Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Rules and Regulations 12737

State, local, or tribal governments in the

aggregate, and therefore a summary

statement or analysis under section

202(a) of the Unfunded Mandates

Reform Act of 1995 is not required.

VI. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effects 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. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

VII. Paperwork Reduction Act of 1995

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 888

Medical devices.

Therefore, under the Federal Food,

Drug, and Cosmetic Act, and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 888 is

amended as follows:

PART 888—ORTHOPEDIC DEVICES

1. The authority citation for 21 CFR

part 888 continues to read as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e,

360j, 371.

2. Section 888.3670 is added to

subpart D to read as follows:

§ 888.3670 Shoulder joint metal/polymer/

metal nonconstrained or semi-constrained

porous-coated uncemented prosthesis.

(a) Identification. A shoulder joint

metal/polymer/metal nonconstrained or

semi-constrained porous-coated

uncemented prosthesis is a device

intended to be implanted to replace a

shoulder joint. The device limits

movement in one or more planes. It has

no linkage across-the-joint. This generic

type of device includes prostheses that

have a humeral component made of

alloys such as cobalt-chromiummolybdenum (Co-Cr-Mo) and titaniumaluminum-vanadium (Ti-6Al-4V) alloys,

and a glenoid resurfacing component

made of ultra-high molecular weight

polyethylene, or a combination of an

articulating ultra-high molecular weight

bearing surface fixed in a metal shell

made of alloys such as Co-Cr-Mo and Ti6Al-4V. The humeral component and

glenoid backing have a porous coating

made of, in the case of Co-Cr-Mo

components, beads of the same alloy or

commercially pure titanium powder,

and in the case of Ti-6Al-4V

components, beads or fibers of

commercially pure titanium or Ti-6Al4V alloy, or commercially pure titanium

powder. The porous coating has a

volume porosity between 30 and 70

percent, an average pore size between

100 and 1,000 microns, interconnecting

porosity, and a porous coating thickness

between 500 and 1,500 microns. This

generic type of device is designed to

achieve biological fixation to bone

without the use of bone cement.

(b) Classification. Class II (special

controls). The special control for this

device is FDA’s ‘‘Class II Special

Controls Guidance: Shoulder Joint

Metal/Polymer/Metal Nonconstrained or

Semi-Constrained Porous-Coated

Uncemented Prosthesis.’’

Dated: February 4, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–4846 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF STATE

22 CFR Part 41

[Public Notice 3568]

RIN 1400 AA–96

Bureau of Consular Affairs; Visas:

Reissuance of O and P Nonimmigrant

Visas

AGENCY: Bureau of Consular Affairs,

Department of State.

ACTION: Final rule.

SUMMARY: This rule amends the

Department’s regulation which allows

designated officers in the Directorate for

Visa Services to reissue certain

categories of nonimmigrant visas for

aliens who are maintaining status and

intend to depart the United States and

reenter in that status after a temporary

absence abroad. This regulation will add

‘‘O’’ and ‘‘P’’ visas to those categories

that can be ‘‘revalidated’’ in the United

States. The Department is also taking

this opportunity to make an editorial

amendment substituting ‘‘Deputy

Assistant Secretary for Visa Services’’

for ‘‘Director of the Visa Office.’’ Some

years ago, as part of an internal

administrative reorganization, the title

‘‘Director of the Visa Office’’ was

replaced by the title ‘‘Deputy Assistant

Secretary for Visa Services.’’ The

powers, duties and responsibilities of

the position have not changed; only the

title. There is, thus, no substantive

significance to this substitution.

DATES: This rule takes effect on

February 28, 2001.

FOR FURTHER INFORMATION CONTACT: H.

Edward Odom, Chief, Legislation and

Regulations Division, Visa Services,

Department of State, Washington, DC

20520–0106, (202) 663–1204.

SUPPLEMENTARY INFORMATION:

What Is the Authority for Reissuing

Visas?

The Department of State regulation at

22 CFR 41.111(b) authorizes the Director

of the Visa Office and such officers of

the Department of State as he or she

may designate for such purpose to

reissue nonimmigrant visas for aliens in

certain nonimmigrant visa

classifications who meet the

requirements set forth in that section.

The purpose of this authority, in part, is

to provide a service to the international

business community.

Why Is the Regulation Being Amended?

Section 207(a)(3) of the Immigration

Act of 1990, (Pub. L, 191–649) amended

INA 101(a)(15) by adding two new

classes of nonimmigrant temporary

workers, ‘‘O’’, aliens of extraordinary

ability in the sciences, arts, education,

business and athletics, and ‘‘P’’,

internationally recognized athletes, and

certain artists and entertainers. Since

that time, the Department has been

reissuing ‘‘O’’ and ‘‘P’’ visas. This rule

codifies this long-established practice

that complements our existing

authority.

Final Rule

How Is the Department Amending Its

Regulation?

The Department is amending 22 CFR

41.111(b) by adding the ‘‘O’’ and ‘‘P’’

visas to those categories of visas that the

Department currently reissues.

Administrative Procedure Act

The Department’s implementation of

this regulation as a final rule is based

upon the ‘‘good cause’’ exceptions

found at 5 U.S.C. 553(b)(B) and (d)(3).

Since the Department is providing an

administrative service by reissuing visas

in the United States for the benefit of

aliens who are currently maintaining

status in a nonimmigrant category who

wish to travel temporarily abroad by

reissuing visas in the United States, the

Department believes that solicitation of

12738 Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Rules and Regulations

public comments would serve no

purpose.

