Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Proposed Rules 46695

or assisted reproduction catheters, to

aspirate, incubate, infuse, and/or

maintain temperature. This generic type

of device may include:

(1) Powered aspiration pumps, used

to provide low flow, intermittent

vacuum for the aspiration of eggs (ova).

(2) Syringe pumps (powered or

manual), used to activate a syringe to

infuse or aspirate small volumes of fluid

during assisted reproduction

procedures.

(3) Collection tube warmers, used to

maintain the temperature of egg (oocyte)

collection tubes at or near body

temperature. A dish/plate/microscope

stage warmer is a device used to

maintain the temperature of the egg

(oocyte) during manipulation.

(4) Embryo incubators, used to store

and preserve gametes and/or embryos at

or near body temperature.

(5) Cryopreservation instrumentation

and devices, used to contain, freeze and

maintain gametes and/or embryos at an

appropriate freezing temperature.

(b) Classification. Class II (special

controls) (premarket notification

guidance and voluntary standards).

§ 884.6400 Assisted reproduction

microtools.

(a) Identification. Assisted

reproduction microtools are pipettes or

other devices used in the laboratory to

denude, micromanipulate, hold or

transfer human gametes or embryos for

assisted hatching, intracytoplasmic

sperm injection (ICSI), embryo biopsy or

other assisted reproduction methods,

including preimplantation diagnosis.

(b) Classification. Class II (special

controls) (premarket notification

guidance and voluntary standards).

§ 884.6500 Assisted reproduction

micropipette fabrication instruments.

(a) Identification. Assisted

reproduction micropipette fabrication

devices are instruments intended to

pull, bevel, or forge a micropipette or

needle for intracytoplasmic sperm

injection (ICSI), in vitro fertilization

(IVF), or other similar procedures.

(b) Classification. Class II (special

controls) (premarket notification

guidance and voluntary standards).

§ 884.6600 Assisted reproduction

micromanipulators and microinjectors.

(a) Identification. Assisted

reproduction micromanipulators are

devices intended to control the position

of an assisted reproduction microtool.

Assisted reproduction microinjectors

are any device intended to control

aspiration or expulsion of the contents

of an assisted reproduction microtool.

(b) Classification. Class II (special

controls).

§ 884.6700 Assisted reproduction labware.

(a) Identification. Assisted

reproduction labware consists of

laboratory equipment or supplies

intended to prepare, store, manipulate,

or transfer human gametes or embryos

for in vitro fertilization (IVF) or other

assisted reproduction techniques. These

include syringes, IVF tissue culture

dishes, IVF tissue culture plates,

pippette tips, dishes, plates, and other

vessels that come into physical contact

with gametes, embryos or tissue culture

media.

(b) Classification. Class II (special

controls).

§ 884.6800 Assisted reproduction water

and water purification systems.

(a) Identification. Assisted

reproduction water purification systems

are devices specifically intended to

generate high quality sterile, pyrogenfree, distilled, deionized water for

reconstitution of media used for

aspiration, incubation, transfer or

storage of gametes or embryos for in

vitro fertilization (IVF) or other assisted

reproduction procedures. It may also be

intended as the final rinse for labware

or other assisted reproduction devices

that will contact the gametes or

embryos. This also includes bottled

water ready for reconstitution available

from a vendor that is specifically

intended for reconstitution of media

used for aspiration, incubation, transfer

or storage of gametes or embryos for IVF

or other assisted reproduction

procedures.

(b) Classification. Class II (special

controls).

§ 884.6900 Reproductive media and

supplements.

(a) Identification. Reproductive media

and supplements are products that are

used for assisted reproduction

procedures. Media include liquid and

powder versions of various substances

that come in direct physical contact

with human gametes or embryos

(including water, or oil used to cover

the media) for the purposes of

preparation, maintenance, transfer or

storage, and supplements are specific

reagents added to media to enhance

specific properties of the media (e.g.,

proteins, sera, antibiotics, etc.).

