Document ID: FDA-2008-N-0424-0004
Agency: fda
Document Type: Notice
Title: Postmarketing Safety Reporting for Combination Products; Extension of Comment Period
Posted Date: 2009-12-11T05:00Z

[Federal Register: December 11, 2009 (Volume 74, Number 237)]
[Proposed Rules]               
[Page 65702]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11de09-15]                         

[[Page 65702]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 4

[Docket No. FDA-2008-N-0424]
RIN 0910-AF82

 
Postmarketing Safety Reporting 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 
January 29, 2009, the comment period for the proposed rule that 
appeared in the Federal Register of October 1, 2009. In the proposed 
rule, FDA requested comments on postmarketing safety reporting 
requirements for 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 published October 1, 
2009 (74 FR 50744), is extended. Submit written or electronic comments 
by January 29, 2010.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2008-
N-0424 and/or RIN number 0910-AF82, 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 and Regulatory Information Number (RIN) 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 October 1, 2009 (74 FR 50744), FDA 
published a proposed rule with a 90-day comment period to request 
comments on postmarketing safety reporting requirements for combination 
products. Comments on the proposed rule will inform FDA's rulemaking to 
establish regulations for postmarketing safety reporting for 
combination products.
    The agency has received requests for a 30-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 30 days, until January 29, 2010. The agency 
believes that a 30-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.

    Dated: December 7, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-29493 Filed 12-10-09; 8:45 am]

BILLING CODE 4160-01-S