27406 Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 16 and 1270

[Docket No. 93N–0453]

Human Tissue for Transplantation and

Human Reproductive Tissue: Scientific

and Regulatory Issues and

Perspectives; Notice of Public

Workshop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of public workshop.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

public workshop entitled ‘‘Human

Tissue for Transplantation and Human

Reproductive Tissue: Scientific and

Regulatory Issues and Perspectives.’’

The purpose of this workshop is to

provide an opportunity for continued

discussion of the regulation of human

tissue for transplantation as outlined by

FDA in an interim rule that published

in the Federal Register of December 14,

1993. The workshop will include

discussions of other related issues,

including regulating reproductive

tissue.

DATES: The public workshop will be

held on Tuesday and Wednesday, June

20 and 21, 1995, 8:30 a.m. to 5:30 p.m.

Preregistration is requested by Friday,

June 9, 1995.

ADDRESSES: The public workshop will

be held at the National Institutes of

Health, Bldg. 45, Natcher Auditorium,

9000 Rockville Pike, Bethesda, MD.

There is no registration fee.

FOR FURTHER INFORMATION CONTACT:

Regarding information on registration:

Julie Furman, KRA Corp., 1010

Wayne Ave., suite 850, Silver

Spring, MD 20910, 301–495–1591,

or FAX 301–495–9410.

Regarding information on this

document: Marty A. Wells, Center

for Biologics Evaluation and

Research (HFM–305), Food and

Drug Administration, 1401

Rockville Pike, suite 200N,

Rockville, MD 20852–1448, 301–

827–0967.

SUPPLEMENTARY INFORMATION: In the

Federal Register of December 14, 1993

(58 FR 65514), FDA published an

interim rule on human tissue intended

for transplantation. This interim rule

requires certain infectious disease

testing, donor screening, and

recordkeeping to help prevent the

transmission of acquired immune

deficiency syndrome (AIDS) and

hepatitis through human tissue used in

transplantation. The regulations in the

interim rule became effective upon

publication.

The objectives of the public workshop

are to: (1) Promote an understanding of

related public health issues based on

scientific knowledge; (2) provide an

opportunity for discussion of current

donor screening and testing practices for

human tissue for transplantation and

human reproductive tissue; (3) identify

the practices and procedures of the

procurer, processor, distributor, and

user of human tissue for transplantation

and human reproductive tissue and

their interactions; and (4) examine the

existing state and industry approaches

to the regulation of human tissue for

transplantation and human reproductive

tissue.

The workshop will consist of plenary

and breakout sessions that will include

the following topics: (1) Donor

screening; (2) infectious disease testing

and inactivation methods; (3) voluntary

standards; (4) assessment of industry

practices related to tracking; (5)

interactions with organ procurement

organizations and procurement

coordination practices; and (6) state

regulatory approaches and industry

practices.

Dated: May 19, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 95–12763 Filed 5–19–95; 3:29 pm]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[CGD13–95–017]

Safety Zone Regulations; Portland

Rose Festival Fireworks Display,

Willamette River, Portland, OR

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Cost Guard is

establishing a safety zone for the

Portland Rose Festival Fireworks

Display which is scheduled to be held

in Portland, Oregon, on June 2, 1995.

The safety zone will be located on the

Willamette River between the Morrison

and Hawthorne Bridges from river mile

12.8 to river mile 13.1. This safety zone

is needed to protect persons, facilities,

and vessels from safety hazards

associated with the fireworks display.

Entry into this safety zone is prohibited

unless authorized by the Captain of the

Port.

EFFECTIVE DATE: This regulation

becomes effective on June 2, 1995, at

8:45 p.m. (PDT) and terminates on June

2, 1995, at 11:10 p.m. (PDT), unless

sooner terminated by the Captain of the

Port. If inclement weather causes the

fireworks display to be postponed, this

regulation will be effective on June 4,

1995, from 8:45 p.m. (PDT) to 11:10

p.m. (PDT), unless sooner terminated by

the Captain of the Port.

