Federal Register / Vol. 65, No. 78 / Friday, April 21, 2000 / Proposed Rules 21381

the public health with respect to a

compound, mixture, or preparation

containing not more than 200

milligrams of codeine per 100 milliliters

or per 100 grams that also includes one

or more nonnarcotic active medicinal

ingredients in sufficient proportion to

confer upon the compound, mixture, or

preparation valuable medicinal qualities

other than those possessed by codeine

alone.

PART 310—NEW DRUGS

20. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 360b-360f, 360j, 361(a), 371, 374,

375, 379e; 42 U.S.C. 216, 241, 242(a), 262,

263b-263n.

§ 310.103 [Amended]

21. Section 310.103 New drug

substances intended for hypersensitivity

testing is amended in paragraph (a)(3)(i)

by removing the phrase ‘‘ ‘Caution:

Federal law prohibits dispensing

without a prescription’ ’’ and adding in

its place the phrase ‘‘ ‘Rx only’ ’’.

PART 329—HABIT–FORMING DRUGS

22. Part 329 is removed.

PART 341—COLD, COUGH, ALLERGY,

BRONCHODILATOR, AND

ANTIASTHMATIC DRUG PRODUCTS

FOR OVER–THE–COUNTER HUMAN

USE

23. The authority citation for 21 CFR

part 341 continues to read as follows:

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

355, 360, 371.

§ 341.14 [Amended]

24. Section 341.14 Antitussive active

ingredients is amended in paragraph

(a)(2) by removing ‘‘§§ 329.20(a) and

341.40’’ and adding in its place

‘‘§ 290.2’’.

PART 361—PRESCRIPTION DRUGS

FOR HUMAN USE GENERALLY

RECOGNIZED AS SAFE AND

EFFECTIVE AND NOT MISBRANDED:

DRUGS USED IN RESEARCH

25. The authority citation for 21 CFR

part 361 continues to read as follows:

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

355, 371; 42 U.S.C. 262.

§ 361.1 [Amended]

26. Section 361.1 Radioactive drugs

for certain research uses is amended in

paragraph (f)(1) by removing the phrase

‘‘ ‘Caution: Federal law prohibits

dispensing without prescription’ ’’ and

adding in its place the phrase ‘‘ ‘Rx

only’ ’’.

PART 369—INTERPRETATIVE

STATEMENTS RE WARNINGS ON

DRUGS AND DEVICES FOR OVER–

THE–COUNTER SALE

27. The authority citation for 21 CFR

part 369 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 355, 371.

§ 369.22 [Removed]

28. Section 369.22 is removed.

PART 606—CURRENT GOOD

MANUFACTURING PRACTICE FOR

BLOOD AND BLOOD COMPONENTS

29. The authority citation for 21 CFR

part 606 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

355, 360, 360j, 371, 374; 42 U.S.C. 216, 262,

263a, 264.

30. Section 606.121 is amended by

revising paragraph (c)(8)(i) to read as

follows:

§ 606.121 Container label.

* * * * *

(c) * * *

(8) * * *

(i) ‘‘Rx only.’’

* * * * *

PART 610—GENERAL BIOLOGICAL

PRODUCTS STANDARDS

31. The authority citation for 21 CFR

part 610 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.

§ 610.60 [Amended]

32. Section 610.60 Container label is

amended in paragraph (a)(6) by

removing the phrase ‘‘ ‘Caution: Federal

law prohibits dispensing without

prescription,’ ’’ and adding in its place

the phrase ‘‘ ‘Rx only’ ’’.

§ 610.61 [Amended]

33. Section 610.61 Package label is

amended in paragraph (s) by removing

the phrase ‘‘ ‘Caution: Federal law

prohibits dispensing without

prescription,’ ’’ and adding in its place

the phrase ‘‘ ‘Rx only’ ’’.

