Federal Register / Vol. 60, No. 97 / Friday, May 19, 1995 / Rules and Regulations 26827

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a supplemental new animal

drug application (NADA) filed by the

American Cyanamid Co. The

supplemental NADA provides for the

safe and effective use of

chlortetracycline bisulfate (CTC

bisulfate) soluble powder concentrate in

the drinking water of chickens and

turkeys for control of certain bacterial

diseases susceptible to CTC, in the

drinking water of swine, and as a

drench in cattle for control and

treatment of certain bacterial diseases

susceptible to CTC. The approved

supplemental NADA reflects

compliance with findings of the

National Academy of Sciences/National

Research Council (NAS/NRC), Drug

Efficacy Study Group’s (DESI)

evaluation of related drug products’

effectiveness and FDA’s conclusions

concerning that evaluation.

EFFECTIVE DATE: May 19, 1995.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: American

Cyanamid Co., Berdan Ave., Wayne, NJ

07470, is the sponsor of NADA 55–020

which provides for use of Aureomycin

CTC (bisulfate) Soluble Powder

Concentrate (available in 1/4 and 10

pound packets) containing CTC

bisulfate equivalent to 102.4 grams of

CTC hydrochloride (CTC HCl) per

pound. The drug product is used to

medicate the drinking water of

chickens, turkeys, swine, calves, beef

cattle, and nonlactating dairy cattle in

accordance with § 520.445b(d)(4) (21

CFR 520.445b(d)(4)). The NADA was

originally approved on June 7, 1963.

American Cyanamid Co. filed a

supplement to NADA 55–020 revising

the product labeling to conform to that

approved for the firm’s supplemental

NADA’s 65–071 (Aureomycin (CTC

HCl) Soluble Powder) and 65–440

(Aureomycin (CTC HCl) Soluble

Powder Concentrate). Approval of those

supplemental NADA’s was published in

the Federal Register of August 3, 1994

(59 FR 39438). The approval reflects

compliance of the products’ labeling

with NAS/NRC findings and FDA’s

concurrence with those findings.

The NAS/NRC evaluation is

concerned only with the drugs’

effectiveness and safety to the treated

animal. It does not take into account the

safety for food use of food derived from

drug-treated animals. Nothing herein

will constitute a bar to further

proceedings with respect to questions of

safety of the drug or its metabolites in

food products derived from treated

animals.

Supplemental NADA 55–020 is

approved as of April 6, 1995, and the

regulations are amended by revising

§ 520.445b(d)(4) to reflect the approval.

The basis for this approval is discussed

in the freedom of information summary.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 514.11(e)(2)(ii)), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

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

through Friday.

Under section 512(c)(2)(F)(iii) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval for food producing animals

does not qualify for marketing

exclusivity because the supplemental

application does not contain reports of

new clinical or field investigations

(other than bioequivalence or residue

studies) and new human food safety

studies (other than bioequivalence or

residue studies) essential to the

approval and conducted or sponsored

by the applicant.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects in 21 CFR Part 520

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.445b is amended by

revising paragraph (d)(4) introductory

text to read as follows:

§ 520.445b Chlortetracycline powder

(chlortetracycline hydrochloride or

chlortetracycline bisulfate).

* * * * *

(d) * * *

(4) The following uses of

chlortetracycline hydrochloride or

chlortetracycline bisulfate in drinking

water or drench were reviewed by the

National Academy of Sciences/National

Research Council (NAS/NRC) and found

effective:

* * * * * *

Dated: May 4, 1995.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 95–12291 Filed 5–18–95; 8:45 am]

BILLING CODE 4160–01–F

NATIONAL ARCHIVES AND RECORDS

ADMINISTRATION

36 CFR Part 1258

RIN 3095–AA63

Reproduction Services; Fee Schedule

AGENCY: National Archives and Records

Administration (NARA).

ACTION: Final rule; confirmation of

interim final rule.

SUMMARY: The National Archives and

Records Administration (NARA) is

adopting as a final rule the interim final

rule on NARA reproduction fees. The

interim rule corrected addresses and

removed certain photographic

reproductions and fees from the

published fee schedule. This rule will

affect Federal agencies and members of

the public who order reproductions

from NARA.

EFFECTIVE DATE: The effective date of

this rule is March 6, 1995.

FOR FURTHER INFORMATION CONTACT:

Mary Ann Hadyka or Nancy Allard on

(301)713–6730.

SUPPLEMENTARY INFORMATION: On

January 30, 1995, NARA issued an

interim final rule. The effective date of

the interim final rule was March 6,

1995. No comments were received

during the 60-day comment period

provided by the interim rule. Therefore,

we are confirming in this final rule the

correction of addresses and removal of

published fees for certain reproductions

in 36 CFR part 1258.

This rule is not a significant

regulatory action for purposes of

Executive Order 12866 of September 30,
26828 Federal Register / Vol. 60, No. 97 / Friday, May 19, 1995 / Rules and Regulations

1993 and has not been reviewed by the

Office of Management and Budget. As

required by the Regulatory Flexibility

Act, it is hereby certified that this rule

will not have a significant impact on

small entities.

List of Subjects in 36 CFR Part 1258

Archives and records.

PART 1258—FEES

Accordingly, the interim final rule

amending 36 CFR part 1258 which was

published at 60 FR 5579 on January 30,

1995, is adopted as a final rule without

change.

