[Federal Register Volume 59, Number 46 (Wednesday, March 9, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5449]
[[Page Unknown]]
[Federal Register: March 9, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 88D-0087]
Manufacture of In Vitro Diagnostic Products; Current Good
Manufacturing Practice Final Guideline; Availability; Extension of
Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice: extension of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is extending to April
11, 1994, the comment period on a final guideline entitled ``Guideline
for the Manufacture of In Vitro Diagnostic Products'' that contains
production practices which are acceptable to FDA for ensuring the
safety and effectiveness of in vitro diagnostic products. This action
is being taken to ensure adequate time for the preparation and
submission of comments on the final guideline.
DATES: Written comments by April 11, 1994.
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: Z. Frank Twardochleb, Center for
Devices and Radiological Health, (HFZ-300), Food and Drug
Administration, 2098 Gaither Rd., Rockville, MD 20850, 301-594-4586.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 10, 1994
(59 FR 1402), FDA announced the availability of a final guideline
entitled ``Guideline for the Manufacture of In Vitro Diagnostic
Products.'' The guideline contains production practices which are
acceptable to FDA for ensuring the safety and effectiveness of in vitro
diagnostic products. Manufacturers of in vitro diagnostic products may
find the information in the guidelines useful in developing procedures
that comply with the current good manufacturing practice regulations
for these products.
Interested person were invited to comment by March 11, 1994. FDA
received one request to extend the comment period for 45 days. The
comment stated that this timeframe would provide sufficient time to
gather the necessary data to respond in a scientific and meaningful
way.
FDA agrees in part with this request and is extending the comment
period for 30 days to ensure adequate time for the preparation of
comments. FDA believes that an extension of more than 30 days is
unnecessary. Therefore, written comments received by April 11, 1994,
will be considered by FDA during its review.
Interested persons may, on or before April 11, 1994, 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 thru Friday.
Dated: March 3, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-5449 Filed 3-8-94; 8:45 am]
BILLING CODE 4160-01-F
