 

application. 

(a) Any person seeking to have any 

anabolic steroid product, which is 

expressly intended for administration 

through implants to cattle or other 

nonhuman species and which has been 

approved by the Secretary of Health and 

Human Services for such 

administration, identified as being 

excluded from any schedule, pursuant 

to section 102(41)(B)(i) of the Act (21 

U.S.C. 802(41)(B)(i)), may apply to the 

Office of Diversion Control, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 25. Section 1308.26 is amended by 

revising paragraph (a) to read as follows: 

§ 1308.26 Excluded veterinary anabolic 

steroid implant products. 

(a) Products containing an anabolic 

steroid, that are expressly intended for 

administration through implants to 

cattle or other nonhuman species and 

which have been approved by the 

Secretary of Health and Human Services 

for such administration are excluded 

from all schedules pursuant to section 

102(41)(B)(i) of the Act (21 U.S.C. 

802(41)(B)(i)). A listing of the excluded 

products may be obtained by submitting 

a written request to the Drug and 

Chemical Evaluation Section, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 26. Section 1308.31 is amended by 

revising paragraph (a) to read as follows: 

§ 1308.31 Application for exemption of a 

nonnarcotic prescription product. 

(a) Any person seeking to have any 

compound, mixture, or preparation 

containing any nonnarcotic controlled 

substance listed in § 1308.12(e), or in 

§ 1308.13(b) or (c), or in § 1308.14, or in 

§ 1308.15, exempted from application of 

all or any part of the Act pursuant to 

section 201(g)(3)(A), of the Act (21 

U.S.C. 811(g)(3)(A)) may apply to the 

Office of Diversion Control, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 27. Section 1308.32 is revised to read 

as follows: 

§ 1308.32 Exempted prescription products. 

The compounds, mixtures, or 

preparations that contain a nonnarcotic 

controlled substance listed in 

§ 1308.12(e) or in § 1308.13(b) or (c) or 

in § 1308.14 or in § 1308.15 listed in the 

Table of Exempted Prescription 

Products have been exempted by the 

Administrator from the application of 

sections 302 through 305, 307 through 

309, and 1002 through 1004 of the Act 

(21 U.S.C. 822–825, 827–829, and 952– 

954) and §§ 1301.13, 1301.22, and 

§§ 1301.71 through 1301.76 of this 

chapter for administrative purposes 

only. An exception to the above is that 

those products containing butalbital 

shall not be exempt from the 

requirement of 21 U.S.C. 952–954 

concerning importation, exportation, 

transshipment and in-transit shipment 

of controlled substances. Any deviation 

from the quantitative composition of 

any of the listed drugs shall require a 

petition of exemption in order for the 

product to be exempted. A listing of the 

Exempted Prescription Products may be 

obtained by submitting a written request 

to the Drug and Chemical Evaluation 

Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

■ 28. Section 1308.33 is amended by 

revising paragraph (b) to read as follows: 

§ 1308.33 Exemption of certain anabolic 

steroid products; application. 

* * * * * 

(b) Any person seeking to have any 

compound, mixture, or preparation 

containing an anabolic steroid as 

defined in part 1300 of this chapter 

exempted from the application of all or 

any part of the Act, pursuant to 

paragraph (a) of this section, may apply 

to the Office of Diversion Control, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 29. Section 1308.34 is revised to read 

as follows: 

§ 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 §§ 1301.13, 

1301.22, and 1301.71 through 1301.76 

of this chapter for administrative 

purposes only may be obtained by 

submitting a written request to the Drug 

and Chemical Evaluation Section, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

■ 30. Section 1308.43 is amended by 

revising paragraph (b) to read as follows: 

§ 1308.43 Initiation of proceedings for 

rulemaking. 

* * * * * 

(b) Petitions shall be submitted in 

quintuplicate to the Administrator. See 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. Petitions shall be in the 

following form: 

llllllllll (Date) 

Administrator, Drug Enforcement 

Administration llllll (Mailing 

Address) 

Dear Sir: The undersigned 

llllllll hereby petitions the 

Administrator to initiate proceedings for 

the issuance (amendment or repeal) of a 

rule or regulation pursuant to section 

201 of the Controlled Substances Act. 

Attached hereto and constituting a 

part of this petition are the following: 

(A) The proposed rule in the form 

proposed by the petitioner. (If the 

petitioner seeks the amendment or 

repeal of an existing rule, the existing 

rule, together with a reference to the 

section in the Code of Federal 

Regulations where it appears, should be 

included.) 

(B) A statement of the grounds which 

the petitioner relies for the issuance 

(amendment or repeal) of the rule. (Such 

grounds shall include a reasonably 

concise statement of the facts relied 

upon by the petitioner, including a 

summary of any relevant medical or 

scientific evidence known to the 

petitioner.) 

