59132 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Rules and Regulations 

§ 520.1192 Ivermectin paste.

* * * * *

(e) Conditions of use—(1) Horses—(i) 

Amount. 200 micrograms per kilogram 

(91 micrograms per pound) of body 

weight.

(ii) Indications for use. For treatment 

and control of:

(A) Large Strongyles (adults): 

Strongylus vulgaris (also early forms in 

blood vessels), S. edentatus (also tissue 

stages), S. equinus, Triodontophorus

spp. including T. brevicauda and T. 

serratus, and Craterostomum 

acuticaudatum; Small Strongyles 

(adults, including those resistant to 

some benzimidazole class compounds): 

Coronocyclus spp. including C. 

coronatus, C. labiatus, and C. labratus, 

Cyathostomum spp. including C. 

catinatum and C. pateratum, 

Cylicocyclus spp. including C. insigne, 

C. leptostomum, C. nassatus, and C. 

brevicapsulatus, Cylicodontophorus

spp., Cylicostephanus spp., including C. 

calicatus, C. goldi, C. longibursatus, and 

C. minutus, and Petrovinema 

poculatum; Small Strongyles (fourthstage larvae); Pinworms (adults and 

fourth stage larvae): Oxyuris equi; 

Ascarids (adults and third- and fourthstage larvae): Parascaris equorum; 

Hairworms (adults): Trichostrongylus 

axei; Large mouth Stomach Worms 

(adults), Habronema muscae; Bots (oral 

and gastric stages): Gasterophilus spp. 

including G. intestinalis and G. nasalis; 

Lungworms (adults and fourth-stage 

larvae): Dictyocaulus arnfieldi; 

Intestinal Threadworms (adults): 

Strongyloides westeri;Summer Sores 

caused by Habronema and Draschia

spp. cutaneous third-stage larvae; 

Dermatitis caused by neck threadworm 

microfilariae, Onchocerca sp.

(B) Large Strongyles (adult) 

(Strongylus equinus), (adult and arterial 

larval stages) (Strongylus vulgaris), 

(adult and migrating tissue stages) 

(Strongylus edentatus), (adult) 

(Triodontophorus spp.); Small 

Strongyles, including those resistant to 

some benzimidazole class compounds 

(adult and fourth-stage larvae) 

(Cyathostomum spp., Cylicocyclus spp., 

Cylicodontophorus spp., 

Cylicostephanus spp.); Pinworms (adult 

and fourth-stage larvae) (Oxyuris equi); 

Ascarids (third- and fourth-stage larvae 

and adults) (Parascaris equorum); 

hairworms (adult) (Trichostrongylus 

axei); Large mouth Stomach Worms 

(adult) (Habronema muscae); Stomach 

Bots (oral and gastric stages) 

(Gastrophilus spp.); Lungworms (adults 

and fourth-stage larvae) (Dictyocaulus 

arnfieldi); Intestinal Threadworms 

(adults) (Strongyloides westeri); Summer 

Sores caused by Habronema and 

Draschia spp. cutaneous third-stage 

larvae; and Dermatitis caused by neck 

threadworm microfilariae (Onchocerca

sp.).

(iii) Limitations. For oral use only. Do 

not use in horses intended for human 

consumption.

* * * * *

Dated: September 14, 2004.

Daniel G. McChesney,

Director, Office of Surveillance and 

Compliance, Center for Veterinary Medicine.

[FR Doc. 04–22182 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. 2003N–0561]

Orthopedic Devices; Effective Date of 

Requirement for Premarket Approval 

for Hip Joint Metal/Polymer or 

Ceramic/Polymer Semiconstrained 

Resurfacing Cemented Prosthesis

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug 

Administration (FDA) is issuing a final 

rule to require the filing of a premarket 

approval application (PMA) or a notice 

of completion of a product development 

protocol (PDP) for the hip joint metal/

polymer or ceramic/polymer 

semiconstrained resurfacing cemented 

prosthesis. The agency also is 

summarizing its proposed findings 

regarding the degree of risk of illness or 

injury designed to be eliminated or 

reduced by requiring the devices to 

meet the statute’s approval requirements 

and the benefits to the public from the 

use of the devices. This action 

implements certain statutory 

requirements.

DATES: This rule is effective October 4, 

2004. Under this final rule, a PMA or a 

notice of completion of a PDP is 

required to be filed on or before January 

3, 2005, for any hip joint metal/polymer 

or ceramic/polymer semiconstrained 

resurfacing cemented prosthesis.

FOR FURTHER INFORMATION CONTACT: Pei 

Sung, 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

The Federal Food, Drug, and Cosmetic 

Act (the act), as amended by the 

Medical Device Amendments of 1976 

(the 1976 amendments) (Public Law 94–

295) and the Safe Medical Devices Act 

of 1990 (Public Law 101–629), 

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).

Section 515(b)(1) of the act (21 U.S.C. 

360e(b)(1)) established the requirement 

that a preamendments device that FDA 

has classified into class III is subject to 

premarket approval. A preamendments 

class III device may be commercially 

distributed without an approved PMA 

or a notice of completion of a PDP until 

90 days after FDA issues a final rule 

requiring premarket approval for the 

device, or 30 months after final 

classification of the device under 

section 513 of the act, whichever is 

later. Also, a preamendments device 

subject to the rulemaking procedure 

under section 515(b) of the act is not 

required to have an approved 

investigational device exemption (IDE) 

(see part 812 (21 CFR part 812)) 

contemporaneous with its interstate 

distribution until the date identified by 

FDA in the final rule requiring the 

submission of a PMA for the device. At 

that time, an IDE is required only if a 

PMA has not been submitted or a PDP 

completed.

When a rule to require premarket 

approval for a preamendments device is 

finalized, section 501(f)(2)(B) of the act 

(21 U.S.C. 351(f)(2)(B)) requires that a 

PMA or notice of completion of a PDP 

for any such device be filed within 90 

days of the date of issuance of the final 

rule or 30 months after the final 

classification of the device under 

section 513 of the act, whichever is 

later. If a PMA or notice of completion 

of a PDP is not filed by the latter of the 

two dates, commercial distribution of 

the device must cease.

The device may, however, be 

distributed for investigational use if the 

manufacturer, importer, or other 

sponsor of the device complies with the 

IDE regulations. If a PMA or notice of 

completion of a PDP is not filed by the 

latter of the two dates, and no IDE is in 

effect, the device is deemed to be 

adulterated within the meaning of 

Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Rules and Regulations 59133

section 510(f)(1)(A) of the act (21 U.S.C. 

360(f)(1)(A)), and subject to seizure and 

condemnation under section 304 of the 

act (21 U.S.C. 334), if its distribution 

continues. Shipment of devices in 

interstate commerce will be subject to 

injunction under section 302 of the act 

(21 U.S.C. 332), and the individuals 

responsible for such shipment will be 

subject to prosecution under section 303 

of the act (21 U.S.C. 333). In the past, 

FDA has requested that manufacturers 

take action to prevent the further use of 

devices for which no PMA has been 

filed and may determine that such a 

request is appropriate for the class III 

device that is the subject of this 

regulation.

The act does not permit an extension 

of the 90-day period after issuance of a 

final rule within which an application 

or notice is required to be filed. The 

House Report on the 1976 amendments 

states that ‘‘* * * the thirty month 

‘grace period’ afforded after 

classification of a device into class III 

* * * is sufficient time for 

manufacturers and importers to develop 

the data and conduct the investigations 

necessary to support an application of 

premarket approval’’ (H. Rept. 94–853, 

94th Cong., 2d sess. 42 (1976)).

In the Federal Register of September 

4, 1987 (47 FR 33686), FDA issued a 

final rule classifying the hip joint metal/

polymer semiconstrained resurfacing 

cemented prosthesis into class III. 

Subsequently, FDA determined that the 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis was 

substantially equivalent to the metal/

polymer semiconstrained resurfacing 

cemented prosthesis.

In the Federal Register of March 5, 

2004 (69 FR 10390), FDA issued a 

proposed rule to require the filing of a 

PMA or a notice of completion of a PDP 

for the hip joint metal/polymer or 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis (the 

proposed rule). In accordance with 

section 515(b)(2)(A) of the act, FDA 

included in the preamble to the 

proposed rule the agency’s proposed 

findings regarding the degree of risk of 

illness or injury intended to be 

eliminated or reduced by requiring the 

device to meet the statute’s approval 

requirements as well as the benefits to 

the public from the use of the device.

