[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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