This section of the FEDERAL REGISTER

contains regulatory documents having general

applicability and legal effect, most of which

are keyed to and codified in the Code of

Federal Regulations, which is published under

50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by

the Superintendent of Documents. Prices of

new books are listed in the first FEDERAL

REGISTER issue of each week.

Rules and Regulations Federal Register

14353

Vol. 60, No. 52

Friday, March 17, 1995

DEPARTMENT OF JUSTICE

Immigration and Naturalization Service

8 CFR Parts 204, 211, 235, 251, 252,

274a, 299, 316 and 334

[INS No. 1703–95]

RIN 1115–AD81

Delay of Effective Date for

Establishment of Form I–551, Alien

Registration Receipt Card, as the

Exclusive Form of Registration for

Lawful Permanent Resident Aliens

AGENCY: Immigration and Naturalization

Service, Justice.

ACTION: Final rule; delay of effective

dates.

SUMMARY: The Immigration and

Naturalization Service (‘‘the Service’’) is

delaying the effective date of a final rule

previously published in the Federal

Register on September 20, 1993, at 58

FR 48775–48780, which provided, inter

alia, for the termination of the validity

of the Form I–151, Alien Registration

Receipt Card.

EFFECTIVE DATE: Effective March 17,

1995, the effective date for the

regulation published on September 20,

1993, amending 8 CFR Parts 204, 211,

235, 251, 252, 274a, 299, 316, and 334,

is delayed until March 20, 1996.

FOR FURTHER INFORMATION CONTACT:

Gerard Casale, Senior Adjudications

Officer, Immigration and Naturalization

Service, Room 3214, 425 I Street NW.,

Washington, DC 20536, telephone (202)

514–5014.

SUPPLEMENTARY INFORMATION:

Background

On September 20, 1993, the Service

published a final rule in the Federal

Register at 58 FR 48775–48780,

establishing the Form I–551, Alien

Registration Receipt Card, as the

exclusive form of registration for lawful

permanent residence, and terminating

the validity of the old Form I–151, Alien

Registration Receipt Card. In addition,

the final rule provided procedures by

which a lawful permanent resident alien

in possession of a Form I–151 or a prior

alien registration document, such as the

Form AR–3 or AR–103, could replace

these documents with the current Form

I–551. The effective date of the

amendments to 8 CFR part 264

concerning application procedures

became effective on October 20, 1993.

The final rule also provided that the

effective date for the removal of

references to the Form I–151 from 8 CFR

parts 204, 211, 223, 235, 251, 252, 274a,

299, 316, and 334 would be September

20, 1994, on which date the validity of

the Form I–151 would officially

terminate. On September 14, 1994, the

Service published a final rule in the

Federal Register at 59 FR 47063, which

extended the validity of the I–151 by

delaying the effective date of the

amendments to 8 CFR parts 204, 211,

223, 235, 251, 252, 274a, 299, 316, and

334, until March 20, 1995. This rule

further extends the validity of the I–151

by delaying the effective date of the

amendments to 8 CFR parts 204, 211,

235, 251, 252, 274a, 299, 316, and 334,

until March 20, 1996. Delaying the

effective date of the amendment to 8

CFR 223 is not necessary since,

pursuant to a final rule published on

January 11, 1994, at 59 FR 1455–1466,

that part no longer contains a reference

to Form I–151.

This delay in the effective date is

necessary in order to minimize the

possibility that lawful permanent

resident aliens who apply for either a

replacement Form I–551 card or for

naturalization prior to March 20, 1995,

as a result of the I–151 replacement

program, will not have had their

applications adjudicated before their old

registration cards expire. The I–151

replacement program will terminate on

March 20, 1995. Any application for a

replacement I–551 card or for

naturalization filed by the bearer of a

Form I–151 or prior alien registration

document after that date will not be

considered as having been filed

pursuant to the I–151 replacement

program. Applicants who wait until

after March 20, 1995, to replace their

cards or to apply for naturalization

assume a much greater risk of being

inconvenienced in the event that their

applications are not adjudicated prior to

the expiration of the Form I–151 on

March 20, 1996. Accordingly, lawful

permanent resident aliens in possession

of a Form I–151 or prior alien

registration document issued before

1979 who have not already applied to

replace that card with a Form I–551 or

for naturalization are urged to apply

without delay. For the convenience of

the public, these application forms may

be ordered by telephone, toll-free, by

calling: 1–800–755–0777.

