Thursday, December 22, 2005

To comment on the condom rules

As I have been working on some end-of-year reviews of the blog, I have found a few "loose ends." One of them relates to an earlier post about new rules being proposed by the Food and Drug Administration for condom labeling. I forgot to tell you how to comment on the rules. If you clicked through on the post title, you already have this information. If not, here it is [with emphasis and formatting added and internal references deleted]:

[Docket No. 2004N-0556]

DATES: Submit written or electronic comments on the proposed rule by February 13, 2006.

ADDRESSES: You may submit comments, identified by Docket No. 2004N-0556 and/RIN number 0910-AF21, 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 in the Electronic Submissions portion of this paragraph.

Instructions: All submissions received must include the agency name and Docket No. 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.

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: Colin M. Pollard, Center for Devices and Radiological Health (HFZ-470), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-1180.


Things to remember:

  • Comment by February 13.
  • Include the Docket Number and the RIN.
  • Use the comment methods allowed; do not send email.
  • Be careful about the personal information that you include (your comment will be on the public record).

Things to do:

  • Comment.

The FDA has done a nice job of laying out the history of the issue, in case you've missed anything. They are proposing to make factual statements in the new labeling for condoms and to steer clear of the "culture war." They are likely to receive a ton of comments that argue that condoms don't prevent HIV, that the package label should include an abstinence message, etc. They will need to hear from folks who support reality-based public health information.

1 comment:

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