New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension, 46612-46613 [2012-19147]
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Federal Register / Vol. 77, No. 151 / Monday, August 6, 2012 / Rules and Regulations
(d) This section does not require the
Bureau to take any action that would
result in a fundamental alteration in the
nature of a program or activity or in
undue financial and administrative
burdens.
emcdonald@gpo.gov on DSK67QTVN1PROD with RULES
§ 1072.112.
Compliance procedures.
(a) Except as provided in paragraph
(b) of this section, this section applies
to all allegations of discrimination on
the basis of disability in programs and
activities conducted by the Bureau and
denial of access to electronic and
information technology.
(b) The Bureau shall process
complaints alleging violations of section
504 with respect to employment
according to the procedures established
by the Equal Employment Opportunity
Commission in 29 CFR part 1614
pursuant to section 501 of the
Rehabilitation Act of 1973 (29 U.S.C.
791).
(c) All other complaints alleging
violations of section 504 or section 508
may be sent to Labor and Employee
Relations, Office of the Chief Human
Capital Officer Consumer Financial
Protection Bureau, 1700 G Street NW.,
Washington, DC 20052. The Office of
the Chief Human Capital Officer shall be
responsible for coordinating
implementation of this section.
(d) Complaint-filing procedures. (1)
Any person who believes that he or she
has been subjected to discrimination
prohibited by this part may by himself
or herself or by his or her authorized
representative file a complaint. Any
person who believes that any specific
class of persons has been subjected to
discrimination prohibited by this part
and who is a member of that class or the
authorized representative of a member
of that class may file a class complaint.
(2) The Bureau shall accept and
investigate each timely filed, complete
complaint over which it has
jurisdiction.
(3) A complete complaint must be
filed within 180 days of the alleged act
of discrimination. A complaint
submitted to the Bureau via first-class
mail will be deemed to have been filed
when postmarked. A complaint
submitted to the Bureau via any other
means of delivery will be deemed to
have been filed when received by the
Bureau. The Bureau may extend this
time period for good cause.
(e) If the Bureau receives a complaint
over which it does not have jurisdiction,
it shall promptly notify the complainant
and shall make reasonable efforts to
refer the complaint to the appropriate
government entity.
(f) The Bureau shall notify the
Architectural and Transportation
VerDate Mar<15>2010
14:44 Aug 03, 2012
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Barriers Compliance Board upon receipt
of any complaint alleging that a building
or facility that is subject to the
Architectural Barriers Act of 1968, as
amended (42 U.S.C. 4151–4157), is not
readily accessible to and usable by
individuals with disabilities.
(g)(1) Within 180 days of the receipt
of a timely filed, complete complaint
over which it has jurisdiction, the
Bureau shall notify the complainant of
the results of the investigation in a letter
containing:
(i) Findings of fact and conclusions of
law;
(ii) A description of a remedy for each
violation found; and
(iii) A notice of the right to appeal.
(2) Bureau employees are required to
cooperate in the investigation and
attempted resolution of complaints.
Employees who are required to
participate in any investigation under
this section shall do so as part of their
official duties and during the course of
regular duty hours.
(3) If a complaint is resolved
informally, the terms of the agreement
shall be reduced to writing and made
part of the complaint file, with a copy
of the agreement provided to the
complainant. The written agreement
shall describe the subject matter of the
complaint and any corrective action to
which the parties have agreed.
(h) Appeals of the findings of fact and
conclusions of law or remedies must be
filed by the complainant within 30 days
of receipt from the Bureau of the letter
required by § 1072.112(g). The Bureau
may extend this time for good cause.
(i) Timely appeals shall be accepted
and processed by the Chief Human
Capital Officer, who will issue the final
agency decision which may include
appropriate corrective action to be taken
by the Bureau.
(j) The Bureau shall notify the
complainant of the results of the appeal
within 60 days of the receipt of the
timely appeal. If the Bureau determines
that it needs additional information
from the complainant, it shall have 60
days from the date it received the
additional information to make its
determination on the appeal.
(k) The time limits cited in paragraphs
(g) and (j) of this section may be
extended for an individual case when
the Chief Human Capital Officer
determines there is good cause, based
on the particular circumstances of that
case, for the extension.
(l) The Bureau may delegate its
authority for conducting complaint
investigations to other federal agencies
or may contract with a nongovernment
investigator to perform the
investigation, but the authority for
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making the final determination may not
be delegated to another entity.
Dated: June 18, 2012.
Richard Cordray,
Director, Bureau of Consumer Financial
Protection.
