60098 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 

Dated: September 28, 2000. 

Claire M. Lathers, 

Director, Office of New Animal Drug 

Evaluation, Center for Veterinary Medicine. 

[FR Doc. 00–25965 Filed 10–6–00; 8:45 am] 

BILLING CODE 4160–01–F 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 872 

[Docket No. 98N–0753] 

Dental Products Devices; 

Reclassification of Endosseous Dental 

Implant Accessories 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is reclassifying 

the manually powered drill bits, 

screwdrivers, countertorque devices, 

placement and removal tools, laboratory 

pieces used for fabrication of dental 

prosthetics, trial abutments, and other 

manually powered endosseous dental 

implant accessories from class III to 

class I. These devices are intended to 

aid in the placement or removal of 

endosseous dental implants and 

abutments, prepare the site for 

placement of endosseous dental 

implants or abutments, aid in the fitting 

of endosseous dental implants or 

abutments, aid in the fabrication of 

dental prosthetics, and be used as an 

accessory with endosseous dental 

implants when tissue contact will last 

less than an hour. FDA is also 

exempting these devices from premarket 

notification. This reclassification is on 

the Secretary of Health and Human 

Services’ own initiative based on new 

information. This action is being taken 

under the Federal Food, Drug, and 

Cosmetic Act (the act), as amended by 

the Medical Device Amendments of 

1976 (the 1976 amendments), the Safe 

Medical Devices Act of 1990 (the 

SMDA), and the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA). 

DATES: This rule is effective November 

9, 2000. 

FOR FURTHER INFORMATION CONTACT: 

Angela Blackwell, Center for Devices 

and Radiological Health (HFZ–480), 

Food and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–827–5283. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

amended by the 1976 amendments 

(Public Law 94–295), the SMDA (Public 

Law 101–629), and 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 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 

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

by 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 21 CFR 

part 807 of the regulations. 

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 classified 

preamendments devices is governed by 

section 513(e) of the act. This section 

provides that FDA may, by rulemaking, 

reclassify a device (in a proceeding that 

parallels the initial classification 

proceeding) based upon ‘‘new 

information.’’ The reclassification can 

be initiated by FDA or by the petition 

of an interested person. The term ‘‘new 

information,’’ as used in section 513(e) 

of the act, includes information 

developed as a result of a reevaluation 

of the data before the agency when the 

device was originally classified, as well 

as information not presented, not 

available, or not developed at that time. 

(See, e.g., Holland Rantos v. United 

States Department of Health, Education, 

and Welfare, 587 F.2d 1173, 1174 n.1 

(D.C. Cir. 1978); Upjohn v. Finch, 422 

F.2d 944 (6th Cir. 1970); Bell v. 

Goddard, 366 F.2d 177 (7th Cir. 1966).) 

Reevaluation of the data previously 

before the agency is an appropriate basis 

for subsequent regulatory action where 

the reevaluation is made in light of 

newly available regulatory authority 

(see Bell v. Goddard, supra, 366 F.2d at 

181; Ethicon, Inc. v. FDA, 762 F. Supp. 

382, 389–91 (D.D.C. 1991)), or in light 

of changes in ‘‘medical science.’’ (See 

Upjohn v. Finch, supra, 422 F.2d at 

951.) Regardless of whether data before 

the agency are past or new data, the 

‘‘new information’’ on which any 

reclassification is based is required to 

consist of ‘‘valid scientific evidence,’’ as 

defined in section 513(a)(3) of the act 

and 21 CFR 860.7(c)(2). (See, e.g., 

General Medical Co. v. FDA, 770 F.2d 

214 (D.C. Cir. 1985); Contact Lens 

Assoc. v. FDA, 766 F.2d 592 (D.C. Cir.), 

cert. denied, 474 U.S. 1062 (1985). FDA 

relies upon ‘‘valid scientific evidence’’ 

in the classification process to 

determine the level of regulation for 

devices. For the purpose of 

reclassification, the valid scientific 

evidence upon which the agency relies 

must be publicly available. Publicly 

available information excludes trade 

secret and/or confidential commercial 

information, e.g., the contents of a 

pending PMA. (See section 520(c) of the 

act (21 U.S.C. 360j(c).) 

FDAMA added a new section 510(l) to 

the act. New section 510(l) of the act 

provides that a class I device is exempt 

from the premarket notification 

requirements under section 510(k) of the 

act, unless the device is intended for a 

use which is of substantial importance 

in preventing impairment of human 

health or it presents a potential 

unreasonable risk of illness or injury. 

Hereafter, these are referred to as 

‘‘reserved criteria.’’ FDA has considered 

the endosseous dental implant 

accessories in accordance with the 

reserved criteria and determined that 


rmajette on DSK29S0YB1PROD with RULES
Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 60099 

the devices do not require premarket 

notification. Such an exemption permits 

manufacturers to introduce into 

commercial distribution generic types of 

devices without first submitting a 

premarket notification to FDA. 

