[Federal Register: April 6, 2001 (Volume 66, Number 67)]
[Notices]
[Page 18257]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06ap01-62]
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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,
Sylviad@cder.fda.gov.
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