Dated: March 31, 2000.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–8737 Filed 4–7–00; 8:45 am]

BILLING CODE 4160–01–F

Editorial Note: FR Doc. 00–8737 which

was originally published in the issue of

Monday, April 10, 2000, at page 18934 is

being republished in its entirety in the issue

of April, 2000, because of typesetting errors.

[FR Doc. 00–8737 Filed 4–20–00; 8:45 am]

BILLING CODE 1505–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[VA084/101–5045b; FRL–6563–1]

Approval and Promulgation of Air

Quality Implementation Plans; Virginia;

Proposed Revised Format for Materials

Being Incorporated by Reference;

Proposed Approval of Recodification

of the Virginia Administrative Code

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to approve the

State Implementation Plan (SIP)

revision submitted by the Virginia

Department of Environmental Quality.

These submittals include miscellaneous

revisions and recodification of

Virginia’s air pollution control

regulations. This proposed

recodification reorganizes and

renumbers the Virginia SIP to match the

numbering system set forth in the

Virginia Administrative Code. EPA also

proposes to revise the format of

regulations for materials submitted by

Virginia that are incorporated by

reference (IBR) into their respective

State implementation plans (SIPs). The

regulations affected by this format

change have all been previously

submitted by the respective State agency

and approved by EPA.

In the Final Rules section of this

Federal Register, EPA is approving the

State’s SIP submittal as a direct final

rule without prior proposal because the

Agency views this as a noncontroversial

submittal and anticipates no adverse

comments. A detailed rationale for the

approval is set forth in the direct final

rule and a Technical Support Document

(TSD) prepared in support of this

rulemaking action. A copy of the TSD is

available, upon request, from the EPA

Regional Office listed in the ADDRESSES

section of this document. If no adverse

comments are received in response to

this action, no further activity is

contemplated. If EPA receives adverse

comments, the direct final rule will be

withdrawn 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 on this action

should do so at this time.

DATES: Comments must be received in

writing by May 22, 2000.

ADDRESSES: Written comments should

be addressed to Marcia L. Spink,

Mailcode 3AP20, U.S. Environmental

21382 Federal Register / Vol. 65, No. 78 / Friday, April 21, 2000 / Proposed Rules

Protection Agency, Region III, 1650

Arch Street, Philadelphia, Pennsylvania

19103. Copies of the documents relevant

to this action are available for public

inspection during normal business

hours at the Air Protection Division,

U.S. Environmental Protection Agency,

Region III, 1650 Arch Street,

Philadelphia, Pennsylvania 19103; and

the Virginia Department of

Environmental Quality, 629 East Main

Street, Richmond, Virginia, 23219.

FOR FURTHER INFORMATION CONTACT:

Harold A. Frankford, (215) 814–2108 at

the EPA Region III address above, or by

e-mail at fankford.harold@epa.gov.

SUPPLEMENTARY INFORMATION: For

further information, please see the

information provided in the direct final

action, with the same title, that is

located in the ‘‘Rules and Regulations’’

section of this Federal Register

publication.

Dated: March 6, 2000.

Bradley M. Campbell,

Regional Administrator, Region III.

[FR Doc. 00–9536 Filed 4–20–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[CA 031–0174b; FRL–6580–4]

Approval and Promulgation of

Implementation Plans; California State

Implementation Plan Revision, Lake

County Air Quality Management

District and San Joaquin Valley Unified

Air Pollution Control District

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is approving revisions to

the California State Implementation

Plan. The revisions concern rules from

the following: Lake County Air Quality

Management District (LCAQMD) and

San Joaquin Valley Unified Air

Pollution Control District (SJVUAPCD).

The rules control particulate matter

(PM) emissions from open burning or

processes identified by a weight rate

throughput.

The intended effect of this action is to

regulate emissions of PM in accordance

with the requirements 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 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, no further activity is

contemplated in relation to this 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 on this rule.

Any parties interested in commenting

on this rule should do so at this time.

DATES: Comments must be received in

writing by May 22, 2000.

