12734 Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Rules and Regulations

telephone. At the first voice prompt

press 1 to enter the system. At the

second voice prompt press 1 to order a

document. Enter the document number

(1183) followed by the pound sign (#).

Follow the remaining voice prompts to

complete your request.

Persons interested in obtaining a copy

of the draft guidance may also do so

using the Internet. CDRH maintains an

entry on the Internet for easy access to

information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. The CDRH home page may be

accessed at http://www.fda.gov/cdrh.

‘‘Class II Special Control Guidance

Document for B–Type Natriuretic

Peptide Premarket Notification; Final

Guidance for Industry and FDA

Reviewers’’ is available at http://

www.fda.gov/cdrh/ode/guidance/

1072.pdf.

III. Environmental Impact

The agency has determined under 21

CFR 25.34(b) 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.

IV. 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) (as amended by subtitle

D of the Small Business Regulatory

Fairness Act of 1996 (Public Law 104–

1210), and the Unfunded Mandates

Reform Act of 1995 (Public Law 104–4)).

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 it 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. FDA knows of only one

manufacturer of this type of device.

Classification of these devices in class II

will relieve this manufacturer of the

device of the cost of complying with the

premarket approval requirements of

section 515 of the act (21 U.S.C. 360e)

and may permit small potential

competitors to enter the market place by

lowering their costs. The agency,

therefore, certifies that this final rule

will not have a significant economic

impact on a substantial number of small

entities.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 requires

that agencies prepare a written

statement of anticipated costs and

benefits before proposing any rule that

may result in an expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million in any one year (adjusted

annually for inflation). The Unfunded

Mandates Reform Act does not require

FDA to prepare a statement of costs and

benefits for the final rule, because the

final rule is not expected to result in any

1-year expenditure that would exceed

$100 million.

V. 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.

VI. Paperwork Reduction Act of 1995

This final rule contains no collection

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 862

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 862 is

amended as follows:

PART 862—CLINICAL CHEMISTRY

AND CLINICAL TOXICOLOGY

DEVICES

1. The authority citation for 21 CFR

part 862 continues to read as follows:

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

360j, 371.

2. Section 862.1117 is added to

subpart B to read as follows:

§ 862.1117 B-type natriuretic peptide test

system.

(a) Identification. The B-type

natriuretic peptide (BNP) test system is

an in vitro diagnostic device intended to

measure BNP in whole blood and

plasma. Measurements of BNP are used

as an aid in the diagnosis of patients

with congestive heart failure.

(b) Classification. Class II (special

controls). The special control is ‘‘Class

II Special Control Guidance Document

for B–Type Natriuretic Peptide

Premarket Notifications; Final Guidance

for Industry and FDA Reviewers.’’

Dated: January 11, 2001.

Linda S. Kahan,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 01–4847 Filed 2–27–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 97P–0354]

Medical Devices; Reclassification of

the Shoulder Joint Metal/Polymer/Metal

Nonconstrained or Semi-Constrained

Porous-Coated Uncemented

Prosthesis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it is reclassifying the shoulder joint

metal/polymer/metal nonconstrained or

semi-constrained porous-coated

uncemented prosthesis intended to

replace a shoulder joint from class III to

class II (special controls). The agency is

also announcing that it has issued an

order in the form of a letter to the

Orthopedic Surgical Manufacturers

Association (OSMA) reclassifying the

device. The special control that will

apply is a guidance document entitled

‘‘Class II Special Controls Guidance:

Shoulder Joint Metal/Polymer/Metal

Nonconstrained or Semi-Constrained

Porous-Coated Uncemented Prosthesis.’’

The agency is classifying this device

into class II because special controls, in

addition to general controls, would

provide reasonable assurance of the

safety and effectiveness of the device,

and there is sufficient information to

establish special controls.

Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Rules and Regulations 12735

DATES: This rule is effective March 30,

2001.

