29504 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules

(3) Amphetamines (amphetamine,

dextroamphetamine, and their salts, and

levamfetamine and its salts) for human

use.

(4) Camphorated oil drug products.

(5) Certain halogenated salicylanilides

(tribromsalan (TBS, 3,4’,5-

tribromosalicylanilide), dibromsalan

(DBS, 4’, 5-dibromosalicylanilide),

metabromsalan (MBS, 3, 5-

dibromosalicylanilide), and 3,3’, 4,5’-

tetrachlorosalicylanilide (TC-SA)) as an

ingredient in drug products.

(6) Chloroform used as an ingredient

(active or inactive) in drug products.

(7) Cobalt preparations intended for

use by man.

(8) Intrauterine devices for human use

for the purpose of contraception that

incorporate heavy metals, drugs, or

other active substances.

(9) Oral prenatal drugs containing

fluorides intended for human use.

(10) Parenteral drug products in

plastic containers.

(11) Sterilization of drugs by

irradiation.

(12) Sweet spirits of nitre drug

products.

(13) Thorium dioxide for drug use.

(14) Timed release dosage forms.

(15) Vinyl chloride as an ingredient,

including propellant, in aerosol drug

products.

(b) Any drug listed in paragraph (a) of

this section, when composed wholly or

partly of any antibiotic drug, must be

certified under section 507 of the act or

exempted from certification under

section 507 of the act for marketing.

§ 310.504 [Removed]

9. Section 310.504 Amphetamines

(amphetamine, dextroamphetamine,

and their salts and levamfetamine and

its salts) for human use is removed.

§ 310.506 [Removed]

10. Section 310.506 Use of vinyl

chloride as an ingredient, including

propellant, of aerosol drug products is

removed.

§ 310.507 [Removed]

11. Section 310.507 Aerosol drug

products for human use containing

1,1,1-trichloroethane is removed.

§ 310.508 [Removed]

12. Section 310.508 Use of certain

halogenated salicylanilides as an

inactive ingredient in drug products is

removed.

13. Section 310.509 is revised to read

as follows:

§ 310.509 Parenteral drug products in

plastic containers.

(a) Any parenteral drug product

packaged in a plastic immediate

container is not generally recognized as

safe and effective, is a new drug within

the meaning of section 201(p) of the act,

and requires an approved new drug

application as a condition for marketing.

An ‘‘Investigational New Drug

Application’’ set forth in part 312 of this

chapter is required for clinical

investigations designed to obtain

evidence of safety and effectiveness.

(b) As used in this section, the term

‘‘large volume parenteral drug product’’

means a terminally sterilized aqueous

drug product packaged in a single-dose

container with a capacity of 100

milliliters or more and intended to be

administered or used intravenously in a

human.

(c) Until the results of compatibility

studies are evaluated, a large volume

parenteral drug product for intravenous

use in humans that is packaged in a

plastic immediate container on or after

April 16, 1979, is misbranded unless its

labeling contains a warning that

includes the following information:

(1) A statement that additives may be

incompatible.

(2) A statement that, if additive drugs

are introduced into the parenteral

system, aseptic techniques should be

used and the solution should be

thoroughly mixed.

(3) A statement that a solution

containing an additive drug should not

be stored.

(d) This section does not apply to a

biological product licensed under the

Public Health Service Act of July 1,

1944 (42 U.S.C. 201).

§ 310.510 [Removed]

14. Section 310.510 Use of aerosol

drug products containing zirconium is

removed.

§ 310.513 [Removed]

15. Section 310.513 Chloroform, use

as an ingredient (active or inactive) in

drug products is removed.

§ 310.525 [Removed]

16. Section 310.525 Sweet spirits of

nitre drug products is removed.

§ 310.526 [Removed]

17. Section 310.526 Camphorated oil

drug products is removed.

Dated: June 5, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–14706 Filed 6–6–96; 11:50 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 935

[OH–237–FOR, #71]

Ohio Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; public comment

period and opportunity for public

hearing.

SUMMARY: OSM is announcing receipt of

a proposed amendment to the Ohio

regulatory program (hereinafter the

‘‘Ohio program’’) under the surface

Mining Control and Reclamation Act of

1977 (SMCRA). The proposed

amendment consists of changes to

provisions of the Ohio rules pertaining

to inspections. The amendment is

intended to revise the Ohio program to

be consistent with the corresponding

Federal regulations.

