
[Federal Register: July 1, 2008 (Volume 73, Number 127)]
[Notices]               
[Page 37465-37466]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01jy08-48]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0146]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Requirements for 
Collection of Data Relating to the Prevention of Medical Gas Mix-ups at 
Health Care Facilities-Survey

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing

[[Page 37466]]

that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July 
31, 2008

ADDRESSES:  To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to baguilar@omb.eop.gov. All comments 
should be identified with the OMB control number 0910-0548. Also 
include the FDA docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:  Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1482.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Requirements for Collection of Data Relating to the Prevention of 
Medical Gas Mix-ups at Health Care Facilities-Survey--(OMB Control 
Number 0910-0548)--Extension

    FDA has received four reports of medical gas mix-ups occurring 
during the past 9 years. These reports were received from hospitals and 
nursing homes and involved 7 deaths and 15 injuries to patients who 
were thought to be receiving medical grade oxygen, but who were 
actually receiving a different gas (e.g., nitrogen, argon) that had 
been mistakenly connected to the facility's oxygen supply system. In 
2001, FDA published guidance making recommendations to help hospitals, 
nursing homes, and other health care facilities avoid the tragedies 
that result from medical gas mix-ups and alerting these facilities to 
the hazards. This survey is intended to assess the degree of 
facilities' compliance with safety measures to prevent mix-ups, to 
determine if further steps are warranted to ensure the safety of 
patients.
    In the Federal Register of March 7, 2008 (73 FR 12452), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                 Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
                         No. of        Annual Frequency     Total Annual        Hours per
  21 CFR Section      Respondents        per Response        Responses           Response         Total Hours
----------------------------------------------------------------------------------------------------------------
210 and 211                      285                  1                285                .25              71.25
----------------------------------------------------------------------------------------------------------------
Total                            285                  1                285                .25              71.25
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


    Dated: June 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14888 Filed 6-30-08; 8:45 am]

BILLING CODE 4160-01-S
