New Animal Drugs for Use in Animal Feed; Withdrawal of Approval of a New Animal Drug Application, 59135-59136 [2016-19915]
Download as PDF
<![CDATA[
59135
Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations
Avilamycin in
grams/ton
Combination in
grams/ton
Indications for use
Limitations
(i) 13.6 to 40.9 ..............
........................
Broiler chickens: For the prevention of
mortality caused by necrotic enteritis
associated
with
Clostridium
perfringens in broiler chickens.
Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in broiler chickens,
treatment administration must begin
on or before 10 days of age.
Avilamycin in
grams/ton
Combinationin
grams/ton
Indications for use
Limitations
(i) 73 .............................
........................
Weaned pigs less than 14 weeks of
age: For the reduction in incidence
and overall severity of diarrhea in the
presence of pathogenic Escherichia
coli in groups of weaned pigs.
Feed as the sole ration for 21 consecutive days. To assure responsible antimicrobial drug use in pigs, do not administer to pigs 14 weeks of age or
older.
Sponsor
000986
(ii) [Reserved].
(2) Swine—
Sponsor
000986
(ii) [Reserved].
§ 558.274
[Amended]
24. Effective September 8, 2016, in
§ 558.625, revise paragraphs (b)(1),
(f)(2)(i), (f)(2)(iii), and (f)(2)(vii) and
remove paragraphs (f)(2)(viii) and (ix).
The revisions read as follows:
■
19. Effective September 8, 2016, in
§ 558.274, remove and reserve
paragraphs (c)(1)(ii) and (c)(2)(ii).
■ 20. Effective September 8, 2016, in
§ 558.355, remove and reserve
paragraph (f)(1)(xxviii) and revise
paragraphs (f)(8)(i) and (ii).
The revisions read as follows:
■
§ 558.355
§ 558.625
*
*
*
*
*
(f) * * *
(8) * * *
(i) Decoquinate alone and in
combination as in § 558.195.
(ii) Melengestrol acetate alone and in
combination as in § 558.342.
*
*
*
*
*
§ 558.363
[Amended]
21. Effective September 8, 2016, in
§ 558.363, remove and reserve
paragraph (d)(1)(vi).
■
§ 558.550
[Amended]
22. Effective September 8, 2016, in
§ 558.550, remove and reserve
paragraph (d)(1)(xxii).
■
§ 558.618
jstallworth on DSK7TPTVN1PROD with RULES
Tylosin and sulfamethazine.
*
[Amended]
23. In § 558.618, in paragraphs
(e)(2)(ii) and (iii):
■ a. In the ‘‘Limitations’’ column, add
‘‘Tilmicosin as provided by Nos. 000986
or 016952; monensin as provided by No.
000986 in § 510.600(c) of this chapter.’’
to the end of the existing entries; and
■ b. In the ‘‘Sponsor’’ column,
numerically add ‘‘016952’’.
■
*
*
*
*
(b) * * *
(1) No. 000986: 40 and 100 grams per
pound for use as in paragraph (f) of this
section.
*
*
*
*
*
(f) * * *
(2) * * *
(i) Decoquinate alone and in
combination as in § 558.195.
*
*
*
*
*
(iii) Melengestrol acetate alone and in
combination as in § 558.342.
*
*
*
*
*
(vii) Zilpaterol alone and in
combination as in § 558.665.
■ 25. Effective September 8, 2016, in
§ 558.630, revise paragraph (b)(1) to read
as follows:
§ 558.630
Food and Drug Administration
21 CFR Part 558
Tylosin.
*
Monensin.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
*
*
*
*
(b) * * *
(1) No. 000986: 40 and 100 grams per
pound for use as in paragraph (e) of this
section.
*
*
*
*
*
Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. 2016–19914 Filed 8–26–16; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2016–N–0002]
New Animal Drugs for Use in Animal
Feed; Withdrawal of Approval of a New
Animal Drug Application
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notification of withdrawal.
