[Federal Register Volume 69, Number 121 (Thursday, June 24, 2004)]
[Notices]
[Pages 35379-35380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-14266]


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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