Current Good Manufacturing Practice for Medicated Feeds, 3738-3739 [2014-01299]
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Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Rules and Regulations
Title: FERC–725R, Mandatory
Reliability Standards: Reliability
Standard BAL–003–1.
Action: Proposed Collection of
Information.
OMB Control No: To be determined.
Respondents: Business or other forprofit, and not-for-profit institutions.
Frequency of Responses: Annual.
Necessity of the Information: The
revision of NERC Reliability Standard
BAL–003–1 is part of the
implementation of the Congressional
mandate of the Energy Policy Act of
2005 to develop mandatory and
enforceable Reliability Standards to
better ensure the reliability of the
nation’s Bulk Power System.
Specifically, Reliability Standard BAL–
003–1 is intended to ensure sufficient
Frequency Response from balancing
authorities to maintain Interconnection
Frequency within predefined bounds.
Internal Review: The Commission has
reviewed the revisions to the Reliability
Standard and determined that its action
is necessary to implement section 215 of
the FPA. The Commission has assured
itself, by means of its internal review,
that there is specific, objective support
for the burden estimate associated with
the information requirements.
103. Interested persons may obtain
information on the reporting
requirements by contacting the
following: Federal Energy Regulatory
Commission, 888 First Street NE.,
Washington, DC 20426 [Attention: Ellen
Brown, Office of the Executive Director,
email: DataClearance@ferc.gov, phone:
(202) 502–8663, fax: (202) 273–0873].
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VI. Environmental Analysis
104. The Commission is required to
prepare an Environmental Assessment
or an Environmental Impact Statement
for any action that may have a
significant adverse effect on the human
environment.126 The Commission has
categorically excluded certain actions
from this requirement as not having a
significant effect on the human
environment. Included in the exclusion
are rules that are clarifying, corrective,
or procedural or that do not
substantially change the effect of the
regulations being amended.127 The
actions directed herein fall within this
categorical exclusion in the
Commission’s regulations.
126 Regulations Implementing the National
Environmental Policy Act, Order No. 486, 52 FR
47897 (Dec. 17, 1987), FERC Stats. & Regs.,
Regulations Preambles 1986–1990 ¶ 30,783 (1987).
127 18 CFR 380.4(a)(2)(ii).
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VII. Regulatory Flexibility Act
105. The Regulatory Flexibility Act of
1980 (RFA) 128 generally requires a
description and analysis of proposed
rules that will have significant
economic impact on a substantial
number of small entities. The NERC
registry includes about 132 individual
balancing authorities. Comparison of the
NERC Compliance Registry with data
submitted to the Energy Information
Administration on Form EIA–861
indicates that, of these entities, 15 may
qualify as small entities.129
106. As noted above, the Commission
estimates the annual regulatory burden
for compliance with the Reliability
Standard to be $13,560 per balancing
authority. This estimate for all balancing
authorities was established using 28
events per year, but smaller entities may
have fewer events which qualify for
analysis,130 and the costs for these
smaller entities may be reduced.
Further, while the Reliability Standard
establishes a balancing authority’s
Frequency Response Obligation,
because balancing authorities are
currently providing frequency response,
we do not anticipate additional
compliance costs. Accordingly, we do
not consider the cost of compliance
with the Reliability Standard to be a
significant economic impact for small
entities because it should not represent
a significant percentage of an affected
small entity’s operating budget.
Accordingly, no regulatory flexibility
analysis is required.
VIII. Document Availability
107. In addition to publishing the full
text of this document in the Federal
Register, the Commission provides all
interested persons an opportunity to
view and/or print the contents of this
document via the Internet through the
Commission’s Home Page (https://
www.ferc.gov) and in the Commission’s
Public Reference Room during normal
business hours (8:30 a.m. to 5:00 p.m.
Eastern time) at 888 First Street NE.,
Room 2A, Washington, DC 20426.
128 5
U.S.C. 601–612.
129 The RFA definition of ‘‘small entity’’ refers to
the definition provided in the Small Business Act
(SBA), which defines a ‘‘small business concern’’ as
a business that is independently owned and
operated and that is not dominant in its field of
operation. See 15 U.S.C. 632 (2006). According to
the Small Business Administration, an electric
utility is defined as ‘‘small’’ if, including its
affiliates, it is primarily engaged in the generation,
transmission, and/or distribution of electric energy
for sale and its total electric output for the
preceding fiscal year did not exceed 4 million
megawatt hours.
130 The Procedures establish a minimum of 20
events for analysis, and a process for identifying
when fewer than 20 events are available for
analysis.
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108. From the Commission’s Home
Page on the Internet, this information is
available on eLibrary. The full text of
this document is available on eLibrary
in PDF and Microsoft Word format for
viewing, printing, and/or downloading.
To access this document in eLibrary,
type the docket number excluding the
last three digits of this document in the
docket number field.
109. User assistance is available for
eLibrary and the Commission’s Web site
during normal business hours from the
Commission’s Online Support at 202–
502–6652 (toll free at 1–866–208–3676)
or email at ferconlinesupport@ferc.gov,
or the Public Reference Room at (202)
502–8371, TTY (202) 502–8659. Email
the Public Reference Room at
public.referenceroom@ferc.gov.
IX. Effective Date and Congressional
Notification
110. These regulations are effective
March 24, 2014. The Commission has
determined, with the concurrence of the
Administrator of the Office of
Information and Regulatory Affairs of
OMB, that this rule is not a ‘‘major rule’’
as defined in section 351 of the Small
Business Regulatory Enforcement
Fairness Act of 1996.
By the Commission.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014–01218 Filed 1–22–14; 8:45 am]
BILLING CODE 6717–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 225
[Docket No. FDA–2013–N–0002]
Current Good Manufacturing Practice
for Medicated Feeds
AGENCY:
Food and Drug Administration,
HHS.
