Animal Drugs, Feeds, and Related Products; Withdrawal of Approval of NADAs; Technical Amendment, 18441-18442 [E8-7103]
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Federal Register / Vol. 73, No. 66 / Friday, April 4, 2008 / Rules and Regulations
direct final rule that published in the
Federal Register of December 4, 2007
(72 FR 68064), to amend certain
regulations as the first phase of an
incremental approach to modernize or
clarify some of the current good
manufacturing practice (CGMP)
regulations for finished
pharmaceuticals, as well as harmonize
some of the CGMP requirements with
those of other foreign regulators and
other FDA regulations. The comment
period closed February 19, 2008. FDA is
withdrawing the direct final rule
because the agency received significant
adverse comments. FDA will consider
the comments received under our usual
procedures for notice and comment in
connection with the notice of proposed
rulemaking that was published in the
Federal Register of December 4, 2007,
as a companion to the direct final rule
(72 FR 68113).
DATES: The direct final rule published at
72 FR 68064 on December 4, 2007, is
withdrawn as of April 4, 2008.
FOR FURTHER INFORMATION CONTACT:
Mary Malarkey, Center for Biologics
Evaluation and Research (HFM–
600), Food and Drug
Administration, 1401 Rockville
Pike, Rockville, MD 20852–1448,
301–827–6190, or
Dennis Bensley, Center for Veterinary
Medicine (HFV–140), Food and
Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8268, or
Brian Hasselbalch, Center for Drug
Evaluation and Research (HFD–
320), Food and Drug
Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993, 301–796–3279.
Authority: Therefore, under the
Federal Food, Drug, and Cosmetic Act,
and under authority delegated to the
Commissioner of Food and Drugs, the
direct final rule published on December
4, 2007 (72 FR 68064) is withdrawn.
Dated: March 24, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–7107 Filed 4–3–08; 8:45 am]
BILLING CODE 4160–01–S
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations by removing
those portions that reflect approval of
seven new animal drug applications
(NADAs) because FDA is withdrawing
approval of the NADAs.
DATES:
This rule is effective April 4,
2008.
FOR FURTHER INFORMATION CONTACT:
Pamela K. Esposito, Center for
Veterinary Medicine (HFV–212), Food
and Drug Administration, 7519 Standish
Pl., Rockville, MD 20855, 240–276–
9067; e-mail:
pamela.esposito@fda.hhs.gov.
The
following sponsors have requested that
FDA withdraw approval of the seven
NADAs listed below because the
products are no longer manufactured or
marketed:
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 526, and 558
Animal Drugs, Feeds, and Related
Products; Withdrawal of Approval of
NADAs; Technical Amendment
AGENCY:
Food and Drug Administration,
HHS.
Sponsor
21 CFR Cite Affected
(Sponsor Drug Labeler Code)
NADA Number Product (Drug)
Eon Labs Manufacturing, Inc.,
227–15 North Conduit Ave.,
Laurelton, NY 11413
NADA 65–063,
Tetracycline capsules
520.2345a (000185)
NADA 65–345,
Chloramphenicol capsules
520.390b (000185)
G.C. Hanford Manufacturing Co.,
P.O. Box 1017,
Syracuse, NY 13201
NADA 65–465,
AQUA-MAST
(penicillin G procaine)
526.1696a (010515)
International Nutrition, Inc.,
7706 ‘‘I’’ Plaza,
Omaha, NE 68127
NADA 95–551,
TYLAN 5 Premix
(tylosin phosphate)
558.625 (043733)
NADA 109–688,
HYGROMIX 2.4 Premix
(hygromycin B)
558.274 (043733)
NADA 109–816,
TYLAN 10 SULFA-G Premix
(tylosin phosphate and sulfamethazine)
558.630 (043733)
NADA 103–758,
TERAMIX–10 Premix
(oxytetracycline)
Not codified
Pfizer, Inc.,
235 East 42d St.,
New York, NY 10017
ebenthall on PRODPC61 with RULES
18441
Following the withdrawal of approval
of these NADAs, Eon Labs
Manufacturing, Inc., is no longer
sponsor of an approved application.
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13:41 Apr 03, 2008
Jkt 214001
Therefore, 21 CFR 510.600(c) is
amended to remove entries for this
sponsor.
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As provided below, the animal drug
regulations are amended to reflect the
withdrawal of approvals. The
regulations for penicillin G procaine
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18442
Federal Register / Vol. 73, No. 66 / Friday, April 4, 2008 / Rules and Regulations
intramammary dosage forms (21 CFR
526.1696a) are also amended to correct
several errors and to reflect a current
format.
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 and 526
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, 526, and 558 are
amended as follows:
I
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.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Eon Labs Manufacturing, Inc.’’; and in
the table in paragraph (c)(2) remove the
entry for ‘‘000185’’.
