3124 Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Rules and Regulations

Form N–6 for insurance company separate accounts

that are registered as unit investment trust and that

offer variable life policies.

6 17 CFR 230.482.

7The mandated electronic submissions of rule

101(a)(1)(i) of Regulation S–T [17 CFR

232.101(a)(1)(i)] omcide 482 ads where we require

filers to file them with us. See Release 33–7122 at

footnote 32 and accompanying text.

8 17 CFR 230.425, 230.473, 230.477, and 230.482.

9 5 U.S.C. 553(b).

10 5 U.S.C. 601–612.

11 5 U.S.C. 553(d)(3).

12 15 U.S.C. 77f, 77g, 77h, 77j and 77s(a).

13 15 U.S.C. 78c, 78l, 78m, 78n, 78o, 78w and 78ll.

14 15 U.S.C. 79t.

15 15 U.S.C. 77sss.

16 15 U.S.C. 80a–8, 80a–29, 80a–30 and 80a–37.

• 497AD—Prospectus filed by certain

investment companies under Rule

482 6(482 ads).7 Filers who are required

to file 482 ads with us in accordance

with Rule 497 and the NOTE to Rule

482(c) should submit their 482 ads

under this new submission type.

Appendices A and B of the Filer

Manual contain the descriptions and

associated tagging requirements for all

of the new submission types. We also

have added a new section to Table 6 of

Appendix A, entitled, ‘‘Miscellaneous

Filings Under the Securities Act.’’ This

section groups several new and existing

submission types (425, DEL AM, RW,

AW, and 497AD) used by investment

companies to make filings under

Securities Act Rules 425, 473, 477, and

482.8

We have also made the following

changes effective after Release 6.75 is

issued:

• The EDGAR system will no longer

support the following form types: SC

13E4 and SC 14D1.

• We will add the submission’s

accession number to the subject line of

all notices to filers of acceptance or

suspension.

• We will revise EDGARLink so that

filers will be able to perform a version

verify upgrade of the software while in

a Windows environment.

Finally, we are amending Rule 301 of

Regulation S–T to provide for the

incorporation by reference of the Filer

Manual into the Code of Federal

Regulations, which incorporation by

reference was approved by the Director

of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR Part 51.

The revised Filer Manual and the

amendments to Rule 301 will be

effective on January 24, 2000.

You may obtain paper copies of the

updated Filer Manual at the following

address: Public Reference Room, U.S.

Securities and Exchange Commission,

450 Fifth Street, N.W., Washington D.C.

20549–0102. We will post electronic

format copies on the SEC’s Web Site.

The SEC’s Web Site address for the Filer

Manual is http://www.sec.gov/asec/ofis/

filerman.htm. You may also obtain

copies from Disclosure Incorporated, the

paper and microfiche contractor for the

Commission, at (800) 638–8241.

Since the Filer Manual relates solely

to agency procedures or practice,

publication for notice and comment is

not required under the Administrative

Procedure Act (APA). 9 It follows that

the requirements of the Regulatory

Flexibility Act 10 do not apply.

The effective date for the updated

Filer Manual and the rule amendments

is January 24, 2000. In accordance with

the APA,11 we find that there is good

cause to establish an effective date less

than 30 days after publication of these

rules.

Statutory Basis

We are adopting the amendments to

Regulation S–T under Sections 6, 7, 8,

10, and 19(a) of the Securities Act,12

Sections 3, 12, 13, 14, 15, 23, and 35A

of the Securities Exchange Act of

1934,13 Section 20 of the Public Utility

Holding Company Act of 1935,14

Section 319 of the Trust Indenture Act

of 1939,15 and Sections 8, 30, 31, and 38

of the Investment Company Act.16

List of Subjects in 17 CFR Part 232

Incorporation by reference, Reporting

and recordkeeping requirements,

Securities.

Text of the Amendment

In accordance with the foregoing,

Title 17, Chapter II of the Code of

Federal Regulations is amended as

follows:

PART 232—REGULATION S–T—

GENERAL RULES AND REGULATIONS

FOR ELECTRONIC FILINGS

1. The authority citation for Part 232

continues to read as follows:

Authority: 15 U.S.C. 77f, 77g, 77h, 77j,

77s(a), 77sss(a), 78c(b), 78l, 78m, 78n, 78o(d),

78w(a), 78ll(d), 79t(a), 80a–8, 80a–29, 80a–30

and 80a–37.

2. Section 232.301 is revised to read

as follows:

§ 232.301 EDGAR Filer Manual.