All notices to be sent regarding this 

petition should be addressed to: 

llllllllll (Name) 

llllllllll (Street Address) 

llllllllll (City and State) 

Respectfully yours, 

llllllllll (Signature of 

petitioner) 

* * * * * 


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PART 1309—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

IMPORTERS, AND EXPORTERS OF 

LIST I CHEMICALS 

■ 31. The authority citation for Part 

1309 continues to read as follows: 

Authority: 21 U.S.C. 821, 822, 823, 824, 

830, 871(b), 875, 877, 886a, 958. 

■ 32. Section 1309.03 is revised to read 

as follows: 

§ 1309.03 Information; special 

instructions. 

Information regarding procedures 

under these rules and instructions 

supplementing these rules will be 

furnished upon request by writing to the 

Registration Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

■ 33. Section 1309.32 is amended by 

revising paragraph (c) to read as follows: 

§ 1309.32 Application forms; contents; 

signature. 

* * * * * 

(c) DEA Form 510 may be obtained at 

any divisional office of the 

Administration or by writing to the 

Registration Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

DEA Form 510a will be mailed to each 

List I chemical registrant approximately 

60 days before the expiration date of his 

or her registration; if any registered 

person does not receive such forms 

within 45 days before the expiration 

date of the registration, notice must be 

promptly given of such fact and DEA 

Form 510a must be requested by writing 

to the Registration Section of the 

Administration at the foregoing address. 

* * * * * 

■ 34. Section 1309.33 is amended by 

revising paragraph (a) to read as follows: 

§ 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 § 1321.01 of this 

chapter for the current mailing address. 

The appropriate registration fee and any 

required attachments must accompany 

the application. 

* * * * * 

■ 35. Section 1309.61 is revised to read 

as follows: 

§ 1309.61 Modification in registration. 

Any registrant may apply to modify 

his or her registration to authorize the 

handling of additional List I chemicals 

or to change his or her name or address, 

by submitting a letter of request to the 

Registration Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

The letter shall contain the registrant’s 

name, address, and registration number 

as printed on the certificate of 

registration, and the List I chemicals to 

be added to his registration or the new 

name or address and shall be signed in 

accordance with § 1309.32(g). No fee 

shall be required to be paid for the 

modification. The request for 

modification shall be handled in the 

same manner as an application for 

registration. If the modification in 

registration is approved, the 

Administrator shall issue a new 

certificate of registration (DEA Form 

511) to the registrant, who shall 

maintain it with the old certificate of 

registration until expiration. 

■ 36. Section 1309.71 is amended by 

revising paragraph (c) as follows: 

§ 1309.71 General security requirements. 

* * * * * 

(c) Any registrant or applicant 

desiring to determine whether a 

proposed system of security controls 

and procedures is adequate may submit 

materials and plans regarding the 

proposed security controls and 

procedures either to the Special Agent 

in Charge in the region in which the 

security controls and procedures will be 

used, or to the Regulatory Section, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

PART 1310—RECORDS AND 

REPORTS OF LISTED CHEMICALS 

AND CERTAIN MACHINES 

■ 37. The authority citation for Part 

1310 continues to read as follows: 

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

871(b), 890. 

■ 38. Section 1310.05 is amended by 

revising paragraphs (c), (d), (e)(1), and 

(e)(2) to read as follows: 

§ 1310.05 Reports. 

* * * * * 

(c) Each regulated person who 

imports or exports a tableting machine, 

or encapsulation machine, shall file a 

report (not a 486) of such importation or 

exportation with the Import/Export 

Unit, Drug Enforcement Administration, 

on or before the date of importation or 

exportation. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

In order to facilitate the importation or 

exportation of any tableting machine or 

encapsulating machine and implement 

the purpose of the Act, regulated 

persons may wish to report to the 

Administration as far in advance as 

possible. A copy of the report may be 

transmitted directly to the Drug 

Enforcement Administration through 

electronic facsimile media. Any 

tableting machine or encapsulating 

machine may be imported or exported if 

that machine is needed for medical, 

commercial, scientific, or other 

legitimate uses. However, an 

importation or exportation of a tableting 

machine or encapsulating machine may 

not be completed with a person whose 

description or identifying characteristic 

has previously been furnished to the 

regulated person by the Administration 

unless the transaction is approved by 

the Administration. 

