Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 / Proposed Rules 2971

Given that a commercial OTEC

industry has yet to develop, Part 981

remains unused for the most part.

Removal of Part 981 at this time is

consistent with the purposes and

provisions of the OTEC Act in that it

will allow NOAA to evaluate the

suitability of these regulations at such

time as interest in the commercial

development of OTEC projects occurs.

At such time, NOAA will issue a

proposed rule appropriate to the then

current regulatory needs. Potential

licensees will therefore be assured that

any future OTEC regulations will be up

to date, and will continue to provide

innovation and flexibility necessary for

an emerging OTEC industry.

NOAA is mindful of its responsibility

for licensing of commercial OTEC

facilities and plantships under the

OTEC Act, however, and will take

appropriate steps to review and process

an application should one be made. For

particular inquiries into the licensing of

OTEC projects in the interim period,

NOAA will provide copies of the

provisions of these OTEC regulations in

response to such inquiries. Thus, NOAA

will provide actual and timely notice of

applicable procedures and requirements

to particular individuals. See 5 U.S.C.

§ 552(a). Accordingly, NOAA is

proposing to remove Part 981, the OTEC

regulations, from Title 15 of the CFR.

III. Miscellaneous Rulemaking

Requirements

Executive Order 12612: Federalism

Assessment

NOAA has concluded that this

regulatory action does not have

federalism implications sufficient to

warrant the preparation of a Federalism

Assessment under Executive Order

12612.

Executive Order 12866: Regulatory

Impact

This proposed rule has been

determined to be not significant for

purposes of Executive Order 12866.

Regulatory Flexibility Act

No licenses have been issued for

OTEC projects under 15 CFR Part 981.

When commercial interest in OTEC

projects occurs, NOAA will issue a

proposed rule appropriate to the

regulatory needs at that time. For

particular inquiries into the licensing of

OTEC projects in the interim period,

NOAA will provide actual and timely

notice of applicable procedures and

requirements to particular individuals.

See 5 U.S.C. § 552(a). For these reasons,

the proposed removal of Part 981 is not

expected to have a significant economic

impact on a substantial number of small

entities, and the Assistant General

Counsel for legislation and Regulation

of the Department of Commerce has so

certified to the Chief Counsel for

Advocacy of the Small Business

Administration. As such, an initial

Regulatory Flexibility Analysis was not

prepared.

Paperwork Reduction Act

This rule does not contain an

information collection requirement

subject to review and approval by OMB

under the Paperwork Reduction Act of

1980, 44 U.S.C. 3500 et seq.

National Environmental Policy Act

NOAA has concluded that this

regulatory action does not constitute a

major federal action significantly

affecting the quality of the human

environment. No applications for

licenses of commercial OTEC facilities

or plantships have yet been received by

NOAA, and Part 981 remains unused for

the most part. When commercial

interest in OTEC projects occurs, NOAA

will issue a proposed rule appropriate to

the regulatory needs at that time. For

particular inquiries into the licensing of

OTEC projects in the interim period,

NOAA will provide actual and timely

notice of applicable procedures to

particular individuals. See 5 U.S.C.

552(a). Therefore, an environmental

impact statement is not required.

Authority: Ocean Thermal Energy

Conversion Act of 1980, as amended, 42

U.S.C. 9101 et seq.

List of Subjects in 15 CFR Part 981

Administrative practice and

procedure, Ocean thermal energy

conversion licensing, Environmental

protection, Marine resources, Penalties,

Reporting and recordkeeping

requirements.

Dated: January 24, 1996.

W. Stanley Wilson,

Assistant Administrator for Ocean Services

and Coastal Zone Management.

Accordingly, for the reasons set forth

above, Chapter IX of Title 15 of the Code

of Federal Regulations is proposed to be

amended as follows:

PART 981—OCEAN THERMAL

ENERGY CONVERSION LICENSING

PROGRAM—[REMOVED]

1. Under the authority of the Ocean

Thermal Energy Conversion Act of 1980,

Part 981 is removed.

[FR Doc. 96–1723 Filed 1–29–96; 8:45 am]

BILLING CODE 3510–22–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 201, 208, 314, and 601

[Docket No. 93N–371W]

Prescription Drug Product Labeling;

Public Patient Education Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of a public workshop.

SUMMARY: The Food and Drug

Administration (FDA) is reannouncing a

public patient education workshop to

discuss methods and criteria for

developing and evaluating prescription

drug information for patients.

