Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin; Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone; Pyrantel; Tylosin; Tylosin and Sulfamethazine, 17776-17778 [2011-7560]
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<![CDATA[
17776
Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations
jdjones on DSK8KYBLC1PROD with RULES_2
need only return those records that must
be attached to the client’s required
forms under ERISA and the Internal
Revenue Code. The enrolled actuary,
however, must provide the client with
reasonable access to review and copy
any additional records of the client
retained by the enrolled actuary under
State law that are necessary for the
client to comply with his or her
obligations under ERISA and the
Internal Revenue Code.
(2) For purposes of this section,
records of the client include all
documents or written or electronic
materials provided to the enrolled
actuary, or obtained by the enrolled
actuary in the course of the enrolled
actuary’s representation of the client,
that preexisted the retention of the
enrolled actuary by the client. The term
‘‘records of the client’’ also includes
materials that were prepared by the
client or a third party (not including an
employee or agent of the enrolled
actuary) at any time and provided to the
enrolled actuary with respect to the
subject matter of the representation. The
term ‘‘records of the client’’ also includes
any return, claim for refund, schedule,
affidavit, appraisal or any other
document prepared by the enrolled
actuary, or his or her employee or agent,
that was presented to the client with
respect to a prior representation if such
document is necessary for the taxpayer
to comply with his or her current
obligations under ERISA and the
Internal Revenue Code. The term
‘‘records of the client’’ does not include
any return, claim for refund, schedule,
affidavit, appraisal or any other
document prepared by the enrolled
actuary or the enrolled actuary’s firm,
employees or agents if the enrolled
actuary is withholding such document
pending the client’s performance of its
contractual obligation to pay fees with
respect to such document.
*
*
*
*
*
(l) The rules of this section apply to
all actuarial services and related acts
performed on or after May 2, 2011.
VerDate Mar<15>2010
13:25 Mar 30, 2011
Jkt 223001
Par. 10. Section 901.31 is amended by
revising paragraphs (a) and (c) to read as
follows:
■
§ 901.31 Grounds for suspension or
termination of enrollment.
(a) Failure to satisfy requirements for
enrollment. The enrollment of an
actuary may be terminated if it is found
that the actuary did not satisfy the
eligibility requirements set forth in
§ 901.11 or § 901.12.
*
*
*
*
*
(c) Disreputable conduct. The
enrollment of an actuary may be
suspended or terminated if it is found
that the actuary has, at any time after
he/she applied for enrollment, engaged
in any conduct set forth in § 901.12(f) or
other conduct evidencing fraud,
dishonesty, or breach of trust. Such
other conduct includes, but is not
limited to, the following:
*
*
*
*
*
Par. 11. Section 901.32 is amended by
revising the last sentence to read as
follows:
■
Approved: March 2, 2011.
Carolyn Zimmerman,
Chairman, Joint Board for the Enrollment of
Actuaries.
[FR Doc. 2011–7573 Filed 3–29–11; 11:15 am]
BILLING CODE 4810–25–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and
558
[Docket No. FDA–2011–N–0160]
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of
New Animal Drug Applications;
Chorionic Gonadotropin; Cuprimyxin;
Diethylcarbamazine; Levamisole;
Nitrofurazone; Phenylbutazone;
Pyrantel; Tylosin; Tylosin and
Sulfamethazine
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
§ 901.32 Receipt of information
concerning enrolled actuaries.
ACTION:
* * * If any other person has
information of any such violation, he/
she may make a report thereof to the
Executive Director.
SUMMARY:
Par. 12. Section 901.47 is amended by
revising the last sentence to read as
follows:
■
§ 901.47
Transcript.
* * * Copies of exhibits introduced
at the hearing or at the taking of
depositions will be supplied to parties
upon the payment of a reasonable fee
(31 U.S.C. 9701).
Par. 13. Section 901.72 is added to
read as follows:
■
§ 901.72
Additional rules.
