Federal Register, Volume 75, Number 219, November 15, 2010, Pages 69571-69850 Page: 69,586
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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.
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
21 CFR Part 520
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
PART 510-NEW ANIMAL DRUGS
a 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.
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.
4. In paragraph (b) of 520.2215,
remove "068718" and add in its place
Dated: November 8, 2010.
Steven D. Vaughn,
Director, Office of NewAnimal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 2010-28549 Filed 11-12-10; 8:45 am]
BILLING CODE 4160-01-P
DEPARTMENT OF HEALTH AND
Food and Drug Administration
21 CFR Part 516
[Docket No. FDA-2010-N-0534]
New Animal Drugs for Minor Use and
AGENCY: Food and Drug Administration,
ACTION: Direct final rule.
SUMMARY: 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
Elsewhere in this issue of the Federal
Register, FDA is publishing a
companion proposed rule, under FDA's
usual procedure for notice-and-
comment 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:
Submit electronic comments in the
* Federal eRulemaking Portal: http://
www.regulations.gov. Follow the
instructions for submitting comments.
Submit written submissions in the
* FAX: 301-827-6870.
* Mail/Hand delivery/Courier (for
Division of Dockets Management (HFA-
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
Instructions: All submissions received
must include the Agency name and
docket number for this rulemaking. All
comments received may be posted
without change to http://
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
Docket: For access to the docket to
read background documents or
comments received, go to http://
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.
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
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
paper, disk, or CD-ROM submissions):
dosage form.' The agency proposes to
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United States. Office of the Federal Register. Federal Register, Volume 75, Number 219, November 15, 2010, Pages 69571-69850, periodical, November 15, 2010; Washington D.C.. (digital.library.unt.edu/ark:/67531/metadc52800/m1/24/: accessed September 20, 2017), University of North Texas Libraries, Digital Library, digital.library.unt.edu; crediting UNT Libraries Government Documents Department.