New Animal Drugs; Change of Sponsor; Fomepizole, 28265-28266 [06-4534]
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Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006 / Rules and Regulations
will reduce your SSI payment by $90. We
may consider that to be a substantial
reduction.
Example 2: A Substantial Reduction Exists.
You receive a title II benefit of $550 and an
SSI payment of $73. Your PASS employment
goal will result in work over the SGA level
that eliminates your title II benefit but
increases your SSI payment by $90. We may
consider that a substantial reduction because
your work will eliminate your title II
payment while only slightly increasing your
SSI payment.
Example 3: A Substantial Reduction Does
Not Exist. Your SSI monthly payment
amount is $603 and your PASS employment
goal earnings will reduce your SSI payment
by $90. We may not consider that to be a
substantial reduction.
(8) Contain a beginning date and an
ending date to meet your employment
goal;
(9) Give target dates for meeting
milestones towards your employment
goal;
(10) Show what expenses you will
have and how they are reasonable and
necessary to meet your employment
goal;
(11) Show what money you have and
will receive, how you will use or spend
it to attain your employment goal, and
how you will meet your living expenses;
and
(12) Show how the money you set
aside under the plan will be kept
separate from your other funds.
(b) You must propose a reasonable
ending date for your PASS. If necessary,
we can help you establish an ending
date, which may be different than the
ending date you propose. Once the
ending date is set and you begin your
PASS, we may adjust or extend the
ending date of your PASS based on
progress towards your goal and earnings
level reached.
(c) If your employment goal is selfemployment, you must include a
business plan that defines the business,
provides a marketing strategy, details
financial data, outlines the operational
procedures, and describes the
management plan.
(d) Your progress will be reviewed at
least annually to determine if you are
following the provisions of your plan.
Subpart L—[Amended]
4. The authority citation for subpart L
is revised to read as follows:
cprice-sewell on PROD1PC66 with RULES
I
Authority: Secs. 702(a)(5), 1602, 1611,
1612, 1613, 1614(f), 1621, 1631, and 1633 of
the Social Security Act (42 U.S.C. 902(a)(5),
1381a, 1382, 1382a, 1382b, 1382c(f), 1382j,
1383, and 1383b); sec. 211, Pub. L. 93–66, 87
Stat. 154 (42 U.S.C. 1382 note).
5. Section 416.1225 is revised to read
as follows:
I
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15:11 May 15, 2006
Jkt 208001
§ 416.1225 An approved plan to achieve
self-support; general.
If you are blind or disabled, we will
pay you SSI benefits and will not count
resources that you use or set aside to use
for expenses that we determine to be
reasonable and necessary to fulfill an
approved plan to achieve self-support.
I 6. Section 416.1226 is revised to read
as follows:
§ 416.1226 What is a plan to achieve selfsupport (PASS)?
(a) A PASS must—
(1) Be designed especially for you;
(2) Be in writing;
(3) Be approved by us (a change of
plan must also be approved by us);
(4) Have a specific employment goal
that is feasible for you, that is, a goal
that you have a reasonable likelihood of
achieving;
(5) Have a plan to reach your
employment goal that is viable and
financially sustainable, that is, the
plan—
(i) Sets forth steps that are attainable
in order to reach your goal, and
(ii) Shows that you will have enough
money to meet your living expenses
while setting aside income or resources
to reach your goal;
(6) Be limited to one employment
goal; however, the employment goal
may be modified and any changes
related to the modification must be
made to the plan;
(7) Show how the employment goal
will generate sufficient earnings to
substantially reduce your dependence
on SSI or eliminate your need for title
II disability benefits;
Example 1: A Substantial Reduction Exists.
Your SSI monthly payment amount is $101
and your PASS employment goal earnings
will reduce your SSI payment by $90. We
may consider that to be a substantial
reduction.
Example 2: A Substantial Reduction Exists.
You receive a title II benefit of $550 and an
SSI payment of $73. Your PASS employment
goal will result in work over the SGA level
that eliminates your title II benefit but
increases your SSI payment by $90. We may
consider that a substantial reduction because
your work will eliminate your title II
payment while only slightly increasing your
SSI payment.
Example 3: A Substantial Reduction Does
Not Exist. Your SSI monthly payment
amount is $603 and your PASS employment
goal earnings will reduce your SSI payment
by $90. We may not consider that to be a
substantial reduction.
(8) Contain a beginning date and an
ending date to meet your employment
goal;
(9) Give target dates for meeting
milestones towards your employment
goal;
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28265
(10) Show what expenses you will
have and how they are reasonable and
necessary to meet your employment
goal;
(11) Show what resources you have
and will receive, how you will use them
to attain your employment goal, and
how you will meet your living expenses;
and
(12) Show how the resources you set
aside under the plan will be kept
separate from your other resources.
