Voglio sapere a riguardo di…

37036

Federal Register / Vol. 86, No. 132 / Wednesday, July 14, 2021 / Rules and Regulations
of Animals; Selenomethionine Hydroxy Analogue. 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 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.
lotter on DSK11XQN23PROD with RULES1

FOR FURTHER INFORMATION CONTACT:

Chelsea Cerrito, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.
HFV221, Rockville, MD 20855, 240
4026729, chelsea.cerrito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:

VerDate Sep<11>2014

16:14 Jul 13, 2021

Jkt 253001

I. Background In a document published in the Federal Register of May 11, 2020 85 FR
27692, FDA announced that we had filed a food additive petition animal use FAP 2312 submitted by Adisseo France S.A.S.; Immeuble Antony Parc II, 10 Place du General de Gaulle, 92160
Antony, France. 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 selenomethionine hydroxy analogue as a source of selenium in feed for beef and dairy cattle.
II. Conclusion FDA concludes that the data establish the safety and utility of selenomethionine hydroxy analogue as a source of selenium in feed for beef and dairy cattle 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 environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
V. Objections and Hearing Requests Any person who will be adversely affected by this regulation may file with the Dockets Management Staff see ADDRESSES either electronic or written objections. Each objection shall be separately numbered, and each numbered objection shall specify with particularity the provision of the regulation to which objection is made and the grounds for the objection. Each numbered objection on which a hearing is requested shall specifically so state.
Failure to request a hearing for any particular objection shall constitute a waiver of the right to a hearing on that objection. Each numbered objection for which a hearing is requested shall include a detailed description and analysis of the specific factual information intended to be presented in support of the objection in the event
PO 00000

Frm 00036

Fmt 4700

Sfmt 9990

that a hearing is held. Failure to include such a description and analysis for any particular objection shall constitute a waiver of the right to a hearing on the objection.
List of Subjects in 21 CFR Part 573
Animal feeds, Food additives.
Therefore, 21 CFR part 573 is amended as follows:
PART 573FOOD ADDITIVES
PERMITTED IN FEED AND DRINKING
WATER OF ANIMALS
1. The authority citation for part 573
continues to read as follows:

Authority: 21 U.S.C. 321, 342, 348.

2. In 573.920, revise paragraphs a6, h2 and 3 introductory text to read as follows:

573.920

Selenium.

a
6 Paragraphs b through h of this section provide the currently acceptable levels of selenium supplementation.

h
2 Selenium, as selenomethionine hydroxy analogue, is added to feed as follows:
i In complete feed for chickens, turkeys, swine, beef cattle, and dairy cattle at a level not to exceed 0.3 ppm.
ii In feed supplements for limit feeding for beef cattle at a level not to exceed an intake of 3 milligrams per head per day.
iii In salt-mineral mixtures for freechoice feeding for beef cattle up to 120
parts per million in a mixture for freechoice feeding at a rate not to exceed an intake of 3 milligrams per head per day.
3 To assure safe use of the additive, in addition to the other information required by the Federal Food, Drug, and Cosmetic Act, the label and labeling of selenomethionine hydroxy analogue in its packaged form shall contain:

Dated: July 7, 2021.
Janet Woodcock, Acting Commissioner of Food and Drugs.
Dated: July 12, 2021.
Xavier Becerra, Secretary, Department of Health and Human Services.
FR Doc. 202115072 Filed 71321; 8:45 am BILLING CODE 416401P

E:FRFM14JYR1.SGM

14JYR1