(d) Each regulated bulk manufacturer 

of a listed chemical shall submit 

manufacturing, inventory and use data 

on an annual basis as set forth in 

§ 1310.06(h). This data shall be 

submitted annually to the Drug and 

Chemical Evaluation Section, Drug 

Enforcement Administration, on or 

before the 15th day of March of the year 

immediately following the calendar year 

for which submitted. See the Table of 

DEA Mailing Addresses in § 1321.01 of 

this chapter for the current mailing 

address. A business entity which 

manufactures a listed chemical may 

elect to report separately by individual 

location or report as an aggregate 

amount for the entire business entity 

provided that they inform the DEA of 

which method they will use. This 

reporting requirement does not apply to 

drug or other products which are 

exempted under §§ 1300.02(b)(28)(i)(D) 

or 1300.02(b)(28)(i)(E) except as set forth 

in § 1310.06(h)(5). Bulk manufacturers 

that produce a listed chemical solely for 

internal consumption shall not be 

required to report for that listed 

chemical. For purposes of these 

reporting requirements, internal 

consumption shall consist of any 

quantity of a listed chemical otherwise 

not available for further resale or 

distribution. Internal consumption shall 

include (but not be limited to) quantities 

used for quality control testing, 

quantities consumed in-house or 

production losses. Internal consumption 

does not include the quantities of a 

listed chemical consumed in the 

production of exempted products. If an 

existing standard industry report 

contains the information required in 

§ 1310.06(h) and such information is 


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separate or readily retrievable from the 

report, that report may be submitted in 

satisfaction of this requirement. Each 

report shall be submitted to the DEA 

under company letterhead and signed 

by an appropriate, responsible official. 

For purposes of this paragraph only, the 

term regulated bulk manufacturer of a 

listed chemical means a person who 

manufactures a listed chemical by 

means of chemical synthesis or by 

extraction from other substances. The 

term bulk manufacturer does not 

include persons whose sole activity 

consists of the repackaging or relabeling 

of listed chemical products or the 

manufacture of drug dosage form 

products which contain a listed 

chemical. 

(e) * * * 

(1) Submit a written report, 

containing the information set forth in 

§ 1310.06(i) of this part, on or before the 

15th day of each month following the 

month in which the distributions took 

place. The report shall be submitted 

under company letterhead, signed by 

the person authorized to sign the 

registration application forms on behalf 

of the registrant, to the Import/Export 

Unit, Drug Enforcement Administration 

(see the Table of DEA Mailing 

Addresses in § 1321.01 of this chapter 

for the current mailing address); or 

(2) Upon request to and approval by 

the Administration, submit the report in 

electronic form, either via computer 

disk or direct electronic data 

transmission, in such form as the 

Administration shall direct. Requests to 

submit reports in electronic form should 

be submitted to the Import/Export Unit, 

Drug Enforcement Administration. See 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 39. Section 1310.06 is amended by 

revising paragraphs (d), (g), and (h)(5) to 

read as follows: 

§ 1310.06 Content of records and reports. 

* * * * * 

(d) A suggested format for the reports 

is provided below: 

Supplier: 

Registration Number llllllll

Name lllllllllllllll

Business Address llllllllll

City llllllllllllllll

State llllllllllllllll

Zip llllllllllllllll

Business Phone lllllllllll

Purchaser: 

Registration Number llllllll

Name lllllllllllllll

Business Address llllllllll

City llllllllllllllll

State llllllllllllllll

Zip llllllllllllllll

Business Phone lllllllllll

Identification llllllllllll

Shipping Address (if different than 

purchaser Address): 

Street lllllllllllllll

City llllllllllllllll

State llllllllllllllll

Zip llllllllllllllll

Date of Shipment llllllllll

Name of Listed Chemical(s) lllll

Quantity and Form of Packaging lll

Description of Machine: 

Make lllllllllllllll

Model lllllllllllllll

Serial # llllllllllllll

Method of Transfer lllllllll

If Loss or Disappearance: 

Date of Loss llllllllllll

Type of Loss llllllllllll

Description of Circumstances llll

* * * * * 

(g) Declared exports of machines 

which are refused, rejected, or otherwise 

deemed undeliverable may be returned 

to the U.S. exporter of record. A brief 

written report outlining the 

circumstances must be sent to the 

Import/Export Unit, Drug Enforcement 

Administration, following the return 

within a reasonable time. See the Table 

of DEA Mailing Addresses in § 1321.01 

of this chapter for the current mailing 

address. This provision does not apply 

to shipments that have cleared foreign 

customs, been delivered, and accepted 

by the foreign consignee. Returns to 

third parties in the United States will be 

regarded as imports. 

(h) * * * 

(5) The aggregate quantity of each 

listed chemical manufactured which 

becomes a component of a product 

exempted from §§ 1300.02(b)(28)(i)(D) 

or 1300.02(b)(28)(i)(E) during the 

preceding calendar year. 

* * * * * 

■ 40. Section 1310.13 is amended by 

revising paragraph (b) to read as follows: 

§ 1310.13 Exemption of chemical mixtures; 

application. 

* * * * * 

(b) Any manufacturer seeking an 

exemption for a chemical mixture, not 

exempt under § 1310.12, from the 

application of all or any part of the Act, 

may apply to the Office of Diversion 

Control, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

■ 41. Section 1310.21 is amended by 

revising the introductory text of 

paragraph (b) to read as follows: 

§ 1310.21 Sale by Federal departments or 

agencies of chemicals which could be used 

to manufacture controlled substances. 

