Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 / Proposed Rules 40871

50. Section 640.22 is amended by

revising paragraph (c) to read as follows:

§ 640.22 Collection of source material.

* * * * *

(c) If plateletpheresis is used, the

procedure for collection shall be as

described in a biologics license

application or a supplement to a

biologics license application, and must

have the written approval of the

Director, Center for Biologics Evaluation

and Research, Food and Drug

Administration.

* * * * *

51. Section 640.64 is amended by

revising the second sentence of the

introductory text of paragraph (c) to

read as follows:

§ 640.64 Collection of blood for Source

Plasma.

* * * * *

(c) * * * One of the following

formulas shall be used in the indicated

volumes, except that a different formula

may be used for plasma for manufacture

into noninjectable products if prior

written approval is obtained from the

Director of the Center for Biologics

Evaluation and Research at the time of

licensing or in the form of a supplement

to the biologics license application for

Source Plasma.

* * * * *

52. Section 640.65 is amended by

revising the last sentence of paragraph

(a) to read as follows:

§ 640.65 Plasmapheresis.

(a) * * * This procedure shall be

described in detail in the biologics

license application.

* * * * *

53. Section 640.71 is amended by

revising the introductory text of

paragraphs (a) and (b) and by revising

paragraph (b)(1) to read as follows:

§ 640.71 Manufacturing responsibility.

(a) All steps in the manufacture of

Source Plasma, including donor

examination, blood collection,

plasmapheresis, laboratory testing,

labeling, storage, and issuing shall be

performed by personnel of the licensed

manufacturer of the Source Plasma,

except that the following tests may be

performed by personnel of a

manufacturer licensed for blood or

blood derivatives under section 351(a)

of the Public Health Service Act, or by

a clinical laboratory that meets the

standards of the Clinical Laboratories

Improvement Act of 1967 (CLIA) (42

U.S.C. 263a): Provided, The

establishment or the clinical laboratory

is qualified to perform the assigned

test(s).

* * * * *

(b) Such testing shall not be

considered divided manufacturing,

which requires two biologics licenses

for Source Plasma: Provided, That

(1) The results of such tests are

maintained by the licensed

manufacturer of the Source Plasma

whereby such results may be reviewed

by a licensed physician as required in

§ 640.65(b)(2) and by an authorized

representative of the Food and Drug

Administration.

* * * * *

54. Section 640.74 is amended by

revising paragraph (a) and the last

sentence of paragraph (b)(2) to read as

follows:

§ 640.74 Modification of Source Plasma.

(a) Upon approval by the Director,

Center for Biologics Evaluation and

Research, Food and Drug

Administration, of a supplement to the

biologics license application for Source

Plasma, a manufacturer may prepare

Source Plasma as a liquid product for a

licensed blood derivative manufacturer

who has indicated a need for a liquid

product.

(b) * * *

(2) * * * Such evidence may be

submitted by either the licensed

manufacturer of the Source Plasma

Liquid or the manufacturer of the final

blood derivative product who has

requested the Source Plasma Liquid.

* * * * *

PART 660—ADDITIONAL STANDARDS

FOR DIAGNOSTIC SUBSTANCES FOR

LABORATORY TESTS

55. The authority citation for 21 CFR

part 660 continues to read as follows:

Authority: 21 U.S.C. 321, 351, 352, 353,

355, 360, 371; 42 U.S.C. 216, 262, 263, 263a,

264.

56. Section 660.21 is amended by

revising paragraphs (a)(3) and (d) to read

as follows:

§ 660.21 Processing.

(a) * * *

(3) A lot may be subdivided into

clean, sterile vessels. Each subdivision

shall constitute a sublot. If lots are to be

subdivided, the manufacturer shall

include this information in the biologics

license application. The manufacturer

shall describe the test specifications to

verify that each sublot is identical to

other sublots of the lot.

* * * * *

(d) Volume of final product. Each

manufacturer shall identify the possible

final container volumes in the biologics

license application.

