64266 Federal Register / Vol. 69, No. 213 / Thursday, November 4, 2004 / Proposed Rules 

Part Identification Inspection, Ultrasonic 

Inspection, and Corrective Action 

(h) Inspect the outer cylinder of the MLG 

to determine whether an outer cylinder 

having a serial number (S/N) listed in 

paragraph 1.D., ‘‘Description,’’ of the service 

bulletin is installed. Instead of an inspection 

of the outer cylinder of the MLG, a review 

of airplane maintenance records is acceptable 

if the S/N of the outer cylinder can be 

positively determined from that review.

(1) If no S/N identified in the service 

bulletin is installed, no further action is 

required by this paragraph. 

(2) If any S/N identified in the service 

bulletin is installed, before further flight, do 

an ultrasonic inspection of the outer cylinder 

of the MLG for cracks, all applicable 

specified actions, and any corrective actions 

per the service bulletin. Do any applicable 

corrective action before further flight. 

Reporting a Crack 

(i) Submit a report of any crack is found 

during the inspection required by paragraph 

(h)(2) of this AD to the Manager, Seattle 

Aircraft Certification Office (ACO), FAA, 

1601 Lind Avenue, SW., Renton, 

Washington, at the applicable time specified 

in paragraph (i)(1) or (i)(2) of this AD. The 

report must include the inspection results, a 

description of any discrepancies found, the 

outer cylinder serial number and part 

number, and the number of landings and 

flight hours on the outer cylinder. Under the 

provisions of the Paperwork Reduction Act of 

1980 (44 U.S.C. 3501 et seq.), the Office of 

Management and Budget (OMB) has 

approved the information collection 

requirements contained in this AD and has 

assigned OMB Control Number 2120–0056. 

(1) If the inspection was done after the 

effective date of this AD: Submit the report 

within 10 days after the inspection. 

(2) If the inspection was accomplished 

prior to the effective date of this AD: Submit 

the report within 10 days after the effective 

date of this AD. 

Parts Installation 

(j) As of the effective date of this AD, no 

person may install an outer cylinder having 

a S/N listed in paragraph 1.D., ‘‘Description,’’

of the service bulletin on any airplane unless 

it has been inspected and all specified and 

corrective actions are accomplished in 

accordance with paragraph (h)(2) of this AD. 

Alternative Methods of Compliance 

(AMOCs) 

(k)(1) The Manager, Seattle Aircraft 

Certification Office (ACO), FAA, has the 

authority to approve AMOCs for this AD, if 

requested in accordance with the procedures 

found in 14 CFR 39.19. 

(2) An AMOC that provides an acceptable 

level of safety may be used for any action 

required by this AD, if it is approved by a 

Boeing Company Designated Engineering 

Representative who has been authorized by 

the Manager, Seattle ACO, to make those 

findings. For a repair method to be approved, 

the approval must specifically refer to this 

AD.

Issued in Renton, Washington, on October 

21, 2004. 

Kalene C. Yanamura, 

Acting Manager, Transport Airplane 

Directorate, Aircraft Certification Service.

[FR Doc. 04–24631 Filed 11–3–04; 8:45 am] 

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 890

[Docket No. 2000N–1409]

Medical Devices; Revision of the 

Identification of the Iontophoresis 

Device; Withdrawal

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Proposed rule; withdrawal.

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

the proposed rule the agency issued in 

the Federal Register of August 22, 2000 

(65 FR 50949) (the August 2000 

proposed rule). In that document, FDA 

proposed to amend the physical 

medicine devices regulations to remove 

the class III (premarket approval) 

iontophoresis device identification. In 

response to the comments received on 

the proposed rule, FDA is withdrawing 

the proposed rule and considering and 

other courses of action. Elsewhere in 

this issue of the Federal Register, FDA 

is announcing an opportunity to submit 

information and comments concerning 

FDA’s intent to initiate a proceeding to 

reclassify those iontophoresis devices 

currently in class III into class II (special 

controls).

DATES: The proposed rule is withdrawn 

on November 4, 2004.

FOR FURTHER INFORMATION CONTACT:

Joseph M. Sheehan, Center for Devices 

and Radiological Health (HFZ–215), 

Food and Drug Administration, 1350 

Piccard Dr., Rockville, MD 20850, 301–

827–2974.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 

23, 1983 (48 FR 53032), FDA issued a 

final rule classifying the iontophoresis 

device into class II (performance 

standards before the Safe Medical 

Devices Act of 1990 and now special 

controls) and class III (premarket 

approval), depending on its intended 

use. An iontophoresis device is a device 

that is intended to use a direct current 

to introduce ions of soluble salts or 

other drugs into the body and induce 

sweating for diagnostic or other uses. If 

the iontophoresis device is intended for 

use in the diagnosis of cystic fibrosis or 

another intended use and the labeling of 

the drug intended for use with the 

device bears adequate directions for the 

device’s use with that drug, the device 

is categorized as class II. An 

iontophoresis device that is intended to 

introduce ions of soluble salts or other 

drugs into the body for other purposes 

is categorized as class III.

In the August 2000 proposed rule, 

FDA proposed regulations to amend the 

physical medicine devices regulations 

to remove the class III (premarket 

approval) iontophoresis device 

identification. FDA proposed this action 

because it believed that there were no 

preamendments iontophoresis devices 

marketed for uses other than those 

described in the class II identification. 

FDA expected that manufacturers of 

those devices currently in class III 

would be able to relabel their devices to 

meet the class II identification.

II. Withdrawal of the Proposed Rule

FDA received substantial comment in 

response to the August 2000 proposed 

rule. Several comments disagreed with 

FDA’s assertion that no class III 

preamendments iontophoresis devices 

existed. In response to these comments, 

FDA is considering other courses of 

action and is withdrawing the August 

2000 proposed rule.

III. Alternative Action

Elsewhere in this issue of the Federal 

Register, FDA is providing interested 

persons with an opportunity to submit 

new information concerning the safety 

and effectiveness of the iontophoresis 

device. After FDA reviews any 

information that it receives in response 

to this notice, the agency will decide 

whether it should go forward with a 

reclassification of those iontophoresis 

devices currently in class III and 

whether a panel meeting is necessary 

before taking any action.

Dated: October 25, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–24590 Filed 11–3–04; 8:45 am]

BILLING CODE 4160–01–S