* * * * * 

(b) A Federal department or agency 

must request certification by submitting 

a written request to the Administrator, 

Drug Enforcement Administration. See 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. A request for 

certification may be transmitted directly 

to the Office of Diversion Control, Drug 

Enforcement Administration, through 

electronic facsimile media. A request for 

certification must be submitted no later 

than fifteen calendar days before the 

proposed sale is to take place. In order 

to facilitate the sale of chemicals from 

Federal departments’ or agencies’ 

stocks, Federal departments or agencies 

may wish to submit requests as far in 

advance of the fifteen calendar days as 

possible. The written notification of the 

proposed sale must include: 

* * * * * 

PART 1312—IMPORTATION AND 

EXPORTATION OF CONTROLLED 

SUBSTANCES 

■ 42. The authority citation for Part 

1312 continues to read as follows: 

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

958. 

■ 43. Section 1312.12 is amended by 

revising paragraph (a) to read as follows: 

§ 1312.12 Application for import permit. 

(a) An application for a permit to 

import controlled substances shall be 

made on DEA Form 357. DEA Form 357 

may be obtained from, and shall be filed 

with, the Import/Export Unit, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. Each application shall 

show the date of execution; the 

registration number of the importer; a 

detailed description of each controlled 

substance to be imported including the 

drug name, dosage form, National Drug 

Code (NDC) number, the Administration 

Controlled Substance Code Number as 

set forth in part 1308 of this chapter, the 

number and size of packages or 

containers, the name and quantity of the 

controlled substance contained in any 

finished dosage units, and the net 

quantity of any controlled substance 

(expressed in anhydrous acid, base or 

alkaloid) given in kilograms or parts 


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thereof. The application shall also 

include the following: 

* * * * * 

■ 44. Section 1312.16 is amended by 

revising paragraph (b) to read as follows: 

§ 1312.16 Cancellation of permit; 

expiration date. 

* * * * * 

(b) An import permit shall not be 

valid after the date specified therein, 

and in no event shall the date be 

subsequent to 6 months after the date 

the permit is issued. Any unused import 

permit shall be returned for cancellation 

by the registrant to the Import/Export 

Unit, Drug Enforcement Administration. 

See the Table of DEA Mailing Addresses 

in § 1321.01 of this chapter for the 

current mailing address. 

■ 45. Section 1312.18 is amended by 

revising paragraph (b) to read as follows: 

§ 1312.18 Contents of import declaration. 

* * * * * 

(b) Any person registered or 

authorized to import and desiring to 

import any non-narcotic controlled 

substance in Schedules III, IV, or V 

which is not subject to the requirement 

of an import permit as described in 

paragraph (a) of this section, must 

furnish a controlled substances import 

declaration on DEA Form 236 to the 

Import/Export Unit, Drug Enforcement 

Administration, not later than 15 

calendar days prior to the proposed date 

of importation and distribute four 

copies of same as hereinafter directed in 

§ 1312.19. See the Table of DEA Mailing 

Addresses in § 1321.01 of this chapter 

for the current mailing address. 

* * * * * 

■ 46. Section 1312.19 is amended by 

revising paragraph (b) to read as follows: 

§ 1312.19 Distribution of import 

declaration. 

* * * * * 

(b) Copy 4 shall be forwarded, within 

the time limit required in § 1312.18, 

directly to the Import/Export Unit, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 47. Section 1312.22 is amended by 

revising paragraphs (a) and (d)(8) to read 

as follows: 

§ 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 

§ 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 § 1321.01 of this 

chapter for the current mailing address. 

The Administration will evaluate the 

request after considering all the facts as 

well as the exporter’s registration status 

with the Administration. If the exporter 

provides sufficient documentation, the 

Administration will issue an import 

permit for the return of these drugs, and 

the exporter can then obtain an export 

permit from the country of original 

importation. The substance may be 

returned to the United States only after 

affirmative authorization is issued in 

writing by the Administration. 

* * * * * 

■ 48. Section 1312.24 is amended by 

revising paragraph (a) to read as follows: 

§ 1312.24 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 § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 


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■ 49. Section 1312.27 is amended by 

revising paragraphs (a) and (b)(5)(iv) to 

read as follows: 

§ 1312.27 Contents of special controlled 

substances invoice. 

(a) A person registered or authorized 

to export any non-narcotic controlled 

substance listed in Schedule III, IV, or 

V, which is not subject to the 

requirement of an export permit 

pursuant to § 1312.23 (b) or (c), or any 

person registered or authorized to 

export any controlled substance in 

Schedule V, must furnish a special 

controlled substances export invoice on 

DEA Form 236 to the Import/Export 

Unit, Drug Enforcement Administration, 

not less than 15 calendar days prior to 

the proposed date of exportation, and 

distribute four copies of same as 

hereinafter directed in § 1312.28 of this 

part. See the Table of DEA Mailing 

Addresses in § 1321.01 of this chapter 

for the current mailing address. 

