New Animal Drugs; Change of Sponsor; Moxidectin, 48714-48715 [2011-20182]
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Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Rules and Regulations
introductory text in §§ 946.143 and
946.336. Authority for the change in the
order’s rules and regulations is provided
for in §§ 946.70 and 946.52,
respectively.
This action is not expected to increase
costs associated with the order
requirements. Rather, this action
represents a cost savings for handlers
and has the potential to increase
industry returns. This change extends
the one-year suspension of minimum
quality, maturity, pack, marking, and
inspection requirements indefinitely.
Though inspections will not be
mandated for russet potatoes handled
under the order, handlers may at their
discretion choose to have their potatoes
inspected. Handlers are thus able to
control costs—which are generally
passed on to producers—based on the
demands of their customers. The
opportunities and benefits of this rule
are equally available to all Washington
potato handlers and growers, regardless
of their size.
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C.
Chapter 35), the order’s information
collection requirements have been
previously approved by the Office of
Management and Budget (OMB) and
assigned OMB No. 0581–0178
(Vegetable and Specialty Crop
Marketing Orders). No changes in those
requirements as a result of this action
are necessary. Should any changes
become necessary, they would be
submitted to OMB for approval.
This change continues the monthly
reporting requirement for russet potato
handlers. The reports provide the
Committee with information necessary
to track shipments and collect
assessments. As with all Federal
marketing order programs, reports and
forms are periodically reviewed to
reduce information requirements and
duplication by industry and public
sector agencies. In addition, USDA has
not identified any relevant Federal rules
that duplicate, overlap or conflict with
this rule.
Further, the Committee’s meeting was
widely publicized throughout the
Washington potato industry and all
interested persons were invited to
participate in Committee deliberations.
Like all Committee meetings, the
January 26, 2011, meeting was a public
meeting, and all entities, both large and
small, were able to express views on
this issue.
Comments on the interim rule were
required to be received on or before July
12, 2011. No comments were received.
Therefore, for the reasons given in the
interim rule, we are adopting the
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interim rule as a final rule, without
change.
To view the interim rule, go to:
http:
//www.regulations.gov/
#!documentDetail;D=AMS-FV-11-00240001.
This action also affirms information
contained in the interim rule concerning
Executive Orders 12866 and 12988, the
Paperwork Reduction Act (44 U.S.C.
Chapter 35), and the E-Gov Act (44
U.S.C. 101).
After consideration of all relevant
material presented, it is found that
finalizing the interim rule, without
change, as published in the Federal
Register (76 FR 27850, May 13, 2011)
will tend to effectuate the declared
policy of the Act.
List of Subjects in 7 CFR Part 946
Marketing agreements, Potatoes,
Reporting and recordkeeping
requirements.
Accordingly, the interim rule that
amended 7 CFR 946.143 and 946.336
and that was published at 76 FR 27850
on May 13, 2011, is adopted as a final
rule, without change.
Dated: August 3, 2011.
David R. Shipman,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 2011–20124 Filed 8–8–11; 8:45 am]
BILLING CODE 3410–02–P
Medicine (HFV–100), Food and Drug
Administration, 7520 Standish Pl.,
Rockville, MD 20855, 240–276–8300, email: steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort
Dodge Animal Health, Division of
Wyeth, a wholly owned subsidiary of
Pfizer, Inc., 235 East 42d St., New York,
NY 10017 has informed FDA that it has
transferred ownership of, and all rights
and interest in, the following three
approved NADAs for dosage form
products containing moxidectin to
Boehringer Ingelheim Vetmedica, Inc.,
2621 North Belt Highway, St. Joseph,
MO 64506–2002: NADA 141–099,
NADA 141–220, and NADA 141–247.
Accordingly, the Agency is amending
the regulations in 21 CFR parts 520, 522,
and 524 to reflect the transfer of
ownership.
This rule does not meet the definition
of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because
it is a rule of ‘‘particular applicability.’’
Therefore, it is not subject to the
congressional review requirements in 5
U.S.C. 801–808.
List of Subjects in 21 CFR Parts 520,
522, and 524
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR parts 520, 522, and 524 are
amended as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
Food and Drug Administration
■
21 CFR Parts 520, 522, and 524
[Docket No. FDA–2011–N–0003]
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect a
change of sponsor for three approved
new animal drug applications (NADAs)
for dosage form products containing
moxidectin from Fort Dodge Animal
Health, Division of Wyeth, a wholly
owned subsidiary of Pfizer, Inc., to
Boehringer Ingelheim Vetmedica, Inc.
DATES: This rule is effective August 9,
2011.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Steven D. Vaughn, Center for Veterinary
PO 00000
Frm 00002
Fmt 4700
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Authority: 21 U.S.C. 360b.
2. In § 520.1454, revise paragraphs (b)
and (d) to read as follows:
■
New Animal Drugs; Change of
Sponsor; Moxidectin
AGENCY:
1. The authority citation for 21 CFR
part 520 continues to read as follows:
§ 520.1454
Moxidectin solution.
*
*
*
*
*
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(d) Special considerations. See
§ 500.25 of this chapter.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
4. In § 522.1450, redesignate
paragraph (d) as paragraph (e); add new
paragraph (d); and revise paragraph (b)
■
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Federal Register / Vol. 76, No. 153 / Tuesday, August 9, 2011 / Rules and Regulations
and newly redesignated paragraphs
(e)(1) and (e)(3) to read as follows:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
§ 522.1450
Food and Drug Administration
Moxidectin solution.
*
*
*
*
*
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(d) Special considerations. See
§ 500.25 of this chapter.
(e) * * *
(1) Amount. Administer 0.2 mg/kg of
body weight (0.2 mg/2.2 pound) as a
single, subcutaneous injection.
*
*
*
*
*
(3) Limitations. Do not slaughter cattle
within 21 days of treatment. Because a
withholding time for milk has not been
established, do not use in female dairy
cattle 20 months of age and older. A
withdrawal period has not been
established for pre-ruminating calves.
Do not use in calves to be processed for
veal.
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
5. The authority citation for 21 CFR
part 524 continues to read as follows:
■
6. Redesignate § 524.1451 as
§ 524.1450 and revise paragraphs (a),
(b), and (e)(1) to read as follows:
■
Moxidectin.
(a) Specifications. Each milliliter
contains 5 milligrams (mg) moxidectin
(0.5 percent solution).
(b) Sponsor. See No. 000010 in
§ 510.600(c) of this chapter.
*
*
*
*
*
(e) * * *
(1) Amount. Administer topically 0.5
mg per kilogram of body weight.
*
*
*
*
*
Dated: August 3, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
jlentini on DSK4TPTVN1PROD with RULES
[FR Doc. 2011–20182 Filed 8–8–11; 8:45 am]
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Immunology and Microbiology
Devices; Reclassification of the Herpes
Simplex Virus Serological Assay
Device
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
special controls for the herpes simplex
virus (HSV) serological assay device
type, which is classified as class II
(special controls). These device types
are devices that consist of antigens and
antisera used in various serological tests
to identify antibodies to herpes simplex
virus in serum, and the devices that
consist of herpes simplex virus antisera
conjugated with a fluorescent dye
(immunofluorescent assays) used to
identify herpes simplex virus directly
from clinical specimens or tissue
culture isolates derived from clinical
specimens.
SUMMARY:
This rule is effective September
8, 2011.
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:
§ 524.1451 [Redesignated as § 524.1450
and Amended]
VerDate Mar<15>2010
[Docket No. FDA–2010–N–0429]
DATES:
Authority: 21 U.S.C. 360b.
§ 524.1450
21 CFR Part 866
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I. Regulatory Authorities
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 301 et
seq.), as amended by the Medical Device
Amendments of 1976 (the 1976
amendments) (Pub. L. 94–295), Safe
Medical Devices Act (SMDA) (Pub. L.
101–629), Food and Drug
Administration Modernization Act
(FDAMA) (Pub. L. 105–115), and the
Medical Device User Fee and
Modernization Act (MDUFMA) (Pub. L.
107–250), established a comprehensive
system for the regulation of medical
devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C.
360c) established three categories
(classes) of devices, defined by the
regulatory controls needed to provide
reasonable assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
PO 00000
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48715
Under section 513 of the FD&C Act,
FDA refers to devices that were in
commercial distribution before May 28,
1976 (the date of enactment of the 1976
amendments), as preamendments
devices. FDA classifies these devices
after it takes the following steps: (1)
Receives a recommendation from a
device classification panel (an FDA
advisory committee); (2) publishes the
panel’s recommendation for comment,
along with a proposed regulation
classifying the device; and (3) publishes
a final regulation classifying the device.
FDA has classified most
preamendments devices under these
procedures.