Previously, in the Federal Register of

December 8, 1995 (60 FR 63049), the

agency announced this workshop which

was scheduled for January 9 and 10,

1996. Due to inclement weather, the

agency was forced to postpone the

workshop. The agency has rescheduled

the workshop for February 14 and 15,

1996. The purpose of this workshop is

to obtain views and opinions

concerning the criteria for useful patient

information, and it is part of FDA’s

ongoing initiative to improve the

distribution of adequate and useful

prescription drug information to

patients. FDA encourages health

professionals, consumer groups, and

other interested parties to participate in

the workshop. FDA also invites the

designers of primary information

systems, which produce either written

information or computer programs that

generate prescription drug patient

information, to display their systems for

educational purposes.

DATES: The public patient education

workshop will be held on February 14

and 15, 1996, from 8:30 a.m. to 5 p.m.

Submit registration notices for

participants by February 9, 1996.

Submit registration notices for designers

of information systems by February 7,

1996. Submit written comments by

March 6, 1996.

ADDRESSES: The public patient

education workshop will be held at the

DoubleTree Hotel, 1750 Rockville Pike,

Rockville, MD. Preregistration for

workshop participants is encouraged,

although not required, in order to

facilitate logistical planning of the

breakout discussion groups. There is no

registration fee for this workshop.

Registration forms can be obtained by

calling 301–443–5470 or writing to the

Office of Health Affairs, ATTN: Patient

Education Workshop, Food and Drug

Administration (HFY–40), 5600 Fishers
2972 Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 / Proposed Rules

Lane, Rockville, MD 20857. Submit

written views or comments to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. The designers of

information systems should call the

contact person (address below) for

registration information. A more

detailed agenda and written

presentations will be placed in the

docket, identified with the docket

number found in brackets in the

heading of this document, at the

Dockets Management Branch, and will

be available for review between 9 a.m.

and 4 p.m., Monday through Friday. A

transcript of the general sessions of the

workshop will be available for review or

purchase (10 cents per page) at the

Dockets Management Branch

approximately 5 business days after the

meeting. The breakout sessions will not

be transcribed.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McGinnis, Office of Health

Affairs (HFY–40), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5470.

SUPPLEMENTARY INFORMATION: On

January 9 and 10, 1996, FDA had

intended to hold a public patient

education workshop to discuss methods

and criteria for developing and

evaluating prescription drug

information for patients. The agency

was forced to postpone the workshop

due to the closing of the Federal

Government because of inclement

weather in the metropolitan

Washington, DC area. With this notice

the agency is announcing the

rescheduling of the workshop for

February 14 and 15, 1996. The purpose

and agenda for the meeting are identical

to the previously scheduled workshop,

with a few minor changes in the agenda

due to the scheduling problems of the

original invited presenters.

In the Federal Register of August 24,

1995 (60 FR 44182), FDA published a

proposed rule that, if finalized, is

intended to increase the dissemination

of useful written prescription drug

information to patients who receive

drugs on an outpatient basis. In that

proposal, the agency stated its belief

that the quality of medical care could be

enhanced and substantial costs from

drug misadventures could be reduced

by better informing patients about the

use, side effects, and interactions of

such drugs. At that time, the agency

discussed a mandatory Federal program

that would require such information to

be distributed with most new

prescriptions. However, the agency also

stated that such a program would not be

necessary if private sector efforts now

underway accomplished the stated goal.

Thus, FDA proposed, except where

there is a serious and significant public

health concern, to defer its program for

several years.

To judge the success of those private

efforts, the agency proposed goals

(performance standards) that would

define acceptable levels of information

distribution and quality. To meet the

performance standard for distribution of

information, the agency proposed that

by the year 2000 at least 75 percent of

people receiving new prescriptions

receive useful information. This goal

was adapted from the Public Health

Service’s ‘‘Healthy People 2000’’ report.

In addition, the agency proposed that by

the year 2006, at least 95 percent of the

people who receive new prescriptions

receive useful information.

FDA proposed to periodically

evaluate and report on the achievement

of the goals. If the goals are not met in

the specified timeframes, FDA proposed

to either: (1) Implement a mandatory

comprehensive medication guide

program, or (2) seek public comment on

whether a comprehensive program

should be implemented, or whether,

and what, other steps should be taken

to meet the patient information goals.

