Federal Register / Vol. 72, No. 38 / Tuesday, February 27, 2007 / Proposed Rules 8643 

cause for the extension. The FAA also 

has determined that extension of the 

comment period is consistent with the 

public interest, and that good cause 

exists for taking this action. 

Accordingly, the comment period for 

the Repair Stations, NPRM, Docket No. 

FAA–2006–26408, is extended until 

April 16, 2007. 

Issued in Washington, DC, February 20, 

2007. 

James J. Ballough, 

Director, Flight Standards Service, Aviation 

Safety. 

[FR Doc. E7–3331 Filed 2–26–07; 8:45 am] 

BILLING CODE 4910–13–P 

RAILROAD RETIREMENT BOARD 

20 CFR Part 230 

RIN 3220–AA61 

Reduction and Nonpayment of 

Annuities by Reason of Work 

AGENCY: Railroad Retirement Board. 

ACTION: Proposed rule; withdrawal. 

SUMMARY: The above mentioned 

regulation was previously published as 

a proposed rule on August 16, 1995 (60 

FR 42482). The Railroad Retirement 

Board has determined not to go final 

with that proposed rule and hereby 

withdraws the proposed rule to amend 

20 CFR Part 230. 

ADDRESSES: 844 North Rush Street, 

Chicago, Illinois 60611–2092. 

FOR FURTHER INFORMATION CONTACT: 

Marguerite P. Dadabo, Assistant General 

Counsel, Office of General Counsel, 

Railroad Retirement Board, (312) 751–

4945, FAX (312) 751–7102, TDD (312) 

751–4701. 

Dated: February 21, 2007. 

Beatrice Ezerski, 

Secretary to the Board. 

[FR Doc. 07–872 Filed 2–26–07; 8:45 am] 

BILLING CODE 7905–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 868 

[Docket No. 2007N–0019] 

Medical Devices; Anesthesiology 

Devices; Oxygen Pressure Regulators 

and Oxygen Conserving Devices 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Proposed rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

proposed rule to reclassify pressure 

regulators for use with medical oxygen, 

currently class I devices included in the 

generic type of device called pressure 

regulator, into class II, subject to special 

controls in the form of a guidance 

document. Pressure regulators for use 

with all other medical gases will remain 

in class I, subject only to general 

controls. FDA is also proposing to 

establish a separate classification 

regulation for oxygen conserving 

devices (or oxygen conservers), now 

included in the generic type of device 

called noncontinuous ventilator. 

Oxygen conserving devices will 

continue to be classified in class II, but 

those that incorporate a built-in oxygen 

pressure regulator will become subject 

to the special controls guidance if the 

rule is finalized. Elsewhere in this issue 

of the Federal Register, FDA is 

announcing the availability of a class II 

special controls draft guidance for 

industry and FDA staff entitled ‘‘Class II 

Special Controls Guidance Document: 

Oxygen Pressure Regulators and Oxygen 

Conserving Devices.’’ The agency is 

proposing this action because it believes 

that special controls are necessary to 

provide a reasonable assurance of safety 

and effectiveness for these devices. 

DATES: Submit comments by May 29, 

2007. FDA is proposing that any final 

rule based on this proposed rule be 

effective 2 years after the date of its 

publication in the Federal Register. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2007N–0019, 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described in the 

ADDRESSES portion of this document 

under Electronic Submissions. 

Instructions: All submissions must 

include the agency name and Docket 

No. for this rulemaking. All comments 

received may be posted without change 

to http://www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For additional 

information on submitting comments, 

see section XII ‘‘What if I Have 

Comments to the Proposed Rule’’

heading in the SUPPLEMENTARY

INFORMATION section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http: // 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Christy Foreman, Center for Devices and 

Radiological Health (HFZ–340), Food 

and Drug Administration, 2094 Gaither 

Rd., Rockville, MD 20850, 240–276–

0120. 

SUPPLEMENTARY INFORMATION: 

I. What Are the Highlights of the 

Proposed Rule? 

The highlights of the proposed rule 

are as follows: 

• FDA is dividing the classification of 

pressure regulators into two 

classification regulations. 

• Pressure regulators for use with 

medical gases other than oxygen will 

remain in class I. 

• Pressure regulators for use with 

medical oxygen will be identified as 

‘‘oxygen pressure regulators’’ and will 

be reclassified into class II (special 

controls). 

• FDA is establishing a separate 

classification regulation for oxygen 

conserving devices, which are now 

included in the generic type of device 

called noncontinuous ventilators. 

• Both noncontinuous ventilators and 

oxygen conserving devices will remain 

in class II. 

• Oxygen conservers will be classified 

within their own class according to 

whether or not the device incorporates 

a built-in oxygen pressure regulator. 

• FDA is establishing a special 

controls guidance document for oxygen 

pressure regulators and oxygen 

conservers that have built-in oxygen 

pressure regulators entitled ‘‘Class II 

Special Controls Guidance Document: 

Oxygen Pressure Regulators and Oxygen 


sroberts on PROD1PC70 with PROPOSALS