The implementation of this rule as a

final rule is based upon the ‘‘good

cause’’ exception found at 5 U.S.C.

553(b)(B) and (d)(3). The reason for the

immediate implementation of this final

rule is as follows: A notice and

comment period for a proposed rule is

impracticable and contrary to the public

interest. Absent an extension of the

validity of the Form I–151, several

aliens who have applied for

replacement I–551 cards or for

naturalization pursuant to the I–151

replacement program would no longer

have valid evidence of their status after

March 20, 1995. Accordingly, this

regulation affords a benefit rather than

a burden or penalty of any kind on

affected persons.

Dated: March 10, 1995.

Doris Meissner,

Commissioner, Immigration and

Naturalization Service.

[FR Doc. 95–6711 Filed 3–16–95; 8:45 am]

BILLING CODE 4410–10–M

DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection

Service

9 CFR Parts 101 and 113

[Docket No. 92–201–2]

Viruses, Serums, Toxins, and

Analogous Products; General

Requirements for Inactivated Bacterial

Products

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Final rule.

SUMMARY: We are amending the

regulations to include a general

standard requirement for inactivated

bacterial products that is consistent

with the general standard requirements
14354 Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Rules and Regulations

for live bacterial products, killed virus

vaccines, and live virus vaccines. We

are also including criteria and test

concerning the identity of master seed.

Finally, the amendment provides a

choice of the most appropriate test

methods, including identity tests, for

the broad range of inactivated bacterial

products available today. The final rule

is necessary to update the current

standards and provide uniform, relevant

criteria for inactivated bacterial

products.

EFFECTIVE DATE: April 17, 1995.

FOR FURTHER INFORMATION CONTACT:

Dr. Richard E. Pacer, Senior Staff

Veterinarian, Animal and Plant Health

Inspection Service, Biotechnology,

Biologics, and Environmental

Protection, Veterinary Biologics, 4700

River Road Unit 148, Riverdale, MD

20737–1228, (301) 734–8245.

SUPPLEMENTARY INFORMATION:

Background

In accordance with the regulations in

9 CFR part 113, standard requirements

are prescribed for the licensing of

veterinary biological products. A

standard requirement consists of

specifications, procedures, and test

methods which define the standards of

purity, safety, potency, and efficacy for

a given type of veterinary biological

product.

On March 1, 1994, we published in

the Federal Register (59 FR 9681–9682,

Docket No. 92–201–1) a proposal to

amend the regulations by revising

§ 113.100 to include the relevant criteria

for evaluation of the purity, safety, and

identity of inactivated bacterial

products. In addition, we proposed to

define the master seed concept as it

applies to inactivated bacterial

products. This action was intended to

provide specific criteria for these

inactivated bacterial products. We also

proposed to move certain definitions

from § 113.100 to part 101.

We solicited comments on our

proposal for a 60-day period ending

May 2, 1994. We received one comment

by that date. This comment was from a

licensed manufacturer of veterinary

biological products. The commenter’s

only concern was about the manufacture

of inactivated bacterial products for fish.

The commenter sought clarification of

our requirement for safety tests as

proposed in § 113.100(b). This

requirement states that each bacterial

product shall be evaluated in mice and/

or guinea pigs with the exception that,

if the product is specific for poultry,

then the safety test will be performed in

poultry. The commenter suggested that

an exception similar to that for poultry

should be considered for products

specifically intended for fish. We agree

with the rationale of the commenter

because it would be more appropriate to

evaluate the safety of a biological

product intended for fish in an aquatic

species than in a mammalian species. In

response to the commenter, we have

amended the proposal by adding a new

paragraph (b)(3) in § 113.100 concerning

fish and including other aquatic species

or reptiles which states: ‘‘The product is

recommended for fish, other aquatic

species or reptiles. In such instances,

the product shall be safety tested in fish

or other aquatic species or reptiles as

required by specific Standard

Requirement or Outline of Production

for the product.’’ We have also made a

slight change to the definitions to clarify

the fact that the defined products are

inactivated bacterial products.

Therefore, with the exception of the

above changes, we are adopting the

provisions of the proposal as a final

rule.

