Food and Drug Administration, HHS.
ACTION:Final rule.
SUMMARY:The Food and Drug Administration (FDA, we, the Agency) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. This action is in response to a food additive petition filed by Alzchem AG.
DATES:This rule is effective November 30, 2016. Submit either written or electronic objections and requests for a hearing by December 30, 2016. See section V of this document for information on the filing of objections.
ADDRESSES:You may submit objections and requests for a hearing as follows:
Electronic SubmissionsSubmit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Objections submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your objection will be made public, you are solely responsible for ensuring that your objection does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your objection, that information will be posted on http://www.regulations.gov. If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).Start Printed Page 86269Written/Paper SubmissionsSubmit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper objections submitted to the Division of Dockets Management, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”Instructions: All submissions received must include the Docket No. FDA-2015-F-2337 for “Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid.” Received objections will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable athttp://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections only as a written/paper submission. You should submit two copies in total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS document ConTAINS ConFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of objections. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your objections and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.Docket: For access to the docket to read background documents or the electronic and written/paper objections 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:Chelsea Trull, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6729,chelsea.trull@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:I. BackgroundIn a document published in the Federal Register of July 16, 2015 (80 FR 42069), FDA announced that we had filed a food additive petition (animal use) (FAP 2292) submitted by Alzchem AG, Chemiepark Trostberg, Dr.-Albert-Frank-Str. 32, 83308, Trostberg, Germany. The petition proposed that the regulations for food additives permitted in feed and drinking water of animals be amended to provide for the safe use of guanidinoacetic acid as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds. The notice of petition provided for a 30-day comment period on the petitioner's request for categorical exclusion from preparing an environmental assessment or environmental impact statement.
II. Conclusion
FDA concludes that the data establish the safety and utility of guanidinoacetic acid for use as a substance that spares arginine and serves as a precursor of creatine in broiler chicken and turkey feeds and that the food additive regulations should be amended as set forth in this document.
