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Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration 21 CFR Part 573
Docket No. FDA2019F5401

Food Additives Permitted in Feed and Drinking Water of Animals;
Guanidinoacetic Acid AGENCY:

Food and Drug Administration,
HHS.
ACTION:

Final rule.

The Food and Drug Administration FDA, we, or 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 precursor of creatine in poultry feeds.
This action is in response to a food additive petition filed by Alzchem Trostberg GmbH.
DATES: This rule is effective July 14, 2021. See section V of this document for further information on the filing of objections. Submit either electronic or written objections and requests for a hearing on the final rule by August 13, 2021.
ADDRESSES: You may submit objections and requests for a hearing as follows.
Please note that late, untimely filed objections will not be considered.
Electronic objections must be submitted on or before August 13, 2021. The https www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 13, 2021. Objections received by mail/hand delivery/courier for written/paper submissions will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

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SUMMARY:

Electronic Submissions Submit electronic objections in the following way:
Federal eRulemaking Portal:
https www.regulations.gov. Follow the instructions for submitting objections.
Objections submitted electronically, including attachments, to https
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 elses Social Security number, or confidential business information, such as a manufacturing process. Please note
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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 https 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.
Written/Paper Submissions Submit written/paper submissions as follows:
Mail/Hand delivery/Courier for written/paper submissions: Dockets Management Staff HFA305, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper objections submitted to the Dockets Management Staff, 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
2019F5401 for Food Additives Permitted in Feed and Drinking Water of Animals; Guanidinoacetic Acid.
Received objections, those filed in a timely manner see ADDRESSES, will be placed in the docket and, except for those submitted as Confidential Submissions, publicly viewable at https www.regulations.gov or at the Dockets Management Staff between 9
a.m. and 4 p.m., Monday through Friday, 2404027500.
Confidential SubmissionsTo 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 https
www.regulations.gov. Submit both copies to the Dockets Management Staff.
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
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confidential. Any information marked as confidential will not be disclosed except in accordance with 21 CFR 10.20
and other applicable disclosure law. For more information about FDAs posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or the electronic and written/paper objections received, go to https
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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 2404027500.
FOR FURTHER INFORMATION CONTACT:
Carissa Adams, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.
HFV221, Rockville, MD 20855, 240
4026283, Carissa.Adams@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background In a document published in the Federal Register of November 29, 2019
84 FR 65717, FDA announced that we had filed a food additive petition animal use FAP 2309 submitted by Alzchem Trostberg GmbH, Dr.-AlbertFrank-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 precursor of creatine in poultry feeds.
II. Conclusion FDA concludes that the data establish the safety and utility of guanidinoacetic acid as a precursor of creatine in poultry feeds and that the food additive regulations should be amended as set forth in this document.
III. Public Disclosure In accordance with 571.1h 21 CFR
571.1h, the petition and documents we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure see FOR FURTHER
INFORMATION CONTACT. As provided in 571.1h, we will delete from the documents any materials that are not available for public disclosure.
IV. Analysis of Environmental Impact We have determined under 21 CFR
25.32r that this action is of a type that does not individually or cumulatively have a significant effect on the human
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