FOR FURTHER INFORMATION CONTACT:

Theodore R. Stevens, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION:

I. Background (Regulatory Authorities)

The Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 301 et. seq.), as

amended by the Medical Device

Amendments of 1976 (the 1976

amendments) (Public Law 94–295), the

Safe Medical Devices Act of 1990 (the

SMDA) (Public Law 101–629), and the

Food and Drug Administration

Modernization Act of 1997 (the

FDAMA) (Public Law 105–115),

established a comprehensive system for

the regulation of medical devices

intended for human use. Section 513 of

the act (21 U.S.C. 360c) established

three categories (classes) of devices,

depending on the regulatory controls

needed to provide reasonable assurance

of their safety and effectiveness. The

three categories of devices are class I

(general controls), class II (special

controls), and class III (premarket

approval).

Under section 513 of the act, devices

that were in commercial distribution

before May 28, 1976 (the date of

enactment of the 1976 amendments),

generally referred to as preamendments

devices, are classified after FDA has: (1)

Received a recommendation from a

device classification panel (an FDA

advisory committee); (2) published the

panel’s recommendation for comment,

along with a proposed regulation

classifying the device; and (3) published

a final regulation classifying the device.

FDA has classified most

preamendments devices under these

procedures.

Devices that were not in commercial

distribution prior to May 28, 1976,

generally referred to as postamendments

devices, are classified automatically by

statute (section 513(f) of the act) into

class III without any FDA rulemaking

process. Those devices remain in class

III and require premarket approval,

unless and until: (1) The device is

reclassified into class I or II; (2) FDA

issues an order classifying the device

into class I or II in accordance with new

section 513(f)(2) of the act, as amended

by the FDAMA; or (3) FDA issues an

order finding the device to be

substantially equivalent, under section

513(i) of the act, to a predicate device

that does not require premarket

approval. The agency determines

whether new devices are substantially

equivalent to previously offered devices

by means of premarket notification

procedures in section 510(k) of the act

(21 U.S.C. 360(k)) and part 807 of the

regulations (21 CFR part 807).

A preamendments device that has

been classified into class III may be

marketed, by means of premarket

notification procedures, without

submission of a premarket approval

application (PMA) until FDA issues a

final regulation under section 515(b) of

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

premarket approval.

Reclassification of postamendments

devices is governed by section 513(f)(3)

of the act, formerly section 513(f)(2) of

the act. This section provides that FDA

may initiate the reclassification of a

device classified into class III under

section 513(f)(1) of the act, or the

manufacturer or importer of a device

may petition the Secretary of Health and

Human Services (the Secretary) for the

issuance of an order classifying the

device in class I or class II. FDA’s

regulations in § 860.134 (21 CFR

860.134) set forth the procedures for the

filing and review of a petition for

reclassification of such class III devices.

In order to change the classification of

the device, it is necessary that the

proposed new class have sufficient

regulatory controls to provide

reasonable assurance of the safety and

effectiveness of the device for its

intended use.

The FDAMA added a new section

513(f)(2) to the act which addresses

classification of postamendments

devices. New section 513(f)(2) of the act

provides that, upon receipt of a ‘‘not

substantially equivalent’’ determination,

a 510(k) applicant may request FDA to

classify a postamendments device into

class I or class II. Within 60 days from

the date of such a written request, FDA

must classify the device by written

order. If FDA classifies the device into

class I or II, the applicant has then

received clearance to market the device,

and it can be used as a predicate device

for other 510(k)’s. It is expected that this

process will be used for low risk

devices. This process does not apply to

devices that have been classified by

regulation into class III, i.e.,

preamendments class III devices, or

class III devices for which a PMA is

appropriate.

Under section 513(f)(3)(B)(i) of the

act, formerly section 513(f)(2)(B)(i) of

the act, the Secretary may, for good

cause shown, refer a petition to a device

classification panel. If a petition is

referred to a panel, the panel shall make

a recommendation to the Secretary

respecting approval or denial of the

petition. Any such recommendation

shall contain: (1) A summary of the

reasons for the recommendation, (2) a

summary of the data upon which the

recommendation is based, and (3) an

identification of the risks to health (if

any) presented by the device with

respect to which the petition was filed.

