51370 Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations

5 U.S.C. 553 or by any other law, the

analytical requirements of the

Regulatory Flexibility Act (5 U.S.C. 601

et seq.) are not applicable.

Therefore, this regulation is issued in

final form. Although there is no formal

comment period, public comments on

this regulation are welcome on a

continuing basis. Comments should be

submitted to Sharron Cook, Regulatory

Policy Division, Bureau of Export

Administration, Department of

Commerce, P.O. Box 273, Washington,

DC 20044.

List of Subjects in 15 CFR Part 744

Exports, Foreign trade, Reporting and

recordkeeping requirements.

Accordingly, part 744 of the Export

Administration Regulations (15 CFR

parts 730–774) is amended, as follows:

PART 744—[AMENDED]

1. The authority citation for 15 CFR

part 744 continues to read as follows:

Authority: 50 U.S.C. app. 2401 et seq.; 50

U.S.C. 1701 et seq.; 22 U.S.C. 3201 et seq.;

42 U.S.C. 2139a; E.O. 12058, 43 FR 20947, 3

CFR, 1978 Comp., p. 179; E.O. 12851, 58 FR

33181, 3 CFR, 1993 Comp., p. 608; E.O.

12924, 59 FR 43437, 3 CFR, 1994 Comp., p.

917; E.O. 12938, 59 FR 59099, 3 CFR, 1994

Comp., p. 950; Notice of August 15, 1995 (60

FR 42767, August 17, 1995); Notice of August

14, 1996 (61 FR 42527, August 15, 1996); and

Notice of August 13, 1997 (62 FR 43629,

August 15, 1997).

2. Section 744.1 is amended by

revising paragraph (c) to read as follows:

§ 744.1 General provisions.

* * * * *

(c) A list of entities is included in

Supplement No. 4 to this part 744 of the

EAR (Entity List). Exporters are hereby

informed that these entities are

ineligible to receive any items subject to

the EAR without a license to the extent

specified in the supplement. License

applications will be reviewed under the

license review standards set forth in this

part 744. No License Exceptions are

available for exports or reexports to

listed entities of specified items.

3. Supplement No. 4 to part 744 is

amended by removing the entity

‘‘Bharat Electronics LTD’’ and adding in

its place the following entity to read as

follows:

Supplement No. 4 to Part 744—Entity

List

* * * * *

Bharat Electronics Limited (BEL) in

Bangalore, India; and Bharat Electronics

Limited (BEL) in Hyderabad, India; for all

items subject to the EAR having a

classification other than EAR99. In addition,

exporters are reminded to follow ‘‘BXA’s

Know Your Customer Guidance and Red

Flags’’, see Supplement No. 3 to part 732 of

the EAR, with regard to the specific end-use

of any item subject to the EAR destined to

any Bharat Electronics Limited located in

India.

* * * * *

Dated: September 26, 1997.

James A. Lewis,

Acting Assistant Secretary for Export

Administration.

[FR Doc. 97–26048 Filed 9–30–97; 8:45 am]

BILLING CODE 3510–33–P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA–166F]

Schedules of Controlled Substances

Placement of Butorphanol Into

Schedule IV

AGENCY: Drug Enforcement

Administration, Department of Justice.

ACTION: Final rule.

SUMMARY: With the issuance of this final

rule, the Acting Deputy Administrator

of the Drug Enforcement Administration

(DEA) places the substance butorphanol,

including its salts and optical isomers,

into Schedule IV of the Controlled

Substances Act (CSA). As a result of this

rule, the regulatory controls and

criminal sanctions of Schedule IV will

be applicable to the manufacture,

distribution, dispensing, importation

and exportation of butorphanol and

products containing butorphanol.

EFFECTIVE DATE: October 31, 1997.

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and

Chemical Evaluation Section, Drug

Enforcement Administration,

Washington, DC 20537, Telephone:

(202) 307–7183.

SUPPLEMENTARY INFORMATION:

Butorphanol is classified as an opioid

agonist-antagonist analgesic that is

marketed as a prescription drug under

the trade name Stadol  for the relief of

moderate to severe pain in humans. It is

also marketed as a veterinary product

under the trade names Torbugesic  and

Torbutrol  for use in horses and dogs.

It was first marketed as an injectable

product in 1979. Although there was

limited abuse of the injectable product

among certain populations, significant

abuse was not observed until after the

nasal spray was introduced in 1992.