(b) * * * 

(5) * * * 

(iv) Shipments which have been 

exported from the United States and are 

refused by the consignee in the country 

of destination, or are otherwise 

unacceptable or undeliverable, may be 

returned to the registered exporter in the 

United States upon authorization of the 

Drug Enforcement Administration. In 

this circumstance, the exporter in the 

United States shall file a written request 

for reexport, along with a completed 

DEA Form 236, Import Declaration with 

the Import/Export Unit, Drug 

Enforcement Administration. See the 

Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. A brief summary of the 

facts that warrant the return of the 

substance to the United States along 

with an authorization from the country 

of export will be included with the 

request. DEA will evaluate the request 

after considering all the facts as well as 

the exporter’s registration status with 

DEA. The substance may be returned to 

the United States only after affirmative 

authorization is issued in writing by 

DEA. 

* * * * * 

■ 50. Section 1312.28 is amended by 

revising paragraph (d) to read as 

follows: 

§ 1312.28 Distribution of special controlled 

substances invoice. 

* * * * * 

(d) Copy 4 shall be forwarded, within 

the time limit required in § 1312.27 of 

this part, directly to the Import/Export 

Unit, Drug Enforcement Administration. 

The documentation required by 

§ 1312.27(b)(4) of this part must be 

attached to this copy. See the Table of 

DEA Mailing Addresses in § 1321.01 of 

this chapter for the current mailing 

address. 

* * * * * 

■ 51. Section 1312.31 is amended by 

revising the introductory text of 

paragraph (b) to read as follows: 

§ 1312.31 Schedule I: Application for prior 

written approval. 

* * * * * 

(b) An application for a transshipment 

permit must be submitted to the Import/ 

Export Unit, Drug Enforcement 

Administration, at least 30 days, or in 

the case of an emergency as soon as 

practicable, prior to the expected date of 

importation, transfer or transshipment. 

See the Table of DEA Mailing Addresses 

in § 1321.01 of this chapter for the 

current mailing address. Each 

application shall contain the following: 

* * * * * 

■ 52. Section 1312.32 is amended by 

revising paragraph (a) to read as follows: 

§ 1312.32 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 § 1321.01 

of this chapter for the current mailing 

address. 

* * * * * 

PART 1313—IMPORTATION AND 

EXPORTATION OF LIST I AND LIST II 

CHEMICALS 

■ 53. The authority citation for part 

1313 continues to read as follows: 

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

■ 54. Section 1313.12 is amended by 

revising paragraph (b) and the 

introductory text of paragraph (e) to 

read as follows: 

§ 1313.12 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 § 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 

§ 1321.01 of this chapter for the current 

mailing address. The report shall 

contain the following information 

regarding each individual importation: 

* * * * * 

■ 55. Section 1313.21 is amended by 

revising paragraph (b) and the 

introductory text of paragraph (e) to 

read as follows: 

§ 1313.21 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 § 1321.01 of this 

chapter for the current mailing address. 

A copy of the completed DEA Form 486 

may be transmitted directly to the Drug 

Enforcement Administration through 

electronic facsimile media not later than 

15 days prior to the exportation. 

* * * * * 

(e) For exportations where advance 

notification is waived pursuant to 

paragraph (c)(2) of this section, no DEA 

Form 486 is required; however, the 

regulated person shall file quarterly 

reports with the Import/Export Unit, 

Drug Enforcement Administration, no 

later than the 15th day of the month 

following the end of each quarter. See 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. The report shall 

contain the following information 

regarding each individual exportation: 

* * * * * 

■ 56. Section 1313.22 is amended by 

revising paragraph (e) to read as follows: 

§ 1313.22 Contents of export declaration. 

* * * * * 

(e) Declared exports of listed 

chemicals which are refused, rejected, 

or otherwise deemed undeliverable may 

be returned to the U.S. chemical 

exporter of record. A brief written 

notification (this does not require a DEA 

Form 486) outlining the circumstances 


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must be sent to the Import/Export Unit, 

Drug Enforcement Administration, 

following the return within a reasonable 

time. See the Table of DEA Mailing 

Addresses in § 1321.01 of this chapter 

for the current mailing address. This 

provision does not apply to shipments 

that have cleared foreign customs, been 

delivered, and accepted by the foreign 

consignee. Returns to third parties in 

the United States will be regarded as 

imports. 

■ 57. Section 1313.24 is amended by 

revising paragraph (e) to read as follows: 

§ 1313.24 Waiver of 15-day advance notice 

for chemical exporters. 

