[Federal Register Volume 60, Number 97 (Friday, May 19, 1995)]
[Proposed Rules]
[Page 26854]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-12293]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 896
[Docket No. 83N-0193]
RIN 0905-AD83
Performance Standard for the Infant Apnea Monitor; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is extending to August
21, 1995, the comment period on the proposed rule that published in the
Federal Register of February 21, 1995 (60 FR 9762). The document
proposed to establish a mandatory performance standard for infant apnea
monitors, which are a subset of breathing frequency monitors, also
called neonatal apnea monitors. The infant apnea monitor is a system
intended for use on infants to detect cessation of breathing. This
action is based on a request from industry.
DATES: Written comments by August 21, 1995.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: James J. McCue, Center for Devices and
Radiological Health (HFZ-84), Food and Drug Administration, 2098
Gaither Rd., Rockville, MD 20850, 301-594-4765.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 21, 1995
(60 FR 9762), FDA published a proposed rule to establish a mandatory
performance standard for infant apnea monitors, which are a subset of
breathing frequency monitors, also called neonatal apnea monitors. The
infant apnea monitor is a system intended for use on infants to detect
cessation of breathing. FDA believes that a performance standard is
necessary to ensure that infant apnea monitors accurately and reliably
detect the absence of effective respiration and provide an alarm in
such cases.
Interested persons were invited to comment by May 22, 1995. FDA
received one request from industry to extend the comment period for 90
days. The request stated that this timeframe would allow sufficient
time to gather the necessary data to develop effective comments.
FDA is extending the comment period for 90 days to ensure adequate
time for preparation of comments. Accordingly, FDA finds under section
520(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(d))
that there is good cause for such an extension.
Interested persons may, on or before August 21, 1995, submit to
the Dockets Management Branch (address above) written comments
regarding this notice. 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. Received comments may be seen in the office above
between 9 a.m. and 4 p.m., Monday through Friday.
Dated: May 10, 1995.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 95-12293 Filed 5-18-95; 8:45 am]
BILLING CODE 4160-01-F
