Federal Register / Vol. 61, No. 1 / Tuesday, January 2, 1996 / Notices 75

1988. They are considered medical

devices. Currently, such reagents are

being made widely available to clinical

laboratories under ‘‘research use only’’

or ‘‘investigational use only’’ labeling or

as unlabeled components of a final test.

FDA believes that most analyte

specific reagents may be considered for

classification as class I devices and

exempted from the premarket

notification (510(k)) procedure in

subpart E of 21 CFR part 807 if the

reagents do not make analytical or

clinical performance claims. FDA is

currently considering an approach

under which such analyte specific

reagents would be subject to other

general controls: (1) Registration and

listing, (2) medical device reporting

requirements, and (3) good

manufacturing practice requirements.

FDA is also considering establishing

restrictions under section 520(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360j(e)) on the sale,

distribution, or use of the devices.

The issue of classification and the

nature of appropriate restrictions will be

the subject of the panel meeting.

Although FDA believes that most

analyte specific reagents may be

considered for regulation in this way,

the agency also believes that a small

number of analyte specific reagents (e.g.,

those used to diagnose communicable

diseases through blood or other means)

would be more properly classified into

class II or III and subject to the

premarket controls (510(k) or premarket

approval) applicable to such

classification.

FDA public advisory committee

meetings may have as many as four

separable portions: (1) An open public

hearing, (2) an open committee

discussion, (3) a closed presentation of

data, and (4) a closed committee

deliberation. Every advisory committee

meeting shall have an open public

hearing portion. Whether or not it also

includes any of the other three portions

will depend upon the specific meeting

involved. There are no closed portions

for the meetings announced in this

notice. The dates and times reserved for

the open portions of each committee

meeting are listed above.

The open public hearing portion of

each meeting shall be at least 1 hour

long unless public participation does

not last that long. It is emphasized,

however, that the 1 hour time limit for

an open public hearing represents a

minimum rather than a maximum time

for public participation, and an open

public hearing may last for whatever

longer period the committee

chairperson determines will facilitate

the committee’s work.

Public hearings are subject to FDA’s

guideline (subpart C of 21 CFR part 10)

concerning the policy and procedures

for electronic media coverage of FDA’s

public administrative proceedings,

including hearings before public

advisory committees under 21 CFR part

14. Under 21 CFR 10.205,

representatives of the electronic media

may be permitted, subject to certain

limitations, to videotape, film, or

otherwise record FDA’s public

administrative proceedings, including

presentations by participants.

Meetings of advisory committees shall

be conducted, insofar as is practical, in

accordance with the agenda published

in this Federal Register notice. Changes

in the agenda will be announced at the

beginning of the open portion of a

meeting.

Any interested person who wishes to

be assured of the right to make an oral

presentation at the open public hearing

portion of a meeting shall inform the

contact person listed above, either orally

or in writing, prior to the meeting. Any

person attending the hearing who does

not in advance of the meeting request an

opportunity to speak will be allowed to

make an oral presentation at the

hearing’s conclusion, if time permits, at

the chairperson’s discretion.

The agenda, the questions to be

addressed by the committee, and a

current list of committee members will

be available at the meeting location on

the day of the meeting.

Transcripts of the open portion of the

meeting may be requested in writing

from the Freedom of Information Office

(HFI–35), Food and Drug

Administration, rm. 12A–16, 5600

Fishers Lane, Rockville, MD 20857,

approximately 15 working days after the

meeting, at a cost of 10 cents per page.

The transcript may be viewed at the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, approximately 15

working days after the meeting, between

the hours of 9 a.m. and 4 p.m., Monday

through Friday. Summary minutes of

the open portion of the meeting may be

requested in writing from the Freedom

of Information Office (address above)

beginning approximately 90 days after

the meeting.

This notice is issued under section

10(a)(1) and (2) of the Federal Advisory

Committee Act (5 U.S.C. app. 2), and

FDA’s regulations (21 CFR part 14) on

advisory committees.

