This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

10516

Vol. 60, No. 38

Monday, February 27, 1995

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 955

[Docket No. FV–95–955–1]

Vidalia Onions Grown in Georgia;

Order Directing That a Referendum be

Conducted

AGENCY: Agricultural Marketing Service,

USDA.

ACTION: Referendum order.

SUMMARY: This document directs that a

referendum be conducted among

eligible producers of Vidalia onions to

determine whether they favor

continuance of the marketing order

regulating the handling of Vidalia

onions grown in the production area.

DATES: The referendum will be

conducted from March 1 through March

31, 1995. To vote in this referendum,

growers must have been producing

Vidalia onions during the period

January 1 through August 15, 1994.

ADDRESSES: Copies of the marketing

order may obtained from the office of

the referendum agent at P.O. Box 2276,

Winter Haven, Florida, 33883–2276, or

the Office of the Docket Clerk,

Marketing Order Administration

Branch, Fruit and Vegetable Division,

AMS, USDA, P.O. Box 96456, Room

2525–S, Washington, DC 20090–6456.

FOR FURTHER INFORMATION CONTACT:

William J. Pimental, Southeast

Marketing Field Office, Marketing Order

Administration Branch, Fruit and

Vegetable Division, Agricultural

Marketing Service, U.S. Department of

Agriculture, P.O. Box 2276, Winter

Haven, Florida, 33881–2276; telephone:

(813) 299–4770, or Shoshana Avrishon,

Marketing Order Administration

Branch, Fruit and Vegetable Division,

Agricultural Marketing Service, U.S.

Department of Agriculture, Room 2536–

S, P.O. Box 96456, Washington, DC

20090–6456; telephone: (202) 720–3610.

SUPPLEMENTARY INFORMATION: Pursuant

to Marketing Order No. 955 [7 CFR Part

955], hereinafter referred to as the

‘‘order,’’ and the applicable provisions

of the Agricultural Marketing

Agreement Act of 1937, as amended [7

U.S.C. 601–674], hereinafter referred to

as the ‘‘Act,’’ it is hereby directed that

a referendum be conducted to ascertain

whether continuance of the order is

favored by the producers. The

referendum shall be conducted during

the period March 1 through March 31,

1995, among Vidalia onion producers in

the production area. Only producers

that were engaged in the production of

Vidalia onions during the period of

January 1 through August 15, 1994, may

participate in the continuance

referendum.

The Secretary of Agriculture has

determined that continuance referenda

are an effective means for ascertaining

whether producers favor continuation of

marketing order programs. The

Secretary would consider termination of

the order if less than two-thirds of the

producers voting in the referendum and

producers of less than two-thirds of the

volume of Vidalia onions represented in

the referendum favor continuance. In

evaluating the merits of continuance

versus termination, the Secretary will

not only consider the results of the

continuance referendum. The Secretary

will also consider other relevant

information concerning the operation of

the order; the order’s relative benefits

and disadvantages to producers,

handlers, and consumers; and whether

continued operation of the order would

tend to effectuate the declared policy of

the Act.

In any event, section 8c(16)(B) of the

Act requires the Secretary to terminate

an order whenever the Secretary finds

that a majority of all producers affected

by the order favor termination, and such

majority produced for market more than

50 percent of the commodity covered

under such order.

In accordance with the Paperwork

Reduction Act of 1980 (44 U.S.C.

chapter 35), the ballot materials used in

the referendum herein ordered have

been submitted to and approved by the

Office of Management and Budget

(OMB) and have been assigned OMB

No. 0581–0160 for Vidalia onions. It has

been estimated that it will take an

average of 10 minutes for each of the

approximately 250 producers of Vidalia

onions to cast a ballot. Participation is

voluntary. Ballots postmarked after

March 31, 1995, will not be included in

the vote tabulation.

William J. Pimental and Christian D.

Nissen of the Southeast Marketing Field

Office, Fruit and Vegetable Division,

Agricultural Marketing Service, USDA,

are hereby designated as the referendum

agents of the Secretary of Agriculture to

conduct such referendum. The

procedure applicable to the referendum

shall be the ‘‘Procedure for the Conduct

of Referenda in Connection With

Marketing Orders for Fruits, Vegetables,

and Nuts Pursuant to the Agricultural

Marketing Agreement Act of 1937, as

Amended’’ (7 CFR part 900.400 et seq.).

Ballots will be mailed to all producers

of record and may also be obtained from

the referendum agents.

List of Subjects in 7 CFR Part 955

Marketing agreements, Onions,

Reporting and recordkeeping

requirements.

Authority: 7 U.S.C. 601–674.

Dated: February 21, 1995.

Patricia Jensen,

Acting Assistant Secretary, Marketing and

Regulatory Programs.

[FR Doc. 95–4740 Filed 2–24–95; 8:45 am]

BILLING CODE 3410–02–P

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 308, 310, 318, 320, 325,

326, 327, and 381

[Docket No. 95–005N]

Information Briefings: Pathogen

Reduction; Hazard Analysis and

Critical Control Point (HACCP)

Systems

AGENCY: Food Safety and Inspection

Service, USDA.

ACTION: Announcement of outreach

activities.

SUMMARY: The Food Safety and

Inspection Service (FSIS) is announcing

a series of public outreach activities to

provide information on the proposed

rule titled ‘‘Pathogen Reduction; Hazard

Analysis and Critical Control Points

(HACCP) Systems’’ that was published

on February 3, 1995. These activities

consist of six briefings on the proposal;

three scientific/technical conferences;

and one two-day public hearing. These
Federal Register / Vol. 60, No. 38 / Monday, February 27, 1995 / Proposed Rules 10517

activities are intended to assist the

public in understanding the proposed

rule and in providing comments on the

proposed rule.