(b) Classification. Class II (special

controls) (premarket notification

guidance and voluntary standards).

§ 884.7000 Assisted reproductive

microscopes and microscope accessories.

(a) Identification. Assisted

reproduction microscopes and

microscope accessories (excluding

microscope stage warmers, which are

classified under Assisted Reproduction

Accessories) are optical instruments

used to enlarge images of gametes or

embryos. Variations of microscopes and

accessories used for these purposes

would include phase contrast

microscopes, fluorescence microscopes,

dissecting microscopes, and inverted

stage microscopes.

(b) Classification. Class I. The device

is exempt from the premarket

notification procedures in subpart E of

part 807 of this chapter.

Dated: August 26, 1997.

D. B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 97–23449 Filed 9–2–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Part 934

[ND–032–FOR; Amendment No. XXII]

North Dakota Regulatory Program

AGENCY: Office of Surface Mining

Reclamation and Enforcement, Interior.

ACTION: Proposed rule; reopening and

extension of public comment period on

proposed amendment.

SUMMARY: The Office of Surface Mining

Reclamation and Enforcement (OSM) is

announcing receipt of a revision to a

previously proposed amendment to the

North Dakota regulatory program

(hereinafter, the ‘‘North Dakota

program’’) under the Surface Mining

Control and Reclamation Act of 1977

(SMCRA). The revision for North

Dakota’s proposed rules pertain to

individual civil penalties. The

amendment is intended to revise the

North Dakota program to be consistent

with the corresponding Federal

regulations.

DATES: Written comments must be

received by 4:00 p.m., m.d.t., September

19, 1997.

ADDRESSES: Written comments should

be mailed or hand delivered to Guy

Padgett at the address listed below.

Copies of the North Dakota program,

the proposed revision to the proposed

amendment, the proposed amendment,

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
46696 Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Proposed Rules

amendment by contacting OSM’s Casper

Field Office.

Guy Padgett, Director, Casper Field

Office, Office of Surface Mining

Reclamation and Enforcement, 100

East ‘‘B’’ Street, Room 2128, Casper,

Wyoming 82601–1918, Telephone:

(307) 261–6550, Internet:

gpadgett@osmre.gov

James R. Deutsch, Director, Reclamation

Division, Public Service Commission,

Bismarck, North Dakota 58505–0480,

Telephone: (701) 328–2400

FOR FURTHER INFORMATION CONTACT:

Guy Padgett, Telephone: (307) 261–

6550.

SUPPLEMENTARY INFORMATION:

I. Background on the North Dakota

Program

On December 15, 1980, the Secretary

of the Interior conditionally approved

the North Dakota program. General

background information on the North

Dakota program, including the

Secretary’s findings, the disposition of

comments, and conditions of approval

of the North Dakota program can be

found in the December 14, 1980,

Federal Register (45 FR 82214).

Subsequent actions concerning North

Dakota’s program and program

amendments can be found at 30 CFR

934.15, 934.16, and 934.30.

II. Proposed Amendment

By letter dated April 12, 1995, North

Dakota submitted a proposed

amendment to its program (amendment

No. XXII, administrative record No. ND–

W–1) pursuant to SMCRA. (30 U.S.C.

1201 et seq.) North Dakota submitted

the proposed amendment in response to

the required program amendments at 30

CFR 934.16(y) and (z).

OSM announced receipt of the

proposed amendment in the May 2,

1995 Federal Register (60 FR 21484),

provided an opportunity for a public

hearing or meeting on its substantive

adequacy, and invited public comment

on its adequacy (administrative record

No. ND–W–04). Because no one

requested a public hearing or meeting,

none was held. The public comment

period ended on June 1, 1995.

During its review of the proposed

amendment, OSM identified concerns

and notified North Dakota of the

concerns by letter dated August 28,

1995 (administrative record No. ND–W–

12). North Dakota responded in a letter

dated October 19, 1995.

