31822 Federal Register / Vol. 61, No. 121 / Friday, June 21, 1996 / Rules and Regulations

IMPORT ASSESSMENT TABLE—

Continued

[Raw cotton fiber]

HTS No. Conversion

factor Cents per kg

6210109010 0.2291 0.2949

6210403000 0.0391 0.0503

6210405020 0.4556 0.5865

6211111010 0.1273 0.1639

6211111020 0.1273 0.1639

6211118010 1.1455 1.4747

6211118020 1.1455 1.4747

6211320007 0.8461 1.0893

6211320010 1.0413 1.3406

6211320015 1.0413 1.3406

6211320030 0.9763 1.2569

6211320060 0.9763 1.2569

6211320070 0.9763 1.2569

6211330010 0.3254 0.4189

6211330030 0.3905 0.5027

6211330035 0.3905 0.5027

6211330040 0.3905 0.5027

6211420010 1.0413 1.3406

6211420020 1.0413 1.3406

6211420025 1.1715 1.5082

6211420060 1.0413 1.3406

6211420070 1.1715 1.5082

6211430010 0.2603 0.3351

6211430030 0.2603 0.3351

6211430040 0.2603 0.3351

6211430050 0.2603 0.3351

6211430060 0.2603 0.3351

6211430066 0.2603 0.3351

6212105020 0.2412 0.3105

6212109010 0.9646 1.2418

6212109020 0.2412 0.3105

6212200020 0.3014 0.388

6212900030 0.1929 0.2483

6213201000 1.1809 1.5203

6213202000 1.0628 1.3682

6213901000 0.4724 0.6082

6214900010 0.9043 1.1642

6216000800 0.2351 0.3027

6216001720 0.6752 0.8693

6216003800 1.2058 1.5523

6216004100 1.2058 1.5523

6217109010 1.0182 1.3108

6217109030 0.2546 0.3278

6301300010 0.8766 1.1285

6301300020 0.8766 1.1285

6302100010 1.1689 1.5048

6302215010 0.8182 1.0534

6302215020 0.8182 1.0534

6302217010 1.1689 1.5048

6302219010 0.8182 1.0534

6302217020 1.1689 1.5048

6302219020 0.8182 1.0534

6302217050 1.1689 1.5048

6302219050 0.8182 1.0534

6302222010 0.4091 0.5267

6302222020 0.4091 0.5267

6302313010 0.8182 1.0534

6302313050 1.1689 1.5048

6302315050 0.8182 1.0534

6302317010 1.1689 1.5048

6302317020 1.1689 1.5048

6302317040 1.1689 1.5048

6302317050 1.1689 1.5048

6302319010 0.8182 1.0534

6302319020 0.8182 1.0534

6302319040 0.8182 1.0534

6302319050 0.8182 1.0534

6302322020 0.4091 0.5267

6302322040 0.4091 0.5267

IMPORT ASSESSMENT TABLE—

Continued

[Raw cotton fiber]

HTS No. Conversion

factor Cents per kg

6302402010 0.9935 1.279

6302511000 0.5844 0.7524

6302512000 0.8766 1.1285

6302513000 0.5844 0.7524

6302514000 0.8182 1.0534

6302600010 1.1689 1.5048

6302600020 1.052 1.3543

6302600030 1.052 1.3543

6302910005 1.052 1.3543

6302910015 1.1689 1.5048

6302910025 1.052 1.3543

6302910035 1.052 1.3543

6302910045 1.052 1.3543

6302910050 1.052 1.3543

6302910060 1.052 1.3543

6303110000 0.9448 1.2163

6303910000 0.6429 0.8277

6304111000 1.0629 1.3684

6304190500 1.052 1.3543

6304191000 1.1689 1.5048

6304191500 0.4091 0.5267

6304192000 0.4091 0.5267

6304910020 0.9351 1.2038

6304920000 0.9351 1.2038

6505901540 1.181 1.5204

6505902060 0.9935 1.279

6505902545 0.5844 0.7524

* * * * *

3. In § 1205.510, paragraph (b)(6)(i) is

revised to read as follows:

(6) * * *

(i) A request for such exemption must

be submitted to the Cotton Board by the

importer, prior to the importation of the

cotton product. The Cotton Board will

then issue, if deemed appropriate, a

numbered exemption certificate valid

for 1 year from the date of issue. The

exemption number should be entered by

the importer on the Customs entry

documentation in the appropriate

location as determined by the U.S.

