[Printable PDF]
[Federal Register: October 27, 2003 (Volume 68, Number 207)]
[Proposed Rules]
[Page 61172]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27oc03-24]
[[Page 61172]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 606
[Docket No. 2003N-0211]
Revisions to Labeling and Storage Requirements for Blood and
Blood Components, Including Source Plasma; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; correction.
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SUMMARY: The Food and Drug Administration (FDA) is correcting a
proposed rule that proposed to revise the labeling and storage
requirements for certain human blood and blood components, including
Source Plasma (proposed labeling and storage rule). The proposed rule
appeared in the Federal Register of July 30, 2003 (68 FR 44678). The
proposed regulation included a paragraph that FDA did not intend to
publish. This document corrects that error by removing the incorrect
paragraph from the proposed rule.
DATES: Submit written or electronic comments on the proposed rule by
October 28, 2003.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD, 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Sharon Carayiannis, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION: The proposed rule that published in the
Federal Register of July 30, 2003, inadvertently included Sec.
606.121(c)(13) in the proposed text of the regulation (68 FR 44678 at
44686). As discussed in the proposed labeling and storage rule (68 FR
44678 at 44682), FDA issued a related proposed rule entitled ``Bar Code
Label Requirements for Human Drug Products and Blood'' (proposed bar
code rule) in the Federal Register of March 14, 2003 (68 FR 12499). The
proposed bar code rule would amend Sec. 606.121(c)(13) to require
certain human drug and biological product labels to bear bar codes and
also would require the use of machine-readable information on container
labels for blood and blood components intended for transfusion. FDA did
not intend to propose to revise Sec. 606.121(c)(13) in the proposed
labeling and storage rule, and the agency is removing that paragraph to
eliminate any confusion that might occur.
In FR Doc. 03-19289, appearing on page 44678, in the Federal
Register of July 30, 2003, the following correction is made:
Sec. 606.121 [Corrected]
1. On page 44686, in the third column, Sec. 606.121 Container
label is corrected by removing paragraph (c)(13).
Dated: October 20, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27012 Filed 10-24-03; 8:45 am]
BILLING CODE 4160-01-S