Executive Order 12866 and Regulatory

Flexibility Act

This rule has been reviewed under

Executive Order 12866. The rule has

been determined to be not significant for

purposes of Executive Order 12866, and,

therefore, has not been reviewed by the

Office of Management and Budget.

There are currently no general

requirements for inactivated bacterial

products in the regulations. However,

approximately 30 percent of the 114

currently licensed veterinary biologics

companies manufacture inactivated

bacterial products. Many of these

companies are considered small entities

and will benefit from the adoption of

this rule. The benefits of the rule

include increased efficiency and

reduced time and expense in

accomplishing the steps toward

licensure of an inactivated bacterial

product. These benefits will be realized

because of ready access to clear

requirements, uniformity and

consistency in product development,

and the alleviation of unnecessary steps

in production of these type of products.

These companies should not experience

any additional costs above those which

they currently incur to license an

inactivated bacterial product as a result

of adoption of this rule.

Under these circumstances, the

Administrator for the Animal and Plant

Health Inspection Service has

determined that this action will not

have a significant economic impact on

a substantial number of small entities.

Executive Order 12778

This rule has been reviewed under

Executive Order 12778, Civil Justice

Reform. This rule: (1) Preempts all State

and local laws and regulations that are

in conflict with this rule; (2) has no

retroactive effect; and (3) does not

require administrative proceedings

before parties may file suit in court

challenging this rule.

Paperwork Reduction Act

This rule contains no information

collection or recordkeeping

requirements under the Paperwork

Reduction Act of 1980 (44 U.S.C. 3501

et seq.).

Executive Order 12372

This program/activity is listed in the

Catalog of Federal Domestic Assistance

under No. 10.025 and is subject to

Executive Order 12372, which requires

intergovernmental consultation with

State and local officials. (See 7 CFR part

3015, subpart V.)

List of Subjects

9 CFR Part 101

Animal biologics.

9 CFR Part 113

Animal biologics, Exports, Imports,

Reporting and recordkeeping

requirements.

Accordingly, 9 CFR parts 101 ad 113

are amended as follows:

PART 101—DEFINITIONS

1. The authority citation for part 101

continues to read as follows:

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

2.51, and 371.2(d).

2. Section 101.3, is amended by

adding, at the end of the section, the

following definitions to read as follows:

§ 101.3 Biological products and related

terms.

* * * * *

(m) Bacterin. An inactivated bacterial

product consisting of an antigenic

suspension of organisms or particulate

parts of organisms, representing a whole

culture or a concentrate thereof, with or

without the unevaluated growth

products, which has been inactivated as

demonstrated by acceptable tests

written into the filed Outline of

Production for the product.

(n) Toxoid. An inactivated bacterial

product which consists of a sterile,

antigenic toxin or toxic growth product,

which has resulted from the growth of

bacterial organisms in a culture medium

from which the bacterial cells have been

removed, which has been inactivated
Federal Register / Vol. 60, No. 52 / Friday, March 17, 1995 / Rules and Regulations 14355

without appreciable loss of antigenicity

as measured by suitable tests, and

which is nontoxic as demonstrated by

acceptable tests written into the filed

Outline of Production.

(o) Bacterin-toxoid. An inactivated

bacterial product which is either:

(1) A suspension of organisms,

representing a whole culture or a

concentrate thereof, with the toxic

growth products from the culture which

has been inactivated without

appreciable loss of antigenicity as

measured by suitable tests, the

inactivation of organisms and toxins

being demonstrated by acceptable tests

written into the filed Outline of

Production: Provided, That it shall

contain cellular antigens and shall

stimulate the development of antitoxin;

or

(2) A combination product in which

one or more toxoids or bacterin-toxoids

is combined with one or more bacterins

or one or more bacterin-toxoids.

(p) Bacterial extract. An inactivated

bacterial product which consists of the

sterile, nontoxic, antigenic derivatives

extracted from bacterial organisms or

from culture medium in which bacterial

organisms have grown.

PART 113—STANDARD

REQUIREMENTS

3. The authority citation for part 113

continues to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 217,

2.51, and 371.2(d).

4. In § 113.100, the heading,

introductory paragraph, and paragraphs

(a) through (d) are revised to read as

follows:

§ 113.100 General requirements for

inactivated bacterial products.

Unless otherwise prescribed in an

applicable Standard Requirement or in

the filed Outline of Production, an

inactivated bacterial product shall meet

the applicable requirements in this

section.

