New Animal Drugs; Change of Sponsor; Sulfadiazine and Pyrimethamine Suspension, 69585-69586 [2010-28549]
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Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations
Section 4.3 also issued under 19 U.S.C.
288, 1441;
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Section 4.9 also issued under 42 U.S.C.
269;
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§ 4.2
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[Amended]
2. In § 4.2:
a. Paragraph (a) is amended: by
removing the word ‘‘Customs’’ each time
that it appears and adding in its place
the term ‘‘CBP’’; in the first sentence, by
removing the words ‘‘bonded
merchandise or’’, and by removing the
word ‘‘shall’’ and adding in its place the
word ‘‘must’’, and; in the second
sentence, by removing the word ‘‘shall’’
and adding in its place the word ‘‘may’’;
■ b. Paragraph (b) is amended by
removing the word ‘‘Customs’’ and
adding in its place the word ‘‘customs’’;
■ c. Paragraph (c) is amended, in the
first sentence, by removing the word
‘‘may’’ and adding in its place the word
‘‘must’’, and by removing the word
‘‘shall’’ and adding in its place the word
‘‘must’’; and; in the last sentence, by
removing the word ‘‘shall’’ and adding in
its place the word ‘‘will’’, and by
removing the word ‘‘may’’ and adding in
its place the word ‘‘must’’; and
■ d. Paragraph (d) is amended by
removing the word ‘‘shall’’ and adding in
its place the word ‘‘must’’.
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§ 4.3
[Amended]
3. In § 4.3:
a. Paragraph (a)(3) is amended by
removing the words ‘‘merchandise on
board which is being transported inbond (not including bonded ship’s
stores or supplies), or’’, and adding the
words ‘‘on board’’ after the words
‘‘foreign merchandise’’; and
■ b. Paragraph (b)(2) is amended by
removing the word ‘‘Customs’’ each time
that it appears and adding in its place
the term ‘‘CBP’’.
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§ 4.9
[Amended]
4. In § 4.9:
a. Paragraph (a) is amended by
removing the word ‘‘Customs’’ each time
that it appears and adding in its place
the term ‘‘CBP’’; and
■ b. Paragraph (b) is amended in the
second sentence by removing the words
‘‘when they have merchandise aboard
which is being transported in-bond, or’’,
by removing the third and fourth
sentences, and by removing the word
‘‘Customs’’ in the last sentence and
adding in its place the term ‘‘CBP’’.
jdjones on DSK8KYBLC1PROD with RULES
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§ 4.60
[Amended]
5. In § 4.60:
a. Paragraph (a) is amended by
removing the words ‘‘the Customs
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15:26 Nov 12, 2010
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Service’’ and adding in their place the
term ‘‘CBP’’;
■ b. Paragraph (a)(3) is amended by
removing the words ‘‘merchandise on
board that is being transported in-bond
(not including bonded ship’s stores or
supplies), or’’;
■ c. Paragraph (b)(1) is amended by
removing the word ‘‘Customs’’ and
adding in its place the word ‘‘customs’’;
■ d. Paragraph (c) is amended by
removing the word ‘‘shall’’ and adding in
its place the word ‘‘will’’;
■ e. Paragraph (d) is amended, in the
first sentence, by removing the words
‘‘shall be reported’’ and adding in their
place the words ‘‘must be reported’’, and
by removing the words ‘‘shall note’’ and
adding in their place the words ‘‘will
note’’, and; in the last sentence, by
removing the word ‘‘shall’’ each time
that it appears and adding in its place
the word ‘‘must’’; and
■ f. Paragraph (e) is amended by
removing the word ‘‘shall’’ and adding in
its place the word ‘‘will’’.
PART 10—ARTICLES CONDITIONALLY
FREE, SUBJECT TO A REDUCED
RATE, ETC.
6. The general authority citation for
part 10 continues to read as follows:
■
Authority: 19 U.S.C. 66, 1202 (General
Note 3(i), Harmonized Tariff Schedule of the
United States (HTSUS)), 1321, 1481, 1484,
1498, 1508, 1623, 1624, 3314.
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■ 7. § 10.121 is revised to read as
follows:
§ 10.121 Visual or auditory materials of an
educational, scientific, or cultural character.
(a) Where photographic film and other
articles described in subheading
9817.00.40, Harmonized Tariff Schedule
of the United States (HTSUS), are
claimed to be free of duty under
subheading 9817.00.40, HTSUS, there
must be filed, in connection with the
entry covering such articles, a document
issued by the U.S. Department of State
certifying that it has determined that the
articles are visual or auditory materials
of an educational, scientific, or cultural
character within the meaning of the
Agreement for Facilitating the
International Circulation of Visual and
Auditory Materials of an Educational,
Scientific, and Cultural Character as
required by U.S. note 1(a)(i), Subchapter
XVII, chapter 98, HTSUS.
(b) Articles entered under subheading
9817.00.40, HTSUS, will be released
from CBP custody prior to submission of
the document required in paragraph (a)
of this section only upon the deposit of
estimated duties with the port director.
Liquidation of an entry covering
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69585
merchandise which has been released
under this procedure will be suspended
for a period of 90 days from the date of
entry or until the required document is
submitted, whichever occurs first. In the
event that the director of the port of
entry does not receive the required
document within the 90-day period, the
merchandise will be classified and
liquidated in the ordinary course,
without regard to subheading
9817.00.40, HTSUS.
Dated: November 9, 2010.
David V. Aguilar,
Acting Commissioner, U.S. Customs and
Border Protection.
[FR Doc. 2010–28709 Filed 11–12–10; 8:45 am]
BILLING CODE 9111–14–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Change of
Sponsor; Sulfadiazine and
Pyrimethamine 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 sulfadiazine and
pyrimethamine oral suspension from
Animal Health Pharmaceuticals, LLC, to
Pegasus Laboratories, Inc.
DATES: This rule is effective November
15, 2010.
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: Animal
Health Pharmaceuticals, LLC, 1805 Oak
Ridge Circle, suite 101, St. Joseph, MO
64506, has informed FDA that it has
transferred ownership of, and all rights
and interest in, NADA 141–240 for
REBALANCE (sulfadiazine and
pyrimethamine) Antiprotozoal Oral
Suspension to Pegasus Laboratories,
Inc., 8809 Ely Rd., Pensacola, FL 32514.
Accordingly, the regulations are
amended in 21 CFR 520.2215 to reflect
this change of sponsorship.
Following this change of sponsorship,
Animal Health Pharmaceuticals, LLC, is
no longer the sponsor of an approved
application. Accordingly, § 510.600 (21
SUMMARY:
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69586
Federal Register / Vol. 75, No. 219 / Monday, November 15, 2010 / Rules and Regulations
CFR 510.600) is being amended to
remove the entries for this firm.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 516
[Docket No. FDA–2010–N–0534]
List of Subjects
New Animal Drugs for Minor Use and
Minor Species
21 CFR Part 510
AGENCY:
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
ACTION:
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 and 520 are amended as
follows:
■
PART 510—NEW ANIMAL DRUGS
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.
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1) remove the entry for
‘‘Animal Health Pharmaceuticals, LLC’’;
and in the table in paragraph (c)(2)
remove the entry for ‘‘068718’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
3. The authority citation for 21 CFR
part 520 continues to read as follows:
■
Authority: 21 U.S.C. 360b.
§ 520.2215
[Amended]
4. In paragraph (b) of § 520.2215,
remove ‘‘068718’’ and add in its place
‘‘055246’’.
■
Dated: November 8, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
jdjones on DSK8KYBLC1PROD with RULES
[FR Doc. 2010–28549 Filed 11–12–10; 8:45 am]
BILLING CODE 4160–01–P
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15:26 Nov 12, 2010
Direct final rule.
The Food and Drug
Administration (FDA) is amending its
regulations regarding new animal drugs
for minor use and minor species to
update language and to clarify the
regulations consistent with the
explanations in the preambles to the
proposed and final rules establishing
them. This action is being taken to
ensure accuracy and clarity in the
Agency’s regulations.
