39438 Federal Register / Vol. 62, No. 141 / Wednesday, July 23, 1997 / Rules and Regulations

depiction on charts printed by

publishers of aeronautical materials.

Thus, the advantages of incorporation

by reference are realized and

publication of the complete description

of each SIAP contained in FAA form

documents is unnecessary. The

provisions of this amendment state the

affected CFR (and FAR) sections, with

the types and effective dates of the

SIAPs. This amendment also identifies

the airport, its location, the procedure

identification and the amendment

number.

The Rule

This amendment to part 97 is effective

upon publication of each separate SIAP

as contained in the transmittal. Some

SIAP amendments may have been

previously issued by the FAA in a

National Flight Data Center (FDC)

Notice to Airmen (NOTAM) as an

emergency action of immediate flight

safety relating directly to published

aeronautical charts. The circumstances

which created the need for some SIAP

amendments may require making them

effective in less than 30 days. For the

remaining SIAPs, an effective date at

least 30 days after publication is

provided.

Further, the SIAPs contained in this

amendment are based on the criteria

contained in the U.S. Standard for

Terminal Instrument Approach

Procedures (TERPS). In developing

these SIAPs, the TERPS criteria were

applied to the conditions existing or

anticipated at the affected airports.

Because of the close and immediate

relationship between these SIAPs and

safety in air commerce, I find that notice

and public procedure before adopting

these SIAPs are impracticable and

contrary to the public interest and,

where applicable, that good cause exists

for making some SIAPs effective in less

than 30 days.

The FAA has determined that this

regulation only involves an established

body of technical regulations for which

frequent and routine amendments are

necessary 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 11034; February 26, 1979); and (3)

does not warrant preparation of a

regulatory evaluation as the anticipated

impact is so minimal. For the same

reason, the FAA certifies that this

amendment 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 97

Air Traffic Control, Airports,

Navigation (Air).

Issued in Washington, DC on June 27,

1997.

Richard O. Gordon,

Acting Director, Flight Standards Service.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me, part 97 of the

Federal Aviation Regulations (14 CFR

part 97) is amended by establishing,

amending, suspending, or revoking

Standard Instrument Approach

Procedures, effective at 0901 UTC on

the dates specified, as follows:

PART 97—STANDARD INSTRUMENT

APPROACH PROCEDURES

1. The authority citation for part 97 is

revised to read as follows:

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

40120, 44701; and 14 CFR 11.49(b)(2).

2. Part 97 is amended to read as

follows:

§§ 97.23, 97.25, 97.27, 97.29, 97.31, 97.33,

97.35 [Amended]

By amending: § 97.23 VOR, VOR/

DME, VOR or TACAN, and VOR/DME

or TACAN; § 97.25 LOC, LOC/DME,

LDA, LDA/DME, SDF, SDF/DME;

§ 97.27 NDB; NDB/DME; § 97.29 ILS,

ILS/DME, ISMLS, MLS, MLS/DME,

MLS/RNAV; § 97.31 RADAR SIAPs;

§ 97.33 RNAV SIAPs; and § 97.35

COPTER SIAPs, identified as follows:

* * * Effective July 17, 1997

Caldwell, ID, Caldwell Industrial, GPS RWY

12, Orig

Caldwell, ID, Caldwell Industrial, GPS RWY

30, Orig

Flemingsburg, KY, Fleming-Mason, NDB

RWY 25, Orig

Lumberton, NC, Lumberton Muni, VOR RWY

5, Amdt 8

Lumberton, NC, Lumberton Muni, VOR or

GPS RWY 13, Amdt 9

Lumberton, NC, Lumberton Muni, NDB or

GPS RWY 5, Amdt 1

Lumberton, NC, Lumberton Muni, NDB RWY

13, Amdt 8

Lumberton, NC, Lumberton Muni, ILS RWY

5, Orig

Houston, TX, Ellington Field, ILS RWY 17R,

Amdt 4

Houston, TX, Ellington Field, ILS RWY 22,

Amdt 2

Houston, TX, Ellington Field, ILS RWY 35L,

Amdt 4

* * * Effective August 14, 1997

San Francisco, CA, San Francisco Intl, BAY

ILS/DME RWY 28L, Amdt 1, CANCELLED

Chicago/Prospect Hgts/Wheeling, IL,

Palwaukee Muni, VOR RWY 16, Orig

Chicago/Prospect Hgts/Wheeling, IL,

Palwaukee Muni, ILS RWY 16, Orig

Chicago/Wheeling, IL, Palwaukee Muni, VOR

OR GPS RWY 16, Amdt 19, CANCELLED

Chicago/Wheeling, IL, Palwaukee Muni, ILS

RWY 16, Amdt 6, CANCELLED

Minneapolis, KS, Minneapolis City County,

VOR/DME RWY 34, Orig. CANCELLED

Ft Mead (Odenton), MD, Col William F.

