Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63633

PART 401—GENERAL CROP

INSURANCE REGULATIONS—

REGULATIONS FOR THE 1988 AND

SUBSEQUENT CONTRACT YEARS

1. The authority citation for 7 CFR

part 401 is revised to read as follows:

Authority: 7 U.S.C. 1506(l), 1506(p).

2. Section 401.114 is amended by

revising 10. Contract Changes to read as

follows:

§ 401.114 Canning and processing tomato

endorsement.

* * * * *

10. Contract Changes

The date by which contract changes will be

available in your service office is November

30 (December 17 for the 1998 crop year only)

preceding the cancellation date for counties

with a February 15 cancellation date and

December 31 preceding the cancellation date

for all other counties.

* * * * *

3. Section 401.120 is amended by

revising 9. Contract Changes to read as

follows:

§ 401.120 Rice endorsement.

* * * * *

9. Contract Changes

The date by which contract changes will be

available in your service office is December

31 preceding the cancellation date for

counties with an April 15 cancellation date

and November 30 (December 17 for the 1998

crop year only) preceding the cancellation

date for all other counties.

* * * * *

PART 454—FRESH MARKET TOMATO

(GUARANTEED PRODUCTION PLAN)

CROP INSURANCE REGULATIONS

4. The authority citation for 7 CFR

part 454 is revised to read as follows:

Authority: 7 U.S.C. 1506(l), 1506(p).

5. In § 454.7(d), the insurance policy

is amended by revising section 16.

Contract Changes to read as follows:

§ 454.7 Guaranteed Production Plan of

Fresh Market Tomato Crop Insurance

Policy.

* * * * *

16. Contract Changes

We may change any terms and provisions

of the contract from year to year. If your price

election at which indemnities are computed

is no longer offered, the actuarial table will

provide the price election which you are

deemed to have elected. All contract changes

will be available at your service office by

November 30 (December 17 for the 1998 crop

year only) preceding the cancellation date for

counties with a February 15 cancellation

date, and by December 31 preceding the

cancellation date for counties with an April

15 cancellation date. Acceptance of changes

will be conclusively presumed in the absence

of notice from you to cancel the contract.

* * * * *

PART 457—COMMON CROP

INSURANCE REGULATIONS;

REGULATIONS FOR THE 1994 AND

SUBSEQUENT CONTRACT YEARS

6. The authority citation for 7 CFR

part 457 is revised to read as follows:

Authority: 7 U.S.C. 1506(l), 1506(p).

7. Section 457.104 is amended by

revising 4. Contract Changes to read as

follows:

§ 457.104 Cotton crop insurance

provisions.

* * * * *

4. Contract Changes

The contract change date is November 30

(December 17 for the 1998 crop year only)

preceding the cancellation date (see the

provisions of Section 4 (Contract Changes) of

the Common Crop Insurance Policy).

* * * * *

8. Section 457.105 is amended by

revising 4. Contract Changes to read as

follows:

§ 457.105 Extra long staple cotton crop

insurance provisions.

* * * * *

4. Contract Changes

The contract change date is November 30

(December 17 for the 1998 crop year only)

preceding the cancellation date (see the

provisions of section 4 (Contract Changes) of

the Common Crop Insurance Policy).

* * * * *

9. Section 457.108 is amended by

revising 4. Contract Changes to read as

follows:

§ 457.108 Sunflower seed crop insurance

provisions.

* * * * *

4. Contract Changes

The contract change date is November 30

(December 17 for the 1998 crop year only)

preceding the cancellation date (see the

provisions of Section 4 (Contract Changes) of

the Basic Provisions).

* * * * *

10. Section 457.109 is amended by

revising 4. Contract Changes to read as

follows:

§ 457.109 Sugar beet crop insurance

provisions.

* * * * *

4. Contract Changes

In accordance with the provisions of

section 4 (Contract Changes) of the Basic

Provisions, the contract change date is April

30 preceding the cancellation date for

counties with a July 15 or August 31

cancellation date and November 30

(December 17 for the 1998 crop year only)

preceding the cancellation date for all other

counties.