The March 5, 2004, proposed rule also 

provided an opportunity for interested 

persons to submit comments on the 

proposed rule and the agency’s 

proposed findings. In accordance with 

section 515(b)(2)(A) of the act, FDA also 

provided an opportunity for interested 

persons to request a change in the 

classification of the device based on 

new information relevant to its 

classification. Interested persons 

requesting a change in the classification 

of the devices were to submit a petition 

by March 22, 2004. The comment period 

closed June 3, 2004.

FDA received no petitions requesting 

a change in the classification of the hip 

joint metal/polymer or ceramic/polymer 

semiconstrained resurfacing cemented 

prosthesis. FDA received no comments 

on the proposed rule.

II. Device Subject to This Proposal

A hip joint metal/polymer or ceramic/

polymer semiconstrained resurfacing 

cemented prosthesis is a two-part device 

intended to be implanted to replace the 

articulating surfaces of the hip while 

preserving the femoral head and neck. 

The device limits translation and 

rotation in one or more planes via the 

geometry of its articulating surfaces. It 

has no linkage across the joint. This 

generic type of device includes 

prostheses that consist of a femoral cap 

component made of a metal alloy, such 

as cobalt-chromium-molybdenum, or a 

ceramic material, that is placed over a 

surgically prepared femoral head, and 

an acetabular resurfacing polymer 

component. Both components are 

intended for use with bone cement.

III. Findings With Respect to Risks and 

Benefits

Under section 515(b)(3) of the act, 

FDA is adopting the findings as 

published in the proposed rule of March 

5, 2004. As required by section 515(b) 

of the act, FDA published its findings 

regarding the following topics: (1) The 

degree of risk of illness or injury 

designed to be eliminated or reduced by 

requiring that these devices have an 

approved PMA or a declared completed 

PDP and (2) the benefits to the public 

from the use of the device.

These findings are based on the 

reports and recommendations of the 

Orthopaedic Device Classification 

Panel, an FDA advisory committee, for 

the classification of the device, along 

with FDA’s comprehensive review of 

the literature.

IV. The Final Rule

Under section 515(b)(3) of the act, 

FDA adopts the findings as published in 

the preamble to the proposed rule and 

issues this final rule to require 

premarket approval for the hip joint 

metal/polymer or ceramic/polymer 

semiconstrained resurfacing cemented 

prosthesis. This final rule revises part 

888 (21 CFR part 888).

Under the final rule, a PMA or a 

notice of completion of a PDP is 

required to be filed on or before 90 days 

after the date of publication of this rule 

in the Federal Register (see DATES), for 

any hip joint metal/polymer or ceramic/

polymer semiconstrained resurfacing 

cemented prosthesis that was in 

commercial distribution before May 28, 

1976, or that has been found by FDA to 

be substantially equivalent to such a 

device on or before 90 days after the 

date of publication of this rule in the 

Federal Register. If a PMA or notice of 

completion of a PDP is filed for any 

such device within this time limit, the 

applicant will be permitted to continue 

marketing its hip joint metal/polymer or 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis during 

FDA’s review of its submission. Any 

other hip joint metal/polymer or 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis that 

was not in commercial distribution 

before May 28, 1976, is required to have 

an approved PMA or a declared 

completed PDP in effect before it may be 

marketed.

If a PMA or a notice of completion of 

a PDP for a hip joint metal/polymer or 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis is not 

filed on or before 90 days after the date 

of publication of this rule in the Federal 

Register, that device is deemed 

adulterated under section 501(f)(1)(A) of 

the act (21 U.S.C. 351(f)(1)(A)), and 

commercial distribution of the device 

must cease immediately. The device 

may, however, be distributed for 

investigational use, if the requirements 

of the IDE regulations (part 812) are met. 

Because the hip joint metal/polymer or 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis is 

intended to be used as an implant, FDA 

considers it to be a significant risk 

device as defined in the IDE regulation 

in § 812.3(m)(1).

The exemptions in § 812.2(c)(1) and 

(c)(2) from the requirements of the IDE 

regulations for preamendments class III 

devices cease to apply to any hip joint 

metal/polymer or ceramic/polymer 

semiconstrained resurfacing cemented 

prosthesis that is either: (1) Not legally 

on the market on or before 90 days after 

the date of publication of this rule in the 

Federal Register or (2) legally on the 

market but for which a PMA or notice 

of completion of a PDP is not filed 

within 90 days after the date of 

publication of this final rule in the 

Federal Register, or for which PMA 

approval has been denied or withdrawn. 

