26384 Federal Register / Vol. 60, No. 95 / Wednesday, May 17, 1995 / Proposed Rules

(5) If the initial test shows that

potency is less than the required

minimum potency, the serial may be

retested. If retested, two additional tests,

must be conducted: Provided, That, if

the serial is not retested, the serial shall

be deemed unsatisfactory.

(i) If more than 50% of all valid tests

show that potency equals or exceeds the

required minimum potency, the serial is

satisfactory.

(ii) If more than 50% of all valid tests

show either lack of parallelism or that

potency is less than the required

minimum potency, the serial is

unsatisfactory.

(d) Repeat immunogenicity tests.

(1) The accuracy of the protective

dose established for live products in the

Master Seed immunogenicty test and

defined as live virus titer or live

bacterial count shall be confirmed in 3

years in a manner acceptable to APHIS,

unless use of the lot of Master Seed

previously tested is discontinued.

(2) All determinations of relative

antigen content using parallel line

immunoassays shall be conducted with

an unexpired reference. The lot of

reference used to determine antigenic

content shall have an initial dating

period equal to the dating of the product

or as supported by data acceptable to

APHIS. Prior to the expiration date,

such reference may be granted an

extension of dating by confirming its

immunogenicity using a Qualifying

Serial of product. Tests to establish or

confirm immunogenicity of references

shall be conducted in a manner

acceptable to APHIS. The dating period

of the Master Reference and Working

Reference may be extended as

supported by data acceptable to APHIS

if the minimum potency of the Master

Reference is determined to be

adequately above the minimum level

needed to provide protection in the host

animal. If a new Master Reference is

established, it shall be allowed an initial

dating period equal to the dating of the

product or as supported by data

acceptable to APHIS.

* * * * *

Done in Washington, DC, this 11th day of

May 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Services.

[FR Doc. 95–12152 Filed 5–16–95; 8:45 am]

BILLING CODE 3410–34–M

9 CFR Part 113

[Docket No. 93–039–2]

Viruses, Serums, Toxins, and

Analogous Products; Standard

Requirement or Escherichia Coli

Bacterin

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Notice of reopening and

extension of comment period.

SUMMARY: We are reopening and

extending the comment period for the

proposed Standard Requirement for

Escherichia coli bacterin. This extension

will provide interested persons with

additional time in which to prepare

comments on the proposed rule.

DATES: Consideration will be given only

to written comments on Docket No. 93–

039–1 that are received on or before

August 15, 1995.

ADDRESSES: Please send an original and

three copies of your comments to

Docket No. 93–039–1, Regulatory

Analysis and Development, PPD,

APHIS, Suite 3C03, 4700 River Road

Unit 118, Riverdale, MD 20737–1238.

Please state that your comments refer to

Docket No. 93–039–1. Comments

received may be inspected at USDA,

room 1141, South Building, 14th Street

and Independence Avenue SW.,

Washington, DC, between 8 a.m. and

4:30 p.m., Monday through Friday,

except holidays. Persons wishing to

inspect comments are requested to call

ahead on (202) 690–2817 to facilitate

entry into the comment reading room.

FOR FURTHER INFORMATION CONTACT: Dr.

David Espeseth, Deputy Director,

Veterinary Biologics, BBEP, APHIS,

4700 River Road Unit 148, Riverdale,

MD 20737–1237, (301) 734–8245.

SUPPLEMENTARY INFORMATION: On

October 11, 1994, we published in the

Federal Register (59 FR 51390–51392,

Docket No. 93–039–1) a proposed rule

to amend the regulations in 9 CFR

113.124 to include a Standard

Requirement for Escherichia coli

bacterins. Comments on the proposed

rule were required to be received on or

before December 12, 1994.

So that we may consider comments

submitted after that date, we are

reopening and extending the public

comment period on Docket No. 93–039–

1 until 90 days after the date of

publication of this notice in the Federal

Register. During this period, interested

persons may submit their comments for

our consideration.

Authority: 21 U.S.C. 151–159, 7 CFR 2.17,

2.51, and 371.2(d). Done in Washington, DC,

this 11th day of May 1995.

Lonnie J. King,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–12151 Filed 5–16–95; 8:45 am]

BILLING CODE 3410–34–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Airspace Docket No. 95–ANE–23]

Proposed Establishment of Class E

Airspace; Portland, ME

AGENCY: Federal Aviation

Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking.

SUMMARY: This proposed rule would

establish Class E airspace at Portland

International Jetport, Portland, Maine,

that coincides with the hours that the

associated radar approach control

facility is not in operation. Since the

Portland Class C airspace is predicated

on an operational air traffic control

tower (ATCT) serviced by a radar

control approach facility (TRACON),

Class E airspace must be defined for the

hours when that facility is not in

operation. This proposal would not

change the designated boundaries or

altitudes of the Portland Class C

airspace, but only establish the

necessary Class E airspace to provide

sufficient controlled airspace for those

aircraft operating under instrument

flight rules during the hours when the

Portland ATCT and TRACON are not in

operation.

DATES: Comments must be received on

or before June 16, 1995.

ADDRESSES: Send comments on the

proposal in triplicate to: Manager,

System Management Branch, ANE–530,

Federal Aviation Administration, 12

New England Executive Park,

Burlington, MA 01803–5299; telephone

(617) 238–7530; fax (617) 238–7596.

The official docket may be examined

in the Office of the Assistant Chief

Counsel for the New England Region,

ANE–7, 12 New England Executive

Park, Burlington, MA 01803–5299;

telephone (617) 238–7049; fax (617)

238–7055.

An informal docket may also be

examined during normal business hours

in the Office of the Manager, System

Management Branch, Air Traffic

Division, ANE–530, at the first address

shown above.