51776 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Rules and Regulations

EXCLUDED VETERINARY ANABOLIC STEROID IMPLANT PRODUCTS—Continued

Trade name Company NDC or DIN

No. Delivery system Ingredients Quantity

Revalor-H ........... Hoechst Roussel Vet,

Somerville, NJ.

12799–810 10 implant cartridge, 7

pellets/implant.

Trenbolone acetate ..............

Estradiol ...............................

140 mg/implant

(20 mg/pellet)

14 mg/implant

(2 mg/pellet)

Revalor-S ........... Hoechst Roussel Vet,

Somerville, NJ.

12799–809 10 implant cartridge, 6

pellets/implant.

Trenbolone acetate ..............

Estradiol ...............................

120 mg/implant

(20 mg/pellet)

24 mg/implant

4 mg/pellet)

Synovex H .......... Fort Dodge Labs, Fort

Dodge, IA.

0856–3901 10 implant clip, 8 pellets/

implant.

Testosterone propionate ......

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

200 mg/implant

(25 mg/pellet)

20 mg/implant

(2.5 mg/pellet)

Synovex H .......... Syntex Laboratories, Palo

Alto, CA.

.......................... 10 implant clip, 8 pellets/

implant.

Testosterone propionate ......

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

200 mg/implant

(25 mg/pellet)

20 mg/implant

(2.5 mg/pellet)

Synovex Plus ..... Fort Dodge Labs, Fort

Dodge, IA.

0856–3904 10 implant clip, 8 pellets/

implant.

Trenbolone acetate ..............

Estradiol ...............................

200 mg/implant

(25 mg/pellet)

28 mg/implant

(3.5 mg/pellet)

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 Deputy Assistant Administrator,

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 a

significant economic impact on a

substantial number of small-business

entities. The inclusion of a product in

21 CFR 1308.26 relieves persons who

handle the product in the course of

legitimate business from the

requirements imposed by 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 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 have

significant adverse effects on

competition, employment, investment,

productivity, innovation, or on the

ability of the United States-based

companies to complete 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.

Dated: September 8, 1997.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 97–25973 Filed 10–2–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA No. 160F]

Schedules of Controlled Substances:

Exempt Anabolic Steroid Products

AGENCY: Drug Enforcement

Administration, Department of Justice.

ACTION: Final rule.

SUMMARY: The interim rule (62 FR

29288, May 30, 1997) which identified

ten anabolic steroid products as being

exempt from certain regulatory

provisions of the Controlled Substances

Act (CSA) (21 U.S.C. 801 et seq.) is

adopted without change.

DATES: Effective Date: October 3, 1997.

FOR FURTHER INFORMATION CONTACT:

Frank L. Sapienza, Chief, Drug and

Chemical Evaluation Section, 202–307–

7183.

SUPPLEMENTARY INFORMATION: The

Acting Deputy Assistant Administrator,

Office of Diversion Control, Drug

Enforcement Administration (DEA),

published in the Federal Register, an

interim rule which identified ten

products as being exempt anabolic

steroid products (62 FR 29288, May 30,

1997). Comments were requested, none

were received.

Therefore, 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)9, the Deputy Assistant

Administrator of the Office of Diversion

Control, hereby adopts as a final rule,

without change, the interim rule

amending 21 CFR 1308.34 which was

published at 62 FR 29288 on May 30,

1997.

The anabolic steroid containing

compounds, mixtures, or preparations

which are described in 21 CFR 1308.34

are as follows:
Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Rules and Regulations 51777

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

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

Louis, MO.

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

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

50 mg/ml

2 mg/ml

DEPO-T.E. ............................. Quality Research Pharm.,

Carmel, IN.

52765–257 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 .......... Esterified estrogens .................

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

1.25 mg

2.5 mg

Estratest HS ........................... Solvay Pharmaceuticals, Marietta, GA.0032–1023 TB .......... Esterified estrogens .................

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

0.625 mg

1.25 mg

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

Shreveport, LA.

59243–570 TB .......... Esterified estrogens .................

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

1.25 mg

2.5 mg

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

Shreveport, LA.

59243–560 TB .......... Esterified estrogens .................

Mrethyltestosterone .................

0.625 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.

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

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

1.25 mg

10.0 mg

Premarin with

Methyltestosterone.

Ayerst Labs. Inc., New York,

NY.

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

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

0.625 mg

5.0 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 parts

1 part

Synovex Plus in-process

granulation.

Fort Dodge Animal Health,

Fort Dodge, IA.

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

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

25 parts

3.5 parts

Synovex Plus in-process bulk

pellets.

Fort Dodge Animal Health,

Fort Dodge, IA.

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

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

25 mg/

3.50 mg/pellet

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

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

50 mg/ml

2 mg/ml

TEST-ESTRO Cypionates ..... Rugby Laboratories, Rockville

Centre, NY.

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

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

50 mg/ml

2 mg/ml

Testoderm 4 mg/d .................. Alza Corp., 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 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

2 mg/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 Cypionate/Estradiol Cypionate Injection.The Upjohn Co., kalamazoo,

MI.

