Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Rules and Regulations 12083

listed in this document will be

published subsequently in the Order.

The Rule

This amendment to part 71 of the

Federal Aviation Regulations (14 CFR

part 71) amends the Class E airspace

located at Gallup Municipal Airport,

Gallup, NM, to provide controlled

airspace extending upward from 700

feet AGL for aircraft executing the GPS

SIAP to RWY 24.

The FAA has determined that this

regulation only involves an established

body of technical regulations that need

frequent and routine amendments to

keep them operationally current. It,

therefore—(1) is not a ‘‘significant

regulatory action’’ under Executive

Order 12866; (2) is not a ‘‘significant

rule’’ under DOT Regulatory Policies

and Procedures (44 FR 11035; February

26, 1979); and (3) does not warrant

preparation of a regulatory evaluation as

the anticipated impact is so minimal.

Since this is a routine matter that will

only affect air traffic procedures and air

navigation, it is certified that this rule

will not have a significant economic

impact on a substantial number of small

entities under the criteria of the

Regulatory Flexibility Act.

List of Subject in 14 CFR Part 71

Airspace, Incorporation by reference,

Navigation (air).

Adoption of the Amendment

In consideration of the foregoing, the

Federal Aviation Administration

amends 14 CFR part 71 as follows:

PART 71—[AMENDED]

1. The authority citation for 14 CFR

part 71 continues to read as follows:

AUTHORITY: 49 U.S.C. 40103, 40113, 40120;

E.O. 10854; 24 FR 9565, 3 CFR, 1959–1963

Comp., p. 389; 49 U.S.C. 106(g); 14 CFR

11.69.

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9D,

Airspace Designations and Reporting

Points, dated September 4, 1996, and

effective September 16, 1996, is

amended as follows:

Paragraph 6005 Class E Airspace areas

extending upward from 700 feet or more

above the surface of the earth.

* * * * *

ASW NM E5 Gallup, NM [Revised]

Gallup Municipal Airport, NM

(Lat 35°30′40′′N., long 108°47′22′′W.)

Gallup VORTAC

(Lat. 35°28′34′′N., long 108°52′21′′W.)

Gallup ILS Localizer

(Lat 35°30′53′′N., long 108°46′28′′W.)

That airspace extending upward from 700

feet above the surface within a 6.7-mile

radius of Gallup Municipal Airport and

within 1.9 miles each side of the Gallup ILS

Localizer southwest course extending from

the 6.7-mile radius to 12.6 miles southwest

of the airport and within 2 miles each side

of the 074° bearing from the airport extending

from the 6.7-mile radius to 9.1 miles east of

the airport and within 1.3 miles each side of

the 242° radial of the Gallup VORTAC

extending from the 6.7-mile radius to 11.5

miles southwest of the airport and that

airspace extending upward from 1,200 feet

above the surface within an area bounded by

a line beginning at lat 35°47′30′′N, long

108°34′02′′W; to lat 35°26′50′′N, long

108°34′02′′W; to lat 35°13′15′′N, long

109°06′02′′W’ to lat 35°20′25′′N, long

109°10′42′′W; to lat 35°52′00′′N, long

108°47′02′′W; to point of beginning

excluding that airspace within the New

Mexico, NM, Class E airspace area.

* * * * *

Issued in Fort Worth, TX, on March 7,

1997.

Albert L. Viselli,

Acting Manager, Air Traffic Division,

Southwest Region.

[FR Doc. 97–6529 Filed 3–13–97; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 200, 250, and 310

[Docket No. 96N–0183]

RIN 0910–AA53

Consolidation of Drug Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is consolidating a

list of drugs, previously determined by

rulemaking to be new drugs, into one

section. This document also removes

the sections now providing for these

drugs, except for certain information in

the regulations that FDA considers to be

necessary. This action, which will make

the regulations more concise and

efficient, is being taken in response to

the President’s regulatory reinvention

initiative (REGO).

