New Animal Drugs; Deslorelin, 81455-81456 [2010-32554]
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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Rules and Regulations
claims for exemptions are still pending,
will be revised.
e. Internal references will be
corrected.
These regulations are being published
as a direct final rule because the
amendments do not impose any
requirements on any member of the
public. These amendments are the most
efficient means for the Joint Board to
implement its internal requirements for
complying with the Privacy Act.
Accordingly, pursuant to 5 U.S.C.
553(b)(3)(B), the Joint Board finds good
cause that prior notice and other public
procedures with respect to this rule are
unnecessary, and good cause for making
this direct final rule effective 90 days
after publication in the Federal
Register.
Pursuant to Executive Order 12866, it
has been determined that this direct
final rule is not a significant regulatory
action, and therefore, does not require a
regulatory impact analysis.
Because no notice of proposed
rulemaking is required, the provisions
of the Regulatory Flexibility Act, 5
U.S.C. 601–612, do not apply.
List of Subjects in 20 CFR Part 903
Access to Records.
Adoption of Amendments to the
Regulations
Accordingly, 20 CFR part 903 is
amended as follows:
■
PART 903—ACCESS TO RECORDS
1. The authority citation for 20 CFR
part 903 continues to read as follows:
■
Authority: 5 U.S.C. 552a.
2. Section 903.8, is amended by:
a. Revising paragraph (a);
b. Revising paragraph (b);
c. Revising the last sentence of
paragraph (c)(2)(i);
■ d. Revising the last sentence of
paragraph (c)(2)(ii);
■ e. Amending paragraph (c)(2)(iii) by
removing the reference ‘‘the preceding
subparagraph (2)(B)’’ and by adding in
its place, the reference ‘‘the preceding
subsection (2)(ii)’’;
■ f. Revising the last sentence of
paragraph (c)(2)(iii);
■ g. Amending paragraph (c)(2)(iv) by
removing the reference ‘‘the preceding
subparagraph (2)(B)’’ and by adding in
its place the reference ‘‘the preceding
subsection (2)(ii)’’;
■ g. Amending paragraph (c)(2)(iv) by
removing the reference ‘‘afforded by
subsections (c)(4)(G)’’ and by adding in
its place the reference ‘‘afforded by
subsections (e)(4)(G)’’; and
■ h. Revising the last sentence of
paragraphs (c)(2)(iv), (c)(2)(v), and
(c)(2)(vi).
srobinson on DSKHWCL6B1PROD with RULES
■
■
■
■
VerDate Mar<15>2010
18:14 Dec 27, 2010
Jkt 223001
The revisions read as follows:
§ 903.8
Exemptions.
(a) Names of systems: JBEA–2,
Enrolled Actuary Disciplinary Records;
and JBEA–4, Enrolled Actuary
Enrollment Records.
(b) Provisions from which exempted:
These systems contain records
described in section (k)(2) of the Privacy
Act of 1974, 5 U.S.C. 552a(k)(2).
Exemptions are claimed for such
records only where appropriate from the
following provisions: sections (c)(3); (d);
(e)(1); (e)(4)(G), (e)(4)(H), and (e)(4)(I);
and (f) of 5 U.S.C. 552a.
(c) * * *
(2) * * *
(i) * * * For these reasons, the Joint
Board claims exemption from the
requirements of subsection (c)(3) of the
Act.
(ii) * * * For these reasons, the Joint
Board claims exemptions from the
requirements of subsections (d)(1),
(e)(4)(H), and (f)(2), (3), and (5) of the
Act.
(iii) * * * Therefore, the Joint Board
claims exemptions from the
requirements of subsections (d)(2), (3),
and (4), (e)(4)(H), and (f)(4).
(iv) * * * For these reasons, the Joint
Board claims exemptions from the
requirements of subsections (e)(4)(G)
and (f)(1).
(v) * * * For these reasons, the Joint
Board claims exemption from the
requirements of subsection (e)(1).
(vi) * * * For these reasons, the Joint
Board claims exemption from the
requirements of subsection (e)(4)(I).
Dated: November 4, 2010.
Carolyn E. Zimmerman,
Chair, Joint Board for the Enrollment of
Actuaries.
[FR Doc. 2010–32165 Filed 12–27–10; 8:45 am]
BILLING CODE 4830–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA–2010–N–0002]
New Animal Drugs; Deslorelin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 Thorn
Frm 00085
Fmt 4700
Bioscience LLC. The NADA provides for
the use of deslorelin acetate injectable
suspension in mares for inducing
ovulation.
DATES: This rule is effective December
28, 2010.
FOR FURTHER INFORMATION CONTACT:
Amy L. Omer, Center for Veterinary
Medicine (HFV–114), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8336, email: amy.omer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Thorn
Bioscience LLC, 1044 East Chestnut St.,
Louisville, KY 40204, filed NADA 141–
319 that provides for use of
SUCROMATE Equine (deslorelin
acetate), an injectable suspension, in
mares for inducing ovulation. The
NADA is approved as of November 5,
2010, and the regulations are amended
in 21 CFR 522.533 to reflect the
approval.
In addition, Thorn Bioscience LLC
has not been previously listed in the
animal drug regulations as a sponsor of
an approved application. Accordingly,
21 CFR 510.600(c) is being amended to
add entries for this firm.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
The Agency 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.
Under section 512(c)(2)(F)(ii) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360b(c)(2)(F)(ii)), this
approval qualifies for 3 years of
marketing exclusivity beginning on the
date of approval.
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
Final rule.
SUMMARY:
PO 00000
81455
Sfmt 4700
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
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Federal Register / Vol. 75, No. 248 / Tuesday, December 28, 2010 / Rules and Regulations
21 CFR Part 522
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 522 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.
2. In § 510.600, in the table in
paragraph (c)(1) alphabetically add an
entry for ‘‘Thorn Bioscience LLC’’; and
in the table in paragraph (c)(2)
numerically add an entry for ‘‘051330’’
to read as follows:
*
*
*
*
*
■
§ 510.600 Names, addresses, and drug
labeler codes of sponsors of approved
applications.
(c) * * *
(1) * * *
Firm name and address
*
*
*
Thorn Bioscience LLC, 1044
East Chestnut St., Louisville, KY 40204 ..................
Drug labeler
code
*
*
051330
(2) Each milliliter (mL) of suspension
contains 1.8 mg deslorelin acetate.
(b) Sponsors. See sponsor numbers in
§ 510.600(c) of this chapter as follows:
(1) No. 043246 for use of product
described in paragraph (a)(1) as in
paragraph (c)(1) of this section.
(2) No. 051330 for use of product
described in paragraph (a)(2) as in
paragraph (c)(2) of this section.
(c) Conditions of use—(1) Horses and
ponies—(i) Amount. One implant per
mare subcutaneously in the neck.
(ii) Indications for use. For inducing
ovulation within 48 hours in estrous
mares with an ovarian follicle greater
than 30 mL in diameter.
(iii) Limitations. Do not use in horses
or ponies intended for human
consumption. Federal law restricts this
drug to use by or on the order of a
licensed veterinarian.
(2) Horses—(i) Amount. Administer
1.8 mg (1 mL) by intramuscular
injection in the neck.
(ii) Indications for use. For inducing
ovulation within 48 hours in cyclic
estrous mares with an ovarian follicle
between 30 and 40 mL in diameter.
(iii) Limitations. Do not use in horses
intended for human consumption.
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian.
Dated: December 9, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010–32554 Filed 12–27–10; 8:45 am]
*
*
*
*
*
BILLING CODE 4160–01–P
(2) * * *
Drug labeler code
Firm name
and address
.
*
*
*
051330 ..................................
*
*
*
*
*
Thorn
Bioscience
LLC, 1044
East Chestnut
St., Louisville,
KY 40204
*
*
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
3. The authority citation for 21 CFR
part 522 continues to read as follows:
srobinson on DSKHWCL6B1PROD with RULES
Authority: 21 U.S.C. 360b.
4. Revise § 522.533 to read as follows:
§ 522.533
Deslorelin.
(a) Specifications—(1) Each implant
contains 2.1 milligrams (mg) deslorelin
acetate.
VerDate Mar<15>2010
20:48 Dec 27, 2010
Jkt 223001
Internal Revenue Service
26 CFR Part 1
Background
The final regulations (TD 9505) that
are the subject of this document are
under section 411 of the Internal
Revenue Code.
Need for Correction
As published, the final regulations
(TD 9505) contain errors that may prove
to be misleading and are in need of
clarification.
List of Subject 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:
■
PART 1—INCOME TAXES
Paragraph 1. The authority citation
for part 1 continues to read in part as
follows:
■
Authority: 26 U.S.C. 7805 * * *
Par. 2. Section 1.411(b)(5)–1 is
amended by:
■ 1. Revising the paragraph (b)(1)(ii)(A).
■ 2. Revising the first sentence of
paragraph (b)(1)(iv) Example 4.(iii).
■ 3. Revising the first sentence of
paragraph (c)(5) Example 2.(iv).
■ 4. Revising the third sentence of
paragraph (c)(5) Example 3.(i).
■ 5. Revising the paragraph (d)(1)(iii).
■ 6. Revising the first sentence of
paragraph (f)(2)(iii).
The revisions read as follows:
■
[TD 9505]
§ 1.411(b)(5)–1 Reduction in rate of benefit
accrual under a defined benefit plan.
