Infant Formula: The Addition of Minimum and Maximum Levels of Selenium to Infant Formula and Related Labeling Requirements; Confirmation of Effective Date, 61293 [2015-25960]
Download as PDF
<![CDATA[
Federal Register / Vol. 80, No. 197 / Tuesday, October 13, 2015 / Rules and Regulations
R. Gil Kerlikowske,
Commissioner, U.S. Customs and Border
Protection.
Approved: October 5, 2015.
Mark J. Mazur,
Assistant Secretary of the Treasury.
formulas and 7.0 mg/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.
[FR Doc. 2015–25729 Filed 10–9–15; 8:45 am]
BILLING CODE 9111–14–P; 9111–15–P; 9111–16–P;
9111–17–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
List of Subjects in 21 CFR Part 107
Food and Drug Administration
Food labeling, Infants and children,
Nutrition, Reporting and recordkeeping
requirements, Signs and symbols.
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.
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.
ACTION:
Final rule; confirmation of
effective date.
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.
Dated: October 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–25960 Filed 10–9–15; 8:45 am]
SUMMARY:
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 mg selenium
per 100 kilocalories (/100 kcal) as the
minimum level of selenium in infant
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, 556,
and 558
[Docket No. FDA–2015–N–0002]
asabaliauskas on DSK5VPTVN1PROD with RULES
DATES:
VerDate Sep<11>2014
17:03 Oct 09, 2015
Jkt 238001
New Animal Drugs; Approval of New
Animal Drug Applications; Withdrawal
of Approval of a New Animal Drug
Application; Change of Sponsor;
Change of Sponsor’s Address
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
application-related actions for new
animal drug applications (NADAs) and
abbreviated new animal drug
SUMMARY:
PO 00000
Frm 00017
Fmt 4700
Sfmt 4700
61293
applications (ANADAs) during July and
August 2015. FDA is also informing the
public of the availability of summaries
of the basis of approval and of
environmental review documents,
where applicable. The animal drug
regulations are also being amended to
reflect a change of sponsor, a change of
sponsor’s address, a revised food safety
warning, the voluntary withdrawal of
approval of an NADA, and a technical
amendment. This technical amendment
is being made to improve the accuracy
of the regulations.
This rule is effective October 13,
2015, except for the amendment to 21
CFR 558.460, which is effective October
23, 2015.
DATES:
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5689,
george.haibel@fda.hhs.gov.
FDA is
amending the animal drug regulations to
reflect approval actions for NADAs and
ANADAs during July and August 2015,
as listed in table 1. In addition, FDA is
informing the public of the availability,
where applicable, of documentation of
environmental review required under
the National Environmental Policy Act
(NEPA) and, for actions requiring
review of safety or effectiveness data,
summaries of the basis of approval (FOI
Summaries) under the Freedom of
Information Act (FOIA). These public
documents may be seen in the Division
of Dockets Management (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD
20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with
access to the Internet may obtain these
documents at the CVM FOIA Electronic
Reading Room: https://www.fda.gov/
AboutFDA/CentersOffices/
OfficeofFoods/CVM/
CVMFOIAElectronicReadingRoom/
default.htm. Marketing exclusivity and
patent information may be accessed in
FDA’s publication, Approved Animal
Drug Products Online (Green Book) at:
https://www.fda.gov/AnimalVeterinary/
Products/
ApprovedAnimalDrugProducts/
default.htm.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\13OCR1.SGM
13OCR1
]]>Agencies
[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]
=======================================================================
-----------------------------------------------------------------------
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