FDA cautions that manufacturers who 

are not immediately planning to submit 

a PMA or notice of completion of a PDP 

should submit IDE applications to FDA 

by 60 days after the date of publication 

of this final rule in the Federal Register, 

59134 Federal Register / Vol. 69, No. 191 / Monday, October 4, 2004 / Rules and Regulations 

to minimize the possibility of 

interrupting shipment of the device. At 

this time, FDA is not aware of any firm 

that is marketing this device.

V. PMA Requirements

A PMA for these devices must include 

the information required by section 

515(c)(1) of the act. Such a PMA should 

also include a detailed discussion of the 

risks identified previously, as well as a 

discussion of the effectiveness of the 

device for which premarket approval is 

sought. In addition, a PMA must 

include all data and information on the 

following topics: (1) Any risks known, 

or that should be reasonably known, to 

the applicant that have not been 

identified in this document; (2) the 

effectiveness of the device that is the 

subject of the application; and (3) full 

reports of all preclinical and clinical 

information from investigations on the 

safety and effectiveness of the device for 

which premarket approval is sought.

VI. PDP Requirements

A PDP for any of these devices may 

be submitted in lieu of a PMA, and must 

follow the procedures outlined in 

section 515(f) of the act. A PDP should 

provide the following information: (1) A 

description of the device, (2) preclinical 

trial information (if any), (3) clinical 

trial information (if any), (4) a 

description of the manufacturing and 

processing of the devices, (5) labeling of 

the device, and (6) all other relevant 

information about the device. In 

addition, the PDP must include progress 

reports and records of the trials 

conducted under the protocol on the 

safety and effectiveness of the device for 

which the completed PDP is sought.

Information about the PDP process is 

also available from the Center for 

Devices and Radiological Health on the 

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

devadvice/pma/

app_methods.html#product_dev.

VII. Environmental Impact

The agency has determined under 21 

CFR 25.30(h) 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.

VIII. 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), 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 not a 

significant regulatory action 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 device has fallen 

out of use and FDA is not aware of any 

firm marketing the device, the agency 

has concluded that there is little or no 

interest in marketing this device in the 

future. The agency, therefore, certifies 

that the 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, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $110 

million. FDA does not expect this final 

rule to result in any 1-year expenditure 

that would meet or exceed this amount.

IX. Paperwork Reduction Act of 1995

This final rule contains information 

collection provisions that are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (PRA). The 

burden hours required for § 888.3410(c), 

included in the collection entitled 

‘‘Premarket Approval of Medical 

Devices—21 CFR Part 814,’’ are reported 

and approved under OMB control 

number 0910–0231. Therefore, 

clearance by OMB under the PRA 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 888.3410 is revised to read 

as follows:

§ 888.3410 Hip joint metal/polymer or 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis.

(a) Identification. A hip joint metal/

polymer or ceramic/polymer semiconstrained resurfacing cemented 

prosthesis is a two-part device intended 

to be implanted to replace the 

articulating surfaces of the hip while 

preserving the femoral head and neck. 

The device limits translation and 

rotation in one or more planes via the 

geometry of its articulating surfaces. It 

has no linkage across the joint. This 

generic type of device includes 

prostheses that consist of a femoral cap 

component made of a metal alloy, such 

as cobalt-chromium-molybdenum, or a 

ceramic material, that is placed over a 

surgically prepared femoral head, and 

an acetabular resurfacing polymer 

component. Both components are 

intended for use with bone cement 

(§ 888.3027).

(b) Classification. Class III.

(c) Date PMA or notice of completion 

of a PDP is required. A PMA or a notice 

of completion of a PDP is required to be 

filed with the Food and Drug 

Administration on or before January 3, 

2005, for any hip joint metal/polymer or 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis that 

was in commercial distribution before 

May 28, 1976, or that has, on or before 

January 3, 2005, been found to be 

substantially equivalent to a hip joint 

metal/polymer or ceramic/polymer 

semiconstrained resurfacing cemented 

prosthesis that was in commercial 

distribution before May 28, 1976. Any 

other hip joint metal/polymer or 

ceramic/polymer semiconstrained 

resurfacing cemented prosthesis must 

have an approved PMA or a declared 

completed PDP in effect before being 

placed in commercial distribution.

Dated: September 23, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–22210 Filed 10–1–04; 8:45 am]

BILLING CODE 4160–01–S