Subsequently, on July 30, 1997, OSM

notified North Dakota by telephone of

an additional concern (administrative

record No. ND–W–17). In response,

North Dakota proposed a revision to its

proposed coal exploration regulations at

North Dakota Administrative Code

(NDAC) 43–02–001 (administrative

record No. ND–W–18).

Specifically, North Dakota proposes to

further revise its proposed regulations at

NDAC 43–02–01 dealing with

individual civil penalties, from: ‘‘any

director, officer, or agent of such

corporation who willfully and

knowingly authorized or carried out

such violation * * *.’’ (emphasis

added); to: ‘‘any director, officer, or

agent of such corporation who willfully

or knowingly authorized or carried out

such violation * * *’’ (emphasis

added). The only change is that the

word ‘‘and’’ would be replaced by the

word ‘‘or.’’ According to North Dakota,

the intent of the resulting requirement

in North Dakota’s regulations at NDAC

43–02–01 is that it would then be

consistent with the requirement in

North Dakota’s statute at NDCC 38–

12.1–08, upon which the requirement in

North Dakota’s regulations is based.

III. Public Comment Procedures

OSM is reopening the comment

period on the proposed program

amendment to provide the public an

opportunity to reconsider the adequacy

of the proposed amendment in light of

the additional material submitted. In

accordance with the provisions of 30

CFR 732.17(h), OSM is seeking

comments on whether the proposed

revision to the proposed amendment

satisfies the applicable program criteria

of 30 CFR 732.15. If the revision and the

amendment are deemed adequate, they

will become part of the North Dakota

program.

Written comments should be specific,

pertain only to the issue 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 Casper Field Office will

not necessarily be considered in the

final rulemaking or included in the

administrative record.

IV. Procedural Determinations

1. 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).

2. Executive Order 12988

The Department of the Interior has

conducted the reviews required by

section 3 of Executive Order 12988

(Civil Justice Reform) and has

determined that 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

the Federal regulations at 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.

3. 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)).

4. 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.).

5. 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

that 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.

6. Unfunded Mandates

This rule will not impose a cost of

$100 million or more in any given year

on any governmental entity or the

private sector.
Federal Register / Vol. 62, No. 171 / Thursday, September 4, 1997 / Proposed Rules 46697

List of Subjects in 30 CFR Part 934

Intergovernmental relations, Surface

mining, Underground mining.

Dated: August 27, 1997.

Russell F. Price,

Acting Regional Director, Western Regional

Coordinating Center.

[FR Doc. 97–23423 Filed 9–3–97; 8:45 am]

BILLING CODE 4310–05–M

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 117

[CGD08–97–004]

RIN 2115–AE47

Drawbridge Operation Regulation for

the Minnesota River

AGENCY: Coast Guard, DOT.

ACTION: Notice of proposed rule making.

SUMMARY: The Coast Guard proposes

removing the 24 hour advance notice

requirement from the regulation

governing operation of drawbridges over

the Minnesota River between the mouth

and LeSueur, MN. This action is being

taken to update the regulation to reflect

existing conditions and to ensure the

reasonable needs of navigation are met.

The change will require drawbridges on

that reach of the river to open on

demand in accordance with the general

drawbridge operating regulations under

33 CFR 117 Subpart A.

DATES: Comments must be received on

or before November 3, 1997.

ADDRESSES: Comments may be mailed to

Director, Western Rivers Operations

(ob), Eighth Coast Guard District, 1222

Spruce Street, St. Louis, MO 63103–

2832, Attention: Bridge Administrator.

Comments may also be delivered to

Room 2.107f at the above address

between 8 a.m. and 3 p.m., Monday

through Friday, except Federal holidays.

The telephone number is (314) 539–

3900, extension 378.

The Bridge Branch, Director Western

Rivers Operations, maintains the public

docket for this rulemaking. Comments

will become part of the public docket

and the docket will be available for

inspection or copying in room 2.107f at

the above address.

FOR FURTHER INFORMATION CONTACT:

Roger K. Wiebusch, Bridge

Administrator, Director Western Rivers

Operations, 314–539–3900, extension

378.

SUPPLEMENTARY INFORMATION:

Request for Comments

The Coast Guard encourage interested

persons to particiate in this rulemaking

by submitting written data, views, or

arguments. The Coast Guard is soliciting

comments on the regulation change

until November 3, 1997. The Coast

Guard will consider all comments

received during the comment period. It

may change this proposal in view of the

comments.

The Coast Guared plans no public

hearing. Persons may request a public

hearing by writing to the Bridge

Administrator at the address under

ADDRESSES. The request should include

the reasons why a hearing would be

beneficial. If it determines that the

opportunity for oral presentations will

aid this rulemaking, the Coast Guard

will hold a public hearing at the time

and place announced by a later notice

in the Federal Register.

Background and Purpose

The proposed change will ensure the

regulation reflects favorable existing

drawbridge operating practices.

Coordination between the Coast Guard,

waterway users and owners of the only

affected drawbridge at Savage, MN, Mile

14.3 on the Minnesota River, have

resulted in the bridge being operated in

a manner that meets the needs of both

navigation and the railroad. (All written

correspondence regarding this

coordination is available in the public

docket). Operation of the Savage

Drawbridge will revert to the existing

general drawbridge regulations found in

33 CFR, 117 Subpart A, i.e. it will open

on demand. Approval of this proposal

will eliminate an obsolete and

undesirable drawbridge regulation and

ensure continued favorable drawbridge

operation practices.

Discussion of Change

This proposed rule will remove the

requirement in 33 CFR 117.663,

paragraph (a), that currently requires

river traffic to provide 24 hours advance

notice for drawbridge operation. All

bridges below (downstream of) LeSueur,

MN will now operate under the general

bridge requirements found in 33 CFR

117 Subpart A, i.e. will have to open

upon demand. The only bridge that will

be affected is the railroad drawbridge at

Savage, MN. The proposed rule will

maintain the existing language in the

second paragraph of 33 CFR 117.663

stating that the draws of bridges above

LeSueur, MN need not be opened for the

passage of vessels.

Regulatory Evaluation

This rule is not a significant

regulatory action under 3(f) of Executive

Order 12866 and does not require an

assessment of potential cost 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 FR 11040; February 26, 1979). The

Coast Guard expects the economic

impact of this rule to be so minimal that

a full Regulatory Evaluation under

paragraph 10e of the regulatory policies

and procedures of DOT is unnecessary.

The proposed rule affects one

drawbridge and is not expected to

significantly alter the day-to-day

activities of any businesses.

Small Entities

Under the Regulatory Flexibility Act

(5 U.S.C. 601 et seq.), the Coast Guard

must consider whether this change, if

adopted, will have a significant

economic impact on a substantial

number of small entities. ‘‘Small

entities’’ may include (1) small

businesses and not-for-profit

organizations that are independently

owned and operated and are not

dominant in their fields and (2)

governmental jurisdictions with

populations of less than 50,000. Because

the proposed rule affects only one

drawbridge and requires the bridge to

open upon demand, the Coast Guard

expects the impact of this change to be

minimal. Therefore, the Coast Guard

certifies under 5 U.S.C. 605(b) that this

change, if adopted, will not have a

significant economic impact on a

substantial number of small entities. If,

however, you think that your business

or organization qualifies as a small

entity and that this proposed rule will

have a significant economic impact on

your business or organization, please

submit a comment (See ADDRESSES)

explaining why you think it qualifies

and in what way and to what degree this

proposed rule will economically affect

it.

Collection of Information

This proposed rule contains no

collection of information requirements

under the Paperwork Reduction Act of

1995 (44 U.S.C. 3501 et seq.).

Federalism

The Coast Guard has analyzed this

rule under the principles and criteria

contained in Executive Order 12612 and

has determined that this change does

not have sufficient federalism