34724 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Rules and Regulations

Regulatory Policies and Procedures (44

FR 11034; 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 Subjects 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 part 71

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40103, 40113,

40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–

1963 Comp., p. 389; 14 CFR 11.69

§ 71.1 [Amended]

2. The incorporation by reference in

14 CFR 71.1 of the Federal Aviation

Administration Order 7400.9C, Airspace

Designations and Reporting Points,

dated August 17, 1995, and effective

September 16, 1995, is amended as

follows:

Paragraph 6010(a) Domestic VOR Federal

Airways

* * * * *

V–163 [Revised]

From Matamoros, Mexico; via Brownsville,

TX; 27 miles standard width, 37 miles 7

miles wide (3 miles E and 4 miles W of

centerline); Corpus Christi, TX; Three

Rivers, TX; INT Three Rivers 345° and

San Antonio, TX, 168° radials; San

Antonio; Lampasas, TX; Glen Rose, TX;

Millsap, TX; Bowie, TX; Ardmore, OK; to

Will Rogers, OK. The airspace within

Mexico is excluded.

* * * * *

V–194 [Revised]

From Cedar Creek, TX; College Station, TX;

INT College Station 151° and Hobby, TX,

290° radials; Hobby; Sabine Pass, TX;

Lafayette, LA; Baton Rouge, LA;

McComb, MS; INT McComb 055° and

Meridian, MS; 221° radials; Meridian.

From Liberty, NC, via Raleigh-Durham,

NC; Tar River, NC, Cofield, NC, to INT

Cofield 077° and Norfolk, VA, 209°

radials.

* * * * *

V–278 [Revised]

From Texico, NM, via Plainview, TX;

Guthrie, TX; Bowie, TX; Bonham, TX;

Paris, TX; Texarkana, AR; Monticello,

AR; Greenville, MS; Sidon, MS; Bigbee,

MS; to Vulcan, AL.

* * * * *

V–355 [Revised]

From Bowie, TX; to Wichita Falls, TX.

* * * * *

V–358 [Revised]

From San Antonio, TX, via Stonewall, TX;

Lampasas, TX; INT Lampasas 041° and

Waco, TX, 249° radials; Waco; Glen

Rose, TX; Millsap, TX; Bowie, TX;

Ardmore, OK; INT Ardmore 327° and

Will Rogers, OK, 195° radials; to Will

Rogers.

* * * * *

V–369 [Revised]

From Dallas-Fort Worth, TX; to Navasota, TX.

* * * * *

V–477 [Revised]

From Leona, TX; to Cedar Creek, TX.

* * * * *

V–568 [Revised]

From Corpus Christi, TX, via INT Corpus

Christi 296° and Three Rivers, TX, 165°

radials; Three Rivers; INT Three Rivers

327° and San Antonio, TX, 183° radials;

San Antonio; Stonewall, TX; Llano, TX;

INT Llano 026° and Glen Rose, TX, 216°

radials; Glen Rose; Millsap, TX; to

Wichita Falls, TX.

V–569 [Revised]

From Beaumont, TX, via INT Beaumont 338°

and Lufkin, TX, 146° radials; Lufkin;

Frankston, TX; to Cedar Creek, TX.

* * * * *

V–571 [Revised]

From Humble, TX, via Navasota, TX; Leona,

TX; INT Leona 331° and Cedar Creek,

TX, 186° radials; to Cedar Creek.

* * * * *

V–583 [Revised]

From Austin, TX; INT Austin 062° and

College Station, TX, 270° radials; College

Station; Leona, TX; Frankston, TX;

Quitman, TX; Paris, TX; to McAlester,

OK.

* * * * *

Issued in Washington, DC, on June 25,

1996.

Nancy B. Kalinowski,

Acting Program Director for Air Traffic

Airspace Management.

[FR Doc. 96–17040 Filed 7–2–96; 8:45 am]

BILLING CODE 4910–13–P

Office of the Secretary

14 CFR Parts 211 and 213

RIN 2105–AC53

Aviation Economic Regulations:

Updates and Corrections

AGENCY: Office of the Secretary, DOT.

ACTION: Final rule.

SUMMARY: The Department is amending

14 CFR Parts 211 and 213 to eliminate

obsolete provisions and references, to

conform citations to the recodification

by Pub. L. 103–272 of the Federal

Aviation Act and other transportation

statutes, and to update organizational

titles.

