Document ID: FDA-2008-N-0146-0001
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2008-03-07T05:00Z

[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Notices]               
[Page 12452-12453]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07mr08-88]                         

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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