Document ID: FDA-2008-N-0146-0003
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2008-07-31T04:00Z

[Federal Register: July 31, 2008 (Volume 73, Number 148)]
[Notices]               
[Page 44748-44749]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31jy08-50]                         

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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.

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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 
September 2, 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 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3792.

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

    On March 7, 2008 (73 FR 12452) and July 1, 2008 (73 FR 37465) 
respectively, FDA published a 60-day and 30-day notice stating that it 
had received 4 reports of medical gas mix-ups occurring during the past 
9 years which 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. These 
reported incidents actually occurred between 1998 and 2000 which, at 
the time, prompted the FDA in 2001 to publish 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\
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                                                              No. of         Annual frequency       Total annual        Hours per
                    21 CFR section                         respondents         per response          responses           response         Total hours
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210 and 211                                                           285                     1                285                .25              71.25
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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 44749]]

    Dated: July 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-17566 Filed 7-30-08; 8:45 am]

BILLING CODE 4160-01-S