The Acting Deputy Administrator of

the DEA received a letter dated

September 30, 1996, from the Assistant

Secretary for Health, on behalf of the

Secretary of the Department of Health

and Human Services (DHHS),

recommending that the drug product,

Stadol  NS Nasal Spray, be placed into

Schedule IV of the CSA. Enclosed with

the September 30, 1996, letter from the

Assistant Secretary was a scientific and

medical evaluation prepared by the

Food and Drug Administration (FDA).

The document contained a review of the

factors which the CSA requires the

Secretary to consider (21 U.S.C. 811(b)).

Correspondence from the Acting

Assistant Secretary for Health dated

June 19, 1997, confirmed that the DHHS

recommendation included the substance

butorphanol and its salts and isomers.

The Acting Deputy Administrator of the

DEA, in a July 10, 1997, Federal

Register notice (62 FR 37004 proposed

to place butorphanol into Schedule IV

of the CSA. The notice provided an

opportunity for all interested persons to

submit their comments, objections, or

requests for a hearing in writing on the

proposed scheduling of butorphanol

until August 11, 1997. DEA received

nine comments regarding the proposal.

Comments in support of the proposal

were received from six organizations:

National Association of Boards of

Pharmacy, Missouri Department of

Mental Health, Missouri Department of

Health, Missouri Department of

Economic Development’s State Board of

Registration for the Healing Arts, Texas

State Board of Pharmacy and Public

Citizen. The American Veterinary

Medical Association noted that

controlled substances are subject to

additional recordkeeping and storage

requirements, but recognized the abuse

potential of butorphanol. It

recommended that if butorphanol is to

be controlled, it be classified at a level

no greater than Schedule IV.

Bristol-Myers Squibb commented that

the abuse potential of butorphanol nasal

spray is low, as evidenced by the low

number of adverse reaction reports

received by the company per number of

prescriptions. Bristol-Myers Squibb did

support the placement of butorphanol in

Schedule IV. Fort Dodge Animal Health

commented that there was little abuse of

the butorphanol veterinary products and

did not support the scheduling of the

veterinary products. This scheduling

action, however, is based on the abuse

and dependence potentials of the

substance butorphanol. It was

determined that butorphanol, whether

administered orally, intravenously, or

intranasally, had an abuse potential

consistent with control in Schedule IV

of the CSA. Furthermore, available data

does not differentiate the abuse

potential of butorphanol-containing
Federal Register / Vol. 62, No. 190 / Wednesday, October 1, 1997 / Rules and Regulations 51371

human products from that of veterinary

products. Fort Dodge presented no

additional data in this regard.

Based on the scientific and medical

evaluation and the recommendation of

the Assistant Secretary for Health,

received in accordance with section

201(b) of the Act [21 U.S.C. 811(b)], and

the independent review of the DEA, the

Acting Deputy Administrator of the

DEA, pursuant to sections 201(a) and

201(b) of the Act (21 U.S.C. 811(a) and

811(b)), finds that:

(1) Butorphanol has a low potential

for abuse relative to the drugs or other

substances in Schedule III;

(2) Butorphanol has a currently

accepted medical use in treatment in the

United States; and

(3) Abuse of butorphanol may lead to

limited physical dependence and

psychological dependence relative to

the drugs or other substances in

Schedule III.

Based on these findings, the Acting

Deputy Administrator of the DEA

concludes that butorphanol, including

its salts and isomers, warrants control in

Schedule IV in the CSA. The Schedule

IV controls of butorphanol will be

effective on October 31, 1997, except as

indicated below. In the event that the

regulations impose special hardships on

the registrants, the DEA will entertain

any justified request for an extension of

time to comply with the Schedule IV

regulations regarding butorphanol. The

applicable regulations are as follows:

1. Registration. Any person who

manufactures, distributes, dispenses,

imports or exports butorphanol

activities or who engages in research or

conducts instructional activities with

butorphanol, or who proposes to engage

in such activities, must submit an

application for Schedule IV registration

in accordance with Part 1301 of Title 21

of the Code of Federal Regulations. Any

person who is currently lawfully

engaged in any of the above activities

must submit an application for

registration by October 31, 1997. Any

such person may then continue their

lawful activities until the

Administration has approved or denied

that application.