I
PART 520—ORAL DOSAGE FORM
NEW ANIMAL DRUGS
§ 526.1696a
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
8. The authority citation for 21 CFR
part 558 continues to read as follows:
I
3. The authority citation for 21 CFR
part 520 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
§ 558.274
Authority: 21 U.S.C. 360b.
§ 520.390b
9. In § 558.274, amend paragraph
(a)(2) by removing ‘‘Nos. 043733 and’’
and adding in its place ‘‘No.’’.
4. In § 520.390b, in paragraph (b)(1),
remove ‘‘, 000185,’’.
§ 558.625
[Amended]
10. In § 558.625, remove and reserve
paragraph (b)(3).
5. In § 520.2345a, remove paragraph
(b)(3).
§ 558.630
ebenthall on PRODPC61 with RULES
PART 526—INTRAMAMMARY DOSAGE
FORMS
6. The authority citation for 21 CFR
part 526 continues to read as follows:
I
Authority: 21 U.S.C. 360b.
7. Revise § 526.1696a to read as
follows:
I
VerDate Aug<31>2005
13:41 Apr 03, 2008
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[Amended]
I
I
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 301
[TD 8697]
RIN 1545–AT91
Simplification of Entity Classification
Rules; Correction
Internal Revenue Service (IRS),
Treasury.
ACTION: Correcting amendment.
AGENCY:
SUMMARY: This document contains a
correction to final regulations (TD
8697), that were published in the
Federal Register on Wednesday,
December 18, 1996 (61 FR 66584). The
final regulations classify certain
business organizations under an elective
regime.
DATES: This correction is effective on
April 4, 2008 and is applicable on
January 1, 1997.
FOR FURTHER INFORMATION CONTACT:
Stephen J. Hawes, (202) 622–3860 (not
a toll-free number).
SUPPLEMENTARY INFORMATION:
Background
The final regulations (TD 8697) that is
the subject of this correction is under
section 7701 of the Internal Revenue
Code.
Need for Correction
As published, TD 8697 contains an
error that may prove to be misleading
and is in need of clarification.
List of Subjects 26 CFR Part 301
Employment taxes, Estate taxes,
Excise taxes, Gift taxes, Income taxes,
Penalties, Reporting and recordkeeping
requirements.
Correction of Publication
Accordingly, 26 CFR part 301 is
corrected by making the following
correcting amendment:
I
[Amended]
I
[Amended]
I
§ 520.2345a
Penicillin G procaine.
(a) Specifications. Each 10-milliliter
single-dose syringe contains penicillin
G procaine equivalent to 100,000 units
of penicillin G.
(b) Related tolerances. See § 556.510
of this chapter.
(c) Sponsors. See Nos. 010515 and
050604 in § 510.600(c) of this chapter.
(d) Conditions of use in lactating
cows—(1) Amount. Infuse one 10milliliter dose into each infected
quarter. Treatment may be repeated at
12-hour intervals for not more than
three doses, as indicated by clinical
response.
(2) Indications for use. For the
treatment of mastitis caused by
Streptococcus agalactiae, S.
dysgalactiae, and S. uberus in lactating
cows.
(3) Limitations. Milk that has been
taken from animals during treatment
and for 60 hours after the latest
treatment must not be used for food.
Animals must not be slaughtered for
food during treatment or within 3 days
after the latest treatment.
(e) Conditions of use in dry cows—(1)
Amount. Infuse one 10-milliliter dose
into each infected quarter at time of
drying-off.
(2) Indications of use. For the
treatment of mastitis caused by
Streptococcus agalactiae in dry cows.
(3) Limitations. Discard all milk for 72
hours (6 milkings) following calving, or
later as indicated by the marketable
quality of the milk. Animals must not be
slaughtered for food within 14 days
postinfusion.
PART 301—PROCEDURE AND
ADMINISTATION
Paragraph 1. The authority citation
for part 301 continues to read in part as
follows:
I
Authority: 26 U.S.C. 7805 * * *
[Amended]
11. In § 558.630, amend paragraph
(b)(10) by removing ‘‘043733,’’.
Par. 2. Section 301.7701–2(b)(8)(i) is
amended by revising the entry for
‘‘Romania, Societe pe Actiuni’’ to read
as follows:
I
I
Dated: March 26, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8–7103 Filed 4–3–08; 8:45 am]
§ 301.7701–2
definitions.
BILLING CODE 4160–01–S
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]]>Agencies
[Federal Register Volume 73, Number 66 (Friday, April 4, 2008)]
[Rules and Regulations]
[Pages 18441-18442]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-7103]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510, 520, 526, and 558
Animal Drugs, Feeds, and Related Products; Withdrawal of Approval
of NADAs; Technical Amendment
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
seven new animal drug applications (NADAs) because FDA is withdrawing
approval of the NADAs.
DATES: This rule is effective April 4, 2008.