Regulatory Flexibility Act

The Department of State, in

accordance with the Regulatory

Flexibility Act (5 U.S.C. 605(b)), has

reviewed this regulation and, by

approving it, certifies that this rule will

not have a significant economic impact

on a substantial number of small

entities.

Unfunded Mandates Reform Act of

1995

This rule will not result in the

expenditure by state, local and tribal

governments, in the aggregate, or by the

private sector, of $100 million or more

in any year and it will not significantly

or uniquely affect small governments.

Therefore, no actions were deemed

necessary under the provisions of the

Unfunded Mandates Reform Act of

1995.

Small Business Regulatory Enforcement

Fairness Act of 1996

This rule is not a major rule as

defined by section 804 of the Small

Business Regulatory Enforcement Act of

1996. This rule will not result in an

annual effect on the economy of $100

million or more; a major increase in

costs or prices; or significant adverse

effects on competition, employment,

investment, productivity, innovation, or

on the ability of United States-based

companies to compete with foreignbased companies in domestic and

export markets.

Executive Order 12866

The Department of State does not

consider this rule, to be a ‘‘significant

regulatory action’’ under Executive

Order 12866, section 3(f), Regulatory

Planning and Review, and the Office of

Management and Budget has waived its

review process under section 6(a)(3)(A).

Executive Order 13132

This regulation will not have

substantial direct effects 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. Therefore, in

accordance with section 6 of Executive

Order 13132, it is determined that this

rule does not have sufficient federalism

implications to warrant the preparation

of a federalism summary impact

statement.

Paperwork Reduction Act

This rule does not impose any new

reporting or record-keeping

requirements. The information

collection requirement (Form OF–156)

contained by reference in this rule was

previously approved for use by the

Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

List of Subjects in 22 CFR Part 41

Aliens, Nonimmigrants, Passports and

visas.

Accordingly, the Department amends

22 CFR part 41 as follows:

PART 41—[AMENDED]

1. The authority citation for Part 41 is

revised to read as follows:

Authority: 8 U.S.C. 1104; 22 U.S.C. 2651a.

2. Revise § 41.111(b) introductory text

and (b)(2) to read as follows:

§ 41.111 Authority to issue visa.

(b) Issuance in the United States in

certain cases. The Deputy Assistant

Secretary for Visa Services and such

officers of the Department as the former

may designate are authorized, in their

discretion, to issue nonimmigrant visas,

including diplomatic visas, to:

* * * * *

(2) Other qualified aliens who:

(i) Are currently maintaining status in

the E, H, I, L, O, or P nonimmigrant

category;

(ii) Intend to reenter the United States

in that status after a temporary absence

abroad; and

(iii) Who also present evidence that:

(A) They were previously issued visas

at a consular office abroad and admitted

to the United States in the status which

they are currently maintaining; and

(B) Their period of authorized

admission in that status has not expired.

Dated: January 21, 2001.

Mary A. Ryan,

Assistant Secretary for Consular Affairs,

Department of State.

[FR Doc. 01–4769 Filed 2–27–01; 8:45 am]

BILLING CODE 4710–06–U

DEPARTMENT OF STATE

22 CFR Part 126

General Policies and Provisions

CFR Correction

In Title 22 of the Code of Federal

Regulations, parts 1 to 299, revised as of

Apr. 1, 2000, in part 126, beginning on

page 469, the second § 126.5 is removed.

[FR Doc. 01–55502 Filed 2–27–01; 8:45 am]

BILLING CODE 1505–01–D

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Office of the Secretary

45 CFR Parts 160 and 164

RIN 0991–AB08

Standards for Privacy of Individually

Identifiable Health Information

AGENCY: Office for Civil Rights, HHS.

ACTION: Final rule; request for

comments.

SUMMARY: This action provides for the

submission of comments on a technical

amendment to the final rule adopting

standards for privacy of individually

identifiable health information

published on December 28, 2000, in the

Federal Register (65 FR 82462), to

convert it to a final rule with request for

comments. The purpose of this action is

to permit public comment on the final

rule for a limited period before the rule

becomes effective.

DATES: 1. Comments will be considered

if received as provided below, no later

than 5 p.m. on March 30, 2001.

2. The effective date of the final rule

with request for comments published

December 28, 2000 (65 FR 82462) was

corrected to be April 14, 2001. See 66

FR 12434 (February 26, 2001).

ADDRESSES: Comments will be

considered only if provided through any

of the following means:

1. Mail written comments (1 original

and, if possible, a floppy disk) to the

following address: U.S. Department of

Health and Human Services, Attention:

Privacy I, Room 801, Hubert H.

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC 20201.

2. Deliver written comments (1

original and, if possible, a floppy disk)

to Room 801, 200 Independence

Avenue, SW., Washington, DC 20201.

3. Submit electronic comments at the

following website: http://aspe.hhs.gov/

admnsimp/.

FOR FURTHER INFORMATION CONTACT:

Kimberly Coleman, 1–866–OCR–PRIV

(1–866–627–7748) or TTY 1–866–788–

4989.

SUPPLEMENTARY INFORMATION:

Comment Procedures, Availability of

Copies, and Electronic Access

Comment procedures: All comments

should include the full name, address,

and telephone number of the sender or

a knowledgeable point of contact. Each

specific comment should specify the

section of the final rule to which the

specific comment pertains. If possible,

please send an electronic version of the