Customs Service.

* * * * *

Dated: June 14, 1996.

Lon Hatamiya,

Administrator.

[FR Doc. 96–15662 Filed 6–20–96; 8:45 am]

BILLING CODE 3410–02–P

Animal and Plant Health Inspection

Service

9 CFR Part 113

[Docket No. 95–012–2]

Viruses, Serums, Toxins, and

Analogous Products; Rabies Vaccine,

Killed Virus and Rabies Vaccine, Live

Virus

AGENCY: Animal and Plant Health

Inspection Service, USDA.

ACTION: Final rule.

SUMMARY: We are amending the

standard requirements for establishing

the immunogenicity of Rabies Vaccine,

Killed Virus and Rabies Vaccine, Live

Virus. The amendment changes and

clarifies alternate test procedures which

may be used in animals other than

carnivores. Under the rule, when a

reduced number of challenge animals is

used in a rabies immunogenicity test, all

vaccinates must survive challenge. If

one or more of the challenged

vaccinates die of rabies, all of the

remainder of the vaccinates will have to

be challenged or the test will be deemed

unsatisfactory and terminated.

This action corrects a problem

associated with rabies immunogenicity

tests in the regulations and makes other

changes deemed necessary for clarity

and consistency.

EFFECTIVE DATE: July 22, 1996.

FOR FURTHER INFORMATION CONTACT:

Dr. David A. Espeseth, Deputy Director,

Veterinary Biologics, BBEP, APHIS,

USDA, 4700 River Road Unit 148,

Riverdale, MD 20737–1237, (301) 734–

8245.

SUPPLEMENTARY INFORMATION:

Background

The regulations in 9 CFR part 113

pertain to standard requirements for the

preparation of veterinary biological

products. A standard requirement

consists of test methods, procedures,

and criteria established by the Animal

and Plant Health Inspection Service

(APHIS) to determine that a veterinary

biological product is pure, safe, potent,

and efficacious and not worthless,

dangerous, contaminated, or harmful.

The standard requirements for Rabies

Vaccine, Killed Virus, and for Rabies

Vaccine, Live Virus, appear in

§§ 113.209 and 113.312, respectively.

Sections 113.209(b)(4) and 113.312(b)(4)

provide for an alternative

immunogenicity test, for domestic

species other than dogs and cats, that

reduces the number of animals that

must be challenged.

On November 16, 1995, we published

in the Federal Register (60 FR 57549–

57550, Docket No. 95–012–1) a

proposed rule to amend the standard

requirements for Rabies Vaccine, Killed

Virus and Rabies Vaccine, Live Virus.

The amendments specify: (1) that for an

immunogenicity study in noncarnivores to be satisfactory, all animals

must survive challenge when less than

25 vaccinates are challenged, and (2)

that a reduced number of challenge

animals may only be used for noncarnivores. The rule more clearly
Federal Register / Vol. 61, No. 121 / Friday, June 21, 1996 / Rules and Regulations 31823

defines which animals must be

challenged when a reduced number of

vaccinates is used.

We solicited comments for a 60-day

comment period ending January 16,

1996. One comment was received by

that date. The comment was from a

licensed manufacturer of veterinary

biological products. The comment

addressed which animals should be

challenged and the percent survival

required for a reduced challenge. The

commenter recommended that less than

100 percent survival be acceptable for a

reduced challenge. The commenter

requested that this be accomplished

through a wording change to the rule.

In response to the commenter, APHIS

believes that when the number of

challenged animals is reduced, survival

of less than 100 percent of the animals

of the lowest titer would not provide

adequate assurance that animals of

higher titer would be protected against

challenge. Because of this, no change to

the regulations is made in response to

this comment.

Therefore, based on the rationale set

forth in the proposed rule and in this

document, we are adopting the

provisions of the proposal as a final rule

without change.

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

the purposes of Executive Order 12866

and, therefore, has not been reviewed by

the Office of Management and Budget.

This rule amending §§ 113.209 and

113.312 is necessary to clarify the

regulations regarding the rabies

immunogenicity test. The amendment

clarifies which animals are to be

challenged in a reduced

immunogenicity study and the

procedures to follow when one or more

of the vaccinates die of rabies. The

amendment requires that additional

vaccinates be challenged if one of the

low titer vaccinates succumbs to rabies.