EFFECTIVE DATE: The rule shall become

effective on August 2, 1996.

FOR FURTHER INFORMATION CONTACT:

George L. Wellington, Chief, Foreign Air

Carrier Licensing Division (X–45),

Office of International Aviation,

Department of Transportation, 400

Seventh Street, SW., Washington, DC

20590, (202) 366–2388.

SUPPLEMENTARY INFORMATION: In his

Regulatory Reinvention Initiative

Memorandum of March 4, 1995,

President Clinton directed Federal

agencies to conduct a page-by-page

review of all of their regulations and to

‘‘eliminate or revise those that are

outdated or otherwise in need of

reform.’’ In response to that directive,

the Department has undertaken a review

of its aviation economic regulations as

contained in 14 CFR Chapter II. This

rule is one result of those efforts.

This rule eliminates obsolete

provisions and references, conforms

citations to the recodification by Pub. L.

103–272 of the Federal Aviation Act and

other transportation statutes, and

updates organizational titles. The

Department finds that notice and

comment are unnecessary and contrary

to the public interest because of the

editorial nature of these changes.

Executive Order 12866 (Regulatory

Planning and Review)

The Department has analyzed the

economic and other effects of the final

rule and has determined that they are

not ‘‘significant’’ within the meaning of

Executive Order 12866. The rule has

not, therefore, been reviewed by the

Office of Management and Budget.

DOT Regulatory Policies and

Procedures

The final rule is not significant under

the Department’s Regulatory Policies

and Procedures, dated February 26,

1979, because it does not involve
Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Rules and Regulations 34725

important Departmental policies; rather,

the changes are being made solely for

the purposes of eliminating obsolete

requirements, correcting out-of-date

references, and enhancing the

organization of the regulations used by

the Department to administer its

aviation economic regulatory functions.

The Department has also determined

that there will be no economic impact

as a result of these changes.

Regulatory Flexibility Act

In accordance with the Regulatory

Flexibility Act, I certify that the

amendments will not have a significant

economic impact on a substantial

number of small entities. The changes

are editorial in nature and will have no

substantive impact.

Executive Order 12612 (Federalism)

The final rule has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612. The Department has determined

that the rule does not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

The amendments will not have a

substantial direct effect on the States, on

the relationship between the national

government and the States, or on the

distribution of power and

responsibilities among the various

levels of government.

National Environmental Policy Act

The Department has also analyzed the

rule for the purpose of the National

Environmental Policy Act. The rule will

not have any significant impact on the

quality of the human environment.

Paperwork Reduction Act

There are no reporting or

recordkeeping requirements associated

with the final rule.

Lists of Subjects

14 CFR Part 211

Foreign air carriers, Economic

authority, Transportation Department.

14 CFR Part 213

Foreign air carriers, Economic

authority, Transportation Department.

Final Rule

For the reasons set out in the

preamble, Title 14, Chapter II of the

Code of Federal Regulations is amended

as follows:

PART 211—[AMENDED]

1. The authority citation for part 211

is revised to read as follows:

Authority: 49 U.S.C. Chapters 401, 411,

413, 415, 417.

2. Throughout the part, remove the

words ‘‘Board’’ and ‘‘Board’s’’ wherever

they appear, and add, in their place, the

words ‘‘Department’’ and

‘‘Department’s.’’ Remove the words

‘‘Docket Section,’’ and add, in their

place, the words ‘‘Docket Facility.’’

§ 211.1 [Amended]

3. In § 211.1, remove the words

‘‘section 402 of the Federal Aviation

Act’’ and add, in their place, the words

‘‘section 41301 of Title 49 of the United

States Code (Transportation).’’

§ 211.10 [Amended]

4. In § 211.10(b), remove the words

‘‘Regulatory Affairs Division, Bureau of

International Aviation, Civil

Aeronautics Board, Washington, DC

20428,’’ and add, in their place, the

words ‘‘Foreign Air Carrier Licensing

Division, Office of International

Aviation, Department of Transportation,

400 Seventh Street, SW., Washington,

DC 20590.’’

§ 211.20 [Amended]

5. In § 211.20(t), remove the words

‘‘CAB form 263,’’ and add, in their

place, the words ‘‘OST Form 4523.’’