Devices that were not in commercial
distribution before May 28, 1976,
generally referred to as postamendments
devices are classified automatically by
statute (section 513(f) of the FD&C Act)
into class III without any FDA
rulemaking process. Those devices
remain in class III until FDA does the
following: (1) Reclassifies the device
into class I or II; (2) issues an order
classifying the device into class I or II
in accordance with section 513(f)(2) of
the FD&C Act; or (3) issues an order
finding the device to be substantially
equivalent, in accordance with section
513(i) of the FD&C Act, to a legally
marketed device that has been classified
into class I or class II. The agency
determines whether new devices are
substantially equivalent to previously
marketed devices by means of
premarket notification procedures in
section 510(k) of the FD&C Act (21
U.S.C. 360(k)) and 21 CFR part 807 of
the regulations.
Under the 1976 amendments, class II
devices were defined as devices for
which there was insufficient
information to show that general
controls themselves would provide
reasonable assurance of safety and
effectiveness, but for which there was
sufficient information to establish
performance standards to provide such
assurance. SMDA broadened the
definition of class II devices to mean
those devices for which the general
controls by themselves are insufficient
to provide reasonable assurance of
safety and effectiveness, but for which
there is sufficient information to
establish special controls to provide
such assurance, including performance
standards, postmarket surveillance,
patient registries, development and
dissemination of guidelines,
recommendations, and any other
appropriate actions the agency deems
necessary (section 513(a)(1)(B) of the
FD&C Act).
Elsewhere in this issue of the Federal
Register, FDA is announcing the
E:\FR\FM\09AUR1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 153 (Tuesday, August 9, 2011)]
[Rules and Regulations]
[Pages 48714-48715]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20182]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 520, 522, and 524
[Docket No. FDA-2011-N-0003]
New Animal Drugs; Change of Sponsor; Moxidectin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect a change of sponsor for three approved new
animal drug applications (NADAs) for dosage form products containing
moxidectin from Fort Dodge Animal Health, Division of Wyeth, a wholly
owned subsidiary of Pfizer, Inc., to Boehringer Ingelheim Vetmedica,
Inc.
DATES: This rule is effective August 9, 2011.
FOR FURTHER INFORMATION CONTACT: Steven D. Vaughn, Center for
Veterinary Medicine (HFV-100), Food and Drug Administration, 7520
Standish Pl., Rockville, MD 20855, 240-276-8300, e-mail:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Fort Dodge Animal Health, Division of Wyeth,
a wholly owned subsidiary of Pfizer, Inc., 235 East 42d St., New York,
NY 10017 has informed FDA that it has transferred ownership of, and all
rights and interest in, the following three approved NADAs for dosage
form products containing moxidectin to Boehringer Ingelheim Vetmedica,
Inc., 2621 North Belt Highway, St. Joseph, MO 64506-2002: NADA 141-099,
NADA 141-220, and NADA 141-247. Accordingly, the Agency is amending the
regulations in 21 CFR parts 520, 522, and 524 to reflect the transfer
of ownership.
This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801-808.
List of Subjects in 21 CFR Parts 520, 522, and 524
Animal drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 520,
522, and 524 are amended as follows:
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
2. In Sec. 520.1454, revise paragraphs (b) and (d) to read as follows:
Sec. 520.1454 Moxidectin solution.
* * * * *
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
* * * * *
(d) Special considerations. See Sec. 500.25 of this chapter.
* * * * *
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
4. In Sec. 522.1450, redesignate paragraph (d) as paragraph (e); add
new paragraph (d); and revise paragraph (b)
[[Page 48715]]
and newly redesignated paragraphs (e)(1) and (e)(3) to read as follows:
Sec. 522.1450 Moxidectin solution.
* * * * *
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
* * * * *
(d) Special considerations. See Sec. 500.25 of this chapter.
(e) * * *
(1) Amount. Administer 0.2 mg/kg of body weight (0.2 mg/2.2 pound)
as a single, subcutaneous injection.
* * * * *
(3) Limitations. Do not slaughter cattle within 21 days of
treatment. Because a withholding time for milk has not been
established, do not use in female dairy cattle 20 months of age and
older. A withdrawal period has not been established for pre-ruminating
calves. Do not use in calves to be processed for veal.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
5. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.1451 [Redesignated as Sec. 524.1450 and Amended]
0
6. Redesignate Sec. 524.1451 as Sec. 524.1450 and revise paragraphs
(a), (b), and (e)(1) to read as follows:
Sec. 524.1450 Moxidectin.
(a) Specifications. Each milliliter contains 5 milligrams (mg)
moxidectin (0.5 percent solution).
(b) Sponsor. See No. 000010 in Sec. 510.600(c) of this chapter.
* * * * *
(e) * * *
(1) Amount. Administer topically 0.5 mg per kilogram of body
weight.
* * * * *
Dated: August 3, 2011.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2011-20182 Filed 8-8-11; 8:45 am]
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