[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]

[[Page 61172]]



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.


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-

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]