II. Regulatory History of the Device 

In the Federal Register of October 7, 

1998 (63 FR 53859), FDA proposed to 

reclassify the manually powered drill 

bits, screwdrivers, countertorque 

devices, placement and removal tools, 

laboratory pieces used for fabrication of 

dental prosthetics, trial abutments, and 

other manually powered endosseous 

dental implant accessories from class III 

to class I. These devices are intended to 

aid in the placement or removal of 

endosseous dental implants and 

abutments, prepare the site for 

placement of endosseous dental 

implants or abutments, aid in the fitting 

of endosseous dental implants or 

abutments, aid in the fabrication of 

dental prosthetics, and be used as an 

accessory with endosseous dental 

implants when tissue contact will last 

less than 1 hour. Interested persons 

were given until January 5, 1999, to 

comment on the proposed regulation. 

FDA received no comments on the 

proposed rule. 

III. Summary of Final Rule 

FDA is reclassifying the manually 

powered drill bits, screwdrivers, 

countertorque devices, placement and 

removal tools, laboratory pieces used for 

fabrication of dental prosthetics, trial 

abutments, and other manually powered 

endosseous dental implant accessories 

from class III to class I. These devices 

are intended to aid in the placement or 

removal of endosseous dental implants 

and abutments, prepare the site for 

placement of endosseous dental 

implants or abutments, aid in the fitting 

of endosseous dental implants or 

abutments, aid in the fabrication of 

dental prosthetics, and be used as an 

accessory with endosseous dental 

implants when tissue contact will last 

less than 1 hour. These devices do not 

have a history of risks associated with 

them. FDA believes that the 

manufacturers’ adherence to current 

good manufacturing practices in the 

quality system regulation will provide 

reasonable assurance of the safety and 

effectiveness of these devices. FDA, 

therefore, believes that class I would 

provide reasonable assurance of safety 

and effectiveness. FDA is also 

exempting the devices from the 

premarket notification requirements. 

Therefore, under section 513 of the 

act, FDA is adopting the assessment of 

the risks to public health stated in the 

proposed rule published on October 7, 

1998. Furthermore, FDA is issuing a 

final rule that revises part 872 (21 CFR 

part 872) in subpart D to add § 872.3980, 

thereby reclassifying the endosseous 

dental implant accessories, from class III 

into class I. 

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 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. Because the final rule 

reclassifying these devices from class III 

to class I will relieve all manufacturers 

of the devices of the cost of complying 

with the premarket approval 

requirements in section 513 of the act, 

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 

the 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 State, local, and tribal 

governments in the aggregate and, 

therefore, a summary statement of 

analysis under section 202(a) of the 

Unfunded Mandates Reform Act of 1995 

is not required. 

VI. 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. 

VII. 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. 

List of Subjects in 21 CFR Part 872 

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 872 in 

subpart D is amended as follows: 

PART 872—DENTAL DEVICES 

1. The authority citation for 21 CFR 

part 872 continues to read as follows: 

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

360j, 371. 

2. Section 872.3980 is added to 

subpart D to read as follows: 

§ 872.3980 Endosseous dental implant 

accessories. 

(a) Identification. Endosseous dental 

implant accessories are manually 

powered devices intended to aid in the 

placement or removal of endosseous 

dental implants and abutments, prepare 

the site for placement of endosseous 

dental implants or abutments, aid in the 

fitting of endosseous dental implants or 

abutments, aid in the fabrication of 

dental prosthetics, and be used as an 

accessory with endosseous dental 

implants when tissue contact will last 

less than 1 hour. These devices include 

drill bits, screwdrivers, countertorque 

devices, placement and removal tools, 

laboratory pieces used for fabrication of 

dental prosthetics, and trial abutments. 

(b) Classification. Class I (general 

controls). The device is exempt from the 

premarket notification procedures in 

subpart E of part 807 of this chapter 

subject to the limitations in § 872.9. 


rmajette on DSK29S0YB1PROD with RULES
60100 Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 

Dated: September 26, 2000. 

Linda S. Kahan, Deputy Director for 

Regulations Policy center for Devices and 

Radiological Health. 

[FR Doc. 00–25811 Filed 10–6–00; 8:45 am] 

BILLING CODE 4160–01–F 

DEPARTMENT OF JUSTICE 

28 CFR Part 0 

[AG Order No. 2328–2000] 

Delegation of Authority: Settlement 

Authority 

AGENCY: Department of Justice 

ACTION: Final rule. 

SUMMARY: This rule delegates to the 

directors and commissioners of 

specified components of the Department 

of Justice authority to settle 

administrative claims presented 

pursuant to the Federal Tort claims Act 

(FTCA), where the amount of the 

settlement does not exceed $50,000. 