Subpart D—[Amended]

6. Throughout subpart D of part 211,

remove the words ‘‘overseas,’’ ‘‘overseas

and interstate,’’ ‘‘overseas or interstate,’’

‘‘interstate and overseas’’, and

‘‘interstate or overseas,’’ wherever they

appear, and add, in their place, the

word ‘‘interstate.’’

§ 211.33 [Amended]

7. In § 211.33(c), remove the words

‘‘section 801(a)’’ and add in their place

the words ‘‘section 41307.’’

PART 213—[AMENDED]

8. The authority citation for part 213

is revised to read as follows:

Authority: 49 U.S.C. Chapters 401, 411,

413, 415, 417.

9. Throughout the part, remove the

words ‘‘Board’’ and ‘‘Board’s’’ wherever

they appear, and add, in their place, the

words ‘‘Department’’ and

‘‘Department’s.’’ Remove the words

‘‘Docket Section,’’ and add, in their

place, the words ‘‘Docket Facility.’’

§ 213.1 [Amended]

10. In § 213.1, remove the words

‘‘section 402 permits authorizing foreign

direct air carriers to engage in’’ and add,

in their place, the words ‘‘foreign air

carrier permits issued under section

41302 of Title 49 of the United States

Code (Transportation) authorizing.’’

Remove the entire sentence that begins

with ‘‘Notwithstanding.’’

§ 213.3 [Amended]

11. In § 213.3(f), remove the words

‘‘section 1005(b) of the Act,’’ and add,

in their place, the words ‘‘49 U.S.C.

46103.’’

§ 213.5 [Amended]

12. The heading of § 213.5 is revised

to read as follows:

§ 213.5 Filing and service of schedules

and applications for approval of schedules;

procedure thereon.

* * * * *

13. In § 213.5(a), remove the words

‘‘each airport notice or,’’ and ‘‘each

application for permission to use an

airport (§ 213.4(b)) or.’’ Remove the

words ‘‘19 copies,’’ and add, in their

place, the words ‘‘seven (7) copies.’’

Remove the entire sentence that begins

with ‘‘Each airport notice or application

. . .’’

14. Section 213.5(b) is revised to read

as follows:

* * * * *

(b) Pleadings by interested persons.

Any interested person may file and

serve upon the foreign air carrier a

memorandum in opposition to, or in

support of, schedules or an application

for approval of schedules within 10

days of the filing opposed or supported.

All memoranda shall set forth in detail

the reasons for the position taken

together with a statement of economic

data and other matters which it is

desired that the Department officially

notice, and affidavits stating other facts

relied upon. Memoranda shall contain a

certificate of service as prescribed in

paragraph (a) of this section. An

executed original and seven (7) true

copies shall be filed with the

Department’s Docket Facility. Unless

otherwise provided by the Department,

further pleadings will not be

entertained.

* * * * *

15. In § 213.5(c), remove the words

‘‘for permission to use an airport or.’’

Remove the entire sentence beginning

with ‘‘Petitions for reconsideration of

the Board’’ determination on an

application for permission to use an

airport . . .’’

§ 213.6 [Amended]

16. In § 213.6, remove the words

‘‘Title IV of the Act’’ and add in their

place the words ‘‘Subtitle VII of Title 49

of the U.S. Code.’’

§ 213.7 [Amended]

17. In § 213.7, remove the

abbreviation ‘‘CAB’’ before the word

‘‘Agreement.’’ Remove the words ‘‘CAB

form 263,’’ and add, in their place, the

words ‘‘OST Form 4523’’, and remove
34726 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Rules and Regulations

the words ‘‘Publications Services

Division, Civil Aeronautics Board,

Washington, DC 20428,’’ and add in

their place the words ‘‘Foreign Air

Carrier Licensing Division (X–45),

Office of International Aviation,

Department of Transportation, 400

Seventh Street, SW., Washington, DC

20590.

Issued in Washington, DC, on May 31,

1996.

Charles A. Hunnicutt,

Assistant Secretary for Aviation and

International Affairs.