* * * * *

11. Section 457.113 is amended by

revising 4. Contract Changes to read as

follows:

§ 457.113 Coarse grains crop insurance

provisions.

* * * * *

4. Contract Changes

The contract change date is November 30

(December 17 for the 1998 crop year only)

preceding the cancellation date (see the

provisions of Section 4 (Contract Changes) of

the Common Crop Insurance Policy).

* * * * *

12. Section 457.150 is amended by

revising 4. Contract Changes to read as

follows:

§ 457.150 Dry bean crop insurance

provisions.

* * * * *

4. Contract Changes

In accordance with section 4 (Contract

Changes) of the Basic Provisions, the contract

change date is November 30 (December 17 for

the 1998 crop year only) preceding the

cancellation date.

* * * * * 4

Signed in Washington, D.C., on November

26, 1997.

Kenneth D. Ackerman,

Manager, Federal Crop Insurance

Corporation.

[FR Doc. 97–31544 Filed 11–26–97; 3:08 pm]

BILLING CODE 3410–08–P

DEPARTMENT OF AGRICULTURE

Federal Crop Insurance Corporation

7 CFR Part 457

Common Crop Insurance Regulations,

Fresh Market Tomato (Dollar Plan)

Crop Insurance Provisions; Correction

AGENCY: Federal Crop Insurance

Corporation, USDA.

ACTION: Final rule, correction.

SUMMARY: The document contains a

correction to the final rule that was

published on Friday, March 28, 1997

(62 FR 14775–14780). The rule pertains

to the insurance of fresh market

tomatoes (dollar plan).

EFFECTIVE DATE: December 2, 1997.

FOR FURTHER INFORMATION CONTACT:

Linda Williams, Insurance Management

Specialist, Research and Development

Division, Federal Crop Insurance

Corporation, United States Department

of Agriculture, 9435 Holmes Road,

Kansas City, MO 64131, telephone (816)

926–7730.
63634 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

SUPPLEMENTARY INFORMATION:

Background

The final rule that is the subject of

this correction was intended to provide

policy changes to better meet the needs

of the insured, include the current fresh

market tomato (dollar plan)

endorsement under the Common Crop

Insurance Policy for ease of use and

consistency of terms, and to restrict the

effect of the current fresh market tomato

(dollar plan) endorsement to the 1997

and prior crop years.

Need for Correction

As published, the final regulation

contained a technical error which may

prove to be misleading and is in need

of clarification.

Correction of Publication

Accordingly, the publication on

March 28, 1997, of the final regulation

at 62 FR 14775–14780 is corrected as

follows:

PART 457—[CORRECTED]

§ 457.139 [Corrected]

On page 14780, in the first column, in

§ 457.139, the paragraph following

section 14(b)(4)(ii)(B) is corrected to

read:

‘‘(5) Multiplying the result of section

14(b)(4) by your share.’’

Signed in Washington D.C. on November

25, 1997.

Kenneth D. Ackerman,

Manager, Federal Crop Insurance

Corporation.

[FR Doc. 97–31545 Filed 12–1–97; 8:45 am]

BILLING CODE 3410–08–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Parts 30 and 32

RIN 3150–AF70

Exempt Distribution of a Radioactive

Drug Containing One Microcurie of

Carbon-14 Urea

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is amending its

regulations to permit NRC licensees to

distribute a radioactive drug containing

one microcurie of carbon-14 urea to any

person for ‘‘in vivo’’ diagnostic use. The

NRC has determined that the radioactive

component of such a drug in capsule

form presents an insignificant radiation

risk and, therefore, regulatory control of

the drug for radiation safety is not

necessary. This amendment makes the

drug more widely available and reduces

costs to patients, insurers, and the

health care industry. This action grants

a petition for rulemaking (PRM–35–12)

from Tri-Med Specialties, Inc. and

completes action on the petition.