In 7 of the last 10 rabies challenge tests

of non-carnivores, firms elected to

challenge 25 or more animals. In the

remaining three cases in which a

reduced number of animals were

challenged in accordance with current

§ 113.209 or § 113.312, paragraph (b)(4),

no additional animals were challenged

and no additional animals would have

been challenged under the amendment.

The amendment, therefore, will have

minimal economic effect.

Under these circumstances, the

Administrator of 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 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.)

Executive Order 12778

This rule has been reviewed under

Executive Order 12778, Civil Justice

Reform. It is not intended to have

retroactive effect. This rule would not

preempt any State or local laws,

regulations, or policies, unless they

present an irreconcilable conflict with

this rule. There are no administrative

procedures which must be exhausted

prior to a judicial challenge to the

provisions of this rule.

Paperwork Reduction Act

This rule contains no new

information collection or record keeping

requirements under the Paperwork

Reduction Act of 1995 (44 U.S.C. 3501

et seq.).

List of Subjects in 9 CFR Part 113

Animal biologics, Exports, Imports,

Reporting and recordkeeping

requirements.

Accordingly, 9 CFR part 113 is

amended as follows:

PART 113—STANDARD

REQUIREMENTS

1. The authority citation for part 113

continues to read as follows:

Authority: 21 U.S.C. 151–159; 7 CFR 2.22,

2.80, and 371.2(d).

2. Section 113.209 is amended by

revising paragraph (b)(4) to read as

follows:

§ 113.209 Rabies Vaccine, Killed Virus.

* * * * *

(b) * * *

(4) An alternative to challenging all

surviving test animals in accordance

with paragraph (b)(3)(iv) of this section

may be used when the test animals are

of species other than carnivores.

Vaccinates shall be challenged at 1 year

postvaccination. These shall include

five vaccinates with the lowest SN titers

at the 270th-day bleeding, five

vaccinates with the lowest SN titers at

the 365th-day bleeding, and all

vaccinates with SN titers below 1:10 by

the mouse SN test or below 1:16 by the

rapid-fluorescent-focus-inhibition test at

any bleeding. At least five SN-negative

controls of each species shall be

challenged at the same time as the

vaccinates. All SN titers shall be titrated

to an endpoint. All of the challenged

vaccinates must remain well for a

period of 90 days, and at least 80

percent of the controls must die of

rabies for a satisfactory test without

further challenge. If one or more of the

vaccinates die from rabies, all the

remaining vaccines, regardless of titer,

along with the five controls shall be

challenged. The cumulative results from

the two challenges shall be evaluated for

acceptance as specified in paragraph

(b)(3)(v) of this section.

* * * * *

3. Section 113.312 is amended by

revising the section heading and

paragraph (b)(4) to read as follows:

§ 113.312 Rabies Vaccine, Live Virus.

* * * * *

(b) * * *

(4) an alternative to challenging all

surviving test animals in accordance

with paragraph (b)(3)(iv) of this section

may be used when the test animals are

of species other than carnivores.

Vaccinates shall be challenged at 1 year

postvaccination. These shall include

five vaccinates with the lowest SN titers

at the 270th-day bleeding, five

vaccinates with the lowest SN titers at

the 365th-day bleeding, and all

vaccinates with SN titers below 1:10 by

the mouse SN test or below 1:16 by the

rapid-fluorescent-focus-inhibition test at

any bleeding. At least five SN-negative

controls of each species shall be

challenged at the same time as the

vaccinates. All SN titers shall be iterated

to an endpoint. All of the challenged

vaccinates must remain well for a

period of 90 days, and at least 80

percent of the controls must die of

rabies for a satisfactory test without

further challenge. If one or more of the

vaccinates die from rabies, all the

remaining vaccinates, regardless of titer,

along with the five controls shall be

challenged. The cumulative results from

the two challenges shall be evaluated for

acceptance as specified in paragraph

(b)(3)(v) of this section.

* * * * *

Done in Washington, DC, this 17th day of

June 1996.

Lonnie J. King,

Administrator, Animal and Plant Health

Inspection Service.

[FR Doc. 96–15854 Filed 6–20–96; 8:45 am]

BILLING CODE 3410–34–M