[Federal Register Volume 73, Number 46 (Friday, March 7, 2008)]
[Notices]
[Pages 12452-12453]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-4474]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0146]
Agency Information Collection Activities; Proposed Collection;
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 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,
including each proposed extension of an existing 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 present mix-
ups with other gases.
DATES: Submit written or electronic comments on the collection of
information by May 6, 2008.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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: 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: 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, including
each proposed extension of an existing 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, when
appropriate, and other forms of information technology.
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.
FDA estimates the burden of this collection of information as
follows:
[[Page 12453]]
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
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.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through FDMS only.
Dated: February 29, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-4474 Filed 3-6-08; 8:45 am]
BILLING CODE 4160-01-S