Normativa EEUUAgo. 26, 2011
Abren plazo para comentarios públicos sobre monto de aranceles bajo la Ley de Modernización de Seguridad Alimentaria
11 August 2011
|Committee on Sanitary and Phytosanitary Measures||Original: English|
The following communication, received on 9 August 2011, is being circulated at the request of the Delegation of the United States.
|Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments|
| The Food and Drug Administration (FDA) seeks comments to obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). FSMA provides the Agency with authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to assess and collect user fees, including those for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections. FDA is seeking public comment on what burdens these fees impose on small business, and whether and how the FDA should alleviate such burdens. In particular, the FDA is seeking public comments on whether a reduction of fees or other consideration for small business is appropriate, and if so, what factors FDA should consider for each. In addition, FDA is seeking public comment on how small business should be defined or recognized. FDA is establishing this docket in order to provide an opportunity for interested parties to provide data and share views that will inform future FDA actions with respect to these matters. The notice published in the Federal Register on 1 August 2011 76 FR 45818. The notice can be found at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19333.pdf.
FDA recognizes that there is significant international interest in how we are implementing the Food Safety Modernization Act of 2010, and as a result has elected to is notify this action to give US trading partners an opportunity to submit comments on the burden of fee amounts on small business, even though this notification is not an obligation under Article 7, Annex B.
|This addendum concerns a:|
|[ ] Modification of final date for comments|
|[ ] Notification of adoption, publication or entry into force of regulation|
|[ ] Modification of content and/or scope of previously notified draft regulation|
|[ ] Withdrawal of proposed regulation|
|[ ] Change in proposed date of adoption, publication or date of entry into force|
|[X] Other: Notice for public comment on fee burdens under the FDA Food Safety Modernization Act (FSMA)|
|Comment period: (If the addendum extends the scope of the previously notified measure in terms of products and/or potentially affected Members, a new deadline for receipt of comments should be provided, normally of at least 60 calendar days. Under other circumstances, such as extension of originally announced final date for comments, the comment period provided in the addendum may vary.)|
|[ ] Sixty days from the date of circulation of the addendum to the notification and/or (dd/mm/yy): 17 October 2011|
|Agency or authority designated to handle comments: [ ] National Notification Authority, [ ] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:|
|Submit electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA 305). Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Please indicate Docket No. FDA-2011-N-0529 with comment submission.
For further information contact: Alexis Nazario-Negron, Office of Financial Management, Food and Drug Administration, 1350 Piccard Dr., rm. 210E,Rockville, MD 20850, 301-796-7223, Alexis.Nazario-Negron@fda.hhs.gov.
|Text available from: [X] National Notification Authority, [ ] National Enquiry Point. Address, fax number and e-mail address (if available) of other body:|
|United States SPS National Notification Authority, USDA Foreign Agricultural Service, International Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250; Tel: +(1 202) 720 1301; Fax: +(1 202) 720 0433; E-mail: email@example.com
Text available on the internet at: http://www.gpo.gov/fdsys/pkg/FR-2011-08-01/pdf/2011-19333.pdf