[Federal Register: September 24, 2007 (Volume 72, Number 184)]
[Proposed Rules]
[Page 54226]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se07-11]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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[[Page 54226]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 610
[Docket No. 2007N-0264]
Revisions to the Requirements Applicable to Blood, Blood
Components, and Source Plasma; Companion Document to Direct Final Rule;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; correction.
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SUMMARY: The Food and Drug Administration is correcting a proposed rule
that appeared in the Federal Register of August 16, 2007 (72 FR 45993).
That document proposed to amend the biologics regulations by removing,
revising, or updating specific regulations applicable to blood, blood
components, and Source Plasma to be more consistent with current
practices in the blood industry and to remove unnecessary or outdated
requirements. The proposal published as a companion document to the
direct final rule that published in the same issue of the Federal
Register (August 16, 2007, 72 FR 45883). Both documents published with
a typographical error in the codified section. This document corrects
the error in the proposed rule. Elsewhere in this issue of the Federal
Register we are correcting the error in the direct final rule.
DATES: Submit written or electronic comments on the proposed rule by
October 30, 2007.
ADDRESSES: You may submit comments on the proposed rule, identified by
Docket No. 2007N-0264, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For additional information
on submitting comments, see the ``Request for Comments'' heading of the
SUPPLEMENTARY INFORMATION section of the proposed rule (72 FR 45993 at
45995).
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: For information regarding this
correction: Joyce Strong, Office of Policy (HF-27), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.
For information regarding the proposed rule: Stephen M. Ripley,
Center for Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.
SUPPLEMENTARY INFORMATION: In FR Doc. E7-15942, appearing on page
45993, in the Federal Register of Thursday, August 16, 2007, the
following correction is made:
Sec. 610.53 [Corrected]
1. On page 45996, in the amendment to Sec. 610.53 Dating periods
for licensed biological products, in the table in paragraph (c),
``65[deg] C'' is corrected to read ``-65[deg] C'' everywhere it
appears.
Dated: September 17, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-18802 Filed 9-21-07; 8:45 am]
BILLING CODE 4160-01-S