(b) You must propose a reasonable
ending date for your PASS. If necessary,
we can help you establish an ending
date, which may be different than the
ending date you propose. Once the
ending date is set and you begin your
PASS, we may adjust or extend the
ending date of your PASS based on
progress towards your goal and earnings
level reached.
(c) If your employment goal is selfemployment, you must include a
business plan that defines the business,
provides a marketing strategy, details
financial data, outlines the operational
procedures, and describes the
management plan.
(d) Your progress will be reviewed at
least annually to determine if you are
following the provisions of your plan.
[FR Doc. 06–4530 Filed 5–15–06; 8:45 am]
BILLING CODE 4191–02–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
New Animal Drugs; Change of
Sponsor; Fomepizole
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 a new animal drug
application (NADA) for fomepizole
solution for injection from Orphan
Medical, Inc., to Jazz Pharmaceuticals,
Inc. The regulations are also being
amended to reflect approval of a
supplemental NADA to remove a vial of
saline diluent from this product.
DATES: This rule is effective May 16,
2006.
FOR FURTHER INFORMATION CONTACT:
Melanie R. Berson, Center for Veterinary
Medicine (HFV–110), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–827–7540, email: melanie.berson@fda.hhs.gov.
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28266
Federal Register / Vol. 71, No. 94 / Tuesday, May 16, 2006 / Rules and Regulations
Orphan
Medical, Inc., 13911 Ridgedale Dr., suite
475, Minnetonka, MN 55305, has
informed FDA that it has transferred
ownership of, and all rights and interest
in, NADA 141–075 for ANTIZOL-VET
(fomepizole) to Jazz Pharmaceuticals,
Inc., 3180 Porter Dr., Palo Alto, CA
94304. A supplement was also filed to
NADA 141–075 to remove a vial of
saline diluent from this product. The
supplemental NADA is approved as of
April 18, 2006, and the regulations are
amended in 21 CFR 522.1004 to reflect
the change of sponsorship, the removal
of a vial of saline diluent from the
product, and a current format.
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.
Following these changes of
sponsorship, Orphan Medical, Inc., is
no longer the sponsor of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to remove
the entries for Orphan Medical, Inc.
The agency has determined under 21
CFR 25.33(d)(1) 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.
SUPPLEMENTARY INFORMATION:
‘‘Orphan Medical, Inc.’’ and
alphabetically add a new entry for ‘‘Jazz
Pharmaceuticals, Inc.’’; and in the table
in paragraph (c)(2) remove the entry for
‘‘062161’’ and numerically add a new
entry for ‘‘068727’’ to read as follows:
DEPARTMENT OF THE TREASURY
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
RIN 1545–BA65
*
*
*
(c) * * *
(1) * * *
*
*
Firm name and address
*
*
*
Jazz Pharmaceuticals, Inc.,
3180 Porter Dr., Palo
Alto, CA 94304.
*
*
*
Drug labeler
code
*
068727
*
*
*
*
068727
*
*
*
Firm name and address
*
*
*
Jazz Pharmaceuticals, Inc.,
3180 Porter Dr., Palo
Alto, CA 94304
*
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
List of Subjects
4. In § 522.1004, revise paragraphs (a),
(b), (c)(1), and (c)(3) to read as follows:
21 CFR Part 510
§ 522.1004
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
(a) Specifications. Each vial contains
1.5 grams fomepizole (1.5 milliliter (mL)
of 1.0 gram per mL solution).
(b) Sponsor. See No. 068727 in
§ 510.600(c) of this chapter.
(c) * * *
(1) Amount. 20 milligrams per
kilogram (mg/kg) of body weight
intravenously initially, followed by 15
mg/kg at 12 and 24 hours, and 5 mg/kg
at 36 hours.
*
*
*
*
*
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
21 CFR Part 522
Animal drugs.
I 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 522 are amended as
follows:
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PART 510—NEW ANIMAL DRUGS
1. The authority citation for 21 CFR
part 510 continues to read as follows:
I
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
I
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I
Fomepizole.
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[TD 9243]
Revision of Income Tax Regulations
Under Sections 367, 884, and 6038B
Dealing With Statutory Mergers or
Consolidations Under Section
368(a)(1)(A) Involving One or More
Foreign Corporations, and Guidance
Necessary To Facilitate Business
Electronic Filing Under Section 6038B;
Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
SUMMARY: This document contains a
correction to final regulations (TD
9243), that was published in the Federal
Register on Thursday, January 26, 2006
(71 FR 4276). This final regulation
amends the income tax regulations
under various provisions of the Internal
Revenue Code to account for statutory
mergers and consolidations.