2. Security. Butorphanol must be

manufactured, distributed and stored in

accordance with §§ 1301.71, 1301.72(b),

(c), and (d), 1301.73, 1301.74,

1301.75(b) and (c) and 1301.76 of Title

21 of the Code of Federal Regulations.

3. Labeling and Packaging. All labels

on commercial containers of, and all

labeling of, butorphanol which is

distributed on and after April 1, 1998

shall comply with the requirements of

§§ 1302.03–1302.07 of Title 21 of the

Code of Federal Regulations. Any

commercial containers of butorphanol

packaged on or before April 1, 1998 and

not meeting the requirements specified

in §§ 1302.03–1302.07 of Title 21 of the

Code of Federal Regulations shall not be

distributed on or after July 1, 1998.

4. Inventory. Registrants possessing

butorphanol are required to take

inventories pursuant to §§ 1304.03,

1304.04 and 1304.11 of Title 21 of the

Code of Federal Regulations.

5. Records. All registrants must keep

records pursuant to §§ 1304.03, 1304.04

and 1304.21–1304.23 of Title 21 of the

Code of Federal Regulations.

6. Prescriptions. All prescriptions for

butorphanol are to be issued pursuant to

§§ 1306.03–1306.06 and 1306.21–

1306.26 of Title 21 of the Code of

Federal Regulations. All prescriptions

for products containing butorphanol

issued on or before October 31, 1997, if

authorized for refilling, shall as of that

date be limited to five refills and shall

not be refilled after April 1, 1998.

7. Importation and Exportation. All

importation and exportation of

butorphanol shall be in compliance

with Part 1312 of Title 21 of the Code

of Federal Regulations.

8. Criminal Liability. Any activity

with butorphanol not authorized by, or

in violation of, the CSA or the

Controlled Substances Import and

Export Act shall be unlawful on or after

October 31, 1997.

In accordance with the provisions of

21 U.S.C. 811(a) of the CSA, this action

is a formal rulemaking ‘‘on the record

after opportunity for a hearing.’’ Such

proceedings are conducted pursuant to

the provisions of 5 U.S.C. 556 and 557

and, as such, are exempt from review by

the Office of Management and Budget

pursuant to Executive Order (E.O.)

12866, section 3(d)(1). The Acting

Deputy Administrator, in accordance

with the Regulatory Flexibility Act [5

U.S.C. 605(b)], has reviewed this

proposed rule and by approving it

certifies that it will not have a

significant economic impact on a

substantial number of small-business

entities. Butorphanol products are

prescription products. Handlers of

butorphanol also handle other

controlled substances which are already

subject to the regulatory requirements of

the CSA.

This rule will not result in the

expenditure by State, local and tribal

governments, in the aggregate, or by the

private sector, of $100,000,000 or more

in any one year, and it will not

significantly or uniquely affect small

governments. Therefore, no actions were

deemed necessary under provisions of

the Unfunded Mandates Reform act of

1995.

This rule is not a major rule as

defined by § 804 of the Small Business

Regulatory Enforcement Fairness Act of

1996. 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 the United States-based

companies to compete with foreignbased companies in domestic and

export markets.

This rule will not have substantial

direct effects on the States, on the

relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with E.O. 12612, it is

determined that this rule will not have

sufficient federalism implications to

warrant the preparation of a Federalism

Assessment.

List of Subjects in 21 CFR Part 1308

Administrative practice and

procedure, Drug traffic control,

Narcotics, Prescription drugs.

Under the authority vested in the

Attorney General by section 201(a) of

the CSA [21 U.S.C. 811(a)], and

delegated to the Administrator of the

DEA by the Department of Justice

regulations (28 CFR 0.100) and

redelegated to the Acting Deputy

Administrator pursuant to 28 CFR

0.104, the Acting Deputy Administrator

hereby amends 21 CFR part 1308 as

follows.

PART 1308—[AMENDED]

1. The authority citation for 21 CFR

part 1308 continues to read as follows:

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

unless otherwise noted.

2. Section 1308.14 is amended by

adding a new paragraph (f)(2) to read as

follows:

§ 1308.14 Schedule IV.

* * * * *

(f) * * *

(2) Butorphanol (including its optical

isomers)—9720

Dated: September 22, 1997.

James S. Milford,

Acting Deputy Administration.

[FR Doc. 97–25969 Filed 9–30–97; 8:45 am]

BILLING CODE 4410–09–M