II. Recommendation of the Panel

On July 23, 1997, FDA filed the

reclassification petition submitted by

OSMA, requesting reclassification of the

shoulder joint metal/polymer/metal

nonconstrained or semi-constrained

porous-coated uncemented prosthesis

intended to replace a shoulder joint

from class III to class II. FDA consulted

with the Orthopedic and Rehabilitation

Devices Panel (the Panel) regarding the

reclassification petition. During an open

public meeting on January 12 and 13,

1998, the Panel recommended that FDA

reclassify the shoulder joint metal/

polymer/metal nonconstrained or semiconstrained porous-coated uncemented

prosthesis intended to replace a

shoulder joint from class III to class II.

The Panel recommended that the

special controls for the device be FDA

guidance documents, consensus

standards, and postmarket surveillance.

FDA considered the Panel’s

recommendation and tentatively agreed

that the generic type of device, the

shoulder joint metal/polymer/metal

nonconstrained or semi-constrained

porous-coated uncemented prosthesis

intended to replace a shoulder joint, be

reclassified from class III to class II.

FDA agrees that guidance documents

and consensus standards are

appropriate special controls for the

device.

FDA disagrees with the Panel that

postmarket surveillance is a necessary

or an appropriate special control for the

device. In their deliberations, the Panel

stated that it was important that adverse

device outcomes should be reported to

FDA and should be tracked through

postmarket surveillance. FDA believes

that another postmarket mechanism

better addresses the Panel’s concern.

FDA believes that the existing

mandatory Medical Device Reporting

system is the appropriate mechanism to

report such adverse events. Therefore,

postmarket surveillance is unnecessary

to address the Panel’s concerns and to

reasonably assure the safety and

effectiveness of the device.

Subsequently, in the Federal Register

of May 28, 1999 (64 FR 29043), FDA

issued the Panel’s recommendation for

public comment. FDA received two

comments on the Panel’s

recommendation. Both comments

supported the Panel’s recommendation

12736 Federal Register / Vol. 66, No. 40 / Wednesday, February 28, 2001 / Rules and Regulations

to reclassify the device into class II. One

comment also provided updated

information on the designations (years

of issuance) and the titles for six of the

American Society for Testing and

Materials (ASTM) consensus standard

special controls for the device. FDA

agrees with these comments and will

incorporate the updated designations

and titles in the special control for the

device.

After reviewing the data in the

petition and presented before the Panel,

and after considering the Panel’s

recommendation and the comments on

the notice of panel recommendation,

FDA issued an order to the petitioner on

December 17, 1999, reclassifying the

shoulder joint metal/polymer/metal

nonconstrained or semi-constrained

porous-coated uncemented prosthesis

intended to replace a shoulder joint, and

substantially equivalent devices of this

generic type, from class III to class II

with the implementation of special

controls.

The special controls listed in the

order to the petitioner were FDA

guidance documents and consensus

standards. The FDA guidance

documents were as follows:

1. ‘‘Guidance Document for Testing

Orthopedic Implants with Modified

Metallic Surfaces Apposing Bone or

Bone Cement;’’

2. ‘‘Guidance Document for Testing

Non-articulating, ‘Mechanically Locked’

Modular Implant Components;’’

3. ‘‘Draft Guidance Document for the

Preparation of Premarket Notification

(510(k)) Applications for Orthopedic

Devices-The Basic Elements;’’

4. ‘‘Use of International Standard

ISO–10993, ‘Biological Evaluation of

Medical Devices Part 1: Evaluation and

Testing;’’’ and

5. ‘‘510(k) Sterility Review Guidance

(# K90–1),’’ 2/12/90.

