47306 Federal Register / Vol. 65, No. 149 / Wednesday, August 2, 2000 / Rules and Regulations

bench studies and clinical trials, other

relevant performance data, and labeling

will ensure that minimum levels of

performance, for both safety and

effectiveness, are addressed before

marketing clearance. Thus, persons who

intend to market this device must

submit to FDA a premarket notification

submission containing information on

the clitoral engorgement device before

marketing the device.

On April 28, 2000, FDA issued an

order to the petitioner classifying

Urometrics EROS–Clitoral Therapy

Device and substantially equivalent

devices of this generic type into class II

under the generic name, clitoral

engorgement device. FDA identifies this

generic type of device as a device

designed to apply a vacuum to the

clitoris. It is intended for use in the

treatment of female sexual arousal

disorder. FDA is codifying this device

by adding 21 CFR 884.5970. This order

also identifies the following special

control applicable to this device: A

special controls guidance document

entitled ‘‘Guidance for Industry and

FDA Reviewers: Class II Special

Controls Guidance for Clitoral

Engorgement Devices.’’

II. Environmental Impact

The agency has determined under 21

CFR 25.34(b) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

III. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Public Law 104–

121)), and the Unfunded Mandates

Reform Act of 1995 (Public Law 104–4).

Executive Order 12866 directs agencies

to assess all costs and benefits of

available regulatory alternatives and,

when regulation is necessary, to select

regulatory approaches that maximize

net benefits (including potential

economic, environmental, public health

and safety, and other advantages;

distributive impacts; and equity). The

agency believes that this final rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

final rule is not a significant regulatory

action as defined by the Executive Order

and so it is not subject to review under

the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. FDA knows of only one

manufacturer of this type of device.

Classification of these devices from

class III to class II will relieve this

manufacturer of the device of the cost of

complying with the premarket approval

requirements of section 515 of the act

(21 U.S.C. 360e) and may permit small

potential competitors to enter the

marketplace by lowering their costs. The

agency, therefore, certifies that the final

rule will not have a significant impact

on a substantial number of small

entities.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 requires

that agencies prepare a written

statement of anticipated costs and

benefits before proposing any rule that

may result in an expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million in any one year (adjusted

annually for inflation). The Unfunded

Mandates Reform Act does not require

FDA to prepare a statement of costs and

benefits for the final rule, because the

final rule is not expected to result in any

1-year expenditure that would exceed

$100 million.

IV. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that 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. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

V. Paperwork Reduction Act of 1995

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 884 is

amended as follows:

List of Subjects in 21 CFR Part 884

Medical devices.

PART 884—OBSTETRICAL AND

GYNECOLOGICAL DEVICES

1. The authority citation for 21 CFR

part 884 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 884.5970 is added to

subpart F to read as follows:

§ 884.5970 Clitoral engorgement device.

(a) Identification. A clitoral

engorgement device is designed to apply

a vacuum to the clitoris. It is intended

for use in the treatment of female sexual

arousal disorder.

(b) Classification. Class II (special

controls). The special control is a

guidance document entitled: ‘‘Guidance

for Industry and FDA Reviewers: Class

II Special Controls Guidance Document

for Clitoral Engorgement Devices.’’

Dated: July 17, 2000.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 00–19489 Filed 8–1–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA–187F]

RIN 1117–AA51

Schedules of Controlled Substances:

Exempt Anabolic Steroids Products;

Republication

Editorial Note: Due to numerous printing

errors, rule document FR Doc. 00-17915

originally published at 65 FR 43690-43694,

Friday, July 14, 2000 is being reprinted in its

entirety.

AGENCY: Drug Enforcement

Administration, Department of Justice.

ACTION: Final rule.

SUMMARY: The Drug Enforcement

Administration (DEA) published an

interim rule with request for comments

(65 FR 3124, Jan. 20, 2000, as corrected

at 65 FR 5024, Feb. 2, 2000) which

identified six anabolic steroid products

as being exempt from certain regulatory

provisions of the Controlled Substances

Act (21 U.S.C. 801 et seq.) (CSA). No

comments were received. Therefore, the

interim rule is being adopted without

change.

EFFECTIVE DATE: July 14, 2000.

