FDA taking public comments on tobacco regulation

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA2009N0294]
Regulation of Tobacco Products; Extension of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; extension of comment period.

More Information
SUMMARY: The Food and Drug Administration (FDA) is extending to December 28, 2009, the comment period for the notice that appeared in the Federal Register of July 1, 2009 (74 FR 31457). In the notice, FDA requested comments on the implementation of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Act). The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments. 

Comments can be submitted to the agency online at http://www.regulations.gov, or by mail to the Division of Dockets Management [HFA-305], Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments should be identified with the docket number, FDA-2009-N-0294.

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Food and Drugs Act Liaison Office

Canadian Contact Information

The Food and Drugs Act Liaison Office (FDALO) is a resource for the public when they are experiencing problems with the regulatory process or with the application of Food and Drugs Act policies or procedures.

Our mandate is to receive complaints, concerns or enquiries about alleged acts, omissions, improprieties and/or broader systemic problems on matters pertaining to the Food and Drugs Act. We will listen, offer options, facilitate resolution, make recommendations, investigate or otherwise examine issues independently and impartially.

We will work to facilitate early resolution of disputes and focus on preventing future similar disputes. We promote transparency and work towards building stronger relationships in a confidential, independent and impartial manner.

So, if:

• You would like help in identifying the next steps to resolve an issue;
• You would like support in your attempts at resolution (coaching, etc.);
• You have tried all that you can think of to resolve the issue at hand;
• You do not know what the next steps are or could be;
• You do not know who to call to help resolve your issue; or
• You have reasons to believe that the process leading to the decision of Health Canada representative was unfair, biased or that due process was not followed...

Food and Drugs Act Liaison Office

Address Locator 3807A
275 Slater
Ottawa, Ontario
K1A 0K9

E-mail:   fdalo@hc-sc.gc.ca
Telephone: 613-957-4284
Toll free: 1-866-339-4998
Facsimile: 613-946-3585
Teletypewriter: 1-800-267-1245 (Health Canada)

In Person:

275 Slater, 7^th Floor
Ottawa Ontario

When to Contact the Food and Drugs Act Liaison Office (FDALO)

You should consider contacting the FDALO if you are in the following circumstances:

• You need help identifying the next steps to resolve an issue related to the Food and Drugs Act
• You are looking for support in your attempts at resolution (i.e. coaching).
• You have tried all that you can think of to resolve the issue at hand.
• You are not sure what the next steps are or could be.
• You don't know who to call to help resolve your issue.
• You have reasons to believe that the process leading to the decision of Health Canada representative was unfair, biased or that due process was not followed.

You should not contact the FDALO if:

• Your comments are related to a case that is in litigation.
• Your comments are not related to the Food and Drugs Act.
• You have not tried to resolve the issue with Health Canada.
• You are not willing to cooperate with the FDALO.

Contact Them by Mail or Telephone

If you have comments or questions you can also contact them by mail:

Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

or by telephone:

• 1-888-INFO-FDA (1-888-463-6332) -- main FDA Phone Number (for general inquiries)
• Electronic Employee Directory
• FDA Public Affairs Specialists

Freedom of Information: FDA cannot accept on-line Freedom of Information Act requests (because such requests must be signed in writing); however, information about filing such requests is available in FDA's Electronic FOI Reading Room.