To develop a performance standard

for the quality of information

distributed, FDA suggested seven

specific components in its August 24

proposal for determining whether

patient information is useful: Scientific

accuracy, consistency with a standard

format, nonpromotional tone and

content, specificity, comprehensiveness,

understandable language, and legibility.

The agency defined these components

of usefulness, as well as criteria that

could be used to judge these

components, and invited comments on

their appropriateness. Because such

criteria are of great interest to affected

parties, and because there is substantial

expertise in the development and

communication of patient information,

FDA also stated its intention to hold a

public meeting that would allow the

many interested groups and individuals

to provide their recommendations

directly to agency officials.

The agency will hold a public patient

education workshop to discuss the

methods and criteria for developing and

evaluating the usefulness of written

information. The patient education

workshop will be designed to obtain

recommendations from the public about

the criteria that should be applied to

help ensure that written information

provided to patients is ‘‘useful.’’

The patient education workshop will

be comprised of both formal

presentations and open breakout

discussion periods. Any interested

person may attend and participate in the

discussions. The workshop will include

general sessions with presentations from

FDA, health professional groups,

consumer groups, the pharmaceutical

industry, academicians, and parties

with legal and regulatory expertise. The

agency also intends to hold breakout

sessions the morning of the second day

to obtain broad participation and input

from workshop attendees.

On Wednesday, February 14, 1996,

there will be a series of presentations by

consumer organizations, health

professional organizations, researchers,

and academicians. There will be time

set aside for comments and questions

from workshop participants. On

Thursday, February 15, 1996, workshop

participants will be divided into several

breakout groups for discussions and

development of recommendations

regarding elements of useful

information. These recommendations

will then be presented to the workshop

participants with time for comments

and questions.

FDA believes that it would be helpful

for workshop participants, including

FDA staff, to learn about the design of

current patient information systems,

particularly programs that generate

drug-specific patient information. The

agency invites the designers of primary

information systems, not the

customizers of systems for retail outlets,

to display their systems at the workshop

for educational purposes only. No sales

or solicitations may be made by

exhibitors at the workshop site. Due to

space limitations, FDA may be forced to

limit the number of systems on display.

In doing so, FDA would seek to permit

display of the most representative/

comprehensive systems available for

patient information. However, the

agency invites all interested persons to

submit their views, comments, and

descriptions of computer programs to

the Dockets Management Branch

(address above).

The agency notes that the comment

period for the proposed rule that

published in the Federal Register of

August 24, 1995, closed on December

22, 1995 (60 FR 58025, November 24,

1995). Because this workshop will occur

after the comment period has closed, the

agency will accept additional comments

to the proposed rule on the specific

issues raised at the workshop. These

comments will be considered as part of

the agency’s deliberations regarding

further action on this rulemaking. For

this limited purpose, written comments

may be submitted to the Dockets

Management Branch (address above)
Federal Register / Vol. 61, No. 20 / Tuesday, January 30, 1996 / Proposed Rules 2973

until March 6, 1996. Comments are to be

identified with the docket number

found in brackets in the heading of this

document.

A summary of the workshop will be

included in a subsequent Federal

Register notice related to this

prescription drug labeling initiative.

Dated: January 22, 1996.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 96–1740 Filed 1–29–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

Bureau of Economic and Business

Affairs

22 CFR Part 89

[Public Notice No. 2323]

Foreign Prohibitions on Longshore

Work by U.S. Nationals

AGENCY: Department of State.

ACTION: Proposed rule; Extension of

comment period.

SUMMARY: On November 24, 1995, the

Department of State issued a proposed

rulemaking regarding longshore work by

foreign nationals in U.S. ports and

waters. To assess the full effects of the

proposed rule, the Department is

extending the deadline for comments by

7 days, from January 26, 1996 to

February 2, 1996.

DATES: Interested parties are invited to

submit comments in triplicate no later

than February 2, 1996.

ADDRESSES: Comments may be mailed to

the Office of Maritime and Land

Transport (EB/TRA/MA), Room 5828,

Department of State, Washington, DC

20520–5816.

FOR FURTHER INFORMATION CONTACT:

Richard T. Miller, Office of Maritime

and Land Transport, Department of

State, (202) 647–6961.