The Joint Board may, in notice or
other guidance of general applicability,
provide additional rules regarding the
enrollment of actuaries.
PO 00000
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The Food and Drug
Administration (FDA) is amending the
animal drug regulations by removing
those portions that reflect approval of 13
new animal drug applications (NADAs).
In a notice published elsewhere in this
issue of the Federal Register, FDA is
withdrawing approval of these NADAs.
DATES: This rule is effective April 11,
2011.
John
Bartkowiak, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–276–9079,
e-mail: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
sponsors of the 13 approved NADAs
listed in table 1 have requested that
FDA withdraw approval because the
products are no longer manufactured or
marketed.
FOR FURTHER INFORMATION CONTACT:
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Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations
17777
TABLE 1—VOLUNTARY REQUESTS FOR WITHDRAWAL OF APPROVAL OF 13 NADAS
21 CFR section
affected
(sponsor’s drug
labeler code)
Sponsor
NADA No. product
(established name of drug)
Roche Vitamins, Inc., 45 Waterview Blvd., Parsippany, NJ
07054–1298.
Quali-Tech Products, Inc., 318 Lake Hazeltine Dr., Chaska,
MN 55318.
Abraxis Pharmaceutical Products, Division of Abraxis Bioscience, 6133 River Rd., suite 500, Rosemont, IL 60018.
Furst-McNess Co., Freeport, IL 61032 .................................
NADA 093–029, UNITOP Cream (cuprimyxin) ....................
524.520 (063238).
NADA 097–981, TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine).
NADA 100–840, Chorionic Gonadotropin for Injection
(chorionic gonadotropin).
NADA 100–991, McNess Custom Premix L200 (tylosin
phosphate).
NADA 101–079 TRAMISOL–10% Pig Wormer (levamisole)
558.630 (016968).
Fort Dodge Animal Health, Division of Wyeth Holdings, a
wholly owned subsidiary of Pfizer, Inc., 235 East 42d St.,
New York, NY 10017.
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704
Waterloo Mills Co., 2050 Mitchell Ave., Waterloo, IA 50704
Pegasus Laboratories, Inc., 8809 Ely Rd., Pensacola, FL
32514.
Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN
56011.
Wendt Laboratories, Inc., 100 Nancy Dr., Belle Plaine, MN
56011.
Furst-McNess Co., Freeport, IL 61032 .................................
Furst-McNess Co., Freeport, IL 61032 .................................
Hess & Clark, Inc., 944 Nandino Blvd., Lexington, KY
40511.
jdjones on DSK8KYBLC1PROD with RULES_2
In a notice published elsewhere in
this issue of the Federal Register, FDA
gave notice that approval of NADAs 93–
029, 97–981, 100–840, 100–991, 101–
079, 101–905, 101–906, 102–824, 108–
487, 108–863, 140–820, 140–825, and
140–910, and all supplements and
amendments thereto, is withdrawn,
effective April 11, 2011. As provided in
the regulatory text of this document, the
animal drug regulations are amended to
reflect these withdrawals of approval
and a current format.
Following these changes of
sponsorship, Abraxis Pharmaceutical
Products, Furst-McNess Co., Roche
Vitamins, Inc., Waterloo Mills Co., and
Wendt Laboratories, Inc., are no longer
the sponsors of an approved
application. Accordingly, 21 CFR
510.600(c) is being amended to remove
the entries for these firms.
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.
VerDate Mar<15>2010
13:25 Mar 30, 2011
Jkt 223001
Not codified (000856).
520.1720a (055246).
NADA 108–487, DEC Tabs (diethylcarbamazine citrate) ....
520.622a (015579).
NADA 108–863, DEC Chewable Tabs (diethylcarbamazine
citrate).
NADA 140–820, TYLAN 40 Sulfa-G Premix (tylosin phosphate/sulfamethazine).
NADA 140–825, BANMINTH Intermediate Premix (pyrantel
tartrate).
NADA 140–910, NFZ Wound Powder (nitrofurazone) ........
520.622c (015579).
21 CFR Part 558
Animal drugs, Animal feeds.
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, 520, 522, 524, and 558
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 entries for
‘‘Abraxis Pharmaceutical Products’’,
‘‘Furst-McNess Co.’’, ‘‘Roche Vitamins,
Inc.’’, ‘‘Waterloo Mills Co.’’, and ‘‘Wendt
Laboratories, Inc.’’; and in the table in
paragraph (c)(2), remove the entries for
‘‘010439’’, ‘‘015579’’, ‘‘017139’’, ‘‘063238’’,
and ‘‘063323’’.
■
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
Fmt 4700
Sfmt 4700
558.630 (017139).
558.630 (010439).
558.485 (010439).
524.1580c (050749).
4. In § 520.622a, remove and reserve
paragraph (a)(1); in paragraph (a)(5),
remove ‘‘000081’ and in its place add
‘‘No. 000061’’; and revise paragraph
(b)(2) to read as follows:
■
§ 520.622a
tablets.
Diethylcarbamazine citrate
*
*
*
*
*
(b) * * *
(2) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
5. In § 520.622c, remove and reserve
paragraph (b)(1); remove reserved
paragraph (b)(7); and revise paragraph
(c)(3) to read as follows:
■
§ 520.622c Diethylcarbamazine citrate
chewable tablets.
*
*
*
*
*
(c) * * *
(3) Limitations. Federal law restricts
this drug to use by or on the order of
a licensed veterinarian.
§ 520.1720a
[Amended]
6. In § 520.1720a, remove and reserve
paragraph (b)(4).
■
3. The authority citation for 21 CFR
part 520 continues to read as follows:
Frm 00023
558.625 (017139).
Authority: 21 U.S.C. 360b.
■
PO 00000
558.625 (010439).
NADA 101–905, Mill Co-Medicator TY–10 (tylosin phosphate).
NADA 101–906, Mill Co-Medicator TS–40 Premix (tylosin
phosphate/sulfamethazine).
NADA 102–824,Phenylbutazone Tablets (phenylbutazone)
21 CFR Parts 520, 522, and 524
Animal drugs.
§ 510.600
522.1081 (063323).
E:\FR\FM\31MRR1.SGM
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17778
Federal Register / Vol. 76, No. 62 / Thursday, March 31, 2011 / Rules and Regulations
PART 522—IMPLANTATION OR
INJECTABLE DOSAGE FORM NEW
ANIMAL DRUGS
DEPARTMENT OF JUSTICE
7. The authority citation for 21 CFR
part 522 continues to read as follows:
21 CFR Part 1310
Drug Enforcement Administration
■
[Docket No. DEA–320F]
Authority: 21 U.S.C. 360b.
§ 522.1081
RIN 1117–AB24
Illicit Production of LSD
[Amended]
8. In paragraph (b)(2) of § 522.1081,
remove ‘‘Nos. 058639 and 063323’’ and
in its place add ‘‘No. 058639’’.
■
Control of Ergocristine, a Chemical
Precursor Used in the Illicit
Manufacture of Lysergic Acid
Diethylamide, as a List I Chemical
Drug Enforcement
Administration (DEA), Department of
Justice.
ACTION: Final rule.
AGENCY:
PART 524—OPHTHALMIC AND
TOPICAL DOSAGE FORM NEW
ANIMAL DRUGS
Authority: 21 U.S.C. 360b.
■
[Removed]
10. Remove § 524.520.
§ 524.1580c
[Amended]
11. In paragraph (b) of § 524.1580c,
remove ‘‘Nos. 000010, 000069, and
050749’’ and in its place add ‘‘Nos.
000010 and 000069’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
12. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
§ 558.485
[Amended]
13. In § 558.485, in paragraph (b)(3),
remove ‘‘010439’’.