* * * * * 

(e) The Administrator may notify any 

chemical exporter that a regular 

customer has been disqualified or that a 

new customer for whom a notification 

has been submitted is not to be accorded 

the status of a regular customer. In the 

event of a disqualification of an 

established regular customer, the 

chemical exporter will be notified in 

writing of the reasons for such action. 

■ 58. Section 1313.31 is amended by 

revising the introductory text of 

paragraph (b) to read as follows: 

§ 1313.31 Advance notice of importation 

for transshipment or transfer. 

* * * * * 

(b) Advance notification must be 

provided to the Import/Export Unit, 

Drug Enforcement Administration, not 

later than 15 days prior to the proposed 

date the listed chemical will transship 

or transfer through the United States. 

See the Table of DEA Mailing Addresses 

in § 1321.01 of this chapter for the 

current mailing address. The written 

notification (not a DEA Form 486) shall 

contain the following information: 

* * * * * 

■ 59. Section 1313.32 is amended by 

revising paragraph (b)(1) to read as 

follows: 

§ 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 § 1321.01 

of this chapter for the current mailing 

address. 

* * * * * 

PART 1314—RETAIL SALE OF 

SCHEDULED LISTED CHEMICAL 

PRODUCTS 

■ 60. The authority citation for part 

1314 continues to read as follows: 

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

875, 877. 

■ 61. Section 1314.110 is amended by 

revising paragraphs (a)(1) and (a)(2) to 

read as follows: 

§ 1314.110 Reports for mail-order sales. 

(a) * * * 

(1) Submit a written report, 

containing the information set forth in 

paragraph (b) of this section, on or 

before the 15th day of each month 

following the month in which the 

distributions took place. The report 

must be submitted under company 

letterhead, signed by the person 

authorized to sign on behalf of the 

regulated seller, to the Import/Export 

Unit, Drug Enforcement Administration 

(see the Table of DEA Mailing 

Addresses in § 1321.01 of this chapter 

for the current mailing address); or 

(2) Upon request to and approval by 

the Administration, submit the report in 

electronic form, either via computer 

disk or direct electronic data 

transmission, in such form as the 

Administration shall direct. Requests to 

submit reports in electronic form should 

be submitted to the Import/Export Unit, 

Drug Enforcement Administration. See 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

PART 1315—IMPORTATION AND 

PRODUCTION QUOTAS FOR 

EPHEDRINE, PSEUDOEPHEDRINE, 

AND PHENYLPROPANOLAMINE 

■ 62. The authority citation for part 

1315 continues to read as follows: 

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

952. 

■ 63. Section 1315.22 is amended by 

revising the introductory text to read as 

follows: 

§ 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 

§ 1321.01 of this chapter for the current 

mailing address. A separate application 

must be made for each chemical desired 

to be manufactured. The applicant must 

state the following: 

* * * * * 

■ 64. Section 1315.32 is amended by 

revising paragraphs (e) and (g) to read as 

follows: 

§ 1315.32 Obtaining a procurement quota. 

* * * * * 

(e) DEA Form 250 must be filed on or 

before April 1 of the year preceding the 

calendar year for which the 

procurement quota is being applied. 

Copies of DEA Form 250 may be 

obtained from the Office of Diversion 

Control Web site, and must be filed with 

the Drug & Chemical Evaluation 

Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

(g) Any person to whom a 

procurement quota has been issued may 

at any time request an adjustment in the 

quota by applying to the Administrator 

with a statement showing the need for 

the adjustment. The application must be 

filed with the Drug & Chemical 

Evaluation Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

The Administrator shall increase or 

decrease the procurement quota of the 

person if and to the extent that he finds, 

after considering the factors enumerated 

in paragraph (f) of this section and any 

occurrences since the issuance of the 

procurement quota, that the need 

justifies an adjustment. 

* * * * * 

■ 65. Section 1315.34 is amended by 

revising paragraph (d) to read as 

follows: 

§ 1315.34 Obtaining an import quota. 

* * * * * 

(d) DEA Form 488 must be filed on or 

before April 1 of the year preceding the 

calendar year for which the import 

quota is being applied. Copies of DEA 

Form 488 may be obtained from the 

Office of Diversion Control Web site, 

and must be filed with the Drug & 

Chemical Evaluation Section. See the 

Table of DEA Mailing Addresses in 


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§ 1321.01 of this chapter for the current 

mailing address. 

* * * * * 

■ 66. Section 1315.36 is amended by 

revising paragraph (b) to read as follows: 

§ 1315.36 Amending an import quota. 

