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Federal Register / Vol. 72, No.

38 / Tuesday, February 27, 2007 / Proposed Rules 8643

cause for the extension. The FAA also SUMMARY: The Food and Drug agency Web site, as described in the
has determined that extension of the Administration (FDA) is publishing a ADDRESSES portion of this document
comment period is consistent with the proposed rule to reclassify pressure under Electronic Submissions.
public interest, and that good cause regulators for use with medical oxygen, Instructions: All submissions must
exists for taking this action. currently class I devices included in the include the agency name and Docket
Accordingly, the comment period for generic type of device called pressure No. for this rulemaking. All comments
the Repair Stations, NPRM, Docket No. regulator, into class II, subject to special received may be posted without change
FAA–2006–26408, is extended until controls in the form of a guidance to http://www.fda.gov/ohrms/dockets/
April 16, 2007. document. Pressure regulators for use default.htm, including any personal
Issued in Washington, DC, February 20, with all other medical gases will remain information provided. For additional
2007. in class I, subject only to general information on submitting comments,
James J. Ballough, controls. FDA is also proposing to see section XII ‘‘What if I Have
Director, Flight Standards Service, Aviation establish a separate classification Comments to the Proposed Rule’’
Safety. regulation for oxygen conserving heading in the SUPPLEMENTARY
[FR Doc. E7–3331 Filed 2–26–07; 8:45 am] devices (or oxygen conservers), now INFORMATION section of this document.
included in the generic type of device Docket: For access to the docket to
BILLING CODE 4910–13–P
called noncontinuous ventilator. read background documents or
Oxygen conserving devices will comments received, go to http: //
continue to be classified in class II, but www.fda.gov/ohrms/dockets/
RAILROAD RETIREMENT BOARD default.htm and insert the docket
those that incorporate a built-in oxygen
20 CFR Part 230 pressure regulator will become subject number, found in brackets in the
to the special controls guidance if the heading of this document, into the
RIN 3220–AA61 rule is finalized. Elsewhere in this issue ‘‘Search’’ box and follow the prompts
of the Federal Register, FDA is and/or go to the Division of Dockets
Reduction and Nonpayment of announcing the availability of a class II Management, 5630 Fishers Lane, rm.
Annuities by Reason of Work special controls draft guidance for 1061, Rockville, MD 20852.
AGENCY: Railroad Retirement Board. industry and FDA staff entitled ‘‘Class II FOR FURTHER INFORMATION CONTACT:
ACTION: Proposed rule; withdrawal. Special Controls Guidance Document: Christy Foreman, Center for Devices and
Oxygen Pressure Regulators and Oxygen Radiological Health (HFZ–340), Food
SUMMARY: The above mentioned Conserving Devices.’’ The agency is and Drug Administration, 2094 Gaither
regulation was previously published as proposing this action because it believes Rd., Rockville, MD 20850, 240–276–
a proposed rule on August 16, 1995 (60 that special controls are necessary to 0120.
FR 42482). The Railroad Retirement provide a reasonable assurance of safety
SUPPLEMENTARY INFORMATION:
Board has determined not to go final and effectiveness for these devices.
with that proposed rule and hereby DATES: Submit comments by May 29, I. What Are the Highlights of the
withdraws the proposed rule to amend 2007. FDA is proposing that any final Proposed Rule?
20 CFR Part 230. rule based on this proposed rule be The highlights of the proposed rule
ADDRESSES: 844 North Rush Street, effective 2 years after the date of its are as follows:
Chicago, Illinois 60611–2092. publication in the Federal Register. • FDA is dividing the classification of
FOR FURTHER INFORMATION CONTACT: ADDRESSES: You may submit comments, pressure regulators into two
Marguerite P. Dadabo, Assistant General identified by Docket No. 2007N–0019, classification regulations.
Counsel, Office of General Counsel, by any of the following methods: • Pressure regulators for use with
Railroad Retirement Board, (312) 751– Electronic Submissions medical gases other than oxygen will
4945, FAX (312) 751–7102, TDD (312) Submit electronic comments in the remain in class I.
751–4701. following ways: • Pressure regulators for use with
Dated: February 21, 2007. • Federal eRulemaking Portal: http:// medical oxygen will be identified as
Beatrice Ezerski, www.regulations.gov. Follow the ‘‘oxygen pressure regulators’’ and will
Secretary to the Board. instructions for submitting comments. be reclassified into class II (special
• Agency Web site: http:// controls).
[FR Doc. 07–872 Filed 2–26–07; 8:45 am]
www.fda.gov/dockets/ecomments. • FDA is establishing a separate
BILLING CODE 7905–01–M
Follow the instructions for submitting classification regulation for oxygen
comments on the agency Web site. conserving devices, which are now
Written Submissions included in the generic type of device
DEPARTMENT OF HEALTH AND Submit written submissions in the called noncontinuous ventilators.
HUMAN SERVICES following ways: • Both noncontinuous ventilators and
• FAX: 301–827–6870. oxygen conserving devices will remain
Food and Drug Administration
• Mail/Hand delivery/Courier [For in class II.
paper, disk, or CD–ROM submissions]: • Oxygen conservers will be classified
21 CFR Part 868
Division of Dockets Management (HFA– within their own class according to
[Docket No. 2007N–0019] 305), Food and Drug Administration, whether or not the device incorporates
5630 Fishers Lane, rm. 1061, Rockville, a built-in oxygen pressure regulator.
Medical Devices; Anesthesiology MD 20852. • FDA is establishing a special
sroberts on PROD1PC70 with PROPOSALS

Devices; Oxygen Pressure Regulators To ensure more timely processing of controls guidance document for oxygen
and Oxygen Conserving Devices comments, FDA is no longer accepting pressure regulators and oxygen
AGENCY: Food and Drug Administration, comments submitted to the agency by e- conservers that have built-in oxygen
HHS. mail. FDA encourages you to continue pressure regulators entitled ‘‘Class II
to submit electronic comments by using Special Controls Guidance Document:
ACTION: Proposed rule.
the Federal eRulemaking Portal or the Oxygen Pressure Regulators and Oxygen

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