(a) Purity tests. (1) Final container

samples of completed product from

each serial and each subserial shall be

tested for viable bacteria and fungi as

provided in § 113.26.

(2) Each lot of Master Seed Bacteria

shall be tested for the presence of

extraneous viable bacteria and fungi in

accordance with the test provided in

§ 113.27(d).

(b) Safety tests. Bulk or final container

samples of completed product from

each serial shall be tested for safety in

young adult mice in accordance with

the test provided in § 113.33(b) unless:

(1) The product contains material

which is inherently lethal for mice.

In such instances, the guinea pig

safety test provided in § 113.38 shall be

conducted in place of the mouse safety

test.

(2) The product is recommended for

poultry. In such instances, the product

shall be safety tested in poultry as

defined in the specific Standard

Requirement or Outline of Production

for the product.

(3) The product is recommended for

fish, other aquatic species, or reptiles. In

such instances, the product shall be

safety tested in fish, other aquatic

species, or reptiles as required by

specific Standard Requirement or

Outline of Production for the product.

(c) Identity test. Methods of

identification of Master Seed Bacteria to

the genus and species level by

laboratory tests shall be sufficient to

distinguish the bacteria from other

similar bacteria according to criteria

described in the most recent edition of

‘‘Bergey’s Manual of Systematic

Bacteriology’’ or the American Society

for Microbiology ‘‘Manual of Clinical

Microbiology’’. If Master Seed Bacteria

are referred to by serotype, serovar,

subtype, pilus type, strain or other

taxonomic subdivision below the

species level, adequate testing must be

used to identify the bacteria to that

level. Tests which may be used to

identify Master Seed Bacteria include,

but are not limited to:

(1) Cultural characteristics,

(2) Staining reaction,

(3) Biochemical reactivity,

(4) Fluorescent antibody tests,

(5) Serologic tests,

(6) Toxin typing,

(7) Somatic or flagellar antigen

characterization, and

(8) Restriction endonuclease analysis.

(d) Ingredient requirements.

Ingredients used for the growth and

preparation of Master Seed Bacteria and

of final product shall meet the

requirements provided in § 113.50.

Ingredients of animal origin shall meet

the applicable requirements provided in

§ 113.53.

* * * * *

Done in Washington, DC, this 13th day of

March 1995.

Terry L. Medley,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 95–6648 Filed 3–16–95; 8:45 am]

BILLING CODE 3410–34–M

9 CFR Part 113

[Docket No. 93–057–2]

Viruses, Serums, Toxins, and

Analogous Products; Sampling of

Biological Products

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Final rule.

SUMMARY: We are amending the

regulations concerning the number of

representative samples of product that a

firm is required to submit to the Animal

and Plant Health Inspection Service for

testing at the National Veterinary

Services Laboratories, Ames, Iowa. The

amendment is applicable to diagnostic

test kits and Master Seeds and Cells,

and will codify provisions which are

not currently in the regulations.

EFFECTIVE DATE: April 17, 1995.

FOR FURTHER INFORMATION CONTACT: Dr.

Richard E. Pacer, Senior Staff

Veterinarian, Animal and Plant Health

Inspection Service, Biotechnology,

Biologics, and Environmental

Protection, Veterinary Biologics, 4700

River Road, Unit 148, Riverdale, MD

20737–1228, (301) 734–8245.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR Part 113

contain standard requirements for

evaluating veterinary biological

products that are licensed by the

Animal and Plant Health Inspection

Service (APHIS), U.S. Department of

Agriculture, under the Virus-SerumToxin Act of 1913, as amended by the

Food Security Act of 1985. Licenses are

required to show that biological

products are pure, safe, potent, and

efficacious.

Purity and identify tests are

performed by the licensee and the

National Veterinary Services

Laboratories (NVSL) on master seed(s)

and master cell stock(s) used in the

production of veterinary biological

products. The licensee is also required

to perform tests on the completed

veterinary biological product for purity,

safety, and potency as prescribed in a

filed outline of production or applicable

standard requirements for the product

in accordance with § 113.5. The

licensee’s test results may be confirmed

by NVSL personnel using representative

biological product samples that the

manufacturer is required to submit to

APHIS in accordance with § 113.3.

Section 113.3 currently provides

licensees and permittees with criteria

for selection and submission of

veterinary biological products, such as