RIN 1545–BG36
*
Hybrid Retirement Plans; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
This document contains
correctioning amendments to correct
errors resulting from the publication of
to final regulations (TD 9505) that were
published in the Federal Register on
Tuesday, October 19, 2010 (75 FR
64123) providing guidance relating to
certain provisions of the Internal
Revenue Code that apply to hybrid
defined benefit pension plans.
DATES: This correcting amendment is
effective on December 28, 2010, and is
applicable on October 19, 2010.
SUMMARY:
■
■
DEPARTMENT OF THE TREASURY
Neil
S. Sandhu, Lauson C. Green, or Linda S.
F. Marshall at (202) 622–6090 (not a
toll-free number).
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00086
Fmt 4700
Sfmt 4700
*
*
*
*
(b) * * *
(1) * * *
(ii) * * * (A) In general. Except as
provided in paragraphs (b)(1)(ii)(B), (C),
and (D) of this section, the safe harbor
provided by section 411(b)(5)(A) and
paragraph (b)(1)(i) of this section is
available with respect to an individual
only if the individual’s accumulated
benefit under the plan is expressed in
terms of only one safe-harbor formula
measure and no similarly situated,
younger individual who is or could be
a participant has an accumulated benefit
that is expressed in terms of any
measure other than that same safeharbor formula measure. Thus, for
example, if a plan provides that the
accumulated benefit of participants who
E:\FR\FM\28DER1.SGM
28DER1
]]>Agencies
[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Rules and Regulations]
[Pages 81455-81456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-32554]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 522
[Docket No. FDA-2010-N-0002]
New Animal Drugs; Deslorelin
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 Thorn Bioscience LLC. The NADA provides for
the use of deslorelin acetate injectable suspension in mares for
inducing ovulation.
DATES: This rule is effective December 28, 2010.
FOR FURTHER INFORMATION CONTACT:
Amy L. Omer, Center for Veterinary Medicine (HFV-114), Food and
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-
8336, e-mail: amy.omer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Thorn Bioscience LLC, 1044 East Chestnut
St., Louisville, KY 40204, filed NADA 141-319 that provides for use of
SUCROMATE Equine (deslorelin acetate), an injectable suspension, in
mares for inducing ovulation. The NADA is approved as of November 5,
2010, and the regulations are amended in 21 CFR 522.533 to reflect the
approval.
In addition, Thorn Bioscience LLC has not been previously listed in
the animal drug regulations as a sponsor of an approved application.
Accordingly, 21 CFR 510.600(c) is being amended to add entries for this
firm.
In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
The Agency 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.
Under section 512(c)(2)(F)(ii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(ii)), this approval qualifies for
3 years of marketing exclusivity beginning on the date of approval.
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.
[[Page 81456]]
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) alphabetically
add an entry for ``Thorn Bioscience LLC''; and in the table in
paragraph (c)(2) numerically add an entry for ``051330'' 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
------------------------------------------------------------------------
* * * * *
Thorn Bioscience LLC, 1044 East Chestnut St., 051330
Louisville, KY 40204...................................
* * * * *
------------------------------------------------------------------------
(2) * * *
------------------------------------------------------------------------
Firm name and
Drug labeler code address
------------------------------------------------------------------------
* * * * *
051330.................................................. Thorn
Bioscience
LLC, 1044 East
Chestnut St.,
Louisville, KY
40204
* * * * *
------------------------------------------------------------------------
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. Revise Sec. 522.533 to read as follows:
Sec. 522.533 Deslorelin.
(a) Specifications--(1) Each implant contains 2.1 milligrams (mg)
deslorelin acetate.
(2) Each milliliter (mL) of suspension contains 1.8 mg deslorelin
acetate.
(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this
chapter as follows:
(1) No. 043246 for use of product described in paragraph (a)(1) as
in paragraph (c)(1) of this section.
(2) No. 051330 for use of product described in paragraph (a)(2) as
in paragraph (c)(2) of this section.
(c) Conditions of use--(1) Horses and ponies--(i) Amount. One
implant per mare subcutaneously in the neck.
(ii) Indications for use. For inducing ovulation within 48 hours in
estrous mares with an ovarian follicle greater than 30 mL in diameter.
(iii) Limitations. Do not use in horses or ponies intended for
human consumption. Federal law restricts this drug to use by or on the
order of a licensed veterinarian.
(2) Horses--(i) Amount. Administer 1.8 mg (1 mL) by intramuscular
injection in the neck.
(ii) Indications for use. For inducing ovulation within 48 hours in
cyclic estrous mares with an ovarian follicle between 30 and 40 mL in
diameter.
(iii) Limitations. Do not use in horses intended for human
consumption. Federal law restricts this drug to use by or on the order
of a licensed veterinarian.
Dated: December 9, 2010.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2010-32554 Filed 12-27-10; 8:45 am]
BILLING CODE 4160-01-P