[FR Doc. 2012–18827 Filed 8–3–12; 8:45 am]
BILLING CODE 4810–AM–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 524
[Docket No. FDA–2012–N–0002]
New Animal Drugs; Change of
Sponsor; Change of Sponsor Address;
Azaperone; Miconazole, Polymyxin B,
and Prednisolone Suspension
AGENCY:
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 two new animal
drug applications (NADAs) from Janssen
Pharmaceutica NV, to Elanco Animal
Health, a Division of Eli Lilly & Co. FDA
is also amending the animal drug
regulations to reflect a change of
sponsor’s address for Veterinary
Service, Inc.
DATES: This rule is effective August 6,
2012.
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,
email: steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Janssen
Pharmaceutica NV, Turnhoutseweg 30,
B–2340 Beerse, Belgium, has informed
FDA that it has transferred ownership
of, and all rights and interest in, NADA
115–732 for STRESNIL (azaperone)
Injection and NADA 141–298 for
SUROLAN (miconazole nitrate,
polymyxin B sulfate, prednisolone
acetate) Otic Suspension to Elanco
Animal Health, a Division of Eli Lilly &
Co., Lilly Corporate Center,
Indianapolis, IN 46285. Following these
changes of sponsorship, Janssen
Pharmaceutica NV will no longer be the
sponsor of an approved application.
Accordingly, the Agency is amending
the regulations in 21 CFR 510.600,
522.150, and 524.1445 to reflect the
transfer of ownership.
In addition, Veterinary Service, Inc.,
416 North Jefferson St., P.O. Box 2467,
SUMMARY:
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06AUR1
Federal Register / Vol. 77, No. 151 / Monday, August 6, 2012 / Rules and Regulations
Modesto, CA 95354 has informed FDA
of a change of address to 4100 Bangs
Ave., Modesto, CA 95356. Accordingly,
the Agency is amending the regulations
in 21 CFR 510.600 to reflect these
changes.
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
Drug labeler
code
Firm name and address
*
*
*
*
*
033008 ........ Veterinary Service, Inc., 4100
Bangs Ave., Modesto, CA
95356.
*
*
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
■
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
Authority: 21 U.S.C. 360b.
§ 522.150
[Amended]
4. In paragraph (b) of § 522.150,
remove ‘‘012578’’ and in its place add
‘‘000986’’.
■
21 CFR Parts 520 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 510, 522, and 524 are
amended as follows:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
5. The authority citation for 21 CFR
part 524 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
6. In § 524.1445, revise paragraph (b)
to read as follows:
■
PART 510—NEW ANIMAL DRUGS
■
1. The authority citation for 21 CFR
part 510 continues to read as follows:
§ 524.1445 Miconazole, polymixin B, and
prednisolone suspension.
Authority: 21 U.S.C. 321, 331, 351, 352,
353, 360b, 371, 379e.
*
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Janssen Pharmaceutica NV’’ and revise
the entry for ‘‘Veterinary Service, Inc.’’;
and in the table in paragraph (c)(2),
remove the entry for ‘‘012758’’ and
revise the entry for ‘‘033008’’ to read as
follows:
Dated: August 1, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
*
*
*
(c) * * *
(1) * * *
*
emcdonald@gpo.gov on DSK67QTVN1PROD with RULES
VerDate Mar<15>2010
and Fort Lee, NJ for the 2012 Ironman
US Championship swim event. This
temporary safety zone is necessary to
protect the maritime public and event
participants from the hazards associated
with swim events. This rule is intended
to restrict all vessels and persons from
entering into, transiting through,
mooring, or anchoring within the safety
zone unless authorized by the Captain
of the Port (COTP) New York or a
designated representative.
DATES: This rule is effective from 6 a.m.
until 10 a.m. on August 11, 2012.
ADDRESSES: Documents mentioned in
this preamble are part of docket [USCG–
2012–0223]. To view documents
mentioned in this preamble as being
available in the docket, go to https://
www.regulations.gov, type the docket
number in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on Open Docket
Folder on the line associated with this
rulemaking. You may also visit the
Docket Management Facility in Room
W12–140 on the ground floor of the
Department of Transportation West
Building, 1200 New Jersey Avenue SE.,
Washington, DC 20590, between 9 a.m.
and 5 p.m., Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
email Ensign Kimberly Farnsworth,
Coast Guard; Telephone (718) 354–4163,
email Kimberly.A.Farnsworth@uscg.mil.
If you have questions on viewing or
submitting material to the docket, call
Renee V. Wright, Program Manager,
Docket Operations, telephone (202)
366–9826.
