80 FR 35841 - Veterinary Feed Directive; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 120 (June 23, 2015)

Page Range		35841-35842
FR Document		2015-15388

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.

Federal Register, Volume 80 Issue 120 (Tuesday, June 23, 2015)

[Federal Register Volume 80, Number 120 (Tuesday, June 23, 2015)]
[Rules and Regulations]
[Pages 35841-35842]
From the Federal Register Online  [www.thefederalregister.org]
[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: [email protected].

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

35842 Federal Register / Vol. 80, No. 120 / Tuesday, June 23, 2015 / Rules and Regulations

Dated: June 18, 2015. commercial distribution before May 28, by section 513(f)(2) of the FD&C Act,
Leslie Kux, 1976 (the date of enactment of the FDA will classify the device by written
Associate Commissioner for Policy. Medical Device Amendments of 1976), order within 120 days. This
[FR Doc. 2015–15388 Filed 6–22–15; 8:45 am] generally referred to as postamendments classification will be the initial
BILLING CODE 4164–01–P devices, are classified automatically by classification of the device. On
statute into class III without any FDA November 21, 2013, Auris Medtech
rulemaking process. These devices Europe, Ltd., submitted a request for
DEPARTMENT OF HEALTH AND remain in class III and require classification of the ProlongTM under
HUMAN SERVICES premarket approval, unless and until section 513(f)(2) of the FD&C Act. The
the device is classified or reclassified manufacturer recommended that the
Food and Drug Administration into class I or II, or FDA issues an order device be classified into class II (Ref. 1).
finding the device to be substantially On June 17, 2014, the request for
21 CFR Part 876 equivalent, in accordance with section classification of ProlongTM was
[Docket No. FDA–2015–N–1297] 513(i) of the FD&C Act, to a predicate transferred from Auris Medtech Europe,
device that does not require premarket Ltd., to Ergon Medical, Ltd., through an
Medical Devices; Gastroenterology- approval. The Agency determines amendment to the request (Ref. 2).
Urology Devices; Classification of the whether new devices are substantially
equivalent to predicate devices by In accordance with section 513(f)(2) of
Vibrator for Climax Control of
means of premarket notification the FD&C Act, FDA reviewed the
Premature Ejaculation; Republication
procedures in section 510(k) of the request in order to classify the device
AGENCY: Food and Drug Administration, FD&C Act (21 U.S.C. 360(k)) and part under the criteria for classification set
HHS. 807 (21 CFR part 807) of the regulations. forth in section 513(a)(1). FDA classifies
ACTION: Final order; republication. Section 513(f)(2) of the FD&C Act, as devices into class II if general controls
amended by section 607 of the Food and by themselves are insufficient to
SUMMARY: The Food and Drug Drug Administration Safety and provide reasonable assurance of safety
Administration (FDA) is republishing in Innovation Act (Pub. L. 112–144), and effectiveness, but there is sufficient
its entirety a final order entitled provides two procedures by which a information to establish special controls
‘‘Medical Devices; Gastroenterology- person may request FDA to classify a to provide reasonable assurance of the
Urology Devices; Classification of the device under the criteria set forth in safety and effectiveness of the device for
Vibrator for Climax Control of section 513(a)(1). Under the first its intended use. After review of the
Premature Ejaculation’’ that published procedure, the person submits a information submitted in the request,
in the Federal Register on May 28, 2015 premarket notification under section FDA determined that the device can be
(80 FR 30353). FDA is republishing to 510(k) of the FD&C Act for a device that classified into class II with the
correct an inadvertent omission of has not previously been classified and, establishment of special controls. FDA
information. FDA is classifying the within 30 days of receiving an order believes these special controls, in
vibrator for climax control of premature classifying the device into class III addition to general controls, will
ejaculation into class II (special under section 513(f)(1) of the FD&C Act, provide reasonable assurance of the
controls). The special controls that will the person requests a classification safety and effectiveness of the device.
apply to the device are identified in this under section 513(f)(2). Under the Therefore, on March 20, 2015, FDA
order and will be part of the codified second procedure, rather than first issued an order to the requestor
language for the classification of the submitting a premarket notification classifying the device into class II. FDA
vibrator for climax control of premature under section 510(k) of the FD&C Act is codifying the classification of the
ejaculation. The Agency is classifying and then a request for classification device by adding 21 CFR 876.5025.
the device into class II (special controls) under the first procedure, the person
in order to provide a reasonable determines that there is no legally Following the effective date of this
assurance of safety and effectiveness of marketed device upon which to base a final classification order, any firm
the device. determination of substantial submitting a premarket notification
DATES: This order is effective June 23, equivalence and requests a classification (510(k)) for a vibrator for climax control
2015. The classification was applicable under section 513(f)(2) of the FD&C Act. of premature ejaculation will need to
on March 20, 2015. If the person submits a request to comply with the special controls named
FOR FURTHER INFORMATION CONTACT: classify the device under this second in this final order. The device is
Tuan Nguyen, Center for Devices and procedure, FDA may decline to assigned the generic name vibrator for
Radiological Health, Food and Drug undertake the classification request if climax control of premature ejaculation,
Administration, 10903 New Hampshire FDA identifies a legally marketed device and it is identified as a device used for
Ave., Bldg. 66, Rm. G118, Silver Spring, that could provide a reasonable basis for males who suffer from premature
MD 20993–0002, 301–796–5174, review of substantial equivalence with ejaculation. It is designed to increase the
tuan.nguyen@fda.hhs.gov. the device or if FDA determines that the time between arousal and ejaculation
device submitted is not of ‘‘low- using the stimulating vibratory effects of
SUPPLEMENTARY INFORMATION:
moderate risk’’ or that general controls the device on the penis.
I. Background would be inadequate to control the risks FDA has identified the following risks
In accordance with section 513(f)(1) of and special controls to mitigate the risks to health associated specifically with
the Federal Food, Drug, and Cosmetic cannot be developed. this type of device, as well as the
mstockstill on DSK4VPTVN1PROD with RULES

Act (the FD&C Act) (21 U.S.C. In response to a request to classify a measures required to mitigate these
360c(f)(1)), devices that were not in device under either procedure provided risks in table 1.

VerDate Sep<11>2014 16:21 Jun 22, 2015 Jkt 235001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\FR\FM\23JNR1.SGM 23JNR1

Document Created: 2018-02-22 11:15:14
Document Modified: 2018-02-22 11:15:14

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; correction.
Dates		Effective: October 1, 2015.
Contact		Sharon Benz, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5939, email: [email protected]
FR Citation		80 FR 35841
RIN Number		0910-AG95

80 FR 35841 - Veterinary Feed Directive; Correction

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 120 (June 23, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration