80 FR 61293 - Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements; Confirmation of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 197 (October 13, 2015)

Page Range		61293-61293
FR Document		2015-25960

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.

Federal Register, Volume 80 Issue 197 (Tuesday, October 13, 2015)

[Federal Register Volume 80, Number 197 (Tuesday, October 13, 2015)]
[Rules and Regulations]
[Page 61293]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-25960]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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

Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations 61293

R. Gil Kerlikowske, formulas and 7.0 mg/100 kcal as the applications (ANADAs) during July and
Commissioner, U.S. Customs and Border maximum level of selenium in infant August 2015. FDA is also informing the
Protection. formulas. public of the availability of summaries
Approved: October 5, 2015. We gave interested persons until July of the basis of approval and of
Mark J. Mazur, 23, 2015, to file objections or requests environmental review documents,
Assistant Secretary of the Treasury. for a hearing. We received no objections where applicable. The animal drug
[FR Doc. 2015–25729 Filed 10–9–15; 8:45 am] or requests for a hearing on the final regulations are also being amended to
BILLING CODE 9111–14–P; 9111–15–P; 9111–16–P;
rule. Therefore, we find that the reflect a change of sponsor, a change of
9111–17–P effective date of the final rule that sponsor’s address, a revised food safety
published in the Federal Register of warning, the voluntary withdrawal of
June 22, 2016, should be confirmed. approval of an NADA, and a technical
DEPARTMENT OF HEALTH AND amendment. This technical amendment
List of Subjects in 21 CFR Part 107
HUMAN SERVICES is being made to improve the accuracy
Food labeling, Infants and children, of the regulations.
Food and Drug Administration Nutrition, Reporting and recordkeeping
requirements, Signs and symbols. DATES: This rule is effective October 13,
2015, except for the amendment to 21
21 CFR Part 107 ■ Therefore, under the Federal Food, CFR 558.460, which is effective October
[Docket No. FDA–2013–N–0067] Drug, and Cosmetic Act (21 U.S.C. 321, 23, 2015.
343, 350a, 371) and under authority
FOR FURTHER INFORMATION CONTACT:
Infant Formula: The Addition of delegated to the Commissioner of Food
Minimum and Maximum Levels of and Drugs, we are giving notice that no George K. Haibel, Center for Veterinary
Selenium to Infant Formula and objections or requests for a hearing were Medicine (HFV–6), Food and Drug
Related Labeling Requirements; filed in response to the June 23, 2015, Administration, 7519 Standish Pl.,
Confirmation of Effective Date final rule. Accordingly, the amendments Rockville, MD 20855, 240–402–5689,
issued thereby will become effective george.haibel@fda.hhs.gov.
AGENCY: Food and Drug Administration,
June 22, 2016. SUPPLEMENTARY INFORMATION: FDA is
HHS.
Dated: October 7, 2015. amending the animal drug regulations to
ACTION: Final rule; confirmation of reflect approval actions for NADAs and
effective date. Leslie Kux,
ANADAs during July and August 2015,
Associate Commissioner for Policy.
SUMMARY: The Food and Drug as listed in table 1. In addition, FDA is
[FR Doc. 2015–25960 Filed 10–9–15; 8:45 am]
Administration (FDA or we) is informing the public of the availability,
BILLING CODE 4164–01–P
confirming the effective date of June 22, where applicable, of documentation of
2016, for the final rule that appeared in environmental review required under
the Federal Register of June 23, 2015. the National Environmental Policy Act
DEPARTMENT OF HEALTH AND
The final rule amended the regulations (NEPA) and, for actions requiring
HUMAN SERVICES
on nutrient specifications and labeling review of safety or effectiveness data,
for infant formula to add the mineral Food and Drug Administration summaries of the basis of approval (FOI
selenium to the list of required nutrients Summaries) under the Freedom of
and to establish minimum and 21 CFR Parts 510, 520, 522, 524, 556, Information Act (FOIA). These public
maximum levels of selenium in infant and 558 documents may be seen in the Division
formula. of Dockets Management (HFA–305),
[Docket No. FDA–2015–N–0002] Food and Drug Administration, 5630
DATES: Effective date of final rule Fishers Lane, rm. 1061, Rockville, MD
published in the Federal Register of New Animal Drugs; Approval of New
20852, between 9 a.m. and 4 p.m.,
June 23, 2015 (80 FR 35834) confirmed: Animal Drug Applications; Withdrawal
Monday through Friday. Persons with
June 22, 2016. of Approval of a New Animal Drug
access to the Internet may obtain these
FOR FURTHER INFORMATION CONTACT: Application; Change of Sponsor;
documents at the CVM FOIA Electronic
Carrie Assar, Center for Food Safety and Change of Sponsor’s Address
Reading Room: http://www.fda.gov/
Applied Nutrition (HFS–850), Food and AGENCY: Food and Drug Administration, AboutFDA/CentersOffices/
Drug Administration, 5100 Paint Branch HHS. OfficeofFoods/CVM/
Pkwy., College Park, MD 20740–3835, CVMFOIAElectronicReadingRoom/
Final rule; technical
ACTION:
240–402–1451. default.htm. Marketing exclusivity and
amendment.
SUPPLEMENTARY INFORMATION: In the patent information may be accessed in
Federal Register of June 23, 2015 (80 FR SUMMARY: The Food and Drug FDA’s publication, Approved Animal
35834), we amended the regulations on Administration (FDA) is amending the Drug Products Online (Green Book) at:
nutrient specifications and labeling for animal drug regulations to reflect http://www.fda.gov/AnimalVeterinary/
infant formula to add 2.0 mg selenium application-related actions for new Products/
per 100 kilocalories (/100 kcal) as the animal drug applications (NADAs) and ApprovedAnimalDrugProducts/
minimum level of selenium in infant abbreviated new animal drug default.htm.
asabaliauskas on DSK5VPTVN1PROD with RULES

VerDate Sep<11>2014 17:03 Oct 09, 2015 Jkt 238001 PO 00000 Frm 00017 Fmt 4700 Sfmt 4700 E:\FR\FM\13OCR1.SGM 13OCR1

Document Created: 2018-02-27 08:47:44
Document Modified: 2018-02-27 08:47:44

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule; confirmation of effective date.
Dates		Effective date of final rule published in the Federal Register of June 23, 2015 (80 FR 35834) confirmed: June 22, 2016.
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.
FR Citation		80 FR 61293
CFR Associated		Food Labeling; Infants and Children; Nutrition; Reporting and Recordkeeping Requirements and Signs and Symbols

80 FR 61293 - Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements; Confirmation of Effective Date

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 197 (October 13, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration