65388 Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Proposed Rules

neither an environmental assessment

nor an environmental impact statement

is required.

V. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866 and the Regulatory Flexibility Act

(5 U.S.C. 601–612). 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 proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so 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. Because this rule only

interprets the statute and does not

establish any requirements, the agency

certifies that this proposed rule will not

have a significant impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

VI. Request for Comments

Interested persons may, on or before

(insert date 60 days after date of

publication in the Federal Register),

submit to the Dockets Management

Branch (address above) written

comments regarding this proposal. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with the docket number

found in brackets in the heading of this

document. Received comments may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 808

Intergovernmental relations, Medical

devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 808 be amended as follows:

PART 808—EXEMPTIONS FROM

FEDERAL PREEMPTION OF STATE

AND LOCAL MEDICAL DEVICE

REQUIREMENTS

1. The authority citation for 21 CFR

part 808 continues to read as follows:

Authority: 21 U.S.C. 360j, 360k, 371.

2. Section 808.1 is amended by

adding new paragraphs (d)(11) and

(d)(12) to read as follows:

§ 808.1 Scope.

* * * * *

(d) * * *

(11) * * *

(i) An FDA imposed requirement will

preempt a State common law duty only

when:

(A) FDA has expressly imposed, by

regulation or order, a specific

substantive requirement applicable to a

particular device; and

(B) The State common law, as

interpreted and applied, imposes a

substantive requirement applicable to

the same particular device that is

different from, or in addition to, FDA’s

counterpart requirement.

(ii) FDA requirements that are

applicable to devices in general, or that

are established by means other than

through regulation or order, should not

result in preemption of State tort claims.

(12) The clearance or approval of a

particular device for marketing under

section 510(k), 515, or 520(g) of the act

does not in itself constitute the

imposition of a specific substantive

requirement with respect to that

particular device that preempts a State

or local requirement, including a

standard of care imposed under State

common law, with respect to the same

device.

* * * * *

Dated: December 8, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97–32551 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF LABOR

Occupational Safety and Health

Administration

29 CFR Part 1910

[Docket No. H–371]

RIN 1218–AB46

Occupational Exposure to

Tuberculosis

AGENCY: Occupational Safety and Health

Administration (OSHA), Labor

ACTION: Proposed rule; extension of

comment period; rescheduling of the

informal public hearings in Washington

D.C.; announcement of additional

hearings sites.

SUMMARY: On October 17, 1997, the

Occupational Safety and Health

Administration (OSHA) published in

the Federal Register its proposed

standard for occupational exposure to

tuberculosis (62 FR 54160). An informal

public hearing was scheduled for

Washington, D.C., and deadlines were

set for submission of public comments,

Notices of Intention to Appear at the

hearing, and documentary evidence

from parties requesting more than 10

minutes for their hearing presentations.

With this notice, OSHA is extending

those deadlines, rescheduling the

Washington, D.C., hearings to begin

April 7, 1998, and adding three hearing

sites.

DATES: Written comments on the

proposed standard and Notices of

Intention to Appear at the hearings must

be postmarked on or before February 13,

1998.

Testimony and documentary evidence

from parties requesting more than 10

minutes for their presentations at the

hearings must be submitted no later

than February 27, 1998.

The hearings will begin April 7, 1998,

in Washington, D.C., starting at 10:00

a.m. on the first day and at 9:00 a.m. on

succeeding days. Public hearings will

also be held in Los Angeles, CA, and

Chicago, IL, and New York City, NY.

The dates and locations of these

additional hearings will be published in

the Federal Register at a later date.

ADDRESSES: Comments on the proposed

standard, Notices of Intention to Appear

at the hearings, testimony, and

documentary evidence are to be

submitted in quadruplicate to the

Docket Officer, Docket No. H–371,

Room N–2625, U.S. Department of

Labor, 200 Constitution Ave., NW,

Washington, DC 20210, telephone (202)

219–7894. Comments of 10 pages or

fewer may be transmitted by fax to (202)

219–5046, provided the original and

three copies are sent to the Docket

Officer thereafter.

All material related to the

development of this proposed standard

will be available for inspection and

copying in the Docket Office Monday

through Friday from 10:00 a.m. until

4:00 p.m.

The hearing location for Washington,

D.C., is the Frances Perkins Building

Auditorium, U.S. Department of Labor,

200 Constitution Avenue, NW. The

hearing locations and dates for Los

Angeles, CA, and Chicago, IL and New
Federal Register / Vol. 62, No. 239 / Friday, December 12, 1997 / Proposed Rules 65389

York City, NY will be announced at a

later date.

FOR FURTHER INFORMATION CONTACT:

Bonnie Friedman, Office of Information

and Consumer Affairs, Occupational

Safety and Health Administration,

Room N–3647, U.S. Department of

Labor, 200 Constitution Ave., NW,

Washington, DC 20210, Telephone (202)

219–8148, FAX (202) 219–5986.

SUPPLEMENTARY INFORMATION: OSHA

proposed a new standard for

occupational exposure to tuberculosis

on October 17, 1997 (62 FR 54160). The

deadline for submitting written

comments was December 16, 1997. On

November 5, 1997, five organizations

representing more than 4 million

individuals and 5,300 facilities

potentially affected by the proposed

standard, collectively requested that

OSHA consider extending the public

comment period by a minimum of 30

days. Citing the complexity and the farreaching implications of the proposed

standard, these organizations stated that

they believed that the current deadline

of December 16, 1997, provided

insufficient time for a thorough

examination and consideration of the

important issues. A similar request was

made by the American Medical

Association, which urged OSHA to

extend the deadline to allow sufficient

time for a complete and thoughtful

analysis of the proposed TB standard.

OSHA considers the testimony to be

offered by these organizations to be

important and necessary for the

development of the final rule. In

addition, OSHA recognizes that other

parties that will be affected by the

rulemaking may need more time to

prepare their comments and testimony.

In order to accommodate these

organizations and others, OSHA has

extended the comment period and has

rescheduled the informal public

hearings in Washington, D.C.

The deadline for written comments

and Notices of Intention to Appear at

the informal public hearings is being

extended from December 16, 1997, to

February 13, 1998. The deadline for

submission of testimony for parties

requesting more than 10 minutes at the

public hearings or submitting

documentary evidence is being

extended from December 31, 1997, to

February 27, 1998. The hearing

presently scheduled to begin on

February 3, 1998 in Washington, D.C., is

being rescheduled to begin on April 7,

1998.

In addition to the informal public

hearings in Washington D.C., three sites

are being added: Chicago, IL, and Los

Angeles, CA, and New York City, NY.

Because the proposed standard will

impact employees and employers across

the nation, the Agency believes that is

appropriate to hold public hearings at

additional sites in order to give parties

who may not be able to attend the

hearings in Washington, D.C., an

opportunity to participate in the public

hearing process. OSHA has found that

the hearings provide an important

forum for interested parties to submit

their comments and concerns on

OSHA’s proposed rulemakings and that

the hearings provide the Agency with

valuable information in developing its

final standards.

Public Participation

Persons desiring to participate at the

hearings must submit four copies of a

Notice of Intention to Appear containing

the following information:

(1) The name, address, and telephone

number of each person to appear;

(2) The hearing site that the party is

requesting to attend;

(3) The capacity in which the person

will appear;

(4) The approximate amount of time

requested for the presentation;

(5) The specific issues that will be

addressed;

(6) A detailed statement of the

position that will be taken with respect

to each issue addressed;

(7) Whether the party intends to

submit documentary evidence, and if so,

a brief summary of that evidence; and

(8) Whether the party wishes to testify

on the days set aside to focus on

homeless shelters.

A tentative schedule of appearances at

the hearings will be prepared and

distributed to parties who have

submitted Notices of Intention to

Appear so parties will know when

issues that concern them are likely to be

raised at the hearing.

Filing of Testimony and Evidence

Before Hearings

Any party requesting more than 10

minutes for a presentation at the

hearing, or who will present

documentary evidence, must submit

four copies of the complete text of the

testimony, including any documentary

evidence to be presented at the hearing

to the Docket Officer at the above

address.

Each submission will be reviewed in

light of the amount of time requested in

the Notice of Intention to Appear. In

those instances where the information

contained in the submission does not

justify the amount of time requested, a

more appropriate amount of time will be

allocated and the participant will be

notified of that fact.

Any party who has not substantially

complied with this requirement may be

limited to a 10-minute presentation.

Any party who has not filed a Notice of

Intention to Appear may be allowed to

testify, as time permits, at the discretion

of the Administrative Law Judge.

OSHA emphasizes that the hearing is

open to the public, and that interested

persons are welcome to attend.

However, only persons who have filed

Notices of Intention to Appear will be

entitled to ask questions and otherwise

participate fully in the proceeding.

Authority

This document has been prepared

under the direction of Charles N.

Jeffress, Assistant Secretary of Labor for

Occupational Safety and Health, U.S.

Department of Labor, 200 Constitution

Avenue, NW., Washington, D.C. 20210.

It is issued under section 6(b) of the

Occupational Safety Health Act (29

U.S.C. 655), Secretary of Labor’s Order

6–96, (62 FR 111) and 29 CFR Part 1911.

Signed at Washington, D.C. on this 9th day

of December, 1997.

Charles N. Jeffress,

Assistant Secretary of Labor.

[FR Doc. 97–32546 Filed 12–9–97; 3:59 pm]

BILLING CODE 4510–26–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 54

[CC Docket No. 96–45 and 97–160; DA 97–

2372]

Universal Service

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule; guidance for

design and submission of proposed

models.

SUMMARY: The Common Carrier Bureau

(Bureau) provided guidance to

proponents of forward-looking cost

models in the universal service

proceeding on issues related to

customer location and outside plant

design. The Bureau provided this

guidance to improve the models that the

Commission will consider to select a

mechanism for determining non-rural

carriers’ forward-looking cost to provide

the supported services. This guidance is

intended to encourage model

proponents to alter their models to

conform them to the guidance provided

in this Public Notice. Models

conforming to the guidance provided in

this Public Notice are more likely to be

considered favorably in this proceeding.