Filers must prepare electronic filings

in the manner prescribed by the EDGAR

Filer Manual, promulgated by the

Commission, which sets out the

technical formatting requirements for

electronic submissions. The January 24,

2000 edition of the EDGAR Filer

Manual: Guide for Electronic Filing with

the U.S. Securities and Exchange

Commission (Release 6.75) is

incorporated into the Code of Federal

Regulations by reference, which action

was approved by the Director of the

Federal Register in accordance with 5

U.S.C. 552(a) and 1 CFR Part 51. You

must comply with these requirements in

order for documents to be timely

received and accepted. You can obtain

paper copies of the EDGAR Filer

Manual from the following address:

Public Reference Room, U.S. Securities

and Exchange Commission, 450 5th

Street, N.W., Washington, D.C. 20549–

0102 or by calling Disclosure

Incorporated at (800) 638–8241.

Electronic format copies are available on

the SEC’s Web Site. The SEC’s Web Site

address for the Manual is http://

www.sec.gov/asec/ofis/filerman.htm.

Information on becoming an EDGAR e–

mail/electronic bulletin board

subscriber is available by contacting

TRW/UUNET at (703) 345–8900 or at

www.trw–edgar.com.

Dated: January 11, 2000.

By the Commission.

Margaret H. McFarland,

Deputy Secretary.

[FR Doc. 00–1123 Filed 1–19–00; 8:45 am]

BILLIING CODE 8010–10–P

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1308

[DEA No. 187I]

RIN 1117–AA51

Schedules of Controlled Substances:

Exempt Anabolic Steroid Products

AGENCY: Drug Enforcement

Administration, Department of Justice.

ACTION: Interim rule and request for

comments.

SUMMARY: The Drug Enforcement

Administration (DEA) is designating six

preparations as exempt anabolic steroid

products. This action, as part of the

ongoing implementation of the Anabolic

Steroids Control Act of 1990, removes

certain regulatory controls pertaining to

Schedule III substances from the

designated entities.

DATES: Effective date: January 20, 2000.

Comments must be submitted on or

before March 20, 2000.

ADDRESSES: Comments and objections

should be submitted to the Deputy

Assistant Administrator, Office of

Diversion Control, Drug Enforcement

Administration, Washington, DC. 20537;

Attention: DEA Federal Register

Representative/CCR.

Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Rules and Regulations 3125

FOR FURTHER INFORMATION CONTACT:

Frank Sapienza, Chief, Drug and

Chemical Evaluation Section, Drug

Enforcement Administration,

Washington, DC 20537; Telephone:

(202) 307–7183.

SUPPLEMENTARY INFORMATION:

What Does This Rule Accomplish and

by What Authority Is It Being Issued:

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 Controlled Substances

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

purpose of this rule is to identify six

products for which applications were

made and which the Deputy Assistant

Administrator for the DEA Office of

Diversion Control finds meet the exempt

anabolic steroid product criteria.

Why Is DEA Adding Anabolic Steroid

Products to the List of Exemptions?

In accordance with 21 CFR 1308.33

applications for the exemption of six

anabolic steroid products were

submitted by the products’

manufacturers to the Deputy Assistant

Administrator for the DEA Office of

Diversion Control. Each application

delineated a set of facts which the

applicant believed justified the exempt

status of its product. The applicants

provides data 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 these

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 which contain

anabolic steroids should be considered

for exemption from certain portions of

the CSA. The Deputy Assistant

Administrator has received the

determination and recommendations of

the Assistant Secretary for Health and

Surgeon General, that there was

sufficient evidence to establish that

these products do not possess a

significant potential for abuse.

Which Anabolic Steroid Products Are

Affected?

The Deputy Assistant Administrator,

having reviewed the applications, the

recommendations of the Assistant

Secretary for Health and Surgeon

General, and other relevant information,

finds that each of the products

described below has no significant

potential for abuse because of its

concentration, preparation, mixture, or

delivery system.

What Action Can Individuals Take if

They Are Concerned About the Impact

of this Rule?

Interested persons are invited to

submit their comments in writing with

regard to this interim rule. If any

comments or objections raise significant

issues regarding any finding of fact or

conclusion of law upon which this

order is based, the Deputy Assistant

Administrator shall immediately

suspend the effectiveness of this order

until he may reconsider the application

in light of the comments and objections

filed. Thereafter, the Deputy Assistant

Administrator shall reinstate, revoke, or

amend his original order as he

determines appropriate.

Miscellaneous Matter—Correction

In a previously published rule, an

exempt anabolic steroid product was

identified in the list referred to in 21

CFR 1308.34 by its active ingredients

rather than its trade name. See 62 FR

51776, October 3, 1997. Exemptions are

granted, in accordance with the ASCA

and the implementing regulations, to

specific products. Therefore, DEA is

correcting the list referred to in 21 CFR

1308.34 to describe the product by its

specific trade name, Depo-Testadiol.

The corrected information for this

product in the list referred to in 21 CFR

1308.34 is:

Trade name Company NDC No. Form Ingredients Quantity

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

cypionate.

50 mg/ml, 2 mg.ml.

