Federal Register / Vol. 65, No. 196 / Tuesday, October 10, 2000 / Rules and Regulations 60097 

Thunder Bay National Marine Sanctuary 

and Underwater Preserve, which were 

the subject of FR Doc. 00-15638, (65 FR 

39042), is corrected as follows: 

§ 922.3 [Corrected] 

1. On page 39055, in the first column, 

amendatory instruction 3 is corrected to 

read as follows: 

3. Section 922.3 is amended by 

revising the definition for ‘‘Sanctuary 

resource’’ to read as follows: 

2. On page 39055, beginning in the 

first column, in § 922.3, add five 

asterisks before and after the definition 

of ‘‘Sanctuary resource’’. 

§ 922.50 [Corrected] 

3. On page 39056, in the third 

column, in § 922.50, correct the 

paragraph designation (b) to read (a)(2). 

Dated: October 4, 2000. 

Margaret A. Davidson, 

Acting Assistant Administrator for Ocean 

Services and Coastal Zone Management. 

[FR Doc. 00–25938 Filed 10–4–00; 1:57 pm] 

BILLING CODE 3510–08–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 510 

New Animal Drugs; Change of Sponsor 

Name and Address 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending the 

animal drug regulations to reflect a 

change of sponsor name and address for 

Rhone-Poulenc, Inc. 

DATES: This rule is effective October 10, 

2000. 

FOR FURTHER INFORMATION CONTACT: 

Norman J. Turner, Center for Veterinary 

Medicine (HFV–102), Food and Drug 

Administration, 7500 Standish Pl., 

Rockville, MD 20855, 301–827–0214. 

SUPPLEMENTARY INFORMATION: RhonePoulenc, Inc., P.O. Box 125, Black Horse 

Lane, Monmouth Junction, NJ 08852, 

has informed FDA of a change of 

sponsor name and address to Aventis 

Animal Nutrition, Inc., 3480 Preston 

Ridge Rd., suite 650, Alpharetta, GA 

30005–8891. Accordingly, the agency is 

amending the regulations in 21 CFR 

510.600(c) to reflect the change of 

sponsor name and address. 

This rule does not meet the definition 

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because 

it is a rule of ‘‘particular applicability.’’ 

Therefore, it is not subject to the 

congressional review requirements in 5 

U.S.C. 801–808. 

List of Subjects in 21 CFR Part 510 

Administrative practice and 

procedure, Animal drugs, Labeling, 

Reporting and recordkeeping 

requirements. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs and redelegated to 

the Center for Veterinary Medicine, 21 

CFR part 510 is amended as follows: 

PART 510—NEW ANIMAL DRUGS 

1. The authority citation for 21 CFR 

part 510 continues to read as follows: 

Authority: 21 U.S.C. 321, 331, 351, 352, 

353, 360b, 371, 379e. 

2. Section 510.600 is amended in the 

table in paragraph (c)(1) by removing 

the entry for ‘‘Rhone-Poulenc, Inc.’’ and 

alphabetically adding an entry for 

‘‘Aventis Animal Nutrition, Inc.’’ and in 

the table in paragraph (c)(2) by revising 

the entry for ‘‘011526’’ to read as 

follows: 

§ 510.600Names, addresses, and drug 

labeler codes of sponsors of approved 

applications. 

* * * * * 

(c) * * * 

(1) * * * 

Firm name and address Drug labeler code 

* * * * * * * 

Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd., suite 650, 

Alpharetta, GA 30005–8891 

011526 

* * * * * * * 

(2) * * * 

Drug labeler code Firm name and address 

* * * * * * * 

011526 Aventis Animal Nutrition, Inc., 3480 Preston Ridge Rd., suite 650, 

Alpharetta, GA 30005–8891 

* * * * * * * 


rmajette on DSK29S0YB1PROD with RULES
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 


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