[Federal Register: October 10, 2003 (Volume 68, Number 197)]
[Page 58691-58692]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0456]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prevention of Medical Gas Mixups at Health Care 

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 

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 

                               Table 1.--Estimated Annual Recordkeeping Burden\1\
 21 CFR Section    No. of Respondents     Annual Frequency per     Annual     Hours per Response     Total Hours
                                                Response         Responses
210 and 211                       285                  1           285                 .25                71.25
Total                             285                  1           285                 .25                71.25
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

    Dated: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-25754 Filed 10-9-03; 8:45 am]