The Food and Drug
Administration (FDA) is withdrawing
approval of eight new animal drug
applications (NADAs) at the sponsor’s
request because these products are no
longer manufactured or marketed.
DATES: Withdrawal of approval is
effective September 8, 2016.
FOR FURTHER INFORMATION CONTACT:
Sujaya Dessai, Center for Veterinary
Medicine (HFV–212), Food and Drug
Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240–402–5761,
sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco
Animal Health, A Division of Eli Lilly
& Co., Lilly Corporate Center,
Indianapolis, IN 46285 has requested
that FDA withdraw approval of the
NADAs listed in the following table
because the products are no longer
manufactured or marketed:
SUMMARY:
21 CFR
section
File No.
Product name
012–548 1
013–162 1
TYLOSIN (tylosin phosphate)/HYGROMIX (hygromycin B) ...........................................................................................
TYLAN TM (tylosin phosphate) Type A medicated article ..............................................................................................
VerDate Sep<11>2014
14:52 Aug 26, 2016
Jkt 238001
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
E:\FR\FM\29AUR1.SGM
29AUR1
558.274
558.625
59136
Federal Register / Vol. 81, No. 167 / Monday, August 29, 2016 / Rules and Regulations
21 CFR
section
File No.
Product name
013–388 1
015–166 1
127–507 1
TYLAN (tylosin phosphate)/HYGROMIX (hygromycin B) Premix ...................................................................................
TYLAN TM (tylosin phosphate) Type A medicated article ..............................................................................................
TYLAN 5 SULFA-G (tylosin phosphate and sulfamethazine), TYLAN 10 SULFA-G (tylosin phosphate and
sulfamethazine), TYLAN 20 SULFA-G (tylosin phosphate and sulfamethazine), TYLAN 40 SULFA-G (tylosin
phosphate and sulfamethazine).
TYLAN (tylosin phosphate)/COBAN (monensin) ............................................................................................................
TYLAN (tylosin phosphate)/MONTEBAN (narasin) .........................................................................................................
TYLAN TM (tylosin phosphate)/BIO-COX (salinomycin) ................................................................................................
141–164 1
141–170 1
141–198 1
558.274
558.625
558.630
558.355
558.363
558.550
1 These NADAs were identified as being affected by guidance for industry #213, ‘‘New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily
Aligning Product Use Conditions with GFI #209,’’ December 2013.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Center for
Veterinary Medicine, and in accordance
with § 514.116 Notice of withdrawal of
approval of application (21 CFR
514.116), notice is given that approval
of NADAs 012–548, 013–162, 013–388,
015–166, 127–507, 141–164, 141–170,
and 141–198, and all supplements and
amendments thereto, is hereby
withdrawn, effective September 8, 2016.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the voluntary
withdrawal of approval of these
applications.
Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary
Medicine.
[FR Doc. 2016–19915 Filed 8–26–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Parts 97 and 160
[Docket No. USCG–2000–7080]
RIN 1625–AA25 [formerly RIN 2115–AF97]
Cargo Securing Manuals
Coast Guard, DHS.
Correcting amendments.
AGENCY:
ACTION:
The Coast Guard published an
interim rule in the Federal Register on
May 9, 2016, that prescribes when and
how the loss or jettisoning of cargo at
sea must be reported. That rule
contained a typographical error that
erroneously revised a force majeure
regulation instead of a notice of
hazardous conditions regulation. This
document corrects that error.
DATES: Effective August 29, 2016.
FOR FURTHER INFORMATION CONTACT: If
you have questions on this rule, call or
jstallworth on DSK7TPTVN1PROD with RULES
SUMMARY:
VerDate Sep<11>2014
14:52 Aug 26, 2016
Jkt 238001
email Mr. Ken Smith, Office of
Operating and Environmental Standards
(CG–OES–2), Coast Guard; telephone
202–372–1413, email Ken.A.Smith@
uscg.mil.
SUPPLEMENTARY INFORMATION:
