[Federal Register Volume 63, Number 237 (Thursday, December 10, 1998)]
[Proposed Rules]
[Pages 68212-68213]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32744]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 207, 807, and 1271

[Docket No. 97N-484R]
RIN 0910-AB05


Establishment Registration and Listing for Manufacturers of Human 
Cellular and Tissue-Based Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening the 
comment period for the proposed rule concerning establishment 
registration and listing for manufacturers of human cellular and 
tissue-based products that was published in the Federal Register of May 
14, 1998 (63 FR 26744). FDA is taking this action in response to a 
request for an extension and to allow interested parties additional 
time for review and to submit comments.

DATES: Submit written comments on the proposed rule by February 8, 
1999.
ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 14, 1998 (63 
FR 26744), FDA published a proposed rule to require manufacturers of 
certain human cellular and tissue-based products to register with the 
agency and list their products. In addition, the agency proposed to 
amend the registration and listing regulations that currently apply to 
human cellular and tissue-based products regulated as drugs, devices, 
and/or biological products. Interested persons were given until August 
12, 1998, to submit written comments on the proposed rule.

[[Page 68213]]

    On August 6, 1998, a comment was submitted to the docket requesting 
that the agency extend the comment period on the proposed rule 60 days. 
The comment noted that certain information relevant to the rulemaking 
was not included in the public docket. Because the docket was scheduled 
to close on August 12, 1998, there was insufficient time to prepare and 
submit a letter of extension to the docket. However, the agency agrees 
that an additional period will provide time for interested parties to 
review the proposed rule and information now placed in the public 
docket and submit written comments. Therefore, the agency is reopening 
the comment period for an additional 60 days, until February 8, 1999.
    Interested persons may, on or before February 8, 1999 submit to the 
Dockets Management Branch (address above) written comments on the 
proposed rule. 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 proposed rule and received comments are available for 
public examination in the Dockets Management Branch between 9 a.m. and 
4 p.m., Monday through Friday.

    Dated: December 1, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-32744 Filed 12-9-98; 8:45 am]
BILLING CODE 4160-01-F