Veterinary Feed Directive; Correction, 35841-35842 [2015-15388]
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Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations
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§ 107.100
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3. In § 107.100, revise paragraph (a) to
read as follows:
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Nutrient specifications.
(a) An infant formula shall contain the
following nutrients at a level not less
than the minimum level specified and
not more than the maximum level
specified for each 100 kilocalories of the
infant formula in the form prepared for
consumption as directed on the
container:
Nutrients
Unit of measurement
Protein ................................................................................
Fat ......................................................................................
Grams .............................................................
Do. ..................................................................
Percent calories ..............................................
Milligrams ........................................................
Percent calories ..............................................
Linoleic acid ........................................................................
35841
Minimum level
Maximum level
1.8
3.3
30
300
2.7
4.5
6.0
54
............................
............................
250
40
0.7
4
40
60
35
0.15
250
4
300
1.5
8
7
4
750
100
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
............................
60
30
6
0.15
0.5
5
60
5
2
20
80
55
............................
............................
............................
3.0
............................
............................
............................
75
7
60
200
150
Vitamins
Vitamin A ............................................................................
Vitamin D ............................................................................
Vitamin E ............................................................................
Vitamin K ............................................................................
Thiamine (Vitamin B1) ........................................................
Riboflavin (Vitamin B2) .......................................................
Vitamin B6 ...........................................................................
Vitamin B12 .........................................................................
Niacin 1 ...............................................................................
Folic acid (Folacin) .............................................................
Pantothenic acid .................................................................
Biotin 2 ................................................................................
Vitamin C (Ascorbic acid) ...................................................
Choline 2 .............................................................................
Inositol 2 ..............................................................................
International Units ...........................................
Do. ..................................................................
Do. ..................................................................
Micrograms .....................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Milligrams ........................................................
Do. ..................................................................
Do. ..................................................................
Minerals
Calcium ...............................................................................
Phosphorus ........................................................................
Magnesium .........................................................................
Iron .....................................................................................
Zinc .....................................................................................
Manganese .........................................................................
Copper ................................................................................
Iodine ..................................................................................
Selenium .............................................................................
Sodium ...............................................................................
Potassium ...........................................................................
Chloride ..............................................................................
1 The
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Micrograms .....................................................
Do. ..................................................................
Do. ..................................................................
Do. ..................................................................
Milligrams ........................................................
Do. ..................................................................
Do. ..................................................................
generic term ‘‘niacin’’ includes niacin (nicotinic acid) and niacinamide (nicotinamide).
only for non-milk-based infant formulas.
2 Required
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ACTION:
Dated: June 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with RULES
21 CFR Part 558
[Docket No. FDA–2010–N–0155]
RIN 0910–AG95
Veterinary Feed Directive; Correction
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
16:21 Jun 22, 2015
Jkt 235001
The Food and Drug
Administration (FDA) is correcting a
final rule entitled ‘‘Veterinary Feed
Directive’’ that appeared in the Federal
Register of June 3, 2015 (80 FR 31708).
The rule amended FDA’s animal drug
regulations regarding veterinary feed
directive (VFD) drugs. The document
published with typographical and
formatting errors. This document
corrects those errors.
DATES: Effective: October 1, 2015.
FOR FURTHER INFORMATION CONTACT:
Sharon Benz, Center for Veterinary
Medicine (HFV–220), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5939,
email: Sharon.Benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc.
2015–13393, appearing on page 31708
SUMMARY:
[FR Doc. 2015–15394 Filed 6–22–15; 8:45 am]
AGENCY:
Final rule; correction.
PO 00000
Frm 00013
Fmt 4700
Sfmt 4700
in the Federal Register of Wednesday,
June 3, 2015, the following corrections
are made:
§ 558.6
[Corrected]
1. On page 31734, in the second
column, in § 558.6 Veterinary feed
directive drugs, in paragraph (b)(5),
remove ‘‘(b)(2)(vi),’’ and add in its place
‘‘(b)(3)(vi),’’.
■ 2. On page 31734, in the third column,
in § 558.6 Veterinary feed directive
drugs, the introductory text of paragraph
(c) ‘‘Responsibilities of any person who
distributes an animal feed containing a
VFD drug or a combination VFD drug:’’
is corrected as a paragraph heading to
read ‘‘Responsibilities of any person
who distributes an animal feed
containing a VFD drug or a combination
VFD drug.’’
■
E:\FR\FM\23JNR1.SGM
23JNR1
35842
Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations
Dated: June 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–15388 Filed 6–22–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 876
[Docket No. FDA–2015–N–1297]
Medical Devices; GastroenterologyUrology Devices; Classification of the
Vibrator for Climax Control of
Premature Ejaculation; Republication
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final order; republication.
The Food and Drug
Administration (FDA) is republishing in
its entirety a final order entitled
‘‘Medical Devices; GastroenterologyUrology Devices; Classification of the
Vibrator for Climax Control of
Premature Ejaculation’’ that published
in the Federal Register on May 28, 2015
(80 FR 30353). FDA is republishing to
correct an inadvertent omission of
information. FDA is classifying the
vibrator for climax control of premature
ejaculation into class II (special
controls). The special controls that will
apply to the device are identified in this
order and will be part of the codified
language for the classification of the
vibrator for climax control of premature
ejaculation. The Agency is classifying
the device into class II (special controls)
in order to provide a reasonable
assurance of safety and effectiveness of
the device.
DATES: This order is effective June 23,
2015. The classification was applicable
on March 20, 2015.