DATES: See Supplementary Information

for dates of hearings.

ADDRESSES: See Supplementary

Information for locations of hearings.

FOR FURTHER INFORMATION CONTACT: Dan

Vitiello, Director, Planning and

Analysis, Planning Office, Policy,

Evaluation and Planning Staff, FSIS,

USDA, Room 6904 Franklin Court,

Washington, DC 20250, (202) 501–7138.

SUPPLEMENTARY INFORMATION: On

February 3, 1995, FSIS published a

proposed rule titled ‘‘Pathogen

Reduction; Hazard Analysis and Critical

Control Points (HACCP) Systems’’ (60

FR 6774). The proposal provides a

number of requirements applicable to

Federal and State-inspected meat and

poultry establishments. The proposed

requirements are designed to reduce the

occurrence and numbers of pathogenic

organisms in meat and poultry products,

thereby reducing the incidence of

foodborne illness associated with the

consumption of these products.

Information Briefings

To assist the public in understanding

the proposal, FSIS is holding six

briefings as follows. Each briefing will

run from 1:00 p.m. to 5:00 p.m. Any

person who wishes to attend any of the

information briefings should contact the

FSIS Planning Office at (202) 501–7138.

Date City/state Location Contact

Mar. 7 ................. San Francisco, Oakland, CA ........ Henry J. Kaiser Convention Center, 10 Tenth

Street, Oakland, CA 94607.

Linda Russell, (202) 501–7138.

Mar. 14 ............... Dallas, TX ..................................... Dallas Grand Hotel, 1914 Commerce St., Dallas,

TX 75201, (214) 747–7000; 1–800–421–0011.

Dan Vitiello (202) 501–7138.

Mar. 16 ............... Chicago, IL ................................... Holiday Inn O’Hare Airport, 5440 North River Rd.,

Rosemont, IL 60018, (708) 671–6350.

Ken Elane, (202) 501–7138.

Mar. 21 ............... Atlanta, GA ................................... Richard Russell Federal Building, 75 Spring St.,

SW., Atlanta, GA 30303.

Ron Niemeyer, (202) 501–7138.

Mar. 23 ............... New York, NY ............................... Federal Building, 26 Federal Plaza, Room 305,

New York, NY 10278.

Ken Elane, (202) 501–7138.

Mar. 30 ............... Washington, DC ........................... Hyatt Regency Crystal City, 2799 Jefferson Davis

Highway, Arlington, VA 22202, (703) 418–1234.

Linda Russell (202) 501–7138.

The format for each briefing will be

the same:

1. A panel of subject matter specialists

will explain various aspects of the

proposal.

2. Attendees will submit any

questions they have, in writing.

3. Panelists will answer the questions.

Scientific/Technical Conferences

FSIS also plans to hold three

conferences, each addressing a specific

scientific/technical issue. Information

on each specific conference will be

published separately at a later date.

The three conferences are scheduled

to be held as follows:

Issue: ‘‘New Technology to Improve Food

Safety’’

April 12–13, Chicago, IL, Holiday Inn O’Hare

Airport, 5440 North River Road, Rosemont,

IL 60018, (708) 671–6350

Issue: ‘‘The Role of Microbiological Testing

in Verifying Food Safety’’

May 1–2, Philadelphia, PA, Holiday InnIndependence Mall, Fourth and Arch

Streets, Philadelphia, PA 19106, (215) 923–

8860

Issue: ‘‘An Evaluation of the Role of

Microbiological Criteria in Establishing Food

Safety Performance Standards in Meat and

Poultry Products’’

May 18–19, Washington, DC, Georgetown

University, Conference Center, 3800

Reservoir Road, Washington, DC 20007,

(202) 687–3200

Public Hearing

Lastly, FSIS is planning to hold a twoday public hearing for those

commenters who wish to submit oral

comments in response to the proposed

rule. (Oral comments may also be

provided to FSIS by contacting the

persons listed in the proposed rule). The

public hearing will be held:

May 30–31, Washington, DC,

Georgetown University Conference

Center, 3800 Reservoir Road, NW.,

Washington, DC 20007, (202) 687–

3200

Done at Washington, DC, on: February 17,

1995.

Michael R. Taylor,

Acting Under Secretary for Food Safety.

[FR Doc. 95–4498 Filed 2–24–95; 8:45 am]

BILLING CODE 3410–DM–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 211

[Docket No. 94N–0421]

RIN 0905–AE63

Current Good Manufacturing Practice

for Finished Pharmaceuticals; Positron

Emission Tomography

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its regulations to permit

manufacturers of positron emission

tomography (PET) radiopharmaceuticals

to apply to the agency for approval of

an exception or alternative to the

requirements of the current good

manufacturing practice (CGMP)

regulations. This action is intended to

relieve PET manufacturers, nearly all of

whom are small entities, from

regulations that might result in unsafe

handling of PET radiopharmaceuticals,

that are inapplicable or inappropriate,

or that otherwise do not enhance safety

or quality in the manufacture of PET

radiopharmaceuticals.

DATES: Written comments by March 29,

1995. FDA proposes that any final rule

that may issue based on this proposal

become effective on its date of

publication in the Federal Register.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: John

W. Levchuk, Center for Drug Evaluation

and Research (HFD–322), Food and

Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–0095.

SUPPLEMENTARY INFORMATION:

I. Introduction

PET is a diagnostic imaging modality

consisting of onsite production of

radionuclides that are intravenously

injected into patients for diagnostic

purposes. The potential usefulness of a

PET radiopharmaceutical is based upon