Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Proposed Rules 41219

representative has had access and the

date of this access. A licensee or other

person subject to this part shall also

retain Division of Facilities and Security

disclosure authorizations for 5 years

beyond the date of any visit or

inspection when access to classified

information was permitted.

* * * * *

54. In § 95.37, paragraph (c)(1)(iv) is

removed and paragraphs (c)(1)(i) and

(h)(2) are revised to read as follows:

§ 95.37 Classification and preparation of

documents.

* * * * *

(c) * * *

(1) * * *

(i) Derivative classifications of

classified National Security Information

must contain the identity of the source

document or the classification guide,

including the agency and office of

origin, on the ‘‘Derived From’’ line and

its classification date. If more than one

source is cited, the ‘‘Derived From’’ line

should indicate ‘‘Multiple Sources.’’

The derivative classifier shall maintain

the identification of each source with

the file or record copy of the

derivatively classified document.

* * * * *

(h) * * *

(2) In the event of a question

regarding classification review, the

holder of the information or the

authorized classifier shall consult the

NRC Division of Facilities and Security,

Information Security Branch, for

assistance.

* * * * *

55. In § 95.39, the heading, paragraphs

(b)(3) and (c)(2) are revised to read as

follows:

§ 95.39 External transmission of classified

matter.

* * * * *

(b) * * *

(3) The outer envelope or wrapper

must contain the addressee’s classified

mailing address. The outer envelope or

wrapper may not contain any

classification, additional marking or

other notation that indicate that the

enclosed document contains classified

information. The Classified Mailing

Address shall be uniquely designated

for the receipt of classified information.

The classified shipping address for the

receipt of material (e.g., equipment)

should be different from the classified

mailing address for the receipt of

classified documents.

* * * * *

(c) * * *

(2) Confidential matter may be

transported by one of the methods set

forth in paragraph (c)(1) of this section,

by U.S. express or certified mail.

Express or certified mail may be used in

transmission of Confidential documents

to Puerto Rico or any United States

territory or possession.

* * * * *

56. In § 95.45, paragraph (a) is revised

to read as follows:

§ 95.45 Changes in classification.

(a) Documents containing classified

National Security Information must be

downgraded or declassified as

authorized by the NRC classification

guides or as determined by the NRC.

Requests for downgrading or

declassifying any NRC classified

information should be forwarded to the

NRC Division of Facilities and Security,

Office of Administration, Washington,

DC 20555–0001. Requests for

downgrading or declassifying of

Restricted Data will be forwarded to the

NRC Division of Facilities and Security

for coordination with the Department of

Energy.

* * * * *

57. Section 95.47 is revised to read as

follows:

§ 95.47 Destruction of matter containing

classified information.

Documents containing classified

information may be destroyed by

burning, pulping, or another method

that ensures complete destruction of the

information that they contain. The

method of destruction must preclude

recognition or reconstruction of the

classified information. Any doubts on

methods should be referred to the CSA.

58. Section 95.53 is revised to read as

follows:

§ 95.53 Termination of facility clearance.

(a) If the need to use, process, store,

reproduce, transmit, transport, or

handle classified matter no longer

exists, the facility clearance will be

terminated. The facility may deliver all

documents and matter containing

classified information to the

Commission or to a person authorized to

receive them or destroy all such

documents and matter. In either case,

the facility shall submit a certification of

nonpossession of classified information

to the NRC Division of Facilities and

Security within 30 days of termination

of facility clearance.

(b) In any instance where facility

clearance has been terminated based on

a determination of the CSA that further

possession of classified matter by the

facility would not be in the interest of

the national security, the facility shall,

upon notice from the CSA, dispose of

classified documents in a manner

specified by the CSA.

59. Section 95.57 is revised to read as

follows:

§ 95.57 Reports.

Each licensee or other person having

a facility clearance shall report to the

CSA and the Regional Administrator of

the appropriate NRC Regional Office

listed in 10 CFR part 73, Appendix A,

(a) Any alleged or suspected violation

of the Atomic Energy Act, Espionage

Act, or other Federal statutes related to

classified information. Incidents such as

this must be reported within 1 hour of

the event followed by written

confirmation;

(b) Any infractions, losses,

compromises or possible compromise of

classified information or classified

documents not falling within paragraph

(a) of this section. Incidents such as

these must be reported via written

notification within 30 days of the

incident. The report shall include

details of the incident including

corrective action taken;

(c) In addition, NRC requires records

for all classification actions (documents

classified, declassified, or downgraded)

to be submitted to the NRC Division of

Facilities and Security. These may be

submitted on an as completed basis or

every 30 days. The information may be

submitted either electronically by an online system (NRC prefers the use of a

dial-in automated system connected to

the Division of Facilities and Security)

or by paper copy using NRC Form 790.

Dated at Rockville, Maryland, this 16th day

of July, 1998.

For the Nuclear Regulatory Commission.

L. Joseph Callan,

Executive Director for Operations.

[FR Doc. 98–20602 Filed 7–31–98; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 315 and 601

[Docket No. 98N–0040]

Regulations for In Vivo

Radiopharmaceuticals Used for

Diagnosis and Monitoring; Extension

of Comment Period

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule; extension of

comment period.

