Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 /Rules and Regulations 27207

From To MEA

*1200–MRA

Lakes, ND FIX .............................................................................. Jamestown, ND VOR/DME .......................................................... 3900

§ 95.6517 VOR Federal Airway 517 is Amended to Read in Part

London, KY VORTAC ................................................................... Logic, KY FIX ............................................................................... 3300

Logic, KY FIX ................................................................................ Falmouth, KY VOR/DME .............................................................. 2800

§ 95.6607 VOR Federal Airway 607 is Added to Read

Mendocino, CA VORTAC ............................................................. Yager, CA FIX .............................................................................. 9000

Yager, CA FIX .............................................................................. Arcata, CA VOR/DME .................................................................. 8000

Airway segment Changeover points

From To Distance From

§ 95.8003 VOR Federal Airways Changeover Points V–4 is Amended to Delete

Lexington, KY VORTAC .................................................... Newcombe, KY VORTAC ................................................ 37 Lexington.

V–124 is Amended by Adding

Hot Springs, AR VOR/DME ............................................... Little Rock, AR VORTAC ................................................. 14 Hot

Springs.

V–430 is Amended by Adding

.

Devils Lake, ND VOR/DME ............................................... Minot, ND VORTAC ......................................................... 40 Devils Lake.

V–493 is Amended to Delete

Lexington, Ky VORTAC ..................................................... York, KY VORTAC ........................................................... 41 Lexington.

[FR Doc. 98–12997 Filed 5–15–98; 8:45 am]

BILLING CODE 4910–13–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 5

Delegations of Authority and

Organization; Center for Devices and

Radiological Health

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations for delegations of authority

to reflect a new delegation that

authorizes the Division Directors, Office

of Device Evaluation (ODE), Center for

Devices and Radiological Health (CDRH)

to approve, disapprove, or withdraw

approval of product development

protocols and applications for

premarket approval for medical devices.

EFFECTIVE DATE: May 18, 1998.

FOR FURTHER INFORMATION CONTACT:

Debra A. Baclawski, Center for

Devices and Radiological Health

(HFZ–026), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–443–

1060, or

Donna G. Page, Division of

Management Systems and Policy

(HFA–340), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

4816.

SUPPLEMENTARY INFORMATION: FDA is

amending the delegations of authority

regulation in subpart B of part 5 (21 CFR

part 5) by adding authorities to

additional officials within CDRH under

§ 5.53 Approval, disapproval, or

withdrawal of approval of product

development protocols and applications

for premarket approval for medical

devices. As a result of reengineering

initiatives within CDRH, for the

Premarket Approval and Product

Development Protocol Programs, this

delegation will improve the efficiency of

operations for these programs.

These authorities will not be further

redelegated at this time.

List of Subjects in 21 CFR Part 5

Authority delegations (Government

agencies), Imports, Organization and

functions (Government agencies).

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 5 is

amended as follows:

PART 5—DELEGATIONS OF

AUTHORITY AND ORGANIZATION

1. The authority citation for 21 CFR

part 5 continues to read as follows:

Authority: 5 U.S.C. 504, 552, App. 2; 7

U.S.C. 138a, 2271; 15 U.S.C. 638, 1261–1282,

3701–3711a; 15 U.S.C. 1451–1461; 21 U.S.C.

41–50, 61–63, 141–149, 321–394, 467f,

679(b), 801–886, 1031–1309; 35 U.S.C. 156;

42 U.S.C. 241, 242, 242a, 242l, 242n, 243,

262, 263, 264, 265, 300u–300u–5, 300aa–1,

1395y, 3246b, 4332, 4831(a), 10007–10008;

E.O. 11921, 41 FR 24294, 3 CFR, 1977 Comp.,

p. 124–131; E.O. 12591, 52 FR 13414, 3 CFR,

1988 Comp., p. 220–223.

2. Section 5.53 is amended by revising

paragraphs (a)(1) and (b)(1)(i) to read as

follows:

§ 5.53 Approval, disapproval, or

withdrawal of approval of product

development protocols and applications for

premarket approval for medical devices.

(a) * * *

(1) The Director and Deputy Directors,

Center for Devices and Radiological

Health (CDRH), the Director and Deputy

Directors, Office of Device Evaluation

(ODE), CDRH, and the Division

Directors, ODE, CDRH.

* * * * *

(b)(1) * * *
27208 Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 /Rules and Regulations

(i) The Director and Deputy Directors,

CDRH, the Director and Deputy

Directors, ODE, CDRH, and the Division

Directors, ODE, CDRH.

* * * * *

Dated: May 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13046 Filed 5–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Department of the Army

32 CFR Part 507

Manufacture, Sale, Wear, Commercial

Use and Quality Control of Heraldic

Items

AGENCY: Department of the Army, DoD.

ACTION: Final rule.