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and

Chemical Evaluation Section, Drug

Federal Register / Vol. 65, No. 149 / Wednesday, August 2, 2000 / Rules and Regulations 47307

Enforcement Administration,

Washington, D.C. 20537; Telephone

(202) 307–7183.

SUPPLEMENTARY INFORMATION:

What Does This Rule Accomplish and

by What Authority Is It Being Issued?

This rule finalizes an interim rule (65

FR 3124, Jan. 20, 2000, as corrected at

65 FR 5024, Feb. 2, 2000) which

identified six products as being exempt

from certain portions of the Controlled

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

(CSA). Section 1903 of the Anabolic

Steroids Control Act of 1990 (title XIX

of Pub. L. 101–647) (ASCA) provides

that the Attorney General may exempt

products which contain anabolic

steroids from all or any part of the CSA

if the products have no significant

potential for abuse. The procedure for

implementing this section of the ASCA

is described in 21 CFR 1308.33. Exempt

status removes each product from

application of the registration, labeling,

records, reports, prescription, physical

security, and import and export

restrictions associated with Schedule III

substances.

Why Did DEA Add Six Products to the

List of Exempt Anabolic Steroids

Products?

Manufacturers of six anabolic steroid

products submitted exempt status

applications to the Deputy Assistant

Administrator for the DEA Office of

Diversion Control in accordance with 21

CFR 1308.33. Each application

delineated a set of facts which the

applicant believed justified the exempt

status of its product. The applicants

provided information which they

believed showed that because of the

specific product preparation,

concentration, mixture, or delivery

system these products had no

significant potential for abuse. Upon

acceptance of the applications, the

Deputy Assistant Administrator

requested from the Assistant Secretary

for Health, Department of Health and

Human Services (HHS) a

recommendation as to whether these

products should be considered for

exemption from certain portions of the

CSA. The Deputy Assistant

Administrator received the

determination and recommendation of

the Assistant Secretary for Health and

Surgeon General that there was

sufficient evidence to establish that each

product does not possess a significant

potential for abuse.

Which Anabolic Steroid Products Are

Affected and When Does the Rule

Become Effective?

In the interim rule, the Deputy

Assistant Administrator identified the

following six products as being exempt

from application of sections 302 and

through 309 and 1002 through 1004 of

the CSA (21 U.S.C. 822–829 and 952–

954) and 21 CFR 1301.13, 1301.22, and

1301.71 through 1301.76:

EXEMPT ANABOLIC STEROID PRODUCTS

Trade name Company NDC No. Form Ingredients Quantity

Component E–H in process

granulation.

Ivy Laboratories, Inc., Overland Park, KS......................... Pail or drum ... Testosterone propionate .......

Estradiol benzoate ................

10 parts

1 part

Component E–H in process

pellets.

Ivy Laboratories, Inc., Overland Parks, KS......................... Pail ................ Testosterone propionate .......

Estradiol benzoate ................

25 mg/

2.5 mg/pellet

Component TE–S in process

granulation.

Ivy Laboratories, Inc., Overland Park, KS......................... Pail or drum ... Trenbolone acetate ...............

Estradiol USP ........................

5 parts

1 part

Component TE–S in process

pellets.

Ivy Laboratories, Inc., Overland Parks, KS......................... Pail ................ Trenbolone acetate ...............

Estradiol USP ........................

120 mg/

24 mg/pellet

Testoderm with Adhesive 4

mg/d.

Alza Corp., Palo Alto,CA ...... Export only .... Patch ............. Testosterone ......................... 10 mg

Testosterone Ophthalmic Solutions.Allergan, Irvine, CA ............... ........................ Ophthalmic

Solutions.

Testosterone ......................... ≤0.6% w/v

The interim rule became immediately

effective on publication in the Federal

Register, January 20, 2000, in order to

provide a health benefit to the public by

more expeditiously increasing the

access to these anabolic steroid products

and to reduce regulatory restrictions

that DEA (in consultation with HHS)

has determined to be an unnecessary

burden on the businesses manufacturing

these products.

What Comments to the Interim Rule

Were Received?

Comments to the interim rule were

requested, none were received.

What Exempt Anabolic Steroid

Products are Included in the List

Referred to in 21 CFR 1308.34?