* * * * *

57. Section 660.30 is amended by

revising paragraph (b) to read as follows:

§ 660.30 Reagent Red Blood Cells.

* * * * *

(b) Source. Reagent Red Blood Cells

shall be prepared from human

peripheral blood meeting the criteria of

§§ 660.31 and 660.32, or from umbilical

cord cells which shall be collected and

prepared according to the

manufacturer’s biologics license

application.

58. Section 660.33 is amended by

revising the fifth sentence to read as

follows:

§ 660.33 Testing of source material.

* * * Where fewer than three donor

sources of an antibody specificity are

available, test discrepancies shall be

resolved in accordance with the

manufacturer’s biologics license

application. * * *

Dated: July 22, 1998.

Michael A. Friedman,

Acting Commissioner of Food and Drugs.

Donna E. Shalala,

Secretary of Health and Human Services.

[FR Doc. 98–20427 Filed 7–30–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Office of Surface Mining Reclamation

and Enforcement

30 CFR Parts 707 and 874

RIN 1029–AB89

Abandoned Mine Land (AML)

Reclamation Program; Enhancing AML

Reclamation

AGENCY: Office of Surface Mining

Reclamation and Enforcement, Interior.

ACTION: Proposed rule, reopening and

extension of comment period.

SUMMARY: The Office of Surface Mining

Reclamation and Enforcement (OSM) is

reopening and extending the comment

period for the proposed rule, Enhancing

AML Reclamation, published on June

25, 1998 (63 FR 34768). The comment

period closed on July 27, 1998, and is

being reopened and extended for 15

days.

DATES: Written comments: We will

accept written comments on the

proposed rule until 5 p.m., Eastern time,

on August 11, 1998.

ADDRESSES: If you wish to comment,

you may mail or hand deliver comments
40872 Federal Register / Vol. 63, No. 147 / Friday, July 31, 1998 / Proposed Rules

to the Office of Surface Mining

Reclamation and Enforcement,

Administrative Record, Room 101, 1951

Constitution Avenue, NW, Washington,

DC 20240. You may also comment via

the Internet to OSM’s Administrative

Record at: osmrules@osmre.gov.

FOR FURTHER INFORMATION CONTACT:

D. J. Growitz, Office of Surface Mining

Reclamation and Enforcement, U.S.

Department of the Interior, 1951

Constitution Avenue, NW, Washington,

DC 20240; Telephone: 202–208–2634. EMail: dgrowitz@osmre.gov.

SUPPLEMENTARY INFORMATION: In

response to a telephone request from a

member of the public, OSM is reopening

and extending the public comment

period on the proposed rule, Enhancing

AML Reclamation, published in the

Federal Register on June 25, 1998 (63

FR 34768).

OSM is proposing revisions to its

rules regarding the financing of

Abandoned Mine Land reclamation

(AML) projects that involve the

incidental extraction of coal. Projections

of receipts to the AML fund through the

year 2004, when the authority to collect

fees will expire, strongly indicate that

there will be insufficient money to

address all problems currently listed in

the Abandoned Mine Land Inventory

System. Given these limited AML

reclamation resources, OSM is seeking

an innovative way for AML agencies,

working with contractors, to maximize

available funds to increase AML

reclamation.

The first revision would amend the

definition of government-financed

construction to allow less than 50

percent government funding when the

construction is an approved AML

project under the Surface Mining

Control and Reclamation Act of 1977

(SMCRA). The existing definition

requires a minimum government

contribution of 50 percent to exempt

government-financed construction from

regulation under SMCRA.

The second revision would add a new

section which would require specific

consultations and concurrences with the

Title V regulatory authority for AML

construction projects receiving less than

50 percent government financing. These

consultations and concurrences are

intended to ensure the appropriateness

of the project being undertaken as a

Title IV AML project and not under the

Title V regulatory program.

Dated: July 28, 1998.

Richard G. Bryson,

Acting Assistant Director, Program Support.