SUMMARY: This revision authorizes the

manufacture and sale of full size

military medals and decorations. In the

past the manufacture and sale of these

items was prohibited except under

Government contract through the

Defense Personnel Support Center. In

coordination with all the Services, the

Office of the Secretary of Defense

approved the manufacture and sale of

full size military medals and

decorations with the provision that no

version of the Medal of Honor can be

manufactured except under Government

contract with the Defense Personnel

Support Center. This rule also revises

the Department of the Army policy

(Army Regulation 672–8) governing the

manufacture, sale, reproduction,

possession, and wearing of military

decorations, medals, badges, and

insignia. This revision establishes

responsibility for authorizing the

incorporation of insignia designs in

commercial articles; adds procedures for

processing a request to use Army

insignia and the Army emblem design

in advertisement or promotional

materials; clarifies insignia items that

are controlled heraldic items; and

defines the certification process for

heraldic items. This revision has a

direct affect on Departments of the

Army and Air Force personnel who

design, procure from private industry

and who wear military insignia.

EFFECTIVE DATE: May 18, 1998.

ADDRESSES: Director, The Institute of

Heraldry, 9325 Gunston Road, Room S–

112, Fort Belvoir, Virginia 22060–5579.

FOR FURTHER INFORMATION CONTACT:

Stanley W. Haas, Chief, Technical and

Production Division, telephone (703)

806–4984.

SUPPLEMENTARY INFORMATION:

a. Background

The wear, manufacture, and sale of

decorations, medals, badges, and

insignia is restricted by 18 U.S.C. 701

and 704. The Institute of Heraldry, U.S.

Army has been designated to act in

behalf of the Department of Defense,

Department of the Army and

Department of the Air Force in

establishing regulations governing

control in manufacturing and quality.

The revision was previously announced

in the proposed rule section of the

Federal Register, Vol. 63, No. 47, Pages

11858–11862,Wednesday, March 11,

1998 for public comment.

b. Comments and Responses

No comments were received on the

proposed rule.

Executive Order 12866

This rule is not a major rule as

defined by Executive Order 12866.

Regulatory Flexibility Act

The Regulatory Flexibility Act has no

bearing on this rule.

Paperwork Reduction Act

This rule does not contain reporting

or record keeping requirements subject

to the Paperwork Reduction Act.

List of Subjects in 32 CFR Part 507

Decorations, Medals, Awards.

Accordingly, 32 CFR Part 507 is

revised to read as follows:

PART 507—MANUFACTURE AND

SALE OF DECORATIONS, MEDALS,

BADGES, INSIGNIA, COMMERCIAL

USE OF HERALDIC DESIGNS AND

HERALDIC QUALITY CONTROL

PROGRAM

Subpart A—Introduction

Sec.

507.1 Purpose.

507.2 References.

507.3 Explanation of abbreviations and

terms.

507.4 Responsibilities.

507.5 Statutory authority.

Subpart B—Manufacture and sale of

Decorations, Medals, Badges, and Insignia

507.6 Authority to manufacture.

507.7 Authority to sell.

507.8 Articles authorized for manufacture

and sale.

507.9 Articles not authorized for

manufacture or sale.

Subpart C—Commercial Use of Heraldic

Designs

507.10 Incorporation of designs or

likenesses of approved designs in

commercial articles.

507.11 Reproduction of designs.

507.12 Possession and wearing.

Subpart D—Heraldic Quality Control

Program

507.13 General.

507.14 Controlled heraldic items.

507.15 Certification of heraldic items.

507.16 Violations and penalties.

507.17 Procurement and wear of heraldic

items.

507.18 Processing complaints of alleged

breach of policies.

Authority: 10 U.S.C. 3012, 18 U.S.C. 701,

18 U.S.C. 702

Subpart A—Introduction

§ 507.1 Purpose.

This part prescribes the Department of

the Army and the Air Force policy

governing the manufacture, sale,

reproduction, possession, and wearing

of military decorations, medals, badges,

and insignia. It also establishes the

Heraldic Item Quality Control Program

to improve the appearance of the Army

and Air Force by controlling the quality

of heraldic items purchased from

commercial sources.

§ 507.2 References.

Related publications are listed in

paragraphs (a) through (f) of this section.

(A related publication is merely a source

of additional information. The user does

not have to read it to understand this

part). Copies of referenced publications

may be reviewed at Army and Air Force

Libraries or may be purchased from the

National Technical Information

Services, U.S. Department of Commerce,

5285 Port Royal Road, Springfield, VA

22161.

(a) AFI 36–2903, Dress and Personal

Appearance of Air Force Personnel.

(b) AR 360–5, Public Information.

(c) AR 670–1, Wear and Appearance

of Army Uniforms and Insignia.

(d) AR 840–1, Department of the

Army Seal, and Department of the Army

Emblem and Branch of Service Plaques.

(e) AR 840–10, Heraldic Activities,

Flags, Guidons, Streamers, Tabards and

Automobile Plates.

(f) AFR 900–3, Department of the Air

Force Seal, Organizational Emblems,

Use and Display of Flags, Guidons,

Streamers, and Automobile and Aircraft

Plates.

§ 507.3 Explanation of abbreviations and

terms.

(a) Abbreviations.

(1) AFB—Air Force Base.

(2) DA—Department of the Army.