[Federal Register Volume 62, Number 99 (Thursday, May 22, 1997)]
[Notices]
[Pages 28055-28056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13378]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95D-0413]


Draft Guidance on the Content and Format of Premarket 
Notification (510(k)) Submissions for Liquid Chemical Germicides; 
Reopening of Comment Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; reopening of comment period.

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SUMMARY:  The Food and Drug Administration (FDA) is reopening the 
comment period on the notice announcing the availability of a draft 
guidance, which was published in the Federal Register of December 6, 
1996 (61 FR 64755), entitled ``Guidance on the Content and Format of 
Premarket Notification (510(k)) Submissions for Liquid Chemical 
Germicides.'' The draft guidance provides specific directions to 
manufacturers regarding information and data that should be submitted 
to FDA in a premarket notification (510(k)) submission for a liquid 
chemical germicide.

DATES:  Written comments by August 20, 1997.

ADDRESSES:  Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Chiu S. Lin, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-443-8913.

SUPPLEMENTARY INFORMATION:  In the Federal Register of December 6, 1996 
(61 FR 64755), FDA announced the availability of a draft guidance 
entitled ``Guidance on the Content and Format of Premarket Notification 
(510(k)) Submissions for Liquid Chemical Germicides.'' The draft 
guidance provides specific directions to manufacturers regarding 
information and data that should be submitted to FDA in a premarket 
notification (510(k)) submission for a liquid chemical germicide. 
Interested persons were given until March 6, 1997, to submit written 
comments on the notice.
     With the passage of the Food Quality Protection Act of 1996, the 
distribution of the draft guidance was delayed until it could be 
revised to reflect the regulatory changes. However, the revision has 
been more complex than

[[Page 28056]]

anticipated. Therefore, FDA has determined that the important health 
issues involved in the draft guidance provide good cause for reopening 
of the comment period on the original draft guidance in accordance with 
section 520(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(d)). FDA is reopening the comment period for an additional 90 
days.
    Interested persons may, on or before August 20, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
the 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 7, 1997.
Joseph A. Levitt,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 97-13378 Filed 5-21-97; 8:45 am]
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