[Federal Register: June 24, 2004 (Volume 69, Number 121)]
[Notices]
[Page 35379-35380]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jn04-83]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003N-0456]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Prevention of Medical
Gas Mixups 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 July
26, 2004.
ADDRESSES: The Office of Management and Budget (OMB) is still
experiencing significant delays in the regular mail, including first
class and express mail, and messenger deliveries are not being
accepted. 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: Fumie Yokota, Desk
Officer for FDA, FAX: 202-395-6974.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Prevention of Medical Gas Mixups at Health Care Facilities
Background
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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Annual Frequency Total Annual
21 CFR Part No. of Respondents per Response Responses Hours per 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.
In the Federal Register of October 10, 2003 (68 FR 58691), FDA
published a 60-day notice requesting public comment on the information
collection provisions. The agency received two comments. One comment
had specific questions regarding the requirements to register firms
exporting foods from Korea.
The responder of the second comment feels the agency is gathering
facts with the intent of developing and implementing future guidance
that would be enforced on manufacturers,
[[Page 35380]]
fillers, and transfillers of medical gases. This comment also requests
the agency meet with the medical gases industry prior to issuing any
guidance.
The intent of this survey is stated previously and is not
applicable to the medical gases industry.
The agency does however, agree with the statement addressed in the
second comment regarding the initial contact FDA makes with the 285
facilities would be more effective and save valuable resources if made
via telephone. This call could determine whether the health care
facility is one of those covered by this assignment and our April 6,
2001, FDA Public Health Advisory--Guidance for Hospitals, Nursing
Homes, and other Health Care Facilities.
Dated: June 16, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-14266 Filed 6-23-04; 8:45 am]
BILLING CODE 4160-01-S