[Federal Register Volume 66, Number 67 (Friday, April 6, 2001)]
[Notices]
[Page 18257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-8474]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0131]


Guidance for Hospitals, Nursing Homes, and Other Health Care 
Facilities; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Guidance for Hospitals, 
Nursing Homes, and Other Health Care Facilities.'' This guidance is 
intended to alert hospitals, nursing homes, and other health care 
facilities of the potentially fatal hazards of medical gas mixups. This 
guidance makes recommendations that will help hospitals, nursing homes, 
and other health care facilities avoid the injuries and fatalities that 
have resulted from medical gas mixups.

DATES: Submit written comments on the guidance by July 5, 2001. General 
comments on agency guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Drug Information Branch (HFD-210), Center for Drug Evaluation 
and Research, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit written comments on the 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Duane S. Sylvia, Center for Drug 
Evaluation and Research (HFD-325), Food and Drug Administration, 7520 
Standish Pl., Rockville, MD 20855, 301-594-0095, ext. 8, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled 
``Guidance on Hospitals, Nursing Homes, and Other Health Care 
Facilities.'' FDA has received reports during the past 4 years from 
hospitals and nursing homes involving 7 deaths and 15 injuries to 
patients who were thought to be receiving medical grade oxygen, but 
were receiving a different gas (e.g., nitrogen) that had been 
mistakenly connected to the oxygen supply system. As a result of these 
reports, FDA has decided to alert hospitals, nursing homes, and other 
health care facilities to the potentially fatal hazards associated with 
handling medical gases. The agency also is making recommendations that 
should help health care facilities avoid the tragedies that result from 
medical gas mixups.
    Because of the potential danger to the public health of medical gas 
mixups, this guidance is being issued as a Level 1 guidance for 
immediate implementation, consistent with FDA's good guidance practices 
regulation (21 CFR 10.115; 65 FR 56468, September 19, 2000). As with 
other Level 1 guidances for immediate implementation, the agency is 
soliciting comments from the public. This guidance represents the 
agency's current thinking on how to avoid potentially fatal medical gas 
mixups. It does not create or confer any rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach 
may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit written comments on the guidance to 
the Dockets Management Branch (address above). Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. The guidance and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cder/guidance/index.htm.

    Dated: March 29, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-8474 Filed 4-5-01; 8:45 am]
BILLING CODE 4160-01-S