DATES: Written comments must be

received by 4:00 p.m., [E.D.T.] July 11,

1996. If requested, a public hearing on

the proposed amendment will be held

on July 8, 1996. Requests to speak at the

hearing must be received by 4:00 p.m.,

[E.D.T.], on June 26, 1996.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to George

Rieger, Field Branch chief, at the

address listed below.

Copies of the Ohio program, the

proposed amendment, a listing of any

scheduled public hearings, and all

written comments received in response

to this document will be available for

public review at the addresses listed

below during normal business hours,

Monday through Friday, excluding

holidays. Each requester may receive

one free copy of the proposed

amendment by contacting OSM’s

Appalachian Regional Coordinating

Center.

George Rieger, Field Branch Chief,

Appalachian Regional Coordinating

Center, Office of Surface Mining

Reclamation and Enforcement, 3

Parkway Center, Pittsburgh, PA

15220, Telephone: (412) 937–2153

Ohio Division of Mines and

Reclamation, 1855 Fountain Square

Court, Columbus, Ohio 43224,

Telephone: (614) 265–1076.

FOR FURTHER INFORMATION CONTACT:

George Rieger, Field Branch Chief,

Appalachian Regional Coordinating

Center, Telephone: (412) 937–2153.
Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules 29505

SUPPLEMENTARY INFORMATION:

I. Background on the Ohio Program

On August 16, 1982, the Secretary of

the Interior conditionally approved the

Ohio program. Background information

on the Ohio program, including the

Secretary’s findings, the disposition of

comments, and the conditions of

approval can be found in the August 10,

1982, Federal Register (42 FR 34688).

Subsequent actions concerning the

conditions of approval and program

amendments can be found at 30 CFR

935.11, 935.15, and 935.16.

II. Description of the Proposed

Amendment

By letter dated May 17, 1996,

(Administrative Record No. OH–2165–

00) Ohio submitted a proposed

amendment to its program pursuant to

SMCRA at its own initiative. The

provisions of the Ohio Administrative

Code (OAC) that Ohio proposes to

amend are: OAC 1501:13–14–01—

Inspections.

Specifically, in its definition of

‘‘inactive coal mining and reclamation

operation,’’ Ohio proposes to clarify that

only the completion of Phase II

reclamation is necessary for a site to be

considered inactive for the purpose of

inspection frequency by deleting the

reference to bond reduction. Ohio also

proposes to add language that specifies

that those portions of an active

operation on which Phase II reclamation

is complete will be considered inactive

for the purpose of inspection frequency.

Finally, Ohio proposes to delete an

outdated reference to permits other than

permanent program ‘‘D’’ permits.

III. Public Comment Procedures

In accordance with the provisions of

30 CFR 732.17(h), OSM is seeking

comments on whether the proposed

amendment satisfies the applicable

program approval criteria of 30 CFR

732.15. If the amendment is deemed

adequate, it will become part of the

Ohio program.

Written Comments

Written comments should be specific,

pertain only to the issues proposed in

this rulemaking, and include

explanations in support of the

commenter’s recommendations.

Comments received after the time

indicated under DATES or at locations

other than the Appalachian Regional

Coordinating Center will not necessarily

be considered in the final rulemaking or

included in the Administrative Record.

Public Hearing

Persons wishing to speak at the public

hearing should contact the person listed

under FOR FURTHER INFORMATION

CONTACT by 4:00 p.m., [E.D.T.] on June

26, 1996. The location and time of the

hearing will be arranged with those

persons requesting the hearing. If no one

requests an opportunity to speak at the

public hearing, the hearing will not be

held.

Filing of a written statement at the

time of the hearing is requested as it

will greatly assist the transcriber.

Submission of written statements in

advances of the hearing will allow OSM

officials to prepare adequate responses

and appropriate questions.

The pubic hearing will continue on

the specified date until all persons

scheduled to speak have been heard.

Persons in the audience who have not

been scheduled to speak, and who wish

to do so, will be heard following those

who have been scheduled. The hearing

will end after all persons scheduled to

speak and persons present in the

audience who wish to speak have been

heard.

Any disabled individual who has

need for a special accommodation to

attend a public hearing should contact

the individual listed under FOR FURTHER

INFORMATION CONTACT.

Public Meeting

If only one person requests an

opportunity to speak at a hearing, a

public meeting, rather than a public

hearing, may be held. Persons wishing

to meet with OSM representatives to

discuss the proposed amendment may

request a meeting by contacting the

person listed under FOR FURTHER

INFORMATION CONTACT. All such meetings

will be open to the public and, if

possible, notices of meetings will be

posted at the locations listed under

ADDRESSES. A written summary of each

meeting will be made a part of the

Administrative Record.