* * * * * 

(b) Any person to whom an import 

quota has been issued may at any time 

request an increase in the quota quantity 

by applying to the Administrator with a 

statement showing the need for the 

adjustment. The application must be 

filed with the Drug & Chemical 

Evaluation Section, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

The Administrator may increase the 

import quota of the person if and to the 

extent that he determines that the 

approval is necessary to provide for 

medical, scientific, or other legitimate 

purposes regarding the chemical. The 

Administrator shall specify a period of 

time for which the approval is in effect 

or shall provide that the approval is in 

effect until the Administrator notifies 

the applicant in writing that the 

approval is terminated. 

* * * * * 

PART 1316—ADMINISTRATIVE 

FUNCTIONS, PRACTICES, AND 

PROCEDURES 

■ 67. The authority citation for Subpart 

B of part 1316 continues to read as 

follows: 

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

■ 68. Section 1316.23 is amended by 

revising the introductory text of 

paragraph (b) to read as follows: 

§ 1316.23 Confidentiality of identity of 

research subjects. 

* * * * * 

(b) All petitions for Grants of 

Confidentiality shall be addressed to the 

Administrator, Drug Enforcement 

Administration (see the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address): 

* * * * * 

■ 69. Section 1316.24 is amended by 

revising the introductory text of 

paragraph (b) to read as follows: 

§ 1316.24 Exemption from prosecution for 

researchers. 

* * * * * 

(b) All petitions for Grants of 

Exemption from Prosecution for the 

Researcher shall be addressed to the 

Administrator, Drug Enforcement 

Administration, (see the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address) 

and shall contain the following: 

* * * * * 

■ 70. The authority citation for Subpart 

D of part 1316 continues to read as 

follows: 

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

958(d), 965. 

■ 71. Section 1316.45 is revised to read 

as follows: 

§ 1316.45 Filings; address; hours. 

Documents required or permitted to 

be filed in, and correspondence relating 

to, hearings governed by the regulations 

in this chapter shall be filed with the 

Hearing Clerk, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

This office is open Monday through 

Friday from 8:30 a.m. to 5 p.m. eastern 

standard or daylight saving time, 

whichever is effective in the District of 

Columbia at the time, except on national 

legal holidays. Documents shall be 

dated and deemed filed upon receipt by 

the Hearing Clerk. 

■ 72. Section 1316.46 is amended by 

revising paragraph (a) to read as follows: 

§ 1316.46 Inspection of record. 

(a) The record bearing on any 

proceeding, except for material 

described in subsection (b) of this 

section, shall be available for inspection 

and copying by any person entitled to 

participate in such proceeding, during 

office hours in the office of the Hearing 

Clerk, Drug Enforcement 

Administration. See the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address. 

* * * * * 

■ 73. Section 1316.47 is amended by 

revising paragraph (a) to read as follows: 

§ 1316.47 Request for hearing. 

(a) Any person entitled to a hearing 

and desiring a hearing shall, within the 

period permitted for filing, file a request 

for a hearing in the following form (see 

the Table of DEA Mailing Addresses in 

§ 1321.01 of this chapter for the current 

mailing address): 

llllllllll (Date) 

Administrator, Drug Enforcement 

Administration, Attention: DEA Federal 

Register Representative. 

Dear Sir: The undersigned 

llllll (Name of person) hereby 

requests a hearing in the matter of: 

llllllll (Identification of the 

proceeding). 

(A) (State with particularity the 

interest of the person in the proceeding.) 

(B) (State with particularity the 

objections or issues, if any, concerning 

which the person desires to be heard.) 

(C) (State briefly the position of the 

person with regard to the particular 

objections or issues.) 

All notices to be sent pursuant to the 

proceeding should be addressed to: 

llllllllll (Name) 

llllllllll (Street address) 

llllllllll (City and State) 

Respectfully yours, 

llllllllll (Signature of 

person) 

* * * * * 

■ 74. Section 1316.48 is revised to read 

as follows: 

§ 1316.48 Notice of appearance. 

Any person entitled to a hearing and 

desiring to appear in any hearing, shall, 

if he has not filed a request for hearing, 

file within the time specified in the 

notice of proposed rulemaking, a 

written notice of appearance in the 

following form (see the Table of DEA 

Mailing Addresses in § 1321.01 of this 

chapter for the current mailing address): 

llllllllll (Date) 

Administrator, Drug Enforcement 

Administration 

llllllllll (Mailing 

Address), Attention: Federal Register 

Representative 

Dear Sir: Please take notice that 

llllllll (Name of person) will 

appear in the matter of: 

llllllll (Identification of the 

proceeding). 

(A) (State with particularity the 

interest of the person in the proceeding.) 

(B) (State with particularity the 

objections or issues, if any, concerning 

which the person desires to be heard.) 

(C) (State briefly the position of the 

person with regard to the particular 

objections or issues.) 

All notices to be sent pursuant to this 

appearance should be addressed to: 

llllllllll (Name) 

llllllllll (Street address) 

llllllllll (City and State) 

Respectfully yours, 

llllllllll (Signature of 

person) 

■ 75. Part 1321 is added to 21 CFR 

Chapter II to read as follows: 

PART 1321—DEA MAILING 

ADDRESSES 

Sec. 