(Shorty) Tipton, NDB OR GPS RWY 10,

Orig CANCELLED

Jefferson City, MO, Jefferson City Memorial,

NDB RWY 30, Amdt 8A, CANCELLED

Newark, NJ, Newark Intl, ILS RWY 22R,

Amdt 1

* * * Effective September 11, 1997

Davis/Woodland/Winters, CA, Yolo CountyDavis/Woodland/Winters, GPS RWY 34,

Orig

Davis/Woodland/Winters, CA, Yolo CountyDavis/Woodland/Winters, VOR RWY 16,

Orig

Davis/Woodland/Winters, CA, Yolo CountyDavis/Woodland/Winters, GPS RWY 34,

Orig

Livermore, CA, Livermore Muni, GPS RWY

25R, Orig

Ramona, CA, Ramona, VOR/DME OR GPS–A,

Amdt 1

Truckee, Truckee-Tahoe, CA, GPS RWY 19,

Orig

Beverly, MA, Beverly Muni, GPS RWY 16,

Orig

South St. Paul, MN, South St Paul MuniRichard E Fleming Fld, GPS RWY 34, Orig

Montgomery, NY, Orange County, VOR OR

GPS RWY 8, Amdt 8

Montgomery, NY, Orange County, NDB RWY

3, Amdt 3

Montgomery, NY, Orange County, GPS RWY

3, Orig

Gallipolis, OH, Gallia-Meigs Regional, GPS

RWY 23, Orig

Bay City, TX, Bay City Muni, GPS RWY 31,

Orig

Petersburg, WV, Grant County, GPS RWY 31,

Orig

[FR Doc. 97–19359 Filed 7–22–97; 8:45 am]

BILLING CODE 4910–13–M

INTERNATIONAL TRADE

COMMISSION

19 CFR Part 201

Initiation and Conduct of

Investigations

CFR Correction

In Title 19 of the Code of Federal

Regulations, parts 200 to end, revised as

of April 1, 1997, make the following

correction.

On page 21, the text of § 201.7 is

incorrect. The text should appear as

follows:

§ 201.7 Investigative authority and

initiation of investigations.

(a) Investigative authority. In order to

expedite the performance of its

functions, the Commission may engage

in investigative activities preliminary to

and in aid of any authorized
Federal Register / Vol. 62, No. 141 / Wednesday, July 23, 1997 / Rules and Regulations 39439

investigation, consolidate proceedings

before it, and determine the scope and

manner of its proceedings;

(b) Initiation of investigations.

Investigations may be initiated by the

Commission on the Commission’s own

motion, upon request of the President or

the Special Representative for Trade

Negotiations, upon resolution of the

Committee on Ways and Means of the

House of Representatives or the

Committee on Finance of the Senate,

upon resolution of either branch of

Congress, or upon application, petition,

complaint, or request of private parties,

as required or provided for in the

pertinent statute, Presidential

proclamation, Executive Order, or in

this chapter.

[44 FR 76476, Dec. 26, 1979]

[FR Doc. 97–55555 Filed 7–22–97; 8:45 am]

BILLING CODE 1505–01–D

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1 and 50

[Docket No. 95N–0340]

RIN 0910–AA54

Revocation of Certain Regulations;

General

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is revoking

certain regulations that are obsolete or

no longer necessary to achieve public

health goals. These regulations have

been identified for revocation as the

result of a page-by-page review of the

agency’s regulations. This regulatory

review is in response to the

Administration’s ‘‘Reinventing

Government’’ initiative which seeks to

streamline government to ease the

burden on regulated industry and

consumers.

EFFECTIVE DATE: August 22, 1997.

FOR FURTHER INFORMATION CONTACT:

Regarding the regulations mentioned

in this document: Philip L. Chao,

Policy Development and

Coordination Staff (HF–23), Food

and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–3380.

Regarding general information on

FDA’s ‘‘reinventing initiative:’’ Lisa

M. Helmanis, Regulations Policy

Management Staff (HF–26), Food

and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–3480.

