Document ID: FDA-2013-N-0067-0008
Agency: fda
Document Type: Rule
Title: Infant Formula: The Addition of Minimum and Maximum Levels of
Selenium to Infant Formula and Related Labeling Requirements;
Confirmation of Effective Date
Posted Date: 2015-10-13T04:00Z

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Rules and Regulations]
[Page 61293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-25960]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 107

[Docket No. FDA-2013-N-0067]

Infant Formula: The Addition of Minimum and Maximum Levels of 
Selenium to Infant Formula and Related Labeling Requirements; 
Confirmation of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA or we) is confirming the 
effective date of June 22, 2016, for the final rule that appeared in 
the Federal Register of June 23, 2015. The final rule amended the 
regulations on nutrient specifications and labeling for infant formula 
to add the mineral selenium to the list of required nutrients and to 
establish minimum and maximum levels of selenium in infant formula.

DATES: Effective date of final rule published in the Federal Register 
of June 23, 2015 (80 FR 35834) confirmed: June 22, 2016.

FOR FURTHER INFORMATION CONTACT: Carrie Assar, Center for Food Safety 
and Applied Nutrition (HFS-850), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1451.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 23, 2015 (80 
FR 35834), we amended the regulations on nutrient specifications and 
labeling for infant formula to add 2.0 [mu]g selenium per 100 
kilocalories (/100 kcal) as the minimum level of selenium in infant 
formulas and 7.0 [mu]g/100 kcal as the maximum level of selenium in 
infant formulas.
    We gave interested persons until July 23, 2015, to file objections 
or requests for a hearing. We received no objections or requests for a 
hearing on the final rule. Therefore, we find that the effective date 
of the final rule that published in the Federal Register of June 22, 
2016, should be confirmed.

List of Subjects in 21 CFR Part 107

    Food labeling, Infants and children, Nutrition, Reporting and 
recordkeeping requirements, Signs and symbols.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
321, 343, 350a, 371) and under authority delegated to the Commissioner 
of Food and Drugs, we are giving notice that no objections or requests 
for a hearing were filed in response to the June 23, 2015, final rule. 
Accordingly, the amendments issued thereby will become effective June 
22, 2016.

    Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-25960 Filed 10-9-15; 8:45 am]
BILLING CODE 4164-01-P