Withdrawal of Approval of New Animal Drug Applications; Quali-Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin, 52430-52431 [2013-20616]
Download as PDF
<![CDATA[
52430
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Rules and Regulations
entries for ‘‘Penicillin 2.4 to 50’’ and
‘‘Penicillin 2.4 to 50 and roxarsone 22.7
to 45.4’’.
§ 558.460
[Amended]
7. In § 558.460, remove and reserve
paragraph (d)(2)(iv).
■
Dated: August 19, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–20540 Filed 8–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
[Docket No. FDA–2013–N–0002]
Withdrawal of Approval of New Animal
Drug Applications; Quali-Tech
Products, Inc.; Bambermycins;
Pyrantel; Tylosin; Virginiamycin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of four new
animal drug applications (NADAs), held
by Quali-Tech Products, Inc., at the
sponsor’s request because the products
are no longer manufactured or
marketed.
DATES: The rule is effective September
3, 2013.
FOR FURTHER INFORMATION CONTACT:
David Alterman, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–453–6843,
david.alterman@fda.hhs.gov.
SUMMARY:
QualiTech Products, Inc., has requested that
FDA withdraw approval of the
following four NADAs because the
products, used to manufacture Type C
medicated feeds, are no longer
manufactured or marketed: NADA 097–
980 for Quali-Tech TYLAN–10 (tylosin
phosphate) Premix, NADA 118–815 for
Q.T. BAN–TECH (pyrantel tartrate),
NADA 132–705 for FLAVOMYCIN
(bambermycins), and NADA 133–335
for STAFAC (virginiamycin) Swine Pak
10.
Elsewhere in this issue of the Federal
Register, FDA gave notice that approval
of NADAs 097–980, 118–815, 132–705,
and 133–335, and all supplements and
amendments thereto, is withdrawn. As
provided in the regulatory text of this
document, the animal drug regulations
are amended to reflect these voluntary
withdrawals of approval.
Following these withdrawals of
approval, Quali-Tech Products, Inc.,
will no longer be the sponsor of an
approved application. Accordingly, 21
CFR 510.600(c) is being amended to
remove the entries for this firm.
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:
List of Subjects
21 CFR Part 510
Administrative practice and
procedure, Animal drugs, Labeling,
Reporting and recordkeeping
requirements.
21 CFR Parts 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 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.
§ 510.600
[Amended]
2. In § 510.600, in the table in
paragraph (c)(1), remove the entry for
‘‘Quali-Tech Products, Inc.’’; and in the
table in paragraph (c)(2), remove the
entry for ‘‘016968’’.
■
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
3. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
4. In § 558.95, revise paragraphs (a),
(d)(1), (d)(2), (d)(3), (d)(4)(i), and
(d)(4)(ii) to read as follows:
■
§ 558.95
Bambermycins.
(a) Approvals. See sponsors in
§ 510.600(c) of this chapter for use of
Type A medicated articles as in
paragraph (d) of this section:
(1) No. 016592: 2, 4, and 10 grams per
pound for use as in paragraphs (d)(1),
(d)(2), (d)(3), and (d)(4) of this section.
(2) Nos. 012286 and 017790: 2 grams
for use as in paragraph (d)(2) of this
section and 0.4 and 2 grams per pound
for use as in paragraph (d)(3).
*
*
*
*
*
(d) * * *
(1) Chickens. Use in medicated feed as
follows:
Bambermycins in
grams/ton
Indications for use
Limitations
(i) 1 to 2 .....................
Broiler chickens: For increased rate of weight
gain and improved feed efficiency.
Feed continuously as the sole ration ...............
Sponsor
016592.
(ii) [Reserved].
emcdonald on DSK67QTVN1PROD with RULES
(2) Turkeys. Use in medicated feed as
follows:
Bambermycins in
grams/ton
Indications for use
Limitations
(i) 1 to 2 .....................
Growing turkeys: For improved feed efficiency
Feed continuously as the sole ration ...............
(ii) 2 ............................
Growing turkeys: For increased rate of weight
gain and improved feed efficiency.
Feed continuously as the sole ration ...............
VerDate Mar<15>2010
16:22 Aug 22, 2013
Jkt 229001
PO 00000
Frm 00042
Fmt 4700
Sfmt 4700
E:\FR\FM\23AUR1.SGM
Sponsor
23AUR1
012286, 016592,
017790.
012286, 016592,
017790.
52431
Federal Register / Vol. 78, No. 164 / Friday, August 23, 2013 / Rules and Regulations
(3) Swine. Use in medicated feed as
follows:
Bambermycins in
grams/ton
Indications for use
Limitations
(i) 2 ............................
Growing-finishing swine: For increased rate of
weight gain and improved feed efficiency.
Growing-finishing swine: For increased rate of
weight.
Feed continuously as the sole ration ...............
(ii) 2 to 4 ....................
Sponsor
Feed continuously as the sole ration ...............
012286, 016592,
017790.
012286, 016592,
017790.
(4) Cattle. Use in medicated feed as
follows:
Bambermycins in
grams/ton
Indications for use
Limitations
(i) 1 to 4 .....................