Dated: May 11, 1995.

Trudy Huskamp Peterson,

Acting Archivist of the United States.

[FR Doc. 95–12323 Filed 5–18–95; 8:45 am]

BILLING CODE 7515–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 264, 265, 270, and 271

[FRL–5206–9]

RIN 2060–AB94

Hazardous Waste Treatment, Storage,

and Disposal Facilities and Hazardous

Waste Generators; Organic Air

Emission Standards for Tanks, Surface

Impoundments, and Containers

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Notice of postponed effective

date.

SUMMARY: This document postpones the

effective date of the final rule on

Hazardous Waste Treatment, Storage,

and Disposal Facilities and Hazardous

Waste Generators; Organic Air Emission

Standards for Tanks, Surface

Impoundments, and Containers until

December 6, 1995.

EFFECTIVE DATE: The final rule will be

effective as of December 6, 1995. The

EPA specified in the final rule a

schedule that established the

compliance dates by which different

requirements of the rule must be met.

These compliance dates and

requirements are explained further in

the final rule (59 FR 62896, December

6, 1994) under SUPPLEMENTARY

INFORMATION. This document only

changes the June 5, 1995 effective date

to December 6, 1995; all other

compliance dates for the final rule

remain as published in the final rule (59

FR 62896, December 6, 1994.)

ADDRESSES: Docket. The supporting

information used for the final rule is

available for public inspection and

copying in the RCRA docket. The RCRA

docket numbers pertaining to the final

rule are F–91–CESP–FFFFF, F–92–

CESA–FFFFF, F–94–CESF–FFFFF, and

F–94–CE2A–FFFFF. The docket is

available for inspection at the EPA

RCRA Docket Office (5305), Room 2616,

U.S. Environmental Protection Agency,

401 M Street, SW., Washington, DC

20460.

FOR FURTHER INFORMATION CONTACT: For

information about this postponement

contact the RCRA Hotline at (800) 424–

9346 toll-free, or (703) 920–9810.

SUPPLEMENTARY INFORMATION: This

document announces the postponement

of the effective date for the final Air

Emission Standards published under

the Resource Conservation and

Recovery Act. These final standards

were published on December 6, 1994

(59 FR 62896) and were originally

scheduled to become effective as of June

5, 1995. Since promulgation, the EPA

has become aware that certain

provisions of the final standards may

require clarification, and plans to

publish a subsequent Federal Register

document to clarify such provisions.

This process may result in compliance

options that facilities do not now realize

are available. To ensure that all options

are clear to affected facilities, and to

ensure that all affected facilities have

time to make any such alterations in

their compliance plan prior to the

effective date of the standards, EPA is

postponing the effective date of the final

rule for six months. The EPA considers

a postponement of six months to be

adequate time to allow for affected

facilities to make any such necessary

adjustments. The EPA also believes that

it would be inequitable not to postpone

the effective date in light of the

possibility of increased compliance

flexibility, so that a modest

postponement is justified. See 5 U.S.C.

705 (‘‘when an agency finds that justice

so requires, it may postpone the

effective date of action taken by it,

pending judicial review’’). Therefore,

the effective date of the final rule will

be postponed until December 6, 1995.

The final rule text affected by this

change is amended as follows.

List of Subjects

40 CFR Part 264

Environmental protection, Air

pollution control, Hazardous waste,

Insurance, Packaging and containers,

Reporting and recordkeeping

requirements, Security measures, Surety

bonds.

40 CFR Part 265

Air pollution control, Hazardous

waste, Insurance, Packaging and

containers, Reporting and recordkeeping

requirements, Security measures, Surety

bonds, Water supply.

40 CFR Part 271

Administrative practice and

procedure, Confidential business

information, Hazardous materials

transportation, Hazardous waste,

Indians-lands, Intergovernmental

relations, Penalties, Reporting and

recordkeeping requirements, Water

pollution control, Water supply.

Dated: May 8, 1995.

Mary D. Nichols,

Assistant Administrator Office of Air and

Radiation.

For the reasons set out in the

preamble, title 40, chapter I, parts 264,

265, and 271 of the Code of Federal

Regulations are amended as follows:

PART 264—STANDARDS FOR

OWNERS AND OPERATORS OF

HAZARDOUS WASTE TREATMENT,

STORAGE, AND DISPOSAL

FACILITIES

1. The authority citation for part 264

continues to read as follows:

Authority: 42 U.S.C. 6905, 6912(a), 6924

and 6925.

Subpart CC—Air Emission Standards

for Tanks, Surface Impoundments, and

Containers

2. Section 264.1080 is amended by

revising paragraphs (b)(1) and (c) to read

as follows:

§ 264.1080 Applicability.

* * * * *

(b) * * *

(1) A waste management unit that

holds hazardous waste placed in the

unit before December 6, 1995, and in

which no hazardous waste is added to

the unit on or after this date.

* * * * *

(c) For the owner and operator of a

facility subject to this subpart and who

received a final permit under RCRA

section 3005 prior to December 6, 1995,

the requirements of this subpart shall be

incorporated into the permit when the

permit is reissued in accordance with

the requirements of § 124.15 of this

chapter or reviewed in accordance with

the requirements of § 270.50(d) of this

chapter. Until such date when the

owner and operator receives a final

permit incorporating the requirements

of this subpart, the owner and operator

is subject to the requirements of 40 CFR

part 265 subpart CC.