■
§ 558.625
[Amended]
14. In § 558.625, remove and reserve
paragraphs (b)(42) and (b)(45).
■
§ 558.630
[Amended]
15. In § 558.630, remove and reserve
paragraph (b)(4); and in paragraph
(b)(5), remove ‘‘010439,’’ and ‘‘016968,’’.
■
Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–7560 Filed 3–30–11; 8:45 am]
jdjones on DSK8KYBLC1PROD with RULES_2
BILLING CODE 4160–01–P
This rulemaking finalizes a
February 24, 2010, Notice of Proposed
Rulemaking in which DEA proposed to
control the chemical precursor
ergocristine as a List I chemical under
the Controlled Substances Act (CSA).
Clandestine laboratories are using this
chemical as a substitute for the List I
chemicals ergotamine and ergonovine to
illicitly manufacture the schedule I
controlled substance lysergic acid
diethylamide (LSD).
This rule is being finalized as
proposed. Therefore, handlers of
ergocristine shall be subject to the
chemical regulatory provisions of the
CSA and its implementing regulations.
This rulemaking does not establish a
threshold for domestic and international
transactions of ergocristine. As such, all
transactions involving ergocristine,
regardless of size, shall be regulated.
This rulemaking also specifies that
chemical mixtures containing
ergocristine will not be exempt from
regulatory requirements at any
concentration. Therefore, all
transactions of chemical mixtures
containing any quantity of ergocristine
shall be regulated and subject to control
under the CSA.
DATES: This rulemaking becomes
effective May 2, 2011. Persons seeking
registration must apply on or before
May 2, 2011 to continue their business
pending final action by DEA on their
application.
FOR FURTHER INFORMATION CONTACT:
Christine A. Sannerud, PhD, Chief, Drug
and Chemical Evaluation Section, Office
of Diversion Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, VA 22152; telephone: (202)
307–7183.
SUPPLEMENTARY INFORMATION:
SUMMARY:
9. The authority citation for 21 CFR
part 524 continues to read as follows:
■
§ 524.520
Background
Lysergic acid diethylamide (LSD) is a
synthetic schedule I hallucinogen. It is
the most potent hallucinogen known
VerDate Mar<15>2010
13:25 Mar 30, 2011
and only microgram amounts are
required to produce overt
hallucinations. It induces a heightened
awareness of sensory input that is
accompanied by an enhanced sense of
clarity, but reduced ability to control
what is experienced.
Jkt 223001
PO 00000
Frm 00024
Fmt 4700
Sfmt 4700
LSD has been manufactured illegally
since the 1960s. A limited number of
chemists, probably less than a dozen,
are believed to be manufacturing nearly
all of the LSD available in the United
States. Clandestine laboratory operators
must adhere to precise and complex
production procedures, and production
of LSD is relatively difficult.
LSD has historically been produced
from lysergic acid, which is made from
ergotamine or ergonovine, substances
derived from an ergot fungus on rye, or
from lysergic acid amide, a chemical
found in morning glory seeds.
Movement to Ergocristine as LSD
Precursor and Largest LSD Laboratory
Ever Seized by DEA
Because of the existing CSA
regulatory controls on the LSD
precursors lysergic acid, lysergic acid
amide, ergotamine, and ergonovine,
clandestine laboratory operators have
sought uncontrolled sources of
precursor material for the production of
LSD. This has led to the illicit
utilization of the precursor chemical
ergocristine as a direct substitute for
ergotamine and ergonovine for the illicit
production of LSD. In fact, the largest
clandestine LSD laboratory ever seized
by DEA utilized ergocristine as the LSD
precursor. Recipes documenting
procedures for utilizing ergocristine in
LSD synthesis are easily found on the
Internet.