EFFECTIVE DATE: April 14, 1997.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Food and Drug

Administration, Center for Drug

Evaluation and Research (HFD–7), 7500

Standish Pl., Rockville, MD 20855, 301–

594–2041.

SUPPLEMENTARY INFORMATION:

I. Background

On March 4, 1995, President Clinton

issued a memorandum titled

‘‘Regulatory Reinvention Initiative,’’

which directed all Federal agencies to

conduct a page-by-page review of their

existing regulations and to ‘‘eliminate or

revise those that are outdated or

otherwise in need of reform.’’ As a

result of that review and as part of its

response to the President’s directive,

FDA published a document in the

Federal Register of June 11, 1996 (61 FR

29502), proposing to amend those parts

of its drug regulations codified in parts

200, 250, and 310 (21 CFR parts 200,

250, and 310), regarding certain drugs

determined by rulemaking to be new

drugs.

FDA proposed the following: (1) To

revise § 310.502 to consolidate into one

section a list of drugs (now codified in

parts 200, 250, and 310) that have been

determined by rulemaking procedures

to be new drugs requiring approved new

drug applications, and (2) to remove

those sections in parts 200, 250, and 310

now providing for those drugs, except

for certain information in § 310.509 that

FDA considers to be necessary. The

agency received no comments in

response to the proposal to amend or

remove these regulations.

II. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (5

U.S.C. 601–612). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. The Commissioner of Food and

Drugs certifies that the final rule will

not have a significant economic impact

on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.
12084 Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Rules and Regulations

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects

21 CFR Part 200

Drugs, Prescription drugs.

21 CFR Part 250

Drugs.

21 CFR Part 310

Administrative practice and

procedure, Drugs, Labeling, Medical

devices, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, the Public

Health Service Act, and under authority

delegated to the Commissioner of Food

and Drugs, 21 CFR parts 200, 250, and

310 are amended as follows:

PART 200—GENERAL

1. The authority citation for 21 CFR

part 200 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 508, 515, 701, 704, 705 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 331, 351, 352, 353, 355, 356, 357,

358, 360e, 371, 374, 375).

Subpart B [Removed]

2. Subpart B, consisting of §§ 200.30

and 200.31 is removed and reserved.

PART 250—SPECIAL REQUIREMENTS

FOR SPECIFIC HUMAN DRUGS

3. The authority citation for 21 CFR

part 250 continues to read as follows:

Authority: Secs. 201, 306, 402, 502, 503,

505, 601(a), 602(a) and (c), 701, 705(b) of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 336, 342, 352, 353, 355, 361(a),

362(a) and (c), 371, 375(b)).

§ 250.10 [Removed]

4. Section 250.10 Oral prenatal drugs

containing fluorides intended for

human use is removed.

§ 250.103 [Removed]

5. Section 250.103 Thorium dioxide

for drug use is removed.

§ 250.106 [Removed]

6. Section 250.106 Cobalt

preparations intended for use by man is

removed.

PART 310—NEW DRUGS

7. The authority citation for 21 CFR

part 310 continues to read as follows:

Authority: Secs. 201, 301, 501, 502, 503,

505, 506, 507, 512–516, 520, 601(a), 701, 704,

705, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352,

353, 355, 356, 357, 360b–360f, 360j, 361(a),

371, 374, 375, 379e); secs. 215, 301, 302(a),

351, 354–360F of the Public Health Service

Act (42 U.S.C. 216, 241, 242(a), 262, 263b–

263n).

8. Section 310.502 is revised to read

as follows:

§ 310.502 Certain drugs accorded new

drug status through rulemaking

procedures.

(a) The drugs listed in this paragraph

(a) have been determined by rulemaking

procedures to be new drugs within the

meaning of section 201(p) of the act.

Except as provided in paragraph (b) of

this section, an approved new drug

application under section 505 of the act

and part 314 of this chapter is required

for marketing the following drugs:

(1) Aerosol drug products for human

use containing 1,1,1-trichloroethane.