Final rule, correcting
amendment.
ACTION:
The Food and Drug
Administration (FDA) is amending the
regulations for good manufacturing
practice of animal feeds containing a
new animal drug to correctly cite the
applicable section of the Federal Food,
Drug, and Cosmetic Act (FD&C Act).
This action is being taken to improve
the accuracy of the regulations.
DATES: This rule is effective January 23,
2014.
FOR FURTHER INFORMATION CONTACT:
George K. Haibel, Center for Veterinary
SUMMARY:
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Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Rules and Regulations
Medicine (HFV–6), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9019,
ghaibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA has
noticed the regulations for good
manufacturing practice of animal feeds
containing a new animal drug do not
correctly cite the applicable section of
the FD&C Act. At this time, FDA is
making a correcting amendment in 21
CFR 225.1. This action is being taken to
improve the accuracy of the regulations.
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 February
24, 2014. The classification was
effective January 20, 2012.
FOR FURTHER INFORMATION CONTACT: Haja
Sittana El Mubarak, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5519, Silver Spring,
MD 20993–0002, 301–796–6193.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 225
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
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
provided a procedure by which a person
may request that FDA classify a device
under the criteria set forth in section
513(a)(1). 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). In response to a
request to classify a device under the
procedure provided by section 513(f)(2)
of the FD&C Act, FDA will classify the
device by written order within 60 days.
This classification will be the initial
classification of the device. Within 30
days after the issuance of an order
classifying the device, FDA must
publish a notice in the Federal Register
announcing this classification.
In accordance with section 513(f)(1) of
the FD&C Act, FDA issued an order on
December 22, 2011, classifying the
STRATIFY JCVTM antibody enzyme-
Animal drugs, Animal feeds,
Labeling, Packaging and containers,
Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 225 is
amended as follows:
PART 225—CURRENT GOOD
MANUFACTURING PRACTICE FOR
MEDICATED FEEDS
1. The authority citation for 21 CFR
part 225 continues to read as follows:
■
Authority: 21 U.S.C. 351, 352, 360b, 371,
374.
§ 225.1
[Amended]
2. In § 225.1, in the last sentence in
paragraph (b)(1), remove ‘‘section
402(a)(2)(D) of the act’’ and in its place
add ‘‘section 402(a)(2)(C)(ii) of the act’’.
■
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–01299 Filed 1–22–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 866
[Docket No. FDA–2013–N–1662]
Medical Devices; Immunology and
Microbiology Devices; Classification of
John Cunningham Virus Serological
Reagents
AGENCY:
Food and Drug Administration,
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HHS.
ACTION:
Final order.
The Food and Drug
Administration (FDA) is classifying
John Cunningham Virus (JCV)
serological reagents into class II (special
controls). The Agency is classifying the
SUMMARY:
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3739
linked immunosorbent assay (ELISA)
into class III because it was not
substantially equivalent to a device that
was introduced or delivered for
introduction into interstate commerce
for commercial distribution before May
28, 1976, or a device which was
subsequently reclassified into class I or
class II. On January 5, 2012, Focus
Diagnostics, Inc., submitted a request for
de novo classification of the STRATIFY
JCVTM antibody ELISA under section
513(f)(2) of the FD&C Act. The
manufacturer recommended that the
device be classified into class II.
In accordance with section 513(f)(2) of
the FD&C Act, FDA reviewed the
request for de novo classification in
order to classify the device under the
criteria for classification set forth in
section 513(a)(1) of the FD&C Act. 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 will provide reasonable
assurance of the safety and effectiveness
of the device.
The device is assigned the generic
name John Cunningham Virus
serological reagents, which are devices
that consist of antigens and antisera
used in serological assays to identify
antibodies to JCV in serum and plasma.
The identification aids in the risk
stratification for the development of
progressive multifocal
leukoencephalopathy in multiple
sclerosis and Crohn’s disease patients
undergoing natalizumab therapy. These
devices are for adjunctive use, in the
context of other clinical risk factors for
the development of progressive
multifocal leukoencephalopathy.
FDA has identified the following risks
to health associated with this type of
device and the measures required to
mitigate these risks:
TABLE 1—IDENTIFIED RISKS TO
HEALTH AND MITIGATION MEASURES
Identified risks to
health
False positive results
False negative results
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Mitigation measures
Device Description
Performance.
Device Description
Performance.
]]>Agencies
[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Rules and Regulations]
[Pages 3738-3739]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01299]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 225
[Docket No. FDA-2013-N-0002]
Current Good Manufacturing Practice for Medicated Feeds
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule, correcting amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the
regulations for good manufacturing practice of animal feeds containing
a new animal drug to correctly cite the applicable section of the
Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is being
taken to improve the accuracy of the regulations.
DATES: This rule is effective January 23, 2014.
FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary
[[Page 3739]]
Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9019, ghaibel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA has noticed the regulations for good
manufacturing practice of animal feeds containing a new animal drug do
not correctly cite the applicable section of the FD&C Act. At this
time, FDA is making a correcting amendment in 21 CFR 225.1. This action
is being taken to improve the accuracy of the regulations.
List of Subjects in 21 CFR Part 225
Animal drugs, Animal feeds, Labeling, Packaging and containers,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
225 is amended as follows:
PART 225--CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
0
1. The authority citation for 21 CFR part 225 continues to read as
follows:
Authority: 21 U.S.C. 351, 352, 360b, 371, 374.
Sec. 225.1 [Amended]
0
2. In Sec. 225.1, in the last sentence in paragraph (b)(1), remove
``section 402(a)(2)(D) of the act'' and in its place add ``section
402(a)(2)(C)(ii) of the act''.
Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01299 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P