SUPPLEMENTARY INFORMATION: On March

4, 1995, President Clinton announced

plans for reforming the Federal

regulatory system as part of his

‘‘Reinventing Government’’ initiative. In

his March 4 directive, the President

ordered all Federal agencies to conduct

a page-by-page review of their

regulations and to ‘‘eliminate or revise

those that are outdated or otherwise in

need of reform.’’ In the Federal Register

of January 25, 1996 (61 FR 2192), FDA

issued a proposal to revoke certain

obsolete and unnecessary regulations.

The proposal represented FDA’s

continuing effort to implement the

President’s plan and followed other

proposals in previous issues of the

Federal Register revoking or revising

other FDA regulations.

The following is a section-by-section

analysis of the regulations that FDA

proposed to revoke and any comments

or issues associated with those

regulations. These regulations are listed

numerically as they appear in title 21 of

the Code of Federal Regulations (CFR).

I. Section-by-Section Analysis

(1) Section 1.31 Package size saving

(21 CFR 1.31) addressing economy size

packaging. FDA proposed to revoke this

provision because it is obsolete, and

FDA is not aware of its recent use.

FDA received one comment on this

provision, and the comment expressed

no objection to revoking this provision.

Consequently, § 1.31 is revoked.

(2) Section 1.35 ‘‘Cents-off,’’ or other

savings representations (21 CFR 1.35)

prohibiting the placement of any

printed matter stating or representing by

implication that a product is offered for

sale at a price that is lower than the

ordinary and customary retail price.

FDA proposed to revoke this provision

because it is obsolete, and FDA is not

aware of its recent use.

FDA received one comment on this

provision, and the comment expressed

no objection to revoking this provision.

Consequently, the agency has revoked

§ 1.35.

(3) Section 2.5 Imminent hazard to

the public health (21 CFR 2.5) describes

the criteria that the Commissioner of

Food and Drugs would use in

determining whether an imminent

hazard exists. FDA issued this

regulation in the Federal Register of

July 1, 1971 (36 FR 12516). FDA

proposed to revoke § 2.5 in the Federal

Register of August 21, 1979 (44 FR

48983), in conjunction with broader

rulemaking proceedings that would

have established by regulation, among

other things, certain criteria for the

Secretary of Health and Human

Services’ (the Secretary) determination

of an imminent hazard. FDA later

withdrew the 1979 proposed rule on

January 20, 1994 (59 FR 3042).

However, the principle upon which

FDA based its proposed withdrawal of

§ 2.5 in 1979 is still valid, namely, that

it is ‘‘potentially confusing to have

criteria for FDA’s recommendations to

the Secretary separate from the criteria

for the Secretary’s decision’’ (44 FR

48983 at 48985). The criteria used by

the Secretary in finding an imminent

hazard were established in 1977 in the

Secretary’s decision declaring

phenformin hydrochloride to be an

imminent hazard. This decision was

upheld in Forsham v. Califano, 442

F.Supp. 203 (D. D.C. 1977).

Consequently, FDA again proposed to

revoke § 2.5 because it is potentially

confusing and no longer necessary (61

FR 2192).

The agency did not receive any

comments on the proposal to revoke

§ 2.5. However, upon further reflection,

FDA has decided to retain § 2.5 because

the terms ‘‘imminent hazard’’ appear in

several provisions of the Federal Food,

Drug, and Cosmetic Act (the act) and its

implementing regulations (see, e.g.,

section 402(f)(1)(C) of the act ( 21 U.S.C.

342(f)(1)(C)) (concerning adulteration of

dietary supplements); section 512(e)(1)

of the act (21 U.S.C. 360b(e)(1))

concerning withdrawals of approval of

animal drugs); section 802(f) of the act

(21 U.S.C. 382(f)) (concerning

prohibition of exports); 21 CFR

314.153(a)(1) (suspension of approval of

abbreviated new drug applications); 21

CFR 804.28(b)(3) (medical device

reporting for distributors)). Therefore, to

continue providing guidance in

interpreting these and other provisions

in the act and FDA regulations, the

agency is retaining § 2.5.

(4) 21 CFR part 10, subpart C,

Electronic Media Coverage of Public

Administrative Proceedings; Guideline

on Policy and Procedures, described

FDA’s policy on the presence and

operation of electronic recording

equipment at public proceedings. The

preamble to the proposed rule explained

that the subpart ‘‘is a statement of policy

and need not be codified. The

information is available to those

presiding over such proceedings

through appropriate agency publications

(e.g., Policy and Guidance Handbook for

FDA Advisory Committee Members’ and

from the staff in FDA’s Office of Public

Affairs’’ (61 FR 2192 and 2193).

FDA received one comment arguing

against deleting the subpart. The

comment explained that ‘‘policy can