FDA Reopens Comment Period for its Interim Final Rule on the Registration of Food Facilities
The Food and Drug Administration (FDA) has issued a notice announcing that it is reopening through May 14, 2004 the comment period for its interim final rule on the registration of foreign food facilities.
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(On October 10, 2003, the FDA published an interim final rule requiring domestic and foreign food facilities that manufacture/process, pack, or hold food for human or animal consumption in the U.S. to register with the FDA by December 12, 2003. See ITT's Online Archives or 10/14/03 news, 03101420, for previous BP summary on FDA's interim final rule which mentions FDA's intention to reopen the interim final rule comment period at a later date.)
Comments Requested on a Limited Set of Issues
The FDA states that it is reopening the comment period for 30 days on a limited set of issues in order to improve its economic analysis, including (partial list):
The cost to foreign facilities of hiring and retaining a U.S. agent; and
The effects on domestic small businesses, if any, if some foreign facilities cease exporting to the U.S. due to the U.S. agent requirement.
(See FDA notice for complete list of questions on which it is requesting comments.)
(According to the FDA, this reopening of the comment period is consistent with its statement in the October 10, 2003 interim final rule that it would ensure that those commenting on the interim final rule would have had the benefit of FDA outreach and education efforts and would have had some experience with the systems, timeframes, and data elements of the registration program.)
FDA Will Address Comments and Confirm/Amend Interim Final Rule in Final RuleFDA notes that it will address comments received in this reopened comment period and the previous comment period that closed on December 24, 2003, and will confirm or amend the interim final rule in a final rule.
However, FDA states that it will not address any comments that have been previously considered during this rulemaking.
(See ITT's Online Archives or 04/14/04 news, 04041405 and 04041410, for BP summary of FDA's notices announcing a plan with CBP for increasing integration and assessing the coordination of prior notice timeframes and the reopening of the comment period for the interim final rule on prior notice of imported food.)
- written or electronic comments due by May 14, 2004
| FDA contact - | Melissa S. Scales (301) 436-2378 |
Reopening of comment period on food facility registration (FR Pub 04/14/04, D/N 2002N-0276) available at
http://a257.g.akamaitech.net/7/257/2422/14mar20010800/edocket.access.gpo.gov/2004/pdf/04-8516.pdf.