Elsewhere in this issue of the Federal
Register, FDA is publishing a
companion proposed rule, under FDA’s
usual procedure for notice-andcomment rulemaking, to provide a
procedural framework to finalize the
rule in the event the Agency receives
any significant adverse comments and
withdraws this direct final rule. The
companion proposed rule and direct
final rule are substantively identical.
DATES: This rule is effective March 30,
2011. Submit either electronic or
written comments by January 31, 2011.
If FDA receives no significant adverse
comments within the specified
comment period, the Agency will
publish a document confirming the
effective date of the final rule in the
Federal Register within 30 days after
the comment period on this direct final
rule ends. If timely significant adverse
comments are received, the Agency will
publish a document in the Federal
Register withdrawing this direct final
rule before its effective date.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2010–N–
0534, by any of the following methods:
SUMMARY:
21 CFR Part 520
§ 510.600
Food and Drug Administration,
HHS.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
• FAX: 301–827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
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Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
Instructions: All submissions received
must include the Agency name and
docket number for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION section of
this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Meg
Oeller, Center for Veterinary Medicine
(HFV–50), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–9005.
SUPPLEMENTARY INFORMATION:
I. Background
The Minor Use and Minor Species
Animal Health Act of 2004 amended the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) to establish new
regulatory procedures that provide
incentives intended to make more drugs
legally available to veterinarians and
animal owners for the treatment of
minor animal species and uncommon
diseases in major animal species. FDA
published the final rule to implement
these regulations (part 516 (21 CFR part
516)) in the Federal Register of July 26,
2007 (72 FR 41010).
FDA is issuing this direct final rule to
amend its regulations regarding new
animal drugs for minor use and minor
species (MUMS) in part 516 to update
language and clarify the intent of the
regulations consistent with the
preambles to the proposed and final
rules.
In § 516.3(b), FDA is amending the
definition of ‘‘Same dosage form’’ to
make it clearer that the six dosage form
categories listed in the regulations
under § 516.3(b)(i) through (b)(vi) are
the ‘‘categories’’ of dosage forms that the
preamble to the proposed rule
referenced as follows: ‘‘The second test
of sameness which the statute
establishes to determine eligibility of an
animal drug for designation is ‘same
dosage form.’ The agency proposes to
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]]>Agencies
[Federal Register Volume 75, Number 219 (Monday, November 15, 2010)]
[Rules and Regulations]
[Pages 69585-69586]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28549]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 520
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Change of Sponsor; Sulfadiazine and
Pyrimethamine 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 sulfadiazine and
pyrimethamine oral suspension from Animal Health Pharmaceuticals, LLC,
to Pegasus Laboratories, Inc.
DATES: This rule is effective November 15, 2010.
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: Animal Health Pharmaceuticals, LLC, 1805 Oak
Ridge Circle, suite 101, St. Joseph, MO 64506, has informed FDA that it
has transferred ownership of, and all rights and interest in, NADA 141-
240 for REBALANCE (sulfadiazine and pyrimethamine) Antiprotozoal Oral
Suspension to Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL
32514. Accordingly, the regulations are amended in 21 CFR 520.2215 to
reflect this change of sponsorship.
Following this change of sponsorship, Animal Health
Pharmaceuticals, LLC, is no longer the sponsor of an approved
application. Accordingly, Sec. 510.600 (21
[[Page 69586]]
CFR 510.600) is being amended to remove the entries for this firm.
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 Part 520
Animal drugs.
0
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 and
520 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.
Sec. 510.600 [Amended]
0
2. In Sec. 510.600, in the table in paragraph (c)(1) remove the entry
for ``Animal Health Pharmaceuticals, LLC''; and in the table in
paragraph (c)(2) remove the entry for ``068718''.
PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS
0
3. The authority citation for 21 CFR part 520 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 520.2215 [Amended]
0
4. In paragraph (b) of Sec. 520.2215, remove ``068718'' and add in its
place ``055246''.
Dated: November 8, 2010.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 2010-28549 Filed 11-12-10; 8:45 am]
BILLING CODE 4160-01-P