Feed continuously at a rate of 10 to 20 milligrams per head per day.
016592.
(ii) 2 to 40 ..................
Cattle fed in confinement for slaughter: For increased rate of weight gain and improved
feed efficiency.
Pasture cattle (slaughter, stocker, and feeder
cattle, and dairy and beef replacement heifers): For increased rate of weight gain.
Feed continuously at a rate of 10 to 40 milligrams per head per day in at least 1 pound
and not more than 10 pounds of feed. Daily
bambermycins intakes in excess of 20 mg/
head/day have not been shown to be more
effective than 20 mg/head/day.
016592.
*
*
*
§ 558.485
*
*
[Amended]
5. In paragraph (b)(3) of § 558.485,
remove ‘‘Nos. 016968, and 017790’’ and
in its place add ‘‘No. 017790’’.
■
§ 558.625
[Amended]
6. In § 558.625, remove and reserve
paragraph (b)(14).
■
§ 558.635
[Amended]
7. In paragraph (a)(2) of § 558.635,
remove ‘‘046573, 016968, and 017790’’
and in its place add ‘‘046573 and
017790’’.
■
Dated: August 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013–20616 Filed 8–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF THE INTERIOR
Office of Natural Resources Revenue
30 CFR Part 1218
[Docket No. ONRR–2013–0001; DS63610300
DR2PS0000.CH7000 134D0102R2]
emcdonald on DSK67QTVN1PROD with RULES
RIN 1012–AA14
Amendments to ONRR’s Service of
Official Correspondence
Office of the Secretary, Office
of Natural Resources Revenue (ONRR),
Interior.
ACTION: Direct final rule.
AGENCY:
VerDate Mar<15>2010
16:22 Aug 22, 2013
This rule will update the
Service of Official Correspondence
regulations in title 30 of the Code of
Federal Regulations (CFR) to allow
ONRR to serve official correspondence
using any electronic method of delivery
that provides for a receipt of delivery,
or, if there is no receipt, the date of
delivery otherwise documented.
DATES: This rule becomes effective on
October 22, 2013 unless adverse
comment is received by September 23,
2013. If adverse comment is received,
ONRR will publish a timely withdrawal
of the rule in the Federal Register.
ADDRESSES: You may submit comments
on the rulemaking by any of the
following methods. Please use the
Regulation Identifier Number (RIN)
‘‘1012–AA14’’ as an identifier in your
comment. See also Public Availability of
Comments under Procedural Matters.
• Electronically, go to https://
www.regulations.gov. In the entry titled
‘‘Enter Keyword or ID,’’ enter ‘‘ONRR–
2013–0001’’ and then click ‘‘Search.’’
Follow the instructions to submit public
comments. ONRR will post all
comments.
• Mail comments to Armand
Southall, Regulatory Specialist, ONRR,
P.O. Box 25165, MS 61030A, Denver,
CO 80225.
• Hand-carry comments, or use an
overnight courier service, ONRR. Our
courier address is Building 85, Room A–
614, Denver Federal Center, West 6th
Ave. and Kipling St., Denver, Colorado
80225.
FOR FURTHER INFORMATION CONTACT: For
questions on technical issues, contact
SUMMARY:
Jkt 229001
PO 00000
Frm 00043
Fmt 4700
Sfmt 4700
Sponsor
Tim Calahan, Supervisor, ONRR,
telephone (303) 231–3036, or email
Timothy.Calahan@onrr.gov . For a paper
copy of this rule, contact Armand
Southall, Regulatory Specialist, ONRR,
telephone (303) 231–3221; or email
Armand.Southall@onrr.gov. The authors
of this direct final rule are Sarah
Inderbitzin and Timothy Calahan.
SUPPLEMENTARY INFORMATION:
I. Background
On August 31, 2006, the Mineral
Management Service (MMS) established
30 CFR part 218, subpart H—Service of
Official Correspondence. 71 FR 51749
(August 31, 2006). On September 30,
2010, by Secretarial Order No. 3306, the
Secretary of the Department of the
Interior transferred the royalty
management functions of the Minerals
Revenue Management, former arm of
MMS, to the Office of Natural Resources
Revenue (ONRR). As part of that
reorganization, ONRR recodified the
former 30 CFR part 218, subpart H, of
chapter II to a new chapter XII in 30
CFR as part 1218, without substantive
change. 75 FR 61051 (Oct. 4, 2010).
Section 1218.540(a) deals specifically
with methods of service of official
correspondence on companies and
reporting entities.
II. Explanation of Amendments
This direct final rule adds a new
paragraph (4) to 30 CFR 1218.540(a)
updating the Service of Official
Correspondence regulations to allow
ONRR to serve official correspondence
using any electronic method of delivery
E:\FR\FM\23AUR1.SGM
23AUR1
]]>Agencies
[Federal Register Volume 78, Number 164 (Friday, August 23, 2013)]
[Rules and Regulations]
[Pages 52430-52431]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-20616]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 510 and 558
[Docket No. FDA-2013-N-0002]
Withdrawal of Approval of New Animal Drug Applications; Quali-
Tech Products, Inc.; Bambermycins; Pyrantel; Tylosin; Virginiamycin
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect the withdrawal of approval of four new
animal drug applications (NADAs), held by Quali-Tech Products, Inc., at
the sponsor's request because the products are no longer manufactured
or marketed.
