[Federal Register: October 10, 2003 (Volume 68, Number 197)]
[Notices]
[Page 58691-58692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10oc03-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0456]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Prevention of Medical Gas Mixups at Health Care
Facilities
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on measures taken by certain Health Care
medical facilities that use medical oxygen to prevent mixups with other
gases.
DATES: Submit written or electronic comments on the collection of
information by December 9, 2003.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
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: Under the PRA (44 U.S.C. 3501-3520), Federal
agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques,
[[Page 58692]]
when appropriate, and other forms of information technology.
Medical Oxygen Manufacturers and Fillers--21 CFR Parts 210 and 211
The Food and Drug Administration (FDA) has received four reports of
medical gas mixups occurring during the past 5 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.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Recordkeeping Burden\1\
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Total
21 CFR Section No. of Respondents Annual Frequency per Annual Hours per Response Total Hours
Response Responses
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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: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25754 Filed 10-9-03; 8:45 am]
BILLING CODE 4160-01-S