FOR FURTHER INFORMATION CONTACT:

LTJG C.A. Roskam, c/o Captain of the

Port Portland, 6767 N. Basin Ave,

Portland, Oregon 97217–3992, (503)

240–9338.

SUPPLEMENTARY INFORMATION:

Regulatory History

Pursuant to 5 U.S.C. 553, a notice of

proposed rulemaking was not published

for this regulation and good cause exists

for making it effective less than 30 days

after Federal Register publication.

Publishing a NPRM and delaying its

effective date would be contrary to the

public interest since immediate action is

necessary to ensure the safety of

structures and vessels operating in the

area of the fireworks display. Due to the

complex planning and coordination

involved, the event sponsor, the

Portland Rose Festival Association, was

unable to provide the Coast Guard with

notice of the final details until 30 days

prior to the date of the event. Therefore,

sufficient time was not available to

publish the proposed rule in advance of

the event or to provide a delayed

effective date. Following normal

rulemaking procedures in this case

would be impracticable.

Drafting Information

The principal persons involved in

drafting this document are LTJG C.A.

Roskam, Project Officer for the Captain

of the Port of Portland, OR, and LCDR

J.C. Odell, Project Counsel, Thirteenth

Coast Guard District Legal Office.

Background and Purpose

The event requiring this regulation is

a fireworks display sponsored by the

Portland Rose Festival Association, as

part of the Portland Rose Festival in the

Portland, Oregon, area. The fireworks

display is scheduled to begin on June 2,

1995, at 9:45 p.m. (PDT). If the fireworks

display cannot be held on June 2, 1995,

because of inclement weather, it will be

rescheduled for June 4, 1995, at 9:45

p.m. (PDT).

During the fireworks display,

spectator vessels may attempt to

approach the fireworks launching barge

at close range. If allowed to do so, these

vessels and the persons onboard them

may be exposed to potential damage,

fire, and personal injury due to sparks,

falling debris, and unexploded

fireworks.
Federal Register / Vol. 60, No. 100 / Wednesday, May 24, 1995 / Rules and Regulations 27407

In order to protect the safety of life

and property on the navigable waters

during this event, the Coast Guard is

establishing a safety zone around the

fireworks launching barge on the waters

of the Willamette River from river mile

12.8 to river mile 13.1 between the

Morrison and Hawthorne Bridges. Entry

into this zone will be prohibited unless

authorized by the captain of the Port.

This safety zone will be enforced by

representatives of the Captain of the

Port Portland. The Captain of the Port

may be assisted by other federal

agencies.

Regulatory Evaluation

This temporary final rule is not a

significant regulatory action under

section 3(f) of Executive Order 12866

and does not require an assessment of

potential costs 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 proposal to be so minimal

that a full Regulatory Evaluation under

paragraph 10e of the regulatory policies

and procedures of DOT is unnecessary.

This expectation is based on the fact

that the entry into the safety zone will

only be restricted for less than 3 hours

on the day of the event. The entities

most likely to be affected by this action

are commercial tug and barge operators

on the Willamette River. Most of these

entities are aware of the fireworks

display and the safety zone, and they

can schedule their transits accordingly.

If safe to do so, the representative of the

Captain of the Port assigned to enforce

this safety zone may authorize

commercial vessels to pass through the

safety zone on a case-by-case basis.

Small Entities

Under the Regulatory Flexibility Act

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

must consider whether this final rule

will have a significant economic impact

on a substantial number of small

entities. ‘‘Small entities’’ include

independently owned and operated

small businesses that are not dominant

in their field and that otherwise qualify

as ‘‘small business concerns’’ under

section 3 of the Small Business Act (15

U.S.C. 632).

For the reasons outlined in the

Regulatory Evaluation above, the Coast

Guard expects the impact of this final

rule to be minimal on all entities.

Therefore, the Coast Guard certifies

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

will not have a significant economic

impact on a substantial number of small

entities.