(2) Aerosol drug products containing

zirconium.

(3) Amphetamines (amphetamine,

dextroamphetamine, and their salts, and

levamfetamine and its salts) for human

use.

(4) Camphorated oil drug products.

(5) Certain halogenated salicylanilides

(tribromsalan (TBS, 3,4′,5-

tribromosalicylanilide), dibromsalan

(DBS, 4′, 5-dibromosalicylanilide),

metabromsalan (MBS, 3, 5-

dibromosalicylanilide), and 3,3′, 4,5′-

tetrachlorosalicylanilide (TC–SA)) as an

ingredient in drug products.

(6) Chloroform used as an ingredient

(active or inactive) in drug products.

(7) Cobalt preparations intended for

use by man.

(8) Intrauterine devices for human use

for the purpose of contraception that

incorporate heavy metals, drugs, or

other active substances.

(9) Oral prenatal drugs containing

fluorides intended for human use.

(10) Parenteral drug products in

plastic containers.

(11) Sterilization of drugs by

irradiation.

(12) Sweet spirits of nitre drug

products.

(13) Thorium dioxide for drug use.

(14) Timed release dosage forms.

(15) Vinyl chloride as an ingredient,

including propellant, in aerosol drug

products.

(b) Any drug listed in paragraph (a) of

this section, when composed wholly or

partly of any antibiotic drug, must be

certified under section 507 of the act or

exempted from certification under

section 507 of the act for marketing.

§ 310.504 [Removed]

9. Section 310.504 Amphetamines

(amphetamine, dextroamphetamine,

and their salts and levamfetamine and

its salts) for human use is removed.

§ 310.506 [Removed]

10. Section 310.506 Use of vinyl

chloride as an ingredient, including

propellant, of aerosol drug products is

removed.

§ 310.507 [Removed]

11. Section 310.507 Aerosol drug

products for human use containing

1,1,1-trichloroethane is removed.

§ 310.508 [Removed]

12. Section 310.508 Use of certain

halogenated salicylanilides as an

inactive ingredient in drug products is

removed.

13. Section 310.509 is revised to read

as follows:

§ 310.509 Parenteral drug products in

plastic containers.

(a) Any parenteral drug product

packaged in a plastic immediate

container is not generally recognized as

safe and effective, is a new drug within

the meaning of section 201(p) of the act,

and requires an approved new drug

application as a condition for marketing.

An ‘‘Investigational New Drug

Application’’ set forth in part 312 of this

chapter is required for clinical

investigations designed to obtain

evidence of safety and effectiveness.

(b) As used in this section, the term

‘‘large volume parenteral drug product’’

means a terminally sterilized aqueous

drug product packaged in a single-dose

container with a capacity of 100

milliliters or more and intended to be

administered or used intravenously in a

human.

(c) Until the results of compatibility

studies are evaluated, a large volume

parenteral drug product for intravenous

use in humans that is packaged in a

plastic immediate container on or after

April 16, 1979, is misbranded unless its

labeling contains a warning that

includes the following information:

(1) A statement that additives may be

incompatible.

(2) A statement that, if additive drugs

are introduced into the parenteral

system, aseptic techniques should be

used and the solution should be

thoroughly mixed.
Federal Register / Vol. 62, No. 50 / Friday, March 14, 1997 / Rules and Regulations 12085

(3) A statement that a solution

containing an additive drug should not

be stored.

(d) This section does not apply to a

biological product licensed under the

Public Health Service Act of July 1,

1944 (42 U.S.C. 201).

§ 310.510 [Removed]

14. Section 310.510 Use of aerosol

drug products containing zirconium is

removed.

§ 310.513 [Removed]

15. Section 310.513 Chloroform, use

as an ingredient (active or inactive) in

drug products is removed.

§ 310.525 [Removed]

16. Section 310.525 Sweet spirits of

nitre drug products is removed.