FOR FURTHER INFORMATION CONTACT: Pamela K. Esposito, Center for
Veterinary Medicine (HFV-212), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240-276-9067; e-mail:
pamela.esposito@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The following sponsors have requested that
FDA withdraw approval of the seven NADAs listed below because the
products are no longer manufactured or marketed:
------------------------------------------------------------------------
21 CFR Cite
Sponsor NADA Number Product Affected (Sponsor
(Drug) Drug Labeler Code)
------------------------------------------------------------------------
Eon Labs Manufacturing, NADA 65-063, 520.2345a (000185)
Inc., Tetracycline capsules
227-15 North Conduit
Ave.,
Laurelton, NY 11413
NADA 65-345, 520.390b (000185)
Chloramphenicol capsules
------------------------------------------------------------------------
G.C. Hanford NADA 65-465, 526.1696a (010515)
Manufacturing Co., AQUA-MAST
P.O. Box 1017, (penicillin G procaine)
Syracuse, NY 13201
------------------------------------------------------------------------
International Nutrition, NADA 95-551, 558.625 (043733)
Inc., TYLAN 5 Premix
7706 ``I'' Plaza, (tylosin phosphate)
Omaha, NE 68127
NADA 109-688, 558.274 (043733)
HYGROMIX 2.4 Premix
(hygromycin B)
NADA 109-816, 558.630 (043733)
TYLAN 10 SULFA-G Premix
(tylosin phosphate and
sulfamethazine)
------------------------------------------------------------------------
Pfizer, Inc., NADA 103-758, Not codified
235 East 42d St., TERAMIX-10 Premix
New York, NY 10017 (oxytetracycline)
------------------------------------------------------------------------
Following the withdrawal of approval of these NADAs, Eon Labs
Manufacturing, Inc., is no longer sponsor of an approved application.
Therefore, 21 CFR 510.600(c) is amended to remove entries for this
sponsor.
As provided below, the animal drug regulations are amended to
reflect the withdrawal of approvals. The regulations for penicillin G
procaine
[[Page 18442]]
intramammary dosage forms (21 CFR 526.1696a) are also amended to
correct several errors and to reflect a current format.
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 and 526
Animal drugs.
21 CFR Part 558
Animal drugs, Animal feeds.
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,
520, 526, 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 entry
for ``Eon Labs Manufacturing, Inc.''; and in the table in paragraph
(c)(2) remove the entry for ``000185''.
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.
Sec. 520.390b [Amended]
0
4. In Sec. 520.390b, in paragraph (b)(1), remove ``, 000185,''.
Sec. 520.2345a [Amended]
0
5. In Sec. 520.2345a, remove paragraph (b)(3).
PART 526--INTRAMAMMARY DOSAGE FORMS
0
6. The authority citation for 21 CFR part 526 continues to read as
follows:
Authority: 21 U.S.C. 360b.
0
7. Revise Sec. 526.1696a to read as follows:
Sec. 526.1696a Penicillin G procaine.
(a) Specifications. Each 10-milliliter single-dose syringe contains
penicillin G procaine equivalent to 100,000 units of penicillin G.
(b) Related tolerances. See Sec. 556.510 of this chapter.
(c) Sponsors. See Nos. 010515 and 050604 in Sec. 510.600(c) of
this chapter.
(d) Conditions of use in lactating cows--(1) Amount. Infuse one 10-
milliliter dose into each infected quarter. Treatment may be repeated
at 12-hour intervals for not more than three doses, as indicated by
clinical response.
(2) Indications for use. For the treatment of mastitis caused by
Streptococcus agalactiae, S. dysgalactiae, and S. uberus in lactating
cows.
(3) Limitations. Milk that has been taken from animals during
treatment and for 60 hours after the latest treatment must not be used
for food. Animals must not be slaughtered for food during treatment or
within 3 days after the latest treatment.
(e) Conditions of use in dry cows--(1) Amount. Infuse one 10-
milliliter dose into each infected quarter at time of drying-off.
(2) Indications of use. For the treatment of mastitis caused by
Streptococcus agalactiae in dry cows.
(3) Limitations. Discard all milk for 72 hours (6 milkings)
following calving, or later as indicated by the marketable quality of
the milk. Animals must not be slaughtered for food within 14 days
postinfusion.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
8. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
Sec. 558.274 [Amended]
0
9. In Sec. 558.274, amend paragraph (a)(2) by removing ``Nos. 043733
and'' and adding in its place ``No.''.
Sec. 558.625 [Amended]
0
10. In Sec. 558.625, remove and reserve paragraph (b)(3).
Sec. 558.630 [Amended]
0
11. In Sec. 558.630, amend paragraph (b)(10) by removing ``043733,''.
Dated: March 26, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-7103 Filed 4-3-08; 8:45 am]
BILLING CODE 4160-01-S