SUPPLEMENTARY INFORMATION:
Table of Acronyms
DHS Department of Homeland Security
FR Federal Register
CFR Code of Federal Regulations
NPRM Notice of Proposed Rulemaking
COTP Captain of the Port
A. Regulatory History and Information
*
Drug labeler
code
33 CFR Part 165
*
RIN 1625–AA00
*
033008
*
*
[Docket Number USCG–2012–0223]
Safety Zone; 2012 Ironman US
Championship Swim, Hudson River,
Fort Lee, NJ
Coast Guard, DHS.
Final rule.
AGENCY:
ACTION:
(2) * * *
Drug labeler
code
BILLING CODE 4160–01–P
Coast Guard
*
*
*
Veterinary Service, Inc.,
4100 Bangs Ave., Modesto, CA 95356 ...............
*
[FR Doc. 2012–19147 Filed 8–3–12; 8:45 am]
DEPARTMENT OF HOMELAND
SECURITY
*
Firm name and address
*
*
*
*
*
(b) Sponsor. See No. 000986 in
§ 510.600(c) of this chapter.
*
*
*
*
*
46613
The Coast Guard is
establishing a temporary safety zone on
the navigable waters of the Hudson
River in the vicinity of Englewood Cliffs
SUMMARY:
Firm name and address
14:44 Aug 03, 2012
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On June 8, 2012, we published a
notice of proposed rulemaking (NPRM)
entitled 2012 Ironman US
Championship Swim, Hudson River,
Fort Lee, NJ in the Federal Register (77
FR 34285). We received no comments
on the proposed rule. No public meeting
was requested and none was held.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register. This event will occur before 30
days has elapsed after the publication of
the rule. The event sponsor is unable
and unwilling to postpone this event
because the date of this event was
E:\FR\FM\06AUR1.SGM
06AUR1
]]>Agencies
[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Rules and Regulations]
[Pages 46612-46613]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-19147]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 522, and 524
[Docket No. FDA-2012-N-0002]
New Animal Drugs; Change of Sponsor; Change of Sponsor Address;
Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension
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 two new animal drug
applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal
Health, a Division of Eli Lilly & Co. FDA is also amending the animal
drug regulations to reflect a change of sponsor's address for
Veterinary Service, Inc.
DATES: This rule is effective August 6, 2012.
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, email:
steven.vaughn@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Janssen Pharmaceutica NV, Turnhoutseweg 30,
B-2340 Beerse, Belgium, has informed FDA that it has transferred
ownership of, and all rights and interest in, NADA 115-732 for STRESNIL
(azaperone) Injection and NADA 141-298 for SUROLAN (miconazole nitrate,
polymyxin B sulfate, prednisolone acetate) Otic Suspension to Elanco
Animal Health, a Division of Eli Lilly & Co., Lilly Corporate Center,
Indianapolis, IN 46285. Following these changes of sponsorship, Janssen
Pharmaceutica NV will no longer be the sponsor of an approved
application. Accordingly, the Agency is amending the regulations in 21
CFR 510.600, 522.150, and 524.1445 to reflect the transfer of
ownership.
In addition, Veterinary Service, Inc., 416 North Jefferson St.,
P.O. Box 2467,
[[Page 46613]]
Modesto, CA 95354 has informed FDA of a change of address to 4100 Bangs
Ave., Modesto, CA 95356. Accordingly, the Agency is amending the
regulations in 21 CFR 510.600 to reflect these changes.
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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Parts 520 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 510,
522, and 524 are amended as follows:
PART 510--NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 510 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.
0
2. In Sec. 510.600, in the table in paragraph (c)(1), remove the entry
for ``Janssen Pharmaceutica NV'' and revise the entry for ``Veterinary
Service, Inc.''; and in the table in paragraph (c)(2), remove the entry
for ``012758'' and revise the entry for ``033008'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Drug labeler
Firm name and address code
------------------------------------------------------------------------
* * * * *
Veterinary Service, Inc., 4100 Bangs Ave., Modesto, CA 033008
95356..................................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
033008.............................. Veterinary Service, Inc., 4100
Bangs Ave., Modesto, CA 95356.
* * * * *
------------------------------------------------------------------------
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.
Sec. 522.150 [Amended]
0
4. In paragraph (b) of Sec. 522.150, remove ``012578'' and in its
place add ``000986''.
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.
0
6. In Sec. 524.1445, revise paragraph (b) to read as follows:
Sec. 524.1445 Miconazole, polymixin B, and prednisolone suspension.
* * * * *
(b) Sponsor. See No. 000986 in Sec. 510.600(c) of this chapter.
* * * * *
Dated: August 1, 2012.
Elizabeth Rettie,
Deputy Director, Office of New Animal Drug Evaluation, Center for
Veterinary Medicine.
[FR Doc. 2012-19147 Filed 8-3-12; 8:45 am]
BILLING CODE 4160-01-P