FOR FURTHER INFORMATION CONTACT:
Tuan Nguyen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G118, Silver Spring,
MD 20993–0002, 301–796–5174,
tuan.nguyen@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with RULES
SUMMARY:
I. Background
In accordance with section 513(f)(1) of
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
360c(f)(1)), devices that were not in
VerDate Sep<11>2014
16:21 Jun 22, 2015
Jkt 235001
commercial distribution before May 28,
1976 (the date of enactment of the
Medical Device Amendments of 1976),
generally referred to as postamendments
devices, are classified automatically by
statute into class III without any FDA
rulemaking process. These devices
remain in class III and require
premarket approval, unless and until
the device is classified or reclassified
into class I or II, or FDA issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate
device that does not require premarket
approval. The Agency determines
whether new devices are substantially
equivalent to predicate devices by
means of premarket notification
procedures in section 510(k) of the
FD&C Act (21 U.S.C. 360(k)) and part
807 (21 CFR part 807) of the regulations.
Section 513(f)(2) of the FD&C Act, as
amended by section 607 of the Food and
Drug Administration Safety and
Innovation Act (Pub. L. 112–144),
provides two procedures by which a
person may request FDA to classify a
device under the criteria set forth in
section 513(a)(1). Under the first
procedure, the person submits a
premarket notification under section
510(k) of the FD&C Act for a device that
has not previously been classified and,
within 30 days of receiving an order
classifying the device into class III
under section 513(f)(1) of the FD&C Act,
the person requests a classification
under section 513(f)(2). Under the
second procedure, rather than first
submitting a premarket notification
under section 510(k) of the FD&C Act
and then a request for classification
under the first procedure, the person
determines that there is no legally
marketed device upon which to base a
determination of substantial
equivalence and requests a classification
under section 513(f)(2) of the FD&C Act.
If the person submits a request to
classify the device under this second
procedure, FDA may decline to
undertake the classification request if
FDA identifies a legally marketed device
that could provide a reasonable basis for
review of substantial equivalence with
the device or if FDA determines that the
device submitted is not of ‘‘lowmoderate risk’’ or that general controls
would be inadequate to control the risks
and special controls to mitigate the risks
cannot be developed.
In response to a request to classify a
device under either procedure provided
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Frm 00014
Fmt 4700
Sfmt 4700
by section 513(f)(2) of the FD&C Act,
FDA will classify the device by written
order within 120 days. This
classification will be the initial
classification of the device. On
November 21, 2013, Auris Medtech
Europe, Ltd., submitted a request for
classification of the ProlongTM under
section 513(f)(2) of the FD&C Act. The
manufacturer recommended that the
device be classified into class II (Ref. 1).
On June 17, 2014, the request for
classification of ProlongTM was
transferred from Auris Medtech Europe,
Ltd., to Ergon Medical, Ltd., through an
amendment to the request (Ref. 2).
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request in order to classify the device
under the criteria for classification set
forth in section 513(a)(1). FDA classifies
devices into class II if general controls
by themselves are insufficient to
provide reasonable assurance of safety
and effectiveness, but there is sufficient
information to establish special controls
to provide reasonable assurance of the
safety and effectiveness of the device for
its intended use. After review of the
information submitted in the request,
FDA determined that the device can be
classified into class II with the
establishment of special controls. FDA
believes these special controls, in
addition to general controls, will
provide reasonable assurance of the
safety and effectiveness of the device.
Therefore, on March 20, 2015, FDA
issued an order to the requestor
classifying the device into class II. FDA
is codifying the classification of the
device by adding 21 CFR 876.5025.
Following the effective date of this
final classification order, any firm
submitting a premarket notification
(510(k)) for a vibrator for climax control
of premature ejaculation will need to
comply with the special controls named
in this final order. The device is
assigned the generic name vibrator for
climax control of premature ejaculation,
and it is identified as a device used for
males who suffer from premature
ejaculation. It is designed to increase the
time between arousal and ejaculation
using the stimulating vibratory effects of
the device on the penis.
FDA has identified the following risks
to health associated specifically with
this type of device, as well as the
measures required to mitigate these
risks in table 1.
E:\FR\FM\23JNR1.SGM
23JNR1
]]>Agencies
[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35841-35842]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15388]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2010-N-0155]
RIN 0910-AG95
Veterinary Feed Directive; Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a final
rule entitled ``Veterinary Feed Directive'' that appeared in the
Federal Register of June 3, 2015 (80 FR 31708). The rule amended FDA's
animal drug regulations regarding veterinary feed directive (VFD)
drugs. The document published with typographical and formatting errors.
This document corrects those errors.
DATES: Effective: October 1, 2015.
FOR FURTHER INFORMATION CONTACT: Sharon Benz, Center for Veterinary
Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5939, email: Sharon.Benz@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In FR Doc. 2015-13393, appearing on page
31708 in the Federal Register of Wednesday, June 3, 2015, the following
corrections are made:
Sec. 558.6 [Corrected]
0
1. On page 31734, in the second column, in Sec. 558.6 Veterinary feed
directive drugs, in paragraph (b)(5), remove ``(b)(2)(vi),'' and add in
its place ``(b)(3)(vi),''.
0
2. On page 31734, in the third column, in Sec. 558.6 Veterinary feed
directive drugs, the introductory text of paragraph (c)
``Responsibilities of any person who distributes an animal feed
containing a VFD drug or a combination VFD drug:'' is corrected as a
paragraph heading to read ``Responsibilities of any person who
distributes an animal feed containing a VFD drug or a combination VFD
drug.''
[[Page 35842]]
Dated: June 18, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15388 Filed 6-22-15; 8:45 am]
BILLING CODE 4164-01-P