IV. Procedural Determinations.

Executive Order 12866

This rule is exempted from review by

the Office of Management and Budget

(OMB) under Executive Order 12866

(Regulatory Planning and Review).

Executive Order 12778

The Department of the Interior has

conducted the reviews required ′by

section 2 of Executive Order 12778

(Civil Justice Reform) and has

determined that, to the extent allowed

by law, this rule meets the applicable

standards of subsections (a) and (b) of

that section. However, these standards

are not applicable to the actual language

of State regulatory programs and

program amendments since each such

program is drafted and promulgated by

a specific State, not by OSM. Under

sections 503 and 505 of SMCRA (30

U.S.C. 1253 and 1255) and 30 CFR

730.11, 732.15, and 732.17(h)(10),

decisions on proposed State regulatory

programs and program amendments

submitted by the States must be based

solely on a determination of whether the

submittal is consistent with SMCRA and

its implementing Federal regulations

and whether the other requirements of

30 CFR Parts 730, 731, and 732 have

been met.

National Environmental Policy Act

No environmental impact statement is

required for this rule since section

702(d) of SMCRA (30 U.S.C. 1292(d))

provides that agency decisions on

proposed State regulatory program

provisions do not constitute major

Federal actions within the meaning of

section 102(2)(C) of the National

Environmental Policy Act (42 U.S.C.

4332(2)(C)).

Paperwork Reduction Act

This rule does not contain

information collection requirements that

require approval by OMB under the

Paperwork Reduction Act (44 U.S.C.

3507 et seq.).

Regulatory Flexibility Act

The Department of the Interior has

determined that this rule will not have

a significant economic impact on a

substantial number of small entities

under the Regulatory Flexibility Act (5

U.S.C. 601 et seq.). The State submittal

which is the subject of this rule is based

upon counterpart Federal regulations for

which an economic analysis was

prepared and certification made that

such regulations would not have a

significant economic effect upon a

substantial number of small entities.

Accordingly, this rule will ensure that

existing requirements previously

promulgated by OSM will be

implemented by the State. In making the

determination as to whether this rule

would have a significant economic

impact, the Department relied upon the

data and assumptions for the

counterpart Federal regulations.

List of Subjects in 30 CFR Part 935

Intergovernmental relations, Surface

mining, Underground mining.
29506 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Proposed Rules

Dated: May 31, 1996.

Allen D. Klein,

Regional Director, Appalachian Regional

Coordinating Center.

[FR Doc. 96–14606 Filed 6–10–96; 8:45 am]

BILLING CODE 4310–05–M

30 CFR Part 946

[VA–106–FOR]

Virginia Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement (OSM),

Interior.

ACTION: Proposed rule; public comment

period and opportunity for public

hearing.

SUMMARY: OSM is announcing receipt of

a proposed amendment to the Virginia

regulatory program (hereinafter referred

to as the Virginia program) under the

Surface Mining Control and

Reclamation Act of 1977 (SMCRA). The

proposed amendment consists of

regulatory changes to implement the

standards of the Federal Energy Policy

Act of 1992, and the Code of Virginia as

amended in 1993. The amendment is

intended to revise the State program to

be consistent with the Federal

regulations as amended on March 31,

1995 (60 FR 16772).

DATES: Written comments must be

received by 4:00 p.m., on July 11, 1996.

If requested, a public hearing on the

proposed amendment will be held on

July 8, 1996. Requests to speak at the

hearing must be received by 4:00 p.m.,

on June 26, 1996.

ADDRESSES: Written comments and

requests to speak at the hearing should

be mailed or hand delivered to Mr.

Robert A. Penn, Director, Big Stone Gap

Field Office at the first address listed

below.

Copies of the Virginia program, the

proposed amendment, a listing of any

scheduled public hearings, and all

written comments received in response

to this document will be available for

public review at the addresses listed

below during normal business hours,

Monday through Friday, excluding

holidays. Each requestor may receive

one free copy of the proposed

amendment by contacting OSM’s Big

Stone Gap Field Office.

Office of Surface Mining Reclamation

and Enforcement, Big Stone Gap Field

Office, 1941 Neeley Road, Suite 201,

Compartment 116, Big Stone Gap,

Virginia 24219, Telephone: (703) 523–

4303

Virginia Division of Mined Land

Reclamation, P.O. Drawer 900, Big

Stone Gap, Virginia 24219,

Telephone: (703) 523–8100.