[FR Doc. 98–20505 Filed 7–30–98; 8:45 am]

BILLING CODE 4310–05–M

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[CA–071–0069b; FRL–6129–6]

Approval and Promulgation of State

Implementation Plans; California State

Implementation Plan Revision,

Mendocino County Air Quality

Management District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to approve

revisions to the California State

Implementation Plan (SIP). This action

is an administrative change which

revises two definitions and adds one

definition in Mendocino County Air

Quality Management District

(MCAQMD) Rule 130, Definitions.

The intended effect of proposing

approval of this rule is to incorporate

changes to the definitions for clarity and

consistency with revised federal and

state definitions. EPA is proposing

approval of this revision to be

incorporated into the California SIP for

the attainment and maintenance of the

national ambient air quality standards

(NAAQS) under title I of the Clean Air

Act, as amended in 1990 (CAA or the

Act). In the Final Rules Section of this

Federal Register, the EPA is approving

the state’s SIP revision as a direct final

rule without prior proposal because the

Agency views this as a noncontroversial

revision amendment and anticipates no

adverse comments. A detailed rationale

for this approval is set forth in the direct

final rule. If no relevant adverse

comments are received in response to

the direct final rule, no further activity

is contemplated in relation to this

proposed rule. If EPA receives relevant

adverse comments, the direct final rule

will not take effect and all public

comments received will be addressed in

a subsequent final rule based on this

proposed rule. EPA will not institute a

second comment period. Any parties

interested in commenting should do so

at this time.

DATES: Comments must be received in

writing by August 31, 1998.

ADDRESSES: Written comments on this

action should be addressed to: Andrew

Steckel, Rulemaking Office (AIR–4), Air

Division, U.S. Environmental Protection

Agency, Region 9, 75 Hawthorne Street,

San Francisco, CA 94105–3901.

Copies of the rule revisions and EPA’s

evaluation report of each rule are

available for public inspection at EPA’s

Region 9 office during normal business

hours. Copies of the submitted rule

revisions are also available for

inspection at the following locations:

Environmental Protection Agency, Air

Docket (6102), 401 ‘‘M’’ Street, S.W.,

Washington, D.C. 20460

California Air Resources Board,

Stationary Source Division, Rule

Evaluation Section, 2020 ‘‘L’’ Street,

Sacramento, CA 95812

Mendocino County Air Quality

Management District, 306 East Gobbi

Street, Ukiah, California 95482

FOR FURTHER INFORMATION CONTACT:

Cynthia G. Allen, Rulemaking Office

(AIR–4), Air Division, U.S.

Environmental Protection Agency,

Region IX, 75 Hawthorne Street, San

Francisco, CA 94105–3901, Telephone:

(415) 744–1189.

SUPPLEMENTARY INFORMATION: This

document concerns Mendocino County

Air Quality Management District Rule

130, Definitions, submitted to EPA on

November 18, 1993 by the California Air

Resources Board. For further

information, please see the information

provided in the Direct Final action that

is located in the Rules Section of this

Federal Register.

Authority: 42 U.S.C. 7401 et seq.

Dated: July 8, 1998.

Felicia Marcus,

Regional Administrator, Region IX.

[FR Doc. 98–20509 Filed 7–30–98; 8:45 am]

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS

COMMISSION

47 CFR Part 73

[MM Docket No. 98–133, RM–9314]

Radio Broadcasting Services; Zapata,

TX

AGENCY: Federal Communications

Commission.

ACTION: Proposed rule.

SUMMARY: This document requests

comments on a petition filed by Arturo

Lopez and Eleazar Trevino, proposing

the allotment of Channel 274A to

Zapata, Texas. The channel can be

allotted to Zapata without a site

restriction at coordinates 26–54–30 and

99–16–18. Concurrence of the Mexican

government will be requested for this

allotment.

DATES: Comments must be filed on or

before September 14, 1998, and reply

comments on or before September 29,

1998.

ADDRESSES: Federal Communications

Commission, Washington, DC. 20554. In