Dated: December 21, 1995.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 95–31554 Filed 12–29–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Bureau of Reclamation

Conservation Advisory Group, Yakima

River Basin Water Enhancement

Project, Yakima, WA

AGENCY: Bureau of Reclamation,

Interior.

ACTION: Notice of meetings.

SUMMARY: Title XII, The Act of October

31, 1994 (Public Law 103–434), directs

the Secretary of the Interior, in

consultation with the State of

Washington, the Yakama Indian Nation,

Yakima River Basin Water Conservation

Advisory Group and a Facilitator within

12 months of enactment. The purpose of

the Conservation Advisory Group is to

provide technical advice and counsel to

the Secretary and the State on the

structure, implementation, and

oversight of the Yakima River Basin

Water Conservation Program.

DATES: Meetings will be held at the

Upper Columbia Area Office, Bureau of

Reclamation, 1917 Marsh Road, Yakima,

Washington, beginning at 12 noon on

the following dates: January 16, 1996,

February 20, 1996, March 19, 1996.

FOR FURTHER INFORMATION CONTACT:

Walt Fite, Program Manager, Yakima

River Water Enhancement Project, PO

Box 1749, Yakima, Washington 98907,

(509) 575–5848 ext. 267.

SUPPLEMENTARY INFORMATION: The Basin

Conservation Program is structured to

provide economic incentives with

cooperative Federal, State, and local

funding to stimulate the identification

and implementation of structural and

nonstructural cost-effective water

conservation measures in the Yakima

River basin. Improvements in the

efficiency of water delivery and use will

result in improved streamflows for fish

and wildlife and improve the reliability

of water supplies for irrigation.

Dated: December 20, 1995.

Jim Cole,

Area Manager, Upper Columbia Area Office,

Bureau of Reclamation, Yakima, Washington.

[FR Doc. 95–31551 Filed 12–29–95; 8:45 am]

BILLING CODE 4310–94–M
76 Federal Register / Vol. 61, No. 1 / Tuesday, January 2, 1996 / Notices

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for a Waiver of Compliance

In accordance with 49 CFR 211.9 and

211.41, notice is hereby given that the

Federal Railroad Administration (FRA)

has received a request for a waiver of

compliance with certain requirements of

Federal railroad safety regulations. The

individual petitions are described

below, including the party seeking

relief, the regulatory provisions

involved, the nature of the relief being

requested and the petitioner’s

arguments in favor of relief.

Interested parties are invited to

participate in these proceedings by

submitting written views, data, or

comments. FRA does not anticipate

scheduling a public hearing in

connection with these proceedings since

the facts do not appear to warrant a

hearing. If any interested party desires

an opportunity for oral comment, they

should notify FRA, in writing, before

the end of the comment period and

specify the basis for their request.

All communications concerning these

proceedings should identify the

appropriate docket number (e.g., Waiver

Petition Docket No. RSEQ–95–3) and

must be submitted in triplicate to the

Docket Clerk, Office of Chief Counsel,

Federal Railroad Administration, Nassif

Building, 400 Seventh Street, SW,

Washington, DC 20590.

Communications received before March

4, 1996 will be considered by FRA

before final action is taken. Comments

received after that date will be

considered as far as practicable. All

written communications concerning

these proceedings are available for

examination during regular business

hours (9 a.m.–5 p.m.) in Room 8201,

Nassif Building, 400 Seventh Street,

SW, Washington, DC 20590. The waiver

petitions are as follows:

Michigan State Trust for Railway

Preservation, Inc. (MSTP)

FRA Waiver Petition Docket No. RSEQ–

95–3

The MSTP seeks a waiver of

compliance with Title 49, Code of

Federal Regulations (49 CFR), Part 240,

‘‘Qualifications for Locomotive

Engineers.’’ MSTP is a non-profit

educational corporation. MSTP owns

and operates a 1941 Lima built steam

locomotive. The locomotive, No. 1225,

has operated approximately 5000 miles

since 1988 throughout the general

railroad system and has been in

compliance with 49 CFR part 230 since

that time. The MSTP steam locomotive

is located at a repair facility in Owosso,

Michigan. The facility is connected to

the tracks of the Tuscola and Saginaw

Bay Railway (TSBY). The MSTP owns

and controls two (2) lead tracks each

approximately 130 feet long and

extending from the repair shop building

to the connection with the TSBY. The

MSTP requests a waiver from Part 240

which will allow operation of No. 1225

a distance of .875 miles in each

direction by non-certified persons over

TSBY trackage with approved

restrictions. The waiver would allow

MSTP to permit the public to operate

the locomotive on the TSBY trackage. In

addition, MSTP would generate

continued interest in and revenue

required to teach steam technology to

future generations.

Phil Olekszyk,

Deputy Associate Administrator for Safety

Compliance and Program Implementation.

[FR Doc. 95–31547 Filed 12–29–95; 8:45 am]

BILLING CODE 4910–06–M

DEPARTMENT OF THE TREASURY

Treasury Advisory Committee on

Commercial Operations of the U.S.

Customs Service

AGENCY: Department Offices, Treasury.

ACTION: Notice of meeting.

SUMMARY: This notice announces the

date and time of the next meeting and

the agenda for consideration by the

Treasury Advisory Committee on

Commercial Operations of the U.S.

Customs Service.

DATE: The next meeting of the Treasury

Advisory Committee on Commercial

Operations of the U.S. Customs Service

will be held on Friday, January 19,

1996, from 9:30 a.m. to 12:30 p.m. and

from 2:00 p.m. to 3:30 p.m. in the

Stanton Room, 20th Floor, World Trade

Center, Baltimore, Maryland.

FOR FURTHER INFORMATION CONTACT:

Dennis M. O’Connell, Director, Office of

Tariff and Trade Affairs, Office of the

Under Secretary (Enforcement), Room

4004, Department of the Treasury, 1500

Pennsylvania, NW., Washington, DC

20220. Tel.: (202) 622–0220.

SUPPLEMENTARY INFORMATION: At the

January 19, 1996 session, the regular

quarterly meeting of the Advisory

Committee, the Committee is expected

to consider the agenda items listed

below. The agenda may be modified

prior to the meeting.

1. FY 1995 compliance measurement

results.

2. Review of the remote filing test

and future plans.

3. Customs inbond proposal under

the Customs Modernization Act.

4. Fraud detection and cargo

inspection innovations.

5. Protection of confidentiality of

account information and other

proprietary information made available

to Customs.

6. Selective review of Customs

enforcement and administration of other

Federal agency laws, regulations, and

requirements.

The tentative agenda for the meeting

may be modified prior to the meeting

date. Public observers wishing to verify

agenda items prior to the meeting may

do so by contacting the office of Tariff

and Trade Affairs, (202) 622–0220.

The meeting is open to the public;

however participation in the

Committee’s deliberations is limited to

Committee members and Customs and

Treasury Department staff. A person

other than an Advisory Committee

member who wishes to attend the

meeting, should give advance notice by

contacting Ms. Theresa Manning at

(202) 622–0220 no later than January 12,

1996.

Dated: December 27, 1995.

Dennis M. O’Connell,

Acting Deputy Assistant Secretary

(Regulatory, Tariff and Trade Enforcement).

[FR Doc. 95–31575 Filed 12–29–95; 8:45 am]

BILLING CODE 4810–25–M

Customs Service

Public Information Collection

Requirements; Request for Public

Input; Extension of Time in Which To

File Vessel Repair Documents

AGENCY: U.S. Customs, Department of

the Treasury.

ACTION: Notice and request for

comments.

SUMMARY: The Department of the

Treasury, as part of its continuing effort

to reduce paperwork and respondent

burden, Customs invites the general

public and other Federal agencies to

comment on an information collection

requirement concerning the Extension

of Time Limit In Which To File Vessel

Repair Documents. This request for

comment is being made pursuant to the

Paperwork Reduction Act of 1995

(Public Law 104–13; 44 U.S.C.

3506(c)(2)(A)).

DATES: Written comments should be

received on or before March 4, 1996, to

be assured of consideration.

ADDRESSES: Direct all written comments

to U.S. Customs Service, Printing and

Records Services Group, Room 6216,