FOR FURTHER INFORMATION CONTACT:

Mr. Robert A. Penn, Director, Big Stone

Gap Field Office, Telephone: (703) 523–

4303.

SUPPLEMENTARY INFORMATION:

I. Background on the Virginia Program

On December 15, 1981, the Secretary

of the Interior conditionally approved

the Virginia program. Background

information on the Virginia program,

including the Secretary’s findings, the

disposition of comments, and the

conditions of approval can be found in

the December 15, 1981, Federal Register

(46 FR 61085–61115). Subsequent

actions concerning the conditions of

approval and program amendments can

be found at 30 CFR 946.12, 946.13,

946.15 and 946.16.

II. Discussion of the Proposed

Amendment

By letter dated May 21, 1996

(Administrative Record No. VA–882),

Virginia submitted amendments to the

Virginia program concerning subsidence

damage. The amendments are intended

to make the Virginia program consistent

with the Federal regulations as amended

on March 31, 1995 (60 FR 16722).

Virginia stated that the proposed

amendments implement the standards

of the Federal Energy Policy Act of

1992, and sections 45.1–243 and 45.1–

258 of the Code of Virginia.

Virginia also noted that the State has

adopted a revised system for numbering

the Virginia regulations. For the Virginia

program, the prefix ‘‘480–03–19’’ has

been replaced with ‘‘4 VAC 25–130–.’’

The part of the existing Virginia

numbering system that corresponds to

the Federal number remains the same.

For example, old ‘‘480–03–19.700.5’’

has been ‘‘4 VAC 25–130–700.5.’’ The

Virginia Division of Mines, Minerals

and Energy (DMME) will be reprinting

the Virginia program regulations to

incorporate the new prefix, both in the

numbering of the regulations and in

references contained in the regulations.

However, the DMME is continuing to

use the ‘‘480–03–19.’’ prefix pending

the reprint.

The proposed amendments are as

follows:

1. § 480–03–19.700.5 Definitions

(a) ‘‘Drinking, domestic or residential

water supply’’ has been added to mean

water received from a well or spring and

any appurtenant delivery system that

provides water for direct human

consumption or household use. Wells

and springs that serve only agricultural,

commercial or industrial enterprises are

not included except to the extent the

water supply is for direct human

consumption or human sanitation, or

domestic use.

(b) ‘‘Material damage, in the context

of §§ 480–03–19.784.20 and 480–03–

19.817.121’’ of this chapter has been

added to mean:

(a) Any functional impairment of

surface lands, features, structures or

facilities;

(b) Any physical change that has a

significant adverse impact on the

affected land’s capability to support any

current or reasonably foreseeable uses or

causes significant loss in production or

income; or

(c) Any significant change in the

condition, appearance or utility of any

structure or facility from its

presubsidence condition.

(c) ‘‘Non-commercial building’’ has

been added to mean any building, other

than an occupied residential dwelling,

that, at the time the subsidence occurs,

is used on a regular or temporary basis

as a public building or community or

institutional building as those terms are

defined in § 480–03–19.700.5 of this

chapter. Any building used only for

commercial agricultural, industrial,

retail or other commercial enterprises is

excluded.

(d) ‘‘Occupied residential dwelling

and structures related thereto’’ has been

added to mean, for purposes of §§ 480–

03–19.784.20 and 480–03–19.817.121,

any building or other structures that, at

the time the subsidence occurs, is used

either temporally, occasionally,

seasonally, or permanently for human

habitation. This term also includes any

building, structure or facility installed

on, above or below, or a combination

thereof, the land surface if that building,

structure or facility is adjunct to or used

in connection with an occupied

dwelling. Examples of such structures

include, but are not limited to, garages;

storage sheds and barns; greenhouses

and related buildings, utilities and

cables, fences and other enclosures;

retaining walls; paved or improved

patios, walks and driveways; septic

treatment facilities; and lot drainage and

lawn and garden irrigation systems. Any

structure used only for commercial

agricultural, industrial, retail or other

commercial purposes is excluded.

(e) ‘‘Replacement of water supply’’

has been added to mean, with respect to

protected water supplies contaminated,

diminished, or interrupted by coal

mining operations, provision of water

supply on both a temporary and

permanent basis equivalent to

premining quantity and quality.

Replacement includes provision of an