Document ID: FDA-2007-0573-0002
Agency: fda
Document Type: Proposed Rule
Title: Requirements for Human Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use; Extension of Comment Period
Posted Date: 2008-01-11T05:00Z

[Federal Register: January 11, 2008 (Volume 73, Number 8)]
[Proposed Rules]               
[Page 1983]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11ja08-10]                         

========================================================================
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.

========================================================================

[[Page 1983]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 606, 610, 630, 640, 660, 820, and 1270

[Docket No. 2006N-0221]

 
Requirements for Human Blood and Blood Components Intended for 
Transfusion or for Further Manufacturing Use; Extension of Comment 
Period

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Proposed rule; extension of comment period.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is extending to August 
4, 2008, the comment period for the proposed rule that appeared in the 
Federal Register of November 8, 2007 (72 FR 63416). In the proposed 
rule, FDA had requested comments by February 6, 2008. The agency is 
taking this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES:  Submit written and electronic comments by August 4, 2008.

ADDRESSES: You may submit comments, identified by Docket No. 2006N-
0221, 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 No(s). and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) 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 ``Comments'' 
heading of the SUPPLEMENTARY INFORMATION section of this document.
    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(s), 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: Brenda R. Friend,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:

I. Background

    In the Federal Register of November 8, 2007 (72 FR 63416), FDA 
published a proposed rule with a 90-day comment period to request 
comments on the proposed rule. The proposed rule would establish 
regulations for blood and blood components, including Source Plasma and 
Source Leukocytes, to add donor requirements that are consistent with 
current practices in the blood industry, and to more closely align the 
regulations with current FDA recommendations.
    The agency has received requests for a 180-day extension of the 
comment period for the proposed rule. Each request conveyed concern 
that the current 90-day comment period does not allow sufficient time 
to develop a meaningful or thoughtful response to the proposed rule.
    FDA has considered the requests and is extending the comment period 
for the proposed rule for 180 days, until August 4, 2008. The agency 
believes that a 180-day extension allows adequate time for interested 
persons to submit comments without significantly delaying rulemaking on 
these important issues.

II. Request for Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on this document. Submit 
a single copy of electronic comments or two paper copies of any mailed 
comments, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Received comments may be seen in the Division 
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that in January 2008, the FDA Web site is expected to 
transition to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. After the 
transition date, electronic submissions will be accepted by FDA through 
the FDMS only. When the exact date of the transition to FDMS is known, 
FDA will publish a Federal Register notice announcing that date.

    Dated: January 2, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-297 Filed 1-10-08; 8:45 am]

BILLING CODE 4160-01-S