Implantation or Injectable Dosage Form New Animal Drugs; Hyaluronate Sodium, 1274 [2010-207]
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Federal Register / Vol. 75, No. 6 / Monday, January 11, 2010 / Rules and Regulations
tenth month following their receipt are
countable as resources at that time.
(c) Exception: For any payments
described in paragraph (a) of this
section received before March 2, 2004,
we will exclude for the month following
the month of receipt the unspent
portion of any such payment.
8. Amend § 416.1236 by revising
paragraph (a)(24) and adding a new
paragraph (a)(25) to read as follows:
■
she makes to dispose of them, the
resources will be counted at their
current market value and the individual
will be ineligible due to excess
resources. We will use the original
estimate of current market value unless
the individual submits evidence
establishing a lower value (e.g., an
estimate from a disinterested
knowledgeable source).
[FR Doc. 2010–241 Filed 1–8–10; 8:45 am]
BILLING CODE 4191–02–P
§ 416.1236 Exclusions from resources;
provided by other statutes.
(a) * * *
(24) Assistance provided for flood
mitigation activities under section 1324
of the National Flood Insurance Act of
1968, pursuant to section 1 of Public
Law 109–64 (119 Stat. 1997, 42 U.S.C.
4031).
(25) Payments made to individuals
under the Energy Employees
Occupational Illness Compensation
Program Act of 2000, pursuant to
section 1, app. [Div. C. Title XXXVI
section 3646] of Public Law 106–398
(114 Stat. 1654A–510, 42 U.S.C. 7385e).
*
*
*
*
*
■ 9. Revise § 416.1240 to read as
follows:
cprice-sewell on DSK2BSOYB1PROD with RULES
§ 416.1240
Disposition of Resources.
(a) Where the resources of an
individual (and spouse, if any) are
determined to exceed the limitations
prescribed in § 416.1205, such
individual (and spouse, if any) shall not
be eligible for payment except under the
conditions provided in this section.
Payment will be made to an individual
(and spouse, if any) if the individual
agrees in writing to:
(1) Dispose of, at current market
value, the nonliquid resources (as
defined in § 416.1201(c)) in excess of
the limitations prescribed in § 416.1205
within the time period specified in
§ 416.1242; and
(2) Repay any overpayments (as
defined in § 416.1244) with the
proceeds of such disposition.
(b) Payment made for the period
during which the resources are being
disposed of will be conditioned upon
the disposition of those resources as
prescribed in paragraphs (a)(1) and
(a)(2) of this section. Any payments so
made are (at the time of disposition)
considered overpayments to the extent
they would not have been paid had the
disposition occurred at the beginning of
the period for which such payments
were made.
(c) If an individual fails to dispose of
the resources as prescribed in
paragraphs (a)(1) and (a)(2) of this
section, regardless of the efforts he or
VerDate Nov<24>2008
18:55 Jan 08, 2010
Jkt 220001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs; Hyaluronate
Sodium
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FDA has determined under 21 CFR
25.33 that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
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 Part 522
Animal drugs.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under the
authority delegated to the Commissioner
of Food and Drugs and redelegated to
the Center for Veterinary Medicine, 21
CFR part 522 is amended as follows:
■
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
1. The authority citation for 21 CFR
part 522 continues to read as follows:
■
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a supplemental new animal
drug application (NADA) filed by Anika
Therapeutics, Inc. The supplemental
NADA provides for a revised human
food safety warning for use of
hyaluronate sodium injectable solution
in horses.
DATES: This rule is effective January 11,
2010.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8337, email: melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Anika
Therapeutics, Inc., 236 W. Cummings
Park, Woburn, MA 01801, filed a
supplement to NADA 122–578 that
provides for the veterinary prescription
use of HYVISC (hyaluronate sodium)
Sterile Injection in horses. The
supplemental NADA provides for a
revised human food safety warning on
product labeling. The supplemental
NADA is approved as of December 11,
2009, and the regulations are amended
in 21 CFR 522.1145 to reflect the
approval.
Approval of this supplemental NADA
did not require review of additional
safety or effectiveness data or
information. Therefore, a freedom of
information summary is not required.
Authority: 21 U.S.C. 360b.
SUMMARY:
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
§ 522.1145
[Amended]
2. In paragraph (f)(3)(iii) of § 522.1145,
remove the third sentence and in its
place add ‘‘Do not use in horses
intended for human consumption.’’
■
Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–207 Filed 1–8–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA–2009–N–0665]
Implantation or Injectable Dosage
Form New Animal Drugs; Florfenicol
and Flunixin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of an original new animal drug
application (NADA) filed by Intervet,
Inc. The NADA provides for veterinary
prescription use of a combination
injectable solution containing
E:\FR\FM\11JAR1.SGM
11JAR1
]]>Agencies
[Federal Register Volume 75, Number 6 (Monday, January 11, 2010)]
[Rules and Regulations]
[Page 1274]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-207]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 522
[Docket No. FDA-2009-N-0665]
Implantation or Injectable Dosage Form New Animal Drugs;
Hyaluronate Sodium
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Anika Therapeutics, Inc. The supplemental
NADA provides for a revised human food safety warning for use of
hyaluronate sodium injectable solution in horses.
DATES: This rule is effective January 11, 2010.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8337, e-mail:
melanie.berson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Anika Therapeutics, Inc., 236 W. Cummings
Park, Woburn, MA 01801, filed a supplement to NADA 122-578 that
provides for the veterinary prescription use of HYVISC (hyaluronate
sodium) Sterile Injection in horses. The supplemental NADA provides for
a revised human food safety warning on product labeling. The
supplemental NADA is approved as of December 11, 2009, and the
regulations are amended in 21 CFR 522.1145 to reflect the approval.
Approval of this supplemental NADA did not require review of
additional safety or effectiveness data or information. Therefore, a
freedom of information summary is not required.
FDA has determined under 21 CFR 25.33 that this action is of a type
that does not individually or cumulatively have a significant effect on
the human environment. Therefore, neither an environmental assessment
nor an environmental impact statement is required.
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 Part 522
Animal drugs.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under the
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Center for Veterinary Medicine, 21 CFR part 522 is
amended as follows:
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
1. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1145 [Amended]
0
2. In paragraph (f)(3)(iii) of Sec. 522.1145, remove the third
sentence and in its place add ``Do not use in horses intended for human
consumption.''
Dated: December 31, 2009.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-207 Filed 1-8-10; 8:45 am]
BILLING CODE 4160-01-S