ADDRESSES: Comments should be

addressed in writing to: Andrew

Steckel, Rulemaking Office (AIR–4), Air

Division, U.S. Environmental Protection

Agency, Region IX, 75 Hawthorne

Street, San Francisco, CA 94105.

Copies of the rule revisions and EPA’s

evaluation report of each rule are

available for public inspection at EPA’s

Region IX office during normal business

hours. Copies of the submitted rule

revisions are also available for

inspection at the following locations:

Rulemaking Office (AIR–4), Air

Division, U.S. Environmental

Protection Agency, Region IX, 75

Hawthorne Street, San Francisco, CA

94105.

Environmental Protection Agency, Air

Docket (6102), Ariel Rios Building,

1200 Pennsylvania Avenue, NW,

Washington, D.C. 20460.

California Air Resources Board,

Stationary Source Division, Rule

Evaluation Section, 2020 ‘‘L’’ Street,

Sacramento, CA 95812.

Lake County Air Quality Management

District, 883 Lakeport Boulevard,

Lakeport, CA 95453.

San Joaquin Valley Unified Air

Pollution Control District, 1990 East

Gettysburg Street, Fresno, CA 93726.

FOR FURTHER INFORMATION CONTACT: Al

Petersen, Rulemaking Office, (AIR–4),

Air Division, U.S. Environmental

Protection Agency, Region IX, 75

Hawthorne Street, San Francisco, CA

94105, Telephone: (415) 744–1135.

SUPPLEMENTARY INFORMATION: This

document concerns the following rules:

LCAQMD Section (Rule) 226.5, Fire

Season—Burn Ban; LCAQMD Section

(Rule) 431.5, [Non-Agricultural

Burning]; LCAQMD Section (Rule) 433,

[Exemption—Residential]; Lake County

Section (Rule) 1150, Wildland

Vegetation Management Burning; and

SJVUAPCD Rule 4202, Particulate

Matter—Emission Rate. These rules

were adopted on September 13, 1988,

June 13, 1989, July 15, 1997, December

6, 1988, and December 17, 1992,

respectively, and were submitted by the

California Air Resources Board (CARB)

to EPA on July 23, 1999, March 26,

1990, March 10, 1998, February 7, 1989,

and September 28, 1994, respectively.

For further information, see the direct

final action that is located in the Rules

section of this Federal Register.

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

Dated: March 30, 2000.

Laura Yoshii,

Acting Regional Administrator, Region IX.

[FR Doc. 00–9651 Filed 4–20–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[IN99–1b; FRL–6573–6]

Approval and Promulgation of

Implementation Plan; Indiana

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing to approve

revisions to particulate matter (PM)

emissions regulations for Dubois

County, Indiana, which the Indiana

Department of Environmental

Management (IDEM) submitted to EPA

on February 3, 1999, as amendments to

its State Implementation Plan (SIP). The

revisions include relaxation of some PM

limits, elimination of limits for boilers

which are no longer operating, updating

facility names, and changing some

boiler fuel types. Air quality dispersion

modeling provided by IDEM shows that

this SIP revision will not have an

adverse effect on PM air quality.

DATES: EPA must receive written

comments on this proposed rule by May

22, 2000.

ADDRESSES: You should mail written

comments to: J. Elmer Bortzer, Chief,

Regulation Development Section, Air

Programs Branch (AR–18J), U.S.

Environmental Protection Agency,

Region 5, 77 West Jackson Boulevard,

Chicago, Illinois 60604.

You may inspect copies of the State

submittal and EPA’s analysis of it at:

Regulation Development Section, Air

Programs Branch (AR–18J), U.S.

Environmental Protection Agency,

Region 5, 77 West Jackson Boulevard,

Chicago, Illinois 60604.

FOR FURTHER INFORMATION CONTACT:

David Pohlman, Environmental

Scientist, Regulation Development

Section, Air Programs Branch (AR–18J),

U.S. Environmental Protection Agency,