EFFECTIVE DATE: January 2, 1998.

ADDRESS: Copies of the public record,

including the final regulatory analysis

and any public comments received on

the proposed rule, may be examined

and copied for a fee in the

Commission’s Public Document Room

at 2120 L Street, NW. (Lower Level),

Washington, DC.

FOR FURTHER INFORMATION CONTACT: Dr.

Anthony N. Tse, Office of Nuclear

Regulatory Research, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone (301) 415–

6233 or e-mail at ANT@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. The Petition for Rulemaking.

II. Proposed Rule, Public Comments, and

NRC Responses.

III. Summary of the Final Amendments.

IV. Description of the Final Amendments.

V. Agreement State Compatibility.

VI. Finding of No Significant Environmental

Impact: Availability.

VII. Paperwork Reduction Act Statement.

VIII. Regulatory Analysis.

IX. Regulatory Flexibility Certification.

X. Small Business Regulatory Enforcement

Fairness Act.

XI. Backfit Analysis.

List of Subjects

I. The Petition for Rulemaking

On October 6, 1994, the Commission

docketed a petition for rulemaking

(Docket No. PRM–35–12) from Tri-Med

Specialties, Inc (Tri-Med). In a letter

dated August 23, 1994, Tri-Med

petitioned the NRC to amend its

regulations ‘‘to allow for the general

licensing and/or exemption for the

commercial distribution by licensed

pharmaceutical manufacturers of a

capsule containing one micro-Curie

(μCi) of C–14-urea for in vivo diagnostic

testing.’’ The purpose of this diagnostic

test is to detect the presence of the

bacterium Helicobacter pylori (H.

pylori), a cause of peptic ulcers in

humans.

Following the receipt of the petition,

the NRC published for public comment

a notice of receipt of petition for

rulemaking in the Federal Register on

December 2, 1994 (59 FR 61831). The

comment period closed on February 15,

1995. The NRC received 315 public

comment letters, of which 313

supported the petition (they were

mostly form letters) and 2 letters

opposed the petition.

II. Proposed Rule, Public Comments,

and NRC Responses

A proposed rule was published on

June 16, 1997 (62 FR 32552) that would

permit NRC licensees to distribute

capsules containing one microcurie

C–14 urea to any person for ‘‘in vivo’’

diagnostic use. The public comment

period closed on July 16, 1997.

In the preamble of the proposed rule,

the NRC stated that, because the

capsules present an insignificant

radiological risk to the public and the

environment, the NRC believes the

capsules could be distributed for ‘‘in

vivo’’ diagnostic use to persons exempt

from licensing.

This change makes the drug more

widely available and reduces costs to

patients, insurers, and the health care

industry.

The NRC received seven public

comment letters on the proposed rule:

three from industry, three from State

agencies, and one from a physician

associated with a university medical

facility. Four commenters supported the

rule, one opposed the rule, and two

provided comments but did not

explicitly state whether they supported

or opposed the rule. Public comments

and NRC’s responses are presented

below.

Comment 1: Under the proposed

distribution, the NRC should not be

forbidding research use of this drug by

the same physicians who may use it

clinically. Research use also should be

permitted under this exemption because

the radiological risk for using C–14

capsules is insignificant.

Response: The NRC did not change

the final rule in response to this

comment. A common rule entitled

‘‘Federal Policy for the Protection of

Human Subjects; Notices and Rules’’

was promulgated by 16 Federal agencies

on June 18, 1991 (56 FR 28002) and was

intended to ensure the protection of

human research subjects. This rule was

adopted to implement a

recommendation of the President’s

Commission for the Study of Ethical

Problems in Medicine and Biomedical

and Behavioral Research which was

established on November 9, 1978, by

Public Law 95–622. The Federal Policy

requires that Federal agencies that

conduct, fund, support, or regulate

research involving human subjects

ensure adequate protection of the rights

of the human subjects. The Federal

policy represents a societal

determination that any research

(including research involving

radioactive material) must provide for