[Federal Register Volume 74, Number 216 (Tuesday, November 10, 2009)]
[Proposed Rules]
[Pages 57973-57974]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26966]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 4

[Docket No. FDA-2009-N-0435]


Current Good Manufacturing Practice Requirements for Combination 
Products; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
February 5, 2010, the comment period for the proposed rule that 
appeared in the Federal Register of September 23, 2009. In the proposed 
rule, FDA requested comments on current good manufacturing practice 
(CGMP) requirements applicable to combination products. The agency is 
taking this action in response to requests for an extension to allow 
interested persons additional time to submit comments.

DATES: The comment period for the proposed rule publishied September 
23, 2009 (74 FR 48423), is extended. Submit electronic or written 
comments by February 5, 2010.

ADDRESSES:  You may submit comments, identified by Docket No. FDA-2009-
N-0435, by any of the following methods:
Electronic Submissions
    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
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, 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.regulations.gov, 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.regulations.gov 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: John Barlow Weiner, Office of 
Combination Products (HFG-3), Food and Drug Administration, 15800 
Crabbs Branch Way, Suite 200, Rockville, MD 20855 301-427-1934.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 23, 2009 (74 FR 48423), FDA 
published a proposed rule with a 90-day comment period to request 
comments on CGMP requirements applicable to combination products. 
Comments on the proposed rule will inform FDA's rulemaking to establish 
regulations for current good manufacturing practices for combination 
products.

[[Page 57974]]

    The agency has received requests for a 45-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 45 days, until February 5, 2010. The agency 
believes that a 45-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) electronic or written 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.

    Dated: November 4, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-26966 Filed 11-9-09; 8:45 am]
BILLING CODE 4160-01-S