SUMMARY: The Food and Drug

Administration (FDA) is extending to
41220 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Proposed Rules

1EPA adopted completeness criteria on February

16, 1990 (55 FR 5824) and, pursuant to section

110(k)(1)(A) of the CAA, revised the criteria on

August 26, 1991 (56 FR 42216).

October 15, 1998, the comment period

on a proposal rule that was published in

the Federal Register of May 22, 1998 (63

FR 28301). The document proposed to

amend the drug and biologics

regulations by adding provisions that

would clarify the evaluation and

approval of in vivo

radiopharmaceuticals used in the

diagnosis or monitoring of diseases. The

agency is taking this action to provide

interested persons additional time to

submit comments to FDA on the

proposed rule.

DATES: Written comments by October

15, 1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Dano B. Murphy, Center for Biologics

Evaluation and Research (HFM–17),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852–

1448, 301–827–6210, or Brian L.

Pendleton, Center for Drug Evaluation

and Research (HFD–7), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5649.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 22, 1998 (63 FR

28301), FDA published a proposed rule

to amend the drug and biologics

regulations by adding provisions that

would clarify the evaluation and

approval of in vivo

radiopharmaceuticals used in the

diagnosis and monitoring of diseases.

The proposed regulations would

describe certain types of indications for

which FDA may approve diagnostic

radiopharmaceuticals. The proposed

rule would also include criteria that the

agency would use to evaluate the safety

and effectiveness of a diagnostic

radiopharmaceutical under the Federal

Food, Drug, and Cosmetic Act and the

Public Health Service Act. Interested

persons were given until August 5,

1998, to submit comments on the

proposed rule. Due to the technical

nature of the proposed rule, FDA has

decided to extend the comment period

until October 15, 1998, to allow

interested persons additional time to

submit comments on the proposed rule.

Interested persons may, on or before

October 15, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposed rule. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: July 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20596 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[CA 095–0083; FRL–6133–7]

Approval and Promulgation of

Implementation Plans; California State

Implementation Plan Revision, Ventura

County Air Pollution Control District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing a limited

approval and limited disapproval of

revisions to the California State

Implementation Plan (SIP) which

concern the control of the sulfur content

of fuels within the Ventura County Air

Pollution Control District.

The intended effect of proposing

limited approval and limited

disapproval of this rule is to regulate

emissions of sulfur dioxide (SO2) in

accordance with the requirements of the

Clean Air Act, as amended in 1990

(CAA or the Act). EPA’s final action on

this proposed rule will incorporate it

into the federally approved SIP. EPA

has evaluated the rule and is proposing

a simultaneous limited approval and

limited disapproval under provisions of

the CAA regarding EPA action on SIP

submittals and general rulemaking

authority because these revisions, while

strengthening the SIP, also do not fully

meet the CAA provisions regarding plan

submissions.

DATES: Comments must be received on

or before September 2, 1998.

ADDRESSES: Comments may be mailed

to: Andrew Steckel, Rulemaking Office

[AIR–4], Air Division, U.S.

Environmental Protection Agency,

Region IX, 75 Hawthorne Street, San

Francisco, CA 94105–3901.

Copies of the rule and EPA’s

evaluation report of the rule is available

for public inspection at EPA’s Region IX

office during normal business hours.

Copies of the submitted rule are also

available for inspection at the following

locations:

Environmental Protection Agency, Air

Docket, 401 ‘‘M’’ Street, SW.,

Washington, DC 20460.

California Air Resources Board,

Stationary Source Division, Rule

Evaluation Section, 2020 ‘‘L’’ Street,

Sacramento, CA 95812.

Ventura County Air Pollution Control

District, 669 County Square Drive,

Ventura, CA 93003.

FOR FURTHER INFORMATION CONTACT:

Stanley Tong, Rulemaking Office, [AIR–

4], Air Division, U.S. Environmental

Protection Agency, Region IX, 75

Hawthorne Street, San Francisco, CA

94105–3901; Telephone: (415) 744–

1191.

SUPPLEMENTARY INFORMATION:

I. Applicability

The rule being proposed for approval

into the California SIP is Ventura

County Air Pollution Control District

(VCAPCD) Rule 64, Sulfur Content of

Fuels. This rule was submitted by the

California Air Resources Board (CARB)

to EPA on July 13, 1994.

II. Background

40 CFR 81.305 provides the

attainment status designations for air

districts in California. Ventura County

Air Pollution Control District is listed as

being in attainment for the national

ambient air quality standards for sulfur

dioxide (SO2). Sulfur dioxide is formed

by the combustion of fuels containing

sulfur compounds.

VCAPCD adopted Rule 64, Sulfur

Content of Fuels, on June 14, 1994. On

July 13, 1994 the State of California

submitted many rules for incorporation

into its SIP, including the rule being

acted on in this document. VCAPCD

Rule 64 was found to be complete on

September 12, 1994 pursuant to EPA’s

completeness criteria that are set forth

in 40 CFR part 51, appendix V 1 and is

being proposed for limited approval and

limited disapproval. The following is

EPA’s evaluation and proposed action

for this rule.

III. EPA Evaluation and Proposed

Action

In determining the approvability of an

SO2 rule, EPA must evaluate the rule for

consistency with the requirements of

the CAA and EPA regulations, as found

in section 110 and 40 CFR part 51

(Requirements for Preparation,

Adoption, and Submittal of

Implementation Plans).

While the VCAPCD is in attainment

with the SO2 NAAQS, many of the