[Federal Register Volume 73, Number 127 (Tuesday, July 1, 2008)]
[Notices]
[Pages 37465-37466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-14888]
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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
[[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 [email protected]. 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\
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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.
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