With the publication of this final rule,

the complete list of products referred to

in 21 CFR 1308.34 is as follows:

EXEMPT ANABOLIC STEROID PRODUCTS

Trade Name Company NDC No. Form Ingredients Quantity

Andro-Estro 90–4 ..................... Rugby Laboratories, Rockville Centre, NY.0536–1605 Vial ................ Testosterone enanthate ........

Estradiol valerate ..................

90 mg/ml

4 mg/ml

Androgyn L.A. .......................... Forest Pharmaceuticals, St.

Louis, MO.

0456–1005 Vial ................ Testosterone enanthate ........

Estradiol valerate ..................

90 mg/ml

4 mg/ml

Component E–H in process

granulation.

Ivy Laboratories, Inc., Overland Park, KS.Pail or drum ... Testosterone propionate .......

Estradiol benzoate ................

10 parts

1 part

Componenet E–H in process

pellets.

Ivy Laboratories, Inc., Overland Park, KS.Pail ................ Testosterone propionate .......

Estradiol benzoate ................

25 mg/

2.5 mg/pellet

Component TE–S in process

granulation.

Ivy Laboratories, Inc., Overland Park, KS.Pail or drum ... Trenbolone acetate ...............

Estradiol USP ........................

5 parts

1 part

Component TE–S in process

pellets.

Ivy Laboratories, Inc., Overland Park, KS.Pail ................ Trenbolone acetate ...............

Estradiol USP ........................

120 mg/

24 mg/pellet

47308 Federal Register / Vol. 65, No. 149 / Wednesday, August 2, 2000 / Rules and Regulations

EXEMPT ANABOLIC STEROID PRODUCTS—Continued

Trade Name Company NDC No. Form Ingredients Quantity

depANDROGYN ...................... Forest Pharmaceuticals, St.

Louis, MO.

0456–1020 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

DEPTO–T.E. ............................ Quality Research Pharm.,

Carmel, IN.

52765–257 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Depo-Testadiol ......................... The Upjohn Company, Kalamazoo, MI.0009–0253 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

depTESTROGEN ..................... Martica Pharmaceuticals,

Phoenix, AZ.

51698–257 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Duomone ................................. Wintec Pharmaceutical, Pacific, MO.52047–360 Vial ................ Testosterone enanthate ........

Estradiol valerate ..................

90 mg/ml

4 mg/ml

DUO–SPAN II .......................... Primedics Laboratories, Gardena, CA.0684–0102 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

DURATESTRIN ....................... W. E. Hauck, Alpharetta, GA 43797–016 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Estratest ................................... Solvay Pharmaceuticals,

Marietta, GA.

0032–1026 TB .................. Esterifield estrogens .............

Methyltestosterone ................

1.25 mg

2.5 mg

Estratest HS ............................. Solvay Pharmaceuticals,

Marietta, GA.

0032–1023 TB .................. Esterifield estrogens .............

Methyltestosterone ................

0.625 mg

1.25 mg

Menogen .................................. Sage Pharmaceuticals,

Shreveport, LA.

59243–570 TB .................. Esterifield estrogens .............

Methyltestosterone ................

1.25 mg

2.5 mg

Menogen HS ............................ Sage Pharmaceutical,

Shreveport, LA.

59243–560 TB .................. Esterifield estrogens .............

Methyltestosterone ................

.0625 mg

1.25 mg

PAN ESTRA TEST .................. Pan American Labs., Covington, LA.0525–0175 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Premarin with

Methyltestosterone.

Ayerst Labs. Inc,. New York,

NY.

0046–0878 TB .................. Conjugated estrogens ...........

Methyltestosterone ................

0.625 mg

5.0 mg

Premarin with

Methyltestosterone.

Ayerst Labs. Inc., New York,

NY.

0046–0879 TB .................. Conjugated estrogens ...........

Methyltestosterone ................

1.25 mg

10.0 mg

Synovex H in-process bulk pellets.Syntex Animal health, Palo

Alto, CA.

Drum .............. Testosterone propionate .......

Estradiol benzoate ................

25 mg

2.5 mg/pellet

Synovex H in-process granulation.Syntex Animal Health, Palo

Alto, CA.

Drum .............. Testosterone propionate .......

Estradiol benzoate ................

10 part

1 part

Synovex Plus in-process bulk

pellets.

Fort Dodge Animal Health,

Fort Dodge, IA.

