[Federal Register Volume 59, Number 228 (Tuesday, November 29, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-29382]
[[Page Unknown]]
[Federal Register: November 29, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Temporary Deferment of Activities Relating to Medical Device
Submissions
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that the
Office of Device Evaluation (ODE), Center for Devices and Radiological
Health (CDRH) has completed the move from its former Rockville, MD,
location to its new location in that same city. FDA is announcing that
during the period required for the move, from October 7, 1994, through
October 21, 1994 (14 calendar days), the agency continued to accept
mail, but did not officially receive premarket notifications, premarket
approval applications, or investigational device exemption
applications, nor continue its review of such pending submissions. The
statutory review periods on pending submissions were suspended during
this 14-day period needed for the relocation of ODE. The new address
for submissions to ODE is set forth below.
ADDRESSES: Office of Device Evaluation, Document Mail Center, Center
for Devices and Radiological Health (HFZ-401), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850. Submit
written requests for a copy of the exact date adjustments to review
timeframes to the Division of Small Manufacturers Assistance, Center
for Devices and Radiological Health (HFZ-220), Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850, 301-443-6597
(toll free outside MD: 1-800-638-2041).
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-84), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 301-594-4765, extension 157.
SUPPLEMENTARY INFORMATION: In the Federal Register of October 14, 1994
(59 FR 52170), FDA announced its intention to defer activities related
to certain medical device submissions for about 10 days during ODE's
move from its former Rockville, MD, location to its new location in
that same city. FDA also announced that it would provide information on
the exact period during which the activities were temporarily deferred,
and provide the new address for submissions. The agency deferred its
actions on new and existing submissions during the period from October
7, 1994, through October 21, 1994 (14 calendar days). New addresses for
both the Document Mail Center, where device submissions are to be
mailed to ODE, and for the Division of Small Manufacturers Assistance,
where a copy of the exact date adjustments to review timeframes can be
obtained, are provided earlier in this document under the
``ADDRESSES''section.
Dated: November 22, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-29382 Filed 11-28-94; 8:45 am]
BILLING CODE 4160-01-F