Collection of Information

This final rule contains no collection

of information requirements under the

Paperwork Reduction Act (44 U.S.C.

3501 et seq.)

Federalism

The Coast Guard has analyzed this

final rule in accordance with the

principles and criteria contained in

Executive Order 12612, and it has been

determined that this final rule does not

have sufficient federalism implications

to warrant the preparation of a

Federalism Assessment.

Environmental Assessment

The Coast Guard has considered the

environmental impact of this final rule

and has concluded that, under section

2.B.2.c. of Commandant Instruction

M16475.1B, it is categorically excluded

from further environmental

documentation. A Categorical Exclusion

Determination has been prepared and

placed in the rulemaking docket.

List of Subjects in 33 CFR Part 165

Harbors, Marine safety, Navigation

(water), Reporting and recordkeeping

requirements, Security measures,

Waterways.

Final Regulation

For the reasons set out in the

preamble, the Coast Guard amends part

165 of title 33, Code of Federal

Regulations, as follows:

PART 165—[AMENDED]

1. The authority citation for part 165

continues to read as follows:

Authority: 33 U.S.C. 1231; 50 U.S.C. 191;

33 CFR 1.05–1(g), 6.04–1, 6.04–6, and 160.5;

49 CFR 1.46.

2. A temporary § 165.T13015 is added

to read as follows:

§ 165.T13015 Safety Zone; Willamette

River, Portland, OR.

(a) Location. The following area is a

safety zone: All waters on the

Willamette River between the Morrison

and Hawthorne Bridges from river mile

12.8 to river mile 13.1, Portland,

Oregon.

(b) The designated representative of

the Captain of The Port is any Coast

Guard commissioned, warrant, or petty

officer who has been authorized by the

Captain of the Port Portland, to act on

his behalf. The following officers have

or will be designated by the Captain of

the Port: The Coast Guard Patrol

Commander, the senior boarding officer

on each vessel enforcing the safety zone,

and the Duty Officer at Coast Guard

Group Portland, Oregon.

(c) Regulations: (1) In accordance with

the general regulations in § 165.23 of

this part, entry into this safety zone is

prohibited unless authorized by the

Captain of the Port or his designated

representatives.

(2) A succession of sharp, short

signals by whistle, siren, or horn from

vessels patrolling the area under the

direction of the Patrol Commander shall

serve as a signal to stop. Vessels or

persons signalled shall stop and comply

with the orders of the patrol vessels;

failure to do so may result in expulsion

from the area, citation for failure to

comply, or both.

(d) Effective Dates: This section

becomes effective on June 2, 1995, at

8:45 p.m. (PDT) and terminate on June

2, 1995, at 11:10 p.m. (PDT), unless

sooner terminated by the Captain of the

Port. If inclement weather causes the

fireworks display to be postponed, the

regulation will be effective on June 4,

1995, from 8:45 p.m. (PDT) to 11:10

p.m. (PDT), unless sooner terminated by

the Captain of the Port.

Dated: May 9, 1995.

C.E. Bills,

Captain, U.S. Coast Guard, Captain of the

Port.

[FR Doc. 95–12737 Filed 5–23–95; 8:45 am]

BILLING CODE 4910–14–M

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 3

RIN 2900–AF03

Line of Duty

AGENCY: Department of Veterans Affairs.

ACTION: Final rule.

SUMMARY: This document amends

Department of Veterans Affairs (VA)

adjudication regulations concerning

service connection for disabilities

incurred or aggravated in line of duty.

This amendment is necessary to

implement legislation which precludes

the establishment of service connection

for any condition that results from the

abuse of alcohol or drugs by the person

on whose service benefits are claimed.

EFFECTIVE DATE: November 1, 1990.

FOR FURTHER INFORMATION CONTACT:

Lorna Weston, Consultant, Regulations

Staff, Compensation and Pension

Service, Veterans Benefits

Administration, Department of Veterans

Affairs, 810 Vermont Avenue, NW.,

Washington, DC 20420, (202) 273–7210.