Drum .............. Trenbolone acetate ...............

Estradiol benzoate ................

25 mg/

3.50 mg/pellet

Synovex Plus in-process

granulation.

Fort Dodge Animal Health,

Fort Dodge, IA.

Drum .............. Trenbolone acetate ...............

Estradiol benzoate ................

25 parts

3.5 parts

Testagen .................................. Clint Pharmaceuticals, Nashville, TN.55553–257 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

TEST–ESTRO Cypionates ...... Rugby Laboratories Rockvill

Centre, NY.

0536–9470 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Testoderm 4 mg/d ................... Alza Copr., Palo Alto, CA ..... 17314–4608 Patch ............. Testosterone ......................... 10 mg

Testoderm 6 mg/d ................... Alza Corp., Palo Alto, CA ..... 17314–4609 Patch ............. Testosterone ......................... 15 mg

Testoderm with Adhesive 4

mg/d.

Alza Corp., Palo Alto, CA ..... Export only Patch ............. Testosterone ......................... 10 mg

Testoderm with Adhesive 6

mg/d.

Alza Corp., Palo Alto, CA ..... 17314–2836 Patch ............. Testosterone ......................... 15 mg

Testoderm in-process film ....... Alza Corp, Palo Alto, CA ...... Sheet ............. Testosterone ......................... 0.25 mg/cm2

Testoderm with Adhesive inprocess film.Alza Corp., Palo Alto, CA ..... Sheet ............. Testosterone ......................... 0.25 mg/cm2

Testosterone Cypionate/Estradiol Cypionate Injection.Best Generics, No. Miami

Beach, FL.

54274–530 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Testosterone Cypionate/Estradiol Cypionate Injection.Goldline Labs, Ft. Lauderdale, Fl.0182–3069 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2mg/ml

Testosterone Cyp 50 Estradiol

Cyp 2.

I.D.E.-Interstate, Amityville,

NY.

0814–7737 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Testosterone Cypionate/Estradiol Cypionate Injection.Schein Pharmaceuticals, Port

Washington, NY.

0364–6611 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Testosterone Cypionate/Estradiol Cypionate Injection.Steris Labs. Inc., Phoenix,

AZ.

0402–0257 Vial ................ Testosterone cypionate .........

Estradiol cypionate ................

50 mg/ml

2 mg/ml

Testosterone Enanthate/Estradiol Valerate Injection.Goldline Labs, Ft. Lauderdale, Fl.0182–3073 Vial ................ Testosterone enanthate ........

Estradiol valerate ..................

90 mg/ml

4 mg/ml

Testosterone Enanthate/Estradiol Valerate Injection.Schein Pharmaceuticals, Port

Washington, NY.

0364–6618 Vial ................ Testosterone enanthate ........

Estradiol valerate ..................

90 mg/ml

4 mg/ml

Testosterone Enanthate/Estradiol Valerate Injection.Steris Labs. Inc., Phoenix,

AZ.

0402–0360 Vial ................ Testosterone enanthate ........

Estradiol valerate ..................

90 mg/ml

4 mg/ml

Testosterone Ophthalmic Solutions.Allergan, Irvine, CA ............... Ophthalmic

solutions.

Testosterone ......................... ≤0.6% w/v

Tilapia Sex Reversal Feed (Investigational).Rangen, Inc., Buhl, ID .......... Plastic bags ... Methyltestosterone ................ 60 mg/kg fish

feed

Federal Register / Vol. 65, No. 149 / Wednesday, August 2, 2000 / Rules and Regulations 47309

EXEMPT ANABOLIC STEROID PRODUCTS—Continued

Trade Name Company NDC No. Form Ingredients Quantity

Tilapia Sex Reversal Feed (Investigational).Ziegler Brothers, Inc., Gardners, PA.Plastic bags ... Methyltestosterone ................ 60 mg/kg fish

feed

Additional copies of this list may be

obtained by submitting a written request

to the Drug and Chemical Evaluation

Section, Office of Diversion Control,

Drug Enforcement Administration,

Washington, D.C. 20537.

Plain Language Instructions

The Drug Enforcement

Administration makes every effort to

write clearly. If you have suggestions as

to how to improve the clarity of this

regulation, call or write Patricia M.