Why is DEA making this rule

immediately effective?

This rule is being made immediately

effective 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.

Plain English

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, DC 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 a

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.

Administrative Procedure Act 5 U.S.C.

553

This rule provides a health benefit to

the public by more expeditiously

increasing the access to these anabolic

steroid products and reducing

regulatory restrictions that DEA and

HHS have determined to be

unnecessary. Therefore DEA has

determined that it is contrary to the

public interest to delay the effectiveness

of this rule by requiring notice of

proposed rulemaking and delay the

effective date.

The relief from these administrative

restrictions will provide monetary

savings to each of the three

pharmaceutical manufacturers who

applied for these exemptions. In

addition to the economic gain to the

pharmaceutical industry, these

exemptions provide significant benefits

to the general public by increasing the

availability of these drug products for

the legitimate medical treatment for

which they were intended.

3126 Federal Register / Vol. 65, No. 13 / Thursday, January 20, 2000 / Rules and Regulations

Executive Order 12866

This interim rule has been drafted and

reviewed in accordance with Executive

Order 12866, section 1(b), Principles of

Regulation. The Deputy Assistant

Administrator, Office of Diversion

Control, has determined that this rule is

a significant regulatory action under

Executive Order 12866, section 3(f),

Regulatory Planning and Review, and

accordingly this rule has been reviewed

by the Office of Management and

Budget. This regulation exempts those

who handle the affected products in the

course of legitimate business from the

restrictions associated with Schedule III

allowing for a more efficient and cost

effective means of doing business. These

exemptions will provide direct

economic relief and financial savings to

the three manufacturer applicants

requesting these actions. This regulation

is in the public interest and provides

more expedient access to these products

which, in turn, has the potential to

improve the health benefits to the

public.

Executive Order 13132

This rule will not have substantial

direct effects on the United States, on

the relationship between the national

government and the United States, or on

the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 13132,

it is 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 the United States based

companies to compete with foreignbased companies in domestic and

export markets.

PART 1308—[AMENDED]

Pursuant to the authority vested in the

Attorney General by section 1903 of the

ASCA, 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 DEA Office of Diversion Control

pursuant to 28 CFR 0.104, Appendix to

Subpart R, section 7(g), the Deputy

Assistant Administrator hereby orders

that the following compounds,

mixtures, or preparations containing

anabolic steroids be 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 21

CFR 1301.11, 1301,13, 1301.71 through

1301.76 for administrative purposes

only and be included in the list of

products described in 21 CFR 1308.34.

§ 1308.34 Amended

EXEMPT ANABOLIC STEROID PRODUCTS

Trade name Company NDC No. Form Ingredients Quality

Component E–H in Process Pellets.Ivy Laboratories, Inc.

Overland Park, KS.

........................ Pail ................... Testosterone propionate,

Estradiol benzoate.

25 mg/pellet, 2.5

mg/pellet.

Component E–H in Process Granulation.Ivy Laboratories, Inc.

Overland Park, KS.

........................ Pail or Drum ..... Testosterone propionate,

Estradiol benzoate.

10 parts, 1 part.

Component TE–S in Process Pellets.Ivy Laboratories, Inc.

Overland Park, KS.

........................ Pail .................... Trenbolone acetate, Estradiol USP.120 mg/pellet, 24

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.

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.

Dated: January 11, 2000.

John H. King,

Deputy Assistant Administrator, Office of

Diversion Control.

[FR Doc 00–1347 Filed 1–19–00; 8:45 am]

BILLING CODE 4410–09–M

DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Part 250

RIN 1010–AC32

Postlease Operations Safety

AGENCY: Minerals Management Service

(MMS), Interior.

ACTION: Corrections to final regulations.

SUMMARY: This document contains

corrections to the final regulations

which were published Tuesday,

December 28, 1999 (64 FR 72756). The

regulations related to postlease

operations safety. These corrections

relate to an incorrect citation in the

preamble to the published final

regulations and to three documents

incorporated by reference on Boiler and

Pressure Vessel Codes.

EFFECTIVE DATE: January 27, 2000.

The incorporation by reference of

certain publications listed in these rules

was approved by the Director of the

Federal Register as of December 15,

1999, and January 27, 2000.

FOR FURTHER INFORMATION CONTACT:

Kumkum Ray, (703) 787–1600.

SUPPLEMENTARY INFORMATION:

Background

The final regulations that are the

subject of these corrections supersede

30 CFR 250, subpart A, General,

regulations on the effective date and

affect all operators and lessees on the

Outer Continental Shelf.

With respect to the correction of the

three documents incorporated by

reference, on December 15, 1999 (64 FR

69923), MMS published a technical

amendment to § 250.101, ‘‘Documents

incorporated by reference,’’ to update

versions of the ANSI/ASME Boiler and

Pressure Vessel Code, Sections I, IV, and