Availability of the Precursor Chemical
DEA has determined that ergocristine
is readily available from commercial
chemical suppliers. DEA has identified
at least three suppliers of ergocristine, of
which one distributor is located
domestically; the other two are based in
Germany and the Czech Republic.
This rule implements both domestic
and import/export controls on
ergocristine (and its salts). As noted in
the February 24, 2010, Notice of
Proposed Rulemaking (75 FR 8287),
such controls are deemed necessary for
law enforcement to identify domestic
and international transactions in
ergocristine, due to growing concerns
regarding its use for the illicit
manufacture of LSD.
E:\FR\FM\31MRR1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 62 (Thursday, March 31, 2011)]
[Rules and Regulations]
[Pages 17776-17778]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7560]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 522, 524, and 558
[Docket No. FDA-2011-N-0160]
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of New Animal Drug Applications; Chorionic Gonadotropin; Cuprimyxin;
Diethylcarbamazine; Levamisole; Nitrofurazone; Phenylbutazone;
Pyrantel; Tylosin; Tylosin and Sulfamethazine
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations by removing those portions that reflect approval of 13
new animal drug applications (NADAs). In a notice published elsewhere
in this issue of the Federal Register, FDA is withdrawing approval of
these NADAs.
DATES: This rule is effective April 11, 2011.
FOR FURTHER INFORMATION CONTACT: John Bartkowiak, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-276-9079, e-mail: john.bartkowiak@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The sponsors of the 13 approved NADAs listed
in table 1 have requested that FDA withdraw approval because the
products are no longer manufactured or marketed.
[[Page 17777]]
Table 1--Voluntary Requests for Withdrawal of Approval of 13 NADAs
----------------------------------------------------------------------------------------------------------------
NADA No. product 21 CFR section affected (sponsor's
Sponsor (established name of drug) drug labeler code)
----------------------------------------------------------------------------------------------------------------
Roche Vitamins, Inc., 45 Waterview Blvd., NADA 093-029, UNITOP Cream 524.520 (063238).
Parsippany, NJ 07054-1298. (cuprimyxin).
Quali-Tech Products, Inc., 318 Lake NADA 097-981, TYLAN 40 Sulfa- 558.630 (016968).
Hazeltine Dr., Chaska, MN 55318. G Premix (tylosin phosphate/
sulfamethazine).
Abraxis Pharmaceutical Products, Division NADA 100-840, Chorionic 522.1081 (063323).
of Abraxis Bioscience, 6133 River Rd., Gonadotropin for Injection
suite 500, Rosemont, IL 60018. (chorionic gonadotropin).
Furst-McNess Co., Freeport, IL 61032..... NADA 100-991, McNess Custom 558.625 (010439).
Premix L200 (tylosin
phosphate).
Fort Dodge Animal Health, Division of NADA 101-079 TRAMISOL-10% Not codified (000856).
Wyeth Holdings, a wholly owned Pig Wormer (levamisole).
subsidiary of Pfizer, Inc., 235 East 42d
St., New York, NY 10017.
Waterloo Mills Co., 2050 Mitchell Ave., NADA 101-905, Mill Co- 558.625 (017139).
Waterloo, IA 50704. Medicator TY-10 (tylosin
phosphate).
Waterloo Mills Co., 2050 Mitchell Ave., NADA 101-906, Mill Co- 558.630 (017139).
Waterloo, IA 50704. Medicator TS-40 Premix
(tylosin phosphate/
sulfamethazine).
Pegasus Laboratories, Inc., 8809 Ely Rd., NADA 102-824,Phenylbutazone 520.1720a (055246).
Pensacola, FL 32514. Tablets (phenylbutazone).
Wendt Laboratories, Inc., 100 Nancy Dr., NADA 108-487, DEC Tabs 520.622a (015579).
Belle Plaine, MN 56011. (diethylcarbamazine
citrate).
Wendt Laboratories, Inc., 100 Nancy Dr., NADA 108-863, DEC Chewable 520.622c (015579).
