[Federal Register Volume 71, Number 101 (Thursday, May 25, 2006)]
[Notices]
[Pages 30146-30147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7988]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0500]


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 Mixups at 
Health Care Facilities--Survey

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing 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 June 
26, 2006.

ADDRESSES:  OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. 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: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Karen Nelson, Office of Management 
Programs (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 Mixups at Healthcare Facilities--Survey (OMB Control Number 
0910-0548)--Extension

    FDA has received four reports of medical gas mixups occurring 
during the past 7 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 mixups and alerting these facilities to 
the hazards. This survey is intended to assess the degree of 
facilities' compliance with safety measures to prevent mixups and to 
determine if further steps are warranted to ensure the safety of 
patients.
    In the Federal Register of January 3, 2006 (71 FR 122), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

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



[[Page 30147]]

    Dated: May 18, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7988 Filed 5-24-06; 8:45 am]
BILLING CODE 4160-01-S