[FR Doc. 96–16808 Filed 7–2–96; 8:45 am]

BILLING CODE 4910–62–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 452

[Docket No. 96N–0117]

Antibiotic Drugs; Clarithromycin

Granules for Oral Suspension

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

antibiotic drug regulations to include

accepted standards for clarithromycin

for its use in a new dosage form of

clarithromycin, clarithromycin granules

for oral suspension. The manufacturer

has supplied sufficient data and

information to establish its safety and

efficacy.

DATES: Effective August 2, 1996;

comments, notice of participation, and a

request for hearing by August 2, 1996;

data, information, and analyses to

justify a hearing by September 3, 1996.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

James M. Timper, Center for Drug

Evaluation and Research (HFD–520),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2193.

SUPPLEMENTARY INFORMATION: FDA has

evaluated data submitted in accordance

with regulations issued under section

507 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 357), as

amended, with respect to a request for

approval of a new dosage form of

clarithromycin, clarithromycin granules

for oral suspension. The agency has

concluded that the data supplied by the

manufacturer concerning this antibiotic

dosage form are adequate to establish

the safety and efficacy when used as

directed in the labeling and that the

regulations should be amended in part

452 (21 CFR part 452) to include

accepted standards for this product.

Environmental Impact

The agency has determined under 21

CFR 25.24(c)(6) 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.

Submitting Comments and Filing

Objections

This final rule announces standards

that FDA has accepted in a request for

approval of an antibiotic drug. Because

this final rule is not controversial and

because, when effective, it provides

notice of accepted standards, FDA finds

that notice and comment procedure is

unnecessary and not in the public

interest. This final rule, therefore, is

effective August 2, 1996. However,

interested persons may, on or before

August 2, 1996, submit comments to the

Dockets Management Branch (address

above). 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 Dockets Management Branch

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

through Friday.

Any person who will be adversely

affected by this final rule may file

objections to it and request a hearing.

Reasonable grounds for the hearing

must be shown. Any person who

decides to seek a hearing must file (1)

on or before August 2, 1996, a written

notice of participation and request for a

hearing, and (2) on or before September

3, 1996, the data, information, and

analyses on which the person relies to

justify a hearing, as specified in 21 CFR

314.300. A request for a hearing may not

rest upon mere allegations or denials,

but must set forth specific facts showing

that there is a genuine and substantial

issue of fact that requires a hearing. If

it conclusively appears from the face of

the data, information, and factual

analyses in the request for a hearing that

no genuine and substantial issue of fact

precludes the action taken by this order,

or if a request for hearing is not made

in the required format or with the

required analyses, the Commissioner of

Food and Drugs will enter summary

judgment against the person(s) who

request(s) the hearing, making findings

and conclusions and denying a hearing.

All submissions must be filed in three

copies, identified with the docket

number appearing in the heading of this

order and filed with the Dockets

Management Branch.

The procedures and requirements

governing this order, a notice of

participation and request for a hearing,

a submission of data, information, and

analyses to justify a hearing, other

comments, and grant or denial of a

hearing are contained in 21 CFR

314.300.

All submissions under this order,

except for data and information

prohibited from public disclosure under

21 U.S.C. 331(j) or 18 U.S.C. 1905, 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 452

Antibiotics.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 452 is

amended as follows:

PART 452—MACROLIDE ANTIBIOTIC

DRUGS

1. The authority citation for 21 CFR

part 452 continues to read as follows:

Authority: Sec. 507 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 357).

§ 452.150a [Redesignated from § 452.150]

2. Section 452.150 is redesignated as

§ 452.150a and new §§ 452.150 and

452.150b are added to subpart B to read

as follows:

§ 452.150 Clarithromycin oral dosage

forms.

§ 452.150b Clarithromycin granules for

oral suspension.

(a) Requirements for certification—(1)

Standards of identity, strength, quality,

and purity. Clarithromycin granules for

oral suspension is a dry mixture

containing clarithromycin-coated

particles, suitable and harmless

dispersing agents, diluents,

preservatives, and flavorings. It contains

the equivalent of 25 or 50 milligrams of

clarithromycin activity per milliliter of

the reconstituted suspension. Its

potency is satisfactory if it is not less

than 90 percent and not more than 115

percent of the number of milligrams of

clarithromycin that it is represented to

contain. Its loss on drying is not more

than 2.0 percent. When constituted as

directed in the labeling, its pH is not

less than 4.0 nor more than 5.4. The