Currently, the directors and 

commissioners of the Bureau of Prisons, 

Federal Prison Industries, Immigration 

and Naturalization Service, Marshals 

Service, and the Drug Enforcement 

Administration have authority to settle 

FTCA claims not exceeding $10,000. 

This rule will alert the general public to 

the new authority of these officials and 

is being codified in the Code of Federal 

Regulations to provide a permanent 

record of this delegation. 

EFFECTIVE DATE: October 10, 2000. 

FOR FURTHER INFORMATION CONTACT: 

Jeffrey Axelrad, Director, Torts Branch, 

Civil Division, U.S. Department of 

Justice, P.O. Box 888, Benjamin 

Franklin Station, Washington, DC 

20044, (202) 616–4400. 

SUPPLEMENTARY INFORMATION: This rule 

has been issued to delegate settlement 

authority to various Department of 

Justice officials. It is a matter solely 

related to the division of responsibility 

within the Department of Justice. It 

relates to matters of agency policy, 

management, or personnel, and is 

therefore exempt from the usual 

requirements of prior notice and 

comment, and a 30-day delay in the 

effective date. See 5 U.S.C. 553(a)(2), 

(b)(A). 

Executive Order 12866 

This rule falls within a category of 

actions that the Office of Management 

and Budget (OMB) has determined do 

not constitute ‘‘significant regulatory 

actions‘‘ under section 3(f) of Executive 

Order 12866 and, accordingly, was not 

reviewed by OMB. 

Executive Order 13132 

This rule 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, the Department of Justice 

has determined that this rule does not 

have sufficient federalism implications 

to warrant the preparation of a 

federalism summary impact statement. 

Regulatory Flexibility Act 

The Attorney General, in accordance 

with the Regulatory Flexibility Act, 5 

U.S.C. 605(b), has reviewed this 

regulation and, by approving it, certifies 

that this regulation will not have a 

significant economic impact upon 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 $100,000,000 or more 

in any one 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 section 251 of the Small 

Business Regulatory Enforcement 

Fairness Act of 1996, 5 U.S.C. 804. 

This rule will not result in an annual 

effect on the economy of $100,000,000 

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. 

Plain Language Instructions 

We try to write clearly. If you can 

suggest how to improve the clarity of 

these regulations, call or write Jeffrey 

Axelrad at the address and telephone 

number given above. 

List of Subjects in 28 CFR Part 0 

Authority delegations (government 

agencies), Claims. 

Accordingly, Part 0 of Title 28 of the 

Code of Federal Regulations is amended 

as follows: 

PART 0—ORGANIZATION OF THE 

DEPARTMENT 

1. The authority citation for Part 0 

continues to read as follows: 

Authority: 5 U.S.C. 301; 28 U.S.C. 509, 

510, 515–519. 

2. Section 0.172 of Part 0, Subpart Y, 

is amended by revising paragraph (a) to 

read as follows: 

§ 0.172 Authority: Federal tort claims. 

(a) The Director of the Bureau of 

Prisons, the Commissioner of Federal 

Prison Industries, the Commissioner of 

the Immigration and Naturalization 

Service, the Director of the United 

States Marshals Service, and the 

Administrator of the Drug Enforcement 

Administration shall have authority to 

adjust, determine, compromise, and 

settle a claim involving the Bureau of 

Prisons, Federal Prison Industries, the 

Immigration and Naturalization Service, 

the United States Marshals Service, and 

the Drug Enforcement Administration, 

respectively, under section 2672 of title 

28, United States Code, relating to the 

administrative settlement of Federal tort 

claims, if the amount of a proposed 

adjustment, compromise, settlement, or 

award does not exceed $50,000. When, 

in the opinion of one of those officials, 

such a claim pending before him 

presents a novel question of law or a 

question of policy, he shall obtain the 

advice of the Assistant Attorney General 

in charge of the Civil Division before 

taking action on the claim. 

* * * * * 

Dated: October 2, 2000. 

Janet Reno, 

Attorney General. 

[FR Doc. 00–25904 Filed 10–6–00; 8:45 am] 

BILLING CODE 4410–12–M 

SELECTIVE SERVICE SYSTEM 

32 CFR Part 1615 

Additional Methods of Selective 

Service Registration 

AGENCY: Selective Service System (SSS). 

ACTION: Final rule; technical 

amendment. 

SUMMARY: In accordance with 

Proclamation 7275 of February 22, 2000, 

this Final Rule amends the 

Administration of Registration rules by 

providing additional methods of 

registering with the Selective Service 

System. Proclamation 7275 amended 

Proclamation 4771 to allow for 

additional methods of registration. 

These methods include registration on 


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