§ 310.526 [Removed]

17. Section 310.526 Camphorated oil

drug products is removed.

Dated: March 7, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–6411 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lufenuron Tablet

AGENCY: Food and Drug Administration,

HHS.

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 CibaGeigy Animal Health, Ciba-Geigy Corp.

The supplemental NADA provides for

oral administration of lufenuron tablets

at a minimum dose of 30 milligrams per

kilogram (mg/kg) for the control of flea

populations on cats.

EFFECTIVE DATE: March 14, 1997.

FOR FURTHER INFORMATION CONTACT:

Marcia K. Larkins, Center for Veterinary

Medicine (HFV–112), Food and Drug

Administration, 7500 Standish P1.,

Rockville, MD 20855, 301–594–0614.

SUPPLEMENTARY INFORMATION: CibaGeigy Animal Health, Ciba-Geigy Corp.,

P.O. Box 18300, Greensboro, NC 27419–

8300, filed supplemental NADA 141–

035, which provides for oral

administration of Program (lufenuron)

tablets to cats 6 weeks of age or older.

The drug is approved in 90- or 204.9-mg

tablets, given once a month, directly or

broken and mixed into wet food, for the

control of flea populations. Lufenuron

has no deleterious effect on adult fleas

but it prevents most flea eggs from

hatching or maturing into adults. The

supplemental NADA is approved as of

January 23, 1997, and the regulations

are amended in 21 CFR 520.1288 by

revising the heading for paragraph (c)

and by adding new paragraph (d) to

reflect the approval. The basis for

approval is discussed in the freedom of

information summary.

In accordance with the freedom of

information provisions of 21 CFR part

20 and 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, 12420 Parklawn Dr.,

rm. 1–23, 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 qualifies for 3 years of

marketing exclusivity beginning January

23, 1997, because the application

contains substantial evidence of

effectiveness of the drug involved,

studies of animal safety or, in the case

of food-producing animals, human food

safety studies (other than

bioequivalence or residue studies)

required for approval and conducted or

sponsored by the applicant.

The agency has determined under 21

CFR 25.24(d)(1)(iii) that this action is of

a type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

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 520.1288 is amended by

revising the heading for paragraph (c)

and by adding new paragraph (d) to read

as follows:

§ 520.1288 Lufenuron tablets.

* * * * *

(c) Conditions of use in dogs—

* * * * *

(d) Conditions of use in cats—(1)

Amount. 90-milligram tablet for cats up

to 6 pounds of body weight, 204.9-

milligram tablet for cats 7 to 15 pounds,

a combination of tablets for cats over 15

pounds (a minimum of 13.6 milligrams

per pound (30 milligrams per

kilogram)).

(2) Indications for use. For control of

flea populations.

(3) Limitations. For oral use in cats 6

weeks of age or older, once a month,

directly or broken and mixed into wet

food. Administer in conjunction with a

full meal to ensure adequate absorption.

Treat all cats in the household to ensure

maximum benefits. Because the drug

has no affect on adult fleas, the

concurrent use of insecticides that kill

adults may be necessary depending on

the severity of the infestation.

Dated: February 11, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–6412 Filed 3–13–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 556 and 558

Animal Drugs, Feeds, and Related

Products; Chlortetracycline and

Tiamulin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Fermenta

Animal Health Co. The NADA provides

for the use of separately approved Type

A medicated articles containing

chlortetracycline and tiamulin in

making Type C combination medicated

feed. The feed is used in swine for

treatment of bacterial enteritis and

bacterial pneumonia and for control of

swine dysentery. The regulations are

also amended to increase the tolerance

for tiamulin residue in swine liver.

EFFECTIVE DATE: March 14, 1997

FOR FURTHER INFORMATION CONTACT:

George K. Haibel, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: Fermenta

Animal Health Co., 10150 North

Executive Hills Blvd., Kansas City, MO

64153–2314, filed NADA 141–011,