1321.01 DEA mailing addresses. 

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


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10686 Federal Register / Vol. 75, No. 45 / Tuesday, March 9, 2010 / Rules and Regulations 

§ 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 proceedings for rulemaking ...........................................................

316.23(b)—Petition for grant of confidentiality for research subjects. 

1316.24(b)—Petition for exemption from prosecution for researchers. 

Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, 

VA 22152. 

1316.48—Notice of appearance. 

DEA Office of Diversion Control 

1301.52(c)—Controlled substances registration return for cancellation .........................................

1307.03—Exception request filing. 

1307.22—Disposal of controlled substances by the Administration delivery application. 

Drug Enforcement Administration, Attn: Office 

of Diversion Control/OD, 8701 Morrissette 

Drive, 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 review for controlled substances ..................................

1309.71(c)—Security system compliance review for List I chemicals. 

Drug Enforcement Administration, Attn: Regulatory Section/ODG, 8701 Morrissette Drive, 

Springfield, VA 22152 

DEA Import/Export Unit 

1310.05(c)—Importer/exporter of tableting or encapsulation machines reporting ..........................

1310.05(e)(1)—Reporting by persons required to keep records and file reports regarding List I 

chemicals. 

Drug Enforcement Administration, Attn: Import/ 

Export Unit/ODGI, 8701 Morrissette Drive, 

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 substances procurement quota (DEA Form 250) filing 

and request.

1303.12(d)—Controlled substances quota adjustment request. 

Drug Enforcement Administration, Attn: Drug & 

Chemical Evaluation Section/ODE, 8701 

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. 


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TABLE OF DEA MAILING ADDRESSES—Continued 

Code of Federal Regulations Section—Topic DEA Mailing address 

1308.24(d)—Exempt narcotic chemical preparations importer/exporter reporting. 

1308.24(i)—Exempted chemical preparations listing. 

1308.26(a)—Excluded veterinary anabolic steroid implant products listing. 

1308.32—Exempted prescription products listing. 

1308.34—Exempted anabolic steroid products listing. 

1310.05(d)—Bulk manufacturer of listed chemicals reporting. 

1315.22—Application for individual manufacturing quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 189) filing and request. 

1315.32(e)—Application for procurement quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 250) filing and request. 

1315.32(g)—Procurement quota adjustment request for ephedrine, pseudoephedrine, phenylpropanolamine. 

1315.34(d)—Application for import quota for ephedrine, pseudoephedrine, phenylpropanolamine (DEA Form 488) request and filing. 

1315.36(b)—Request import quota increase for ephedrine, pseudoephedrine, or phenylpropanolamine. 

DEA ARCOS Unit 

1304.04(d)—ARCOS separate central reporting identifier request ................................................

1304.33(a)—Reports to ARCOS. 

Drug Enforcement Administration, Attn: 

ARCOS Unit/ODPT, P.O. Box 2520, Springfield, VA 22152–2520, OR Drug Enforcement Administration, Attn: ARCOS Unit, 

8701 Morrissette Drive, Springfield, VA 

22152. 

DEA Registration Section 

1301.03—Procedures information request (controlled substances registration) ............................

1301.13(e)(2)—Request DEA Forms 224, 225, and 363. 

1301.14(a)—Controlled substances registration application submission. 

Drug Enforcement Administration, Attn: Registration Section/ODR P.O. Box 2639, 

Springfield, VA 22152–2639. 

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 ........................................................................................

1316.46(a)—Inspection of record. 

Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, VA 22152. 

DEA Federal Register Representative 

1316.47(a)—Request for hearing .................................................................................................... Drug Enforcement Administration, Attn: Federal 

Register Representative/ODL, 8701 

Morrissette Drive, Springfield, VA 22152. 

Dated: February 25, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–4714 Filed 3–8–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 165 

[Docket No. USCG–2008–1017] 

RIN 1625–AA11 

Regulated Navigation Areas; Bars 

Along the Coasts of Oregon and 

Washington; Correction 

AGENCY: Coast Guard, DHS. 

ACTION: Correcting amendment. 

SUMMARY: The Coast Guard published a 

document in the Federal Register on 

November 17, 2009, adding a section 

and establishing regulated navigation 

areas for bars along the coasts of Oregon 

and Washington. That document 

inadvertently failed to include an option 

for mariners to use VHF–FM Channel 16 

for notifying the Coast Guard, and also 

contained typographical errors 

improperly describing VHF–FM 

Channel 16 and a position of latitude. 

This document corrects the final 

regulations. 

DATES: Effective March 9, 2010. 

FOR FURTHER INFORMATION CONTACT: If 

you have questions about this 


sroberts on DSKD5P82C1PROD with RULES