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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

NOTICE: NOTICES

DOCUMENT ACTION: Notice.

SUBJECT CATEGORY: 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

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

DOCUMENT 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.

SUMMARY: Agency Information Collection Activities; Proposals, Submissions, and Approvals,

SUPPLEMENTAL 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 Health Care FacilitiesSurvey(OMB Control Number 09100548)Extension

FDA has received four reports of medical gas mixups 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 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, 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 60day 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. E814888 Filed 63008; 8:45 am]
BILLING CODE 416001S

FOR FURTHER INFORMATION CONTACT Elizabeth Berbakos, Office of the Chief Information Officer (HFA250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3018271482.