Good, Chief, Liaison and Policy Section,

Office of Diversion Control, Drug

Enforcement Administration,

Washington, D.C. 20537, Telephone

(202) 307–7297.

Certifications

Regulatory Flexibility Act

The Deputy Assistant Administrator,

for the DEA Office of Diversion Control,

in accordance with the Regulatory

Flexibility Act [5 U.S.C. 605(b)], has

reviewed this rule and by approving it,

certifies that it will not have significant

economic impact on a substantial

number of small business entities. The

granting of exempt status relieves

persons who handle the exempt

products in the course of legitimate

business from the registration, labeling,

records, reports, prescription, physical

security, and import and export

restrictions imposed by the CSA.

Executive Order 12866

The Deputy Assistant Administrator

further certifies that this rulemaking has

been drafted in accordance with the

principles in Executive Order 12866,

section 1(b). The Office of Management

and Budget (OMB) reviewed the interim

rule as a significant action; the DEA

received no comments regarding the

interim rule. This final rule falls into a

category of regulatory actions which

OMB has determined are exempt from

regulatory review. Therefore, this action

has not been reviewed by the OMB.

Executive Order 13132

This action has been analyzed in

accordance with the principles and

criteria in Executive Order 13132 and it

has been determined that this rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

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 $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.

Small Business Regulatory Enforcement

Fairness Act of 1996

This rule is not a major rule as

defined by Section 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 United States-based

companies to compete with foreignbased companies in domestic and

export markets.

PART 1308—[AMENDED]

Pursuant to the authority delegated to

the Administrator of the DEA pursuant

to 21 U.S.C. 871(a) and 28 CFR 0.100

and redelegated to the Deputy Assistant

Administrator of the Drug Enforcement

Administration Office of Diversion

Control, pursuant to 28 CFR 0.104,

appendix to subpart R, section 7(g), the

Deputy Assistant Administrator of the

Office of Diversion Control hereby

adopts as a final rule, without change,

the interim rule which was published at

65 FR 3124 on Jan. 20, 2000 and

corrected at 65 FR 5024, on Feb. 2, 2000,

amending the list described in 21 CFR

1308.34.

Dated: July 3, 2000.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control.

[FR Doc. 00–17915 Filed 7–13–00; 8:45 am]

Editorial Note: Due to numerous printing

errors, rule document FR Doc. 00-17915

originally published at 65 FR 43690-43694,

Friday, July 14, 2000 is being reprinted in its

entirety.

[FR Doc. R0–17915 Filed 8–1–00; 8:45 am]

BILLING CODE 1505–01–D

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1310

[DEA–156F]

RIN # 1117–AA43

Listed Chemicals; Final Establishment

of Thresholds for Iodine and

Hydrochloric Gas (Anhydrous

Hydrogen Chloride)

AGENCY: Drug Enforcement

Administration (DEA), Justice.

ACTION: Final Rule with request for

comment.

SUMMARY: Effective October 3, 1996, the

Comprehensive Methamphetamine

Control Act of 1996 (MCA) established

that iodine is a List II chemical;

however, it was not made subject to

import/export regulatory controls.

While exports of the listed chemical

hydrochloric acid (including anhydrous

hydrogen chloride, referred to in the

MCA as hydrochloric gas, which is a

form of hydrogen chloride) were already

regulated pursuant to 21 CFR 1310, the

MCA had the practical effect of

directing the DEA to place domestic

controls on anhydrous hydrogen

chloride. Since no domestic thresholds

for iodine or anhydrous hydrogen

chloride have been established prior to

this Final Rule, all domestic

transactions involving such chemicals

have been subject to recordkeeping and

reporting requirements under the

Controlled Substances Act since

October 3, 1996.

This rule establishes a domestic

threshold of zero (0.0 kilograms) for

anhydrous hydrogen chloride, and a

domestic threshold of 0.4 kilograms for

iodine. Import and export transactions

in anhydrous chloride are unaffected by

this rule. Iodine transactions involving

amounts below the threshold will not be

subject to recordkeeping and reporting

requirements except for reporting of any

unusual or excessive loss or

disappearance as required by 21 U.S.C.

830(b)(1)(C).

Although the threshold for anhydrous

hydrogen chloride is established at 0.0

kilogram, DEA has concluded that

certain transactions in anhydrous

hydrogen chloride are not sources for