[Federal Register Volume 73, Number 148 (Thursday, July 31, 2008)]
[Notices]
[Pages 44748-44749]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17566]
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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 [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
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