Postmarketing Safety Reporting for Combination Products; 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 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.