Belle Plaine, MN 56011. Tabs (diethylcarbamazine
citrate).
Furst-McNess Co., Freeport, IL 61032..... NADA 140-820, TYLAN 40 Sulfa- 558.630 (010439).
G Premix (tylosin phosphate/
sulfamethazine).
Furst-McNess Co., Freeport, IL 61032..... NADA 140-825, BANMINTH 558.485 (010439).
Intermediate Premix
(pyrantel tartrate).
Hess & Clark, Inc., 944 Nandino Blvd., NADA 140-910, NFZ Wound 524.1580c (050749).
Lexington, KY 40511. Powder (nitrofurazone).
----------------------------------------------------------------------------------------------------------------
In a notice published elsewhere in this issue of the Federal
Register, FDA gave notice that approval of NADAs 93-029, 97-981, 100-
840, 100-991, 101-079, 101-905, 101-906, 102-824, 108-487, 108-863,
140-820, 140-825, and 140-910, and all supplements and amendments
thereto, is withdrawn, effective April 11, 2011. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect these withdrawals of approval and a current format.
Following these changes of sponsorship, Abraxis Pharmaceutical
Products, Furst-McNess Co., Roche Vitamins, Inc., Waterloo Mills Co.,
and Wendt Laboratories, Inc., are no longer the sponsors of an approved
application. Accordingly, 21 CFR 510.600(c) is being amended to remove
the entries for these firms.
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 Parts 520, 522, and 524
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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,
520, 522, 524, and 558 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
entries for ``Abraxis Pharmaceutical Products'', ``Furst-McNess Co.'',
``Roche Vitamins, Inc.'', ``Waterloo Mills Co.'', and ``Wendt
Laboratories, Inc.''; and in the table in paragraph (c)(2), remove the
entries for ``010439'', ``015579'', ``017139'', ``063238'', and
``063323''.
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.
0
4. In Sec. 520.622a, remove and reserve paragraph (a)(1); in paragraph
(a)(5), remove ``000081' and in its place add ``No. 000061''; and
revise paragraph (b)(2) to read as follows:
Sec. 520.622a Diethylcarbamazine citrate tablets.
* * * * *
(b) * * *
(2) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
0
5. In Sec. 520.622c, remove and reserve paragraph (b)(1); remove
reserved paragraph (b)(7); and revise paragraph (c)(3) to read as
follows:
Sec. 520.622c Diethylcarbamazine citrate chewable tablets.
* * * * *
(c) * * *
(3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.
Sec. 520.1720a [Amended]
0
6. In Sec. 520.1720a, remove and reserve paragraph (b)(4).
[[Page 17778]]
PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
0
7. The authority citation for 21 CFR part 522 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 522.1081 [Amended]
0
8. In paragraph (b)(2) of Sec. 522.1081, remove ``Nos. 058639 and
063323'' and in its place add ``No. 058639''.
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
0
9. The authority citation for 21 CFR part 524 continues to read as
follows:
Authority: 21 U.S.C. 360b.
Sec. 524.520 [Removed]
0
10. Remove Sec. 524.520.
Sec. 524.1580c [Amended]
0
11. In paragraph (b) of Sec. 524.1580c, remove ``Nos. 000010, 000069,
and 050749'' and in its place add ``Nos. 000010 and 000069''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
12. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.485 [Amended]
0
13. In Sec. 558.485, in paragraph (b)(3), remove ``010439''.
Sec. 558.625 [Amended]
0
14. In Sec. 558.625, remove and reserve paragraphs (b)(42) and
(b)(45).
Sec. 558.630 [Amended]
0
15. In Sec. 558.630, remove and reserve paragraph (b)(4); and in
paragraph (b)(5), remove ``010439,'' and ``016968,''.
Dated: March 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7560 Filed 3-30-11; 8:45 am]
BILLING CODE 4160-01-P
