13274 Federal Register / Vol. 66, No. 43 / Monday, March 5, 2001 / Proposed Rules

like the Commission to reconcile

ESign’s policy with the statutes they

administer. The Commission will act

shortly to provide interpretative

guidance and, where appropriate,

propose or adopt rules consistent with

ESign. These releases will be published

separately in the Federal Register.

Because ESign does not generally

apply to information required to be filed

with government agencies, the

Commission is not currently

contemplating any changes to its

existing filing rules as a result of ESign.

Filers should therefore continue to

follow current filing rules.

Dated: February 28, 2001.

By the Commission.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 01–5328 Filed 3–1–01; 11:12 am]

BILLING CODE 8010–01–P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1304, 1305, 1306, 1311

[DEA–214A]

RIN 1117–AA60, 1117–AA61

Electronic Commerce: Electronic

Orders for Schedule I and II Controlled

Substances; Electronic Prescriptions

for Controlled Substances

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Drug Enforcement

Administration (DEA) is publishing this

Advance Notice of Proposed

Rulemaking to formally notify the

interested public of DEA’s intent to

publish Notices of Proposed

Rulemaking regarding two electronic

initiatives. The first electronic initiative

(RIN 1117–AA60) will propose

regulations to provide DEA registrants

with the option of ordering Schedule I

and II controlled substances

electronically in a manner consistent

with the requirements of the Controlled

Substances Act (21 U.S.C. 801 et seq.).

The regulations will propose that this

electronic system may also be used for

ordering controlled substances in

Schedules III, IV and V. The second

electronic initiative (RIN 1117–AA61)

will propose regulations to permit DEA

registered prescribers to electronically

write, sign and transmit prescriptions.

These proposed regulations would be an

addition to, not a replacement of, the

existing rules. Through these electronic

initiatives, DEA will be proposing

regulations consistent with the

Government Paperwork Elimination Act

(Pub. L. 105–277) (GPEA) and the

Electronic Signatures in Global and

National Commerce Act (Pub. L. 106–

229) (E-Sign). Publication of this

Advance Notice of Proposed

Rulemaking also responds to the

requirements of E-Sign which state that

for a Federal agency which has

announced, proposed, or initiated a

rulemaking proceeding to prescribe a

regulation responding to E-Sign on or

before March 1, 2001, the effect of ESign’s record retention provision is

delayed until June 1, 2001.

FOR FURTHER INFORMATION CONTACT:

Patricia M. Good, Chief, Liaison and

Policy Section, Office of Diversion

Control, Drug Enforcement

Administration, Washington, D.C.

20537, Telephone (202) 307–7297, Web

site: http://www.deadiversion.usdoj.gov.

SUPPLEMENTARY INFORMATION:

Why Is DEA Publishing This Advance

Notice of Proposed Rulemaking?

DEA is publishing this Advance

Notice of Proposed Rulemaking to

formally notify the interested public

that DEA intends to publish, in the near

future, two Notices of Proposed

Rulemaking regarding two electronic

initiatives DEA has undertaken. These

electronic initiatives, and their

accompanying regulations, will permit

DEA to comply with GPEA and E-Sign,

while ensuring appropriate controls

over the ordering and prescribing of

controlled substances in order to

prevent diversion. DEA is publishing

this Advance Notice of Proposed

Rulemaking to comply with Sec.

107(b)(1)(B) of Pub. L. 106–229 which

states: ‘‘DELAYED EFFECT FOR

PENDING RULEMAKINGS. If on March

1, 2001, a Federal regulatory agency or

State regulatory agency has announced,

proposed, or initiated, but not

completed, a rulemaking proceeding to

prescribe a regulation under section

104(b)(3) with respect to a requirement

described in subparagraph (A), this title

shall be effective on June 1, 2001, with

respect to such requirement.’’

What Electronic Initiatives Does DEA

Intend To Propose?

DEA expects to publish, in the near

future, two Notices of Proposed

Rulemaking to propose new regulations

for two electronic initiatives. The first

electronic initiative (RIN 1117–AA60)

will propose regulations to provide DEA

registrants with the option of ordering

Schedule I and II controlled substances

electronically in a manner consistent

with the requirements of the Controlled

Substances Act (21 U.S.C. 801 et seq.).

The regulations will propose that this

electronic system may also be used for

controlled substances in Schedules III,

IV and V. The second electronic

initiative (RIN 1117–AA61) will propose

regulations to permit DEA registered

prescribers to electronically write, sign

and transmit prescriptions. These

proposed regulations would be an

addition to, not a replacement of, the

existing rules.

What Actions Has DEA Already

Undertaken Regarding These Electronic

Initiatives?

In 1999, PEC Solutions, Inc. (PEC)

(formerly Performance Engineering

Corporation) was selected by DEA’s

Office of Diversion Control to analyze

mandated, paper-based regulatory

processes and to design and develop

proposed concepts for public key

infrastructures (PKIs) that would allow

DEA and industry the option of using

the current paper-based systems or

electronic formats to order or prescribe

controlled substances. As part of the

project methodology, DEA/PEC sought

input from persons within the interested

industries to gain an understanding of

processes involved in these regulated

activities. DEA has published relevant

documents and information regarding

both electronic initiatives on the Office

of Diversion Control’s web site, at http:/

/www.deadiversion.usdoj.gov, link to

‘‘Electronic Commerce Initiatives’’.

Finally, DEA has held a number of

public meetings (announced on DEA’s

web site and in letters to the industry)

to detail progress of the projects, answer

questions and solicit further input. DEA

continues to provide information on its

web site regarding project documents,

updates and future meetings.

Rulemaking Analyses and Notices

Due to the preliminary nature of this

document, information to complete the

rulemaking analyses and notice is

unavailable, and thus, not contained in

this Advance Notice of Proposed

Rulemaking.

Dated: February 27, 2001.

Laura M. Nagel,

Deputy Assistant Administrator, Office of

Diversion Control.

[FR Doc. 01–5362 Filed 3–1–01; 11:12 am]

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