SUPPLEMENTARY INFORMATION: On

November 24, 1995, the Department of

State issued a proposed rulemaking (60

FR 58026) updating the list of longshore

work by particular activity, of countries

where performance of such a particular

activity by crewmembers aboard United

States vessels is prohibited by law,

regulation or in practice in the country.

The crews of ships registered in or

owned by nationals of the countries on

the list may not perform the activities

enumerated on the list. On December

20, 1995, the Department extended the

comment period by thirty days in

response to requests from a number of

parties (60 FR 65609). To assess the full

effects of the proposed rule, the

Department is further extending the

deadline for comments by one week,

from January 26, 1996 to February 2,

1996.

(8 U.S.C. 1288, Pub. L. 010–649, 104 Stat,

4878)

Dated: January 25, 1996.

Daniel K. Tarullo,

Assistant Secretary Economic and Business

Affairs Department of State.

[FR Doc. 96–1821 Filed 1–26–96; 10:43 am]

BILLING CODE 4710–07–M

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

23 CFR Parts 630, 635 and 771

[FHWA Docket No. 96–3]

RIN 2125–AD58

Federal-Aid Project Agreement and

Contract Procedures

AGENCY: Federal Highway

Administration (FHWA), DOT.

ACTION: Notice of proposed rulemaking

(NPRM); request for comments.

SUMMARY: The FHWA proposes to

amend its regulation on project

agreements. The Intermodal Surface

Transportation Efficiency Act (ISTEA)

of 1991 modified the requirement that

preliminary engineering and right-ofway projects must be advanced to the

construction stage within certain time

limits. Changes to the agreement

provisions are being proposed to reflect

these adjustments. Additionally,

procedures would be added to provide

flexibility in the format of the agreement

document and to permit the

development of a single document to

serve as both the project authorization

and project agreement document. Other

changes would be made to shorten the

agreement document and to add clarity

to the process.

The FHWA also proposes to amend its

regulation on contract procedures by

incorporating into it provisions

regarding overruns in contract time that

would be removed from the project

agreement regulation. The FHWA

believes this material more

appropriately belongs under contract

procedures.

DATES: Written comments are due on or

before April 1, 1996. Comments

received after that date will be

considered to the extent practicable.

ADDRESSES: All written, signed

comments should refer to the docket

number that appears at the top of this

document and should be submitted to

Federal Highway Administration, Office

of Chief Counsel, Room 4232, HCC–10,

400 Seventh Street, SW., Washington,

DC 20590. All comments and

suggestions received will be available

for examination at the above address

between 8:30 a.m. and 3:30 p.m., e.t.,

Monday through Friday, except Federal

holidays. Those desiring notification of

receipt of comments must include a selfaddressed, stamped postcard.

FOR FURTHER INFORMATION CONTACT: Jack

Wasley, Office of Engineering, 202–366–

0450, or Wilbert Baccus, Office of the

Chief Counsel, 202–366–0780, FHWA,

400 Seventh Street, SW., Washington,

DC 20590. Office hours are from 7:45

a.m. to 4:15 p.m. e.t., Monday through

Friday except Federal holidays.

SUPPLEMENTARY INFORMATION: Under the

provisions of 23 U.S.C. 110, a formal

agreement between the State highway

agency and the FHWA is required for

Federal-aid highway projects. This

agreement, referred to as the ‘‘project

agreement,’’ is in essence a written

contract between the State and the

Federal Government defining the extent

of the work to be undertaken, the State

and the Federal shares of a project’s

cost, and commitments concerning

maintenance of the project.

The present regulation, 23 CFR 630,

subpart C, provides further

requirements concerning the project

agreement. It includes detailed

instructions on preparation of the

project agreement, a standard form for

the agreement, and an assemblage of

agreement provisions that are part of the

standard form. This is a longstanding

regulation and no significant changes

have been made to it in several years.

It is the FHWA’s desire to update and

modify the existing regulation to

incorporate needed changes to reflect

adjustments made by the ISTEA, Pub. L.

102–240, 105 Stat. 1914, to streamline

the project agreement form and

provisions, and to allow more versatility

in its use. The proposed changes are

discussed in the following section-bysection analysis.

Section-by-Section Analysis

Section 630.301 Purpose

The statement of purpose would be

revised with minor changes for clarity.

Section 630.302 Definitions

It is proposed to remove § 630.302.

The terms calendar day, contract time,

incentives/disincentives for early

completion, liquidated damages, and

workday would be relocated to 23 CFR

635.102. The terms bond issue project,