The ASTM consensus standards were

as follows:

1. F 67–95, ‘‘Standard Specifications

for Unalloyed Titanium for Surgical

Implant Applications;’’

2. F 75–98, ‘‘Standard Specification

for Cobalt-28 Chromium-6 Molybdenum

Casting Alloy and Cast Products for

Surgical Implants (UNS R30075);’’

3. F 136–98, ‘‘Standard Specification

for Wrought Titanium-6 Aluminum-4

Vanadium ELI (Extra Low Interstitial

Alloy (UNS R56401)) for Surgical

Implant Applications;’’

4. F 648–98, ‘‘Standard Specification

for Ultra-High Molecular Weight

Polyethylene Powder and Fabricated

Form for Surgical Implants;’’

5. F 1044–95, ‘‘Standard Test Method

for Shear Testing of Porous Metal

Coatings;’’

6. F 1147–99, ‘‘Standard Test Method

for Tension Testing of Calcium

Phosphate and Metallic Coatings;’’

7. F 1160–98, ‘‘Standard Test Method

for Shear and Bending Fatigue Testing

of Calcium Phosphate and Metallic

Medical Coatings;’’

8. F 1377–98a, ‘‘Standard

Specification for Cobalt-28 Chromium-6

Molybdenum Powder for Coating of

Orthopedic Implants (UNS R30075);’’

9. F 1378–99, ‘‘Standard Specification

for Shoulder Prostheses;’’ and

10. F 1580–95, ‘‘Standard

Specification for Titanium and

Titanium-6% Aluminum-4% Vanadium

Alloy Powders for Coatings of Surgical

Implants.’’

FDA has recently incorporated the 5

FDA guidance documents and the 10

ASTM consensus standards into a

special control guidance entitled ‘‘Class

II Special Controls Guidance: Shoulder

Joint Metal/Polymer/Metal

Nonconstrained or Semi-Constrained

Porous-Coated Uncemented Prosthesis.’’

This guidance document is now the

special control for this generic device.

Accordingly, as required by

§ 860.134(b)(6) and (b)(7) of the

regulations, FDA is announcing the

reclassification of the generic shoulder

joint metal/polymer/metal

nonconstrained or semi-constrained

porous-coated uncemented prosthesis

intended to replace a shoulder joint

from class III into class II. On December

17, 1999, FDA issued an order to OSMA

reclassifying the shoulder joint metal/

polymer/metal nonconstrained or semiconstrained porous-coated uncemented

prosthesis into class II. In addition, FDA

is issuing this final rule to codify the

reclassification of the device by adding

new § 888.3670.

III. Access to Special Controls

Persons interested in obtaining a copy

of an FDA guidance may do so using the

Internet. The Center for Devices and

Radiological Health (CDRH) maintains

an entry on the Internet for easy access

to information including text, graphics,

and files that may be downloaded to a

personal computer with access to the

Internet. The CDRH home page may be

accessed at http://www.fda.gov/cdrh .

Guidance documents are also available

from the Division of Small

Manufacturers Assistance (DSMA)

(HFZ–220), Food and Drug

Administration, Center for Devices and

Radiological Health, 1350 Piccard Dr.,

Rockville, MD 20850. In order to receive

the FDA guidance documents via your

fax machine call the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. Press 1 to enter the system

and enter the document number

followed by the pound sign (#). Follow

the remaining voice prompts to

complete your request. The document

number is 1193 for ‘‘Class II Special

Controls Guidance: Shoulder Joint

Metal/Polymer/Metal Nonconstrained or

Semi-Constrained Porous-Coated

Uncemented Prosthesis.’’

IV. Environmental Impact

The agency has determined under 21

CFR 25.34(b) 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.

V. 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 (as amended by subtitle

D of the Small Business Regulatory

Fairness Enforcement Act of 1996

(Public Law 104–121))), and the

Unfunded Mandates Reform Act of 1995

(Public Law 104–4). 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. Reclassification of the device

from class III to class II will relieve all

manufacturers of the device of the cost

of complying with the premarket

approval requirements in section 515 of

the act. Because reclassification will

reduce regulatory costs with respect to

this device, it will impose no significant

economic impact on any small entities,

and it may permit small potential

competitors to enter the marketplace by

lowering their costs. The agency

therefore certifies that this final rule

will not have a significant economic

impact on a substantial number of small

entities. In addition, this final rule will

not impose costs of $100 million or

more on either the private sector or

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