DATES: The rule is effective September 3, 2013.
FOR FURTHER INFORMATION CONTACT: David Alterman, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-453-6843, david.alterman@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Quali-Tech Products, Inc., has requested
that FDA withdraw approval of the following four NADAs because the
products, used to manufacture Type C medicated feeds, are no longer
manufactured or marketed: NADA 097-980 for Quali-Tech TYLAN-10 (tylosin
phosphate) Premix, NADA 118-815 for Q.T. BAN-TECH (pyrantel tartrate),
NADA 132-705 for FLAVOMYCIN (bambermycins), and NADA 133-335 for STAFAC
(virginiamycin) Swine Pak 10.
Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 097-980, 118-815, 132-705, and 133-335, and all
supplements and amendments thereto, is withdrawn. As provided in the
regulatory text of this document, the animal drug regulations are
amended to reflect these voluntary withdrawals of approval.
Following these withdrawals of approval, Quali-Tech Products, Inc.,
will no longer be the sponsor of an approved application. Accordingly,
21 CFR 510.600(c) is being amended to remove the entries for this firm.
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 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 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 ``Quali-Tech Products, Inc.''; and in the table in paragraph
(c)(2), remove the entry for ``016968''.
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
3. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
4. In Sec. 558.95, revise paragraphs (a), (d)(1), (d)(2), (d)(3),
(d)(4)(i), and (d)(4)(ii) to read as follows:
Sec. 558.95 Bambermycins.
(a) Approvals. See sponsors in Sec. 510.600(c) of this chapter for
use of Type A medicated articles as in paragraph (d) of this section:
(1) No. 016592: 2, 4, and 10 grams per pound for use as in
paragraphs (d)(1), (d)(2), (d)(3), and (d)(4) of this section.
(2) Nos. 012286 and 017790: 2 grams for use as in paragraph (d)(2)
of this section and 0.4 and 2 grams per pound for use as in paragraph
(d)(3).
* * * * *
(d) * * *
(1) Chickens. Use in medicated feed as follows:
----------------------------------------------------------------------------------------------------------------
Bambermycins in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 2...................... Broiler chickens: For Feed continuously as 016592.
increased rate of the sole ration.
weight gain and
improved feed
efficiency.
(ii) [Reserved].................
----------------------------------------------------------------------------------------------------------------
(2) Turkeys. Use in medicated feed as follows:
----------------------------------------------------------------------------------------------------------------
Bambermycins in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 2...................... Growing turkeys: For Feed continuously as 012286, 016592, 017790.
improved feed the sole ration.
efficiency.
(ii) 2.......................... Growing turkeys: For Feed continuously as 012286, 016592, 017790.
increased rate of the sole ration.
weight gain and
improved feed
efficiency.
----------------------------------------------------------------------------------------------------------------
[[Page 52431]]
(3) Swine. Use in medicated feed as follows:
----------------------------------------------------------------------------------------------------------------
Bambermycins in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 2........................... Growing-finishing Feed continuously as 012286, 016592, 017790.
swine: For increased the sole ration.
rate of weight gain
and improved feed
efficiency.
(ii) 2 to 4..................... Growing-finishing Feed continuously as 012286, 016592, 017790.
swine: For increased the sole ration.
rate of weight.
----------------------------------------------------------------------------------------------------------------
(4) Cattle. Use in medicated feed as follows:
----------------------------------------------------------------------------------------------------------------
Bambermycins in grams/ton Indications for use Limitations Sponsor
----------------------------------------------------------------------------------------------------------------
(i) 1 to 4...................... Cattle fed in Feed continuously at 016592.
confinement for a rate of 10 to 20
slaughter: For milligrams per head
increased rate of per day.
weight gain and
improved feed
efficiency.
(ii) 2 to 40.................... Pasture cattle Feed continuously at 016592.
(slaughter, stocker, a rate of 10 to 40
and feeder cattle, milligrams per head
and dairy and beef per day in at least
replacement 1 pound and not more
heifers): For than 10 pounds of
increased rate of feed. Daily
weight gain. bambermycins intakes
in excess of 20 mg/
head/day have not
been shown to be
more effective than
20 mg/head/day.
----------------------------------------------------------------------------------------------------------------
* * * * *
Sec. 558.485 [Amended]
0
5. In paragraph (b)(3) of Sec. 558.485, remove ``Nos. 016968, and
017790'' and in its place add ``No. 017790''.
Sec. 558.625 [Amended]
0
6. In Sec. 558.625, remove and reserve paragraph (b)(14).
Sec. 558.635 [Amended]
0
7. In paragraph (a)(2) of Sec. 558.635, remove ``046573, 016968, and
017790'' and in its place add ``046573 and 017790''.
Dated: August 20, 2013.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2013-20616 Filed 8-22-13; 8:45 am]
BILLING CODE 4160-01-P