DATES: This correction is effective
January 23, 2006.
FOR FURTHER INFORMATION CONTACT:
Christopher Trump (202) 622–3860 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The final regulation (TD 9243) that is
the subject of this correction is under
section 367 of the Internal Revenue
Code.
Need for Correction
Dated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug
Evaluation, Center for Veterinary Medicine.
[FR Doc. 06–4534 Filed 5–15–06; 8:45 am]
BILLING CODE 4160–01–S
26 CFR Part 1
AGENCY:
(2) * * *
Drug labeler
code
Internal Revenue Service
As published, TD 9243 contains an
error that may prove to be misleading
and is in need of clarification.
List of Subjects in 26 CFR Part 1
Income taxes, Reporting and
recordkeeping requirements.
Correction of Publication
Accordingly, 26 CFR part 1 is
corrected by making the following
correcting amendments:
I
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
I
Authority: 26 U.S.C. 7805 * * *
§ 1.367(b)–6
[Corrected]
I Par. 2. Section 1.367(b)–6 is amended
by removing the third sentence of
E:\FR\FM\16MYR1.SGM
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]]>Agencies
[Federal Register Volume 71, Number 94 (Tuesday, May 16, 2006)]
[Rules and Regulations]
[Pages 28265-28266]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-4534]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
New Animal Drugs; Change of Sponsor; Fomepizole
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 a new animal drug
application (NADA) for fomepizole solution for injection from Orphan
Medical, Inc., to Jazz Pharmaceuticals, Inc. The regulations are also
being amended to reflect approval of a supplemental NADA to remove a
vial of saline diluent from this product.
DATES: This rule is effective May 16, 2006.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-7540, e-mail:
melanie.berson@fda.hhs.gov.
[[Page 28266]]
SUPPLEMENTARY INFORMATION: Orphan Medical, Inc., 13911 Ridgedale Dr.,
suite 475, Minnetonka, MN 55305, has informed FDA that it has
transferred ownership of, and all rights and interest in, NADA 141-075
for ANTIZOL-VET (fomepizole) to Jazz Pharmaceuticals, Inc., 3180 Porter
Dr., Palo Alto, CA 94304. A supplement was also filed to NADA 141-075
to remove a vial of saline diluent from this product. The supplemental
NADA is approved as of April 18, 2006, and the regulations are amended
in 21 CFR 522.1004 to reflect the change of sponsorship, the removal of
a vial of saline diluent from the product, and a current format.
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.
Following these changes of sponsorship, Orphan Medical, Inc., is no
longer the sponsor of an approved application. Accordingly, 21 CFR
510.600(c) is being amended to remove the entries for Orphan Medical,
Inc.
The agency has determined under 21 CFR 25.33(d)(1) 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
21 CFR Part 510
Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.
21 CFR Part 522
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
522 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 ``Orphan Medical, Inc.'' and alphabetically add a new entry for
``Jazz Pharmaceuticals, Inc.''; and in the table in paragraph (c)(2)
remove the entry for ``062161'' and numerically add a new entry for
``068727'' to read as follows:
Sec. 510.600 Names, addresses, and drug labeler codes of sponsors of
approved applications.
* * * * *
(c) * * *
(1) * * *
------------------------------------------------------------------------
Firm name and address Drug labeler code
------------------------------------------------------------------------
* * * * *
Jazz Pharmaceuticals, Inc., 3180 Porter Dr., 068727
Palo Alto, CA 94304.
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Drug labeler code Firm name and address
------------------------------------------------------------------------
* * * * *
068727 Jazz Pharmaceuticals, Inc., 3180 Porter
Dr., Palo Alto, CA 94304
* * * * *
------------------------------------------------------------------------
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. 522.1004, revise paragraphs (a), (b), (c)(1), and (c)(3) to
read as follows:
Sec. 522.1004 Fomepizole.
(a) Specifications. Each vial contains 1.5 grams fomepizole (1.5
milliliter (mL) of 1.0 gram per mL solution).
(b) Sponsor. See No. 068727 in Sec. 510.600(c) of this chapter.
(c) * * *
(1) Amount. 20 milligrams per kilogram (mg/kg) of body weight
intravenously initially, followed by 15 mg/kg at 12 and 24 hours, and 5
mg/kg at 36 hours.
* * * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Dated: May 3, 2006.
Steven D. Vaughn,
Director, Office of New Animal Drug Evaluation, Center for Veterinary
Medicine.
[FR Doc. 06-4534 Filed 5-15-06; 8:45 am]
BILLING CODE 4160-01-S