0009–0253 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

Tilapia Sex Reversal Feed

(Investigational).

Rangen, Inc., Buhl, ID ............ ........................ Plastic

Bags.

Methyltestosterone .................. 60 mg/kg fish

feed

Tilapia Sex Reversal Feed

(Investigational.

Zeigler Brothers, Inc., Gardners, PA......................... Plastic

Bags.

Methyltestosterone .................. 60 mg/kg fish

feed
51778 Federal Register / Vol. 62, No. 192 / Friday, October 3, 1997 / Rules and Regulations

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 Deputy Assistant Administrator,

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 a

significant economic impact on a

substantial number of small-business

entities. The inclusion of a product in

21 CFR 1308.34 relieves persons who

handle the product in the course of

legitimate business from the

registration, records, reports,

prescription, physical security, import

and export requirements associated with

Schedule III controlled substances

under the CSA. Specifically, the

products are exempted from application

of sections 302 through 309 and 1002

through 1004 of the CSA (21 U.S.C.

822–829 and 952–954) and §§ 1301.11,

1301.13, and 1301.71 through 1301.76

of Title 21 Code of Federal Regulations.

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 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 have

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.

Dated: September 8, 1997.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration.

[FR Doc. 97–25972 Filed 10–2–97; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD13–97–023]

Safety Zone Regulations; Interstate 5

Bridge Repair Project, Columbia River,

Vancouver, WA

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a safety zone for the

Interstate 5 bridge repair project on the

Columbia River in Vancouver,

Washington. This project will run from

Tuesday, September 16, 1997, from 5

a.m. (PDT) through Wednesday, October

8, 1997, at 1 p.m. (PDT). The Coast

Guard, through this action, intends to

protect persons, facilities, and vessels

from safety hazards associated with

heavy equipment and falling debris in

the vicinity of the repair project. Entry

into this safety zone is prohibited unless

authorized by the Captain of the Port.

EFFECTIVE DATES: This regulation

becomes effective on September 16,

1997, at 5 a.m. (PDT) and terminates on

October 8, 1997, at 1 p.m. (PDT).

FOR FURTHER INFORMATION CONTACT:

Lt. T.G. Allan, c/o Captain of the Port,

Portland, 6767 N. Basin Ave., Portland,

Oregon 97217–3992, (503) 240–9327.

SUPPLEMENTARY INFORMATION:

Regulatory History

Pursuant to 5 U.S.C. 553, a notice of

proposed rulemaking was not published

for this regulation and good cause exists

for making it effective less than 30 days

from the date of publication in the

Federal Register. Publishing a NPRM

and delaying its effective date would be

contrary to the public interest since

immediate action is necessary to ensure

the safety of structures and vessels

operating in the area of the bridge

repair. Due to the complex planning and

coordination involved, the event

sponsor, the Oregon Department of

Transportation, was unable to provide

the Coast Guard with notice of the final

details until 30 days prior to the date of

the event. Therefore, sufficient time was

not available to publish a proposed rule

in advance of the event or to provide a

delayed effective date. Following

normal rulemaking procedures in this

case would be impracticable.

Drafting Information: The drafters of

this regulation are LT T.G. Allan, Project

Manager for the Captain of the Port, and

LT K.A. Boodell, Project Counsel,

Thirteenth Coast Guard District Legal

Office.

Background and Purpose

The event requiring this regulation is

the Oregon Department of

Transportation’s Interstate 5 bridge

repair project. The repair project is

scheduled to begin on September 16,

1997, at 5 a.m. (PDT) with work to

continue twenty-four hours a day until

the project is complete on or about

October 8, 1997. This event may result

in a large number of vessels

congregating near the bridge and

construction barges. To promote the

safety of both spectators and workers, a

safety zone is being established on the

waters of the Columbia River around the

repair project, and entry into this safety

zone is prohibited unless authorized by

the Captain of the Port. This action is

necessary due to hazards associated

with heavy equipment and possible

debris falling into the Columbia River in

the vicinity of the repair project. This

safety zone will be enforced by

representatives of the Captain of the

Port, Portland, Oregon. The Captain of

the Port may be assisted by other federal

agencies.

Regulatory Evaluation

This temporary final rule is not a

significant regulatory action under

section 3(f) of Executive Order 12866

and does not require an assessment of

potential costs and benefits under

section 6(a)(3) of that order. It has been

exempted from review by the Office of

Management and Budget under that

order. It is not significant under the

regulatory policies and procedures of

the Department of Transportation (DOT)

(44 CFR 11040, February 26, 1979). The

Coast Guard expects the economic

impact of this proposal to be so minimal

that a full Regulatory Evaluation under

paragraph 10e of the regulatory policies

and procedures of DOT is unnecessary.

This expectation is based on the fact

that the safety zone will restrict less

than a quarter of a square mile of the

waterway. The entities most likely to be

affected by this action are commercial

ship, and tug and barge operators on the

Columbia River. These entities are

aware of the Interstate bridge repair

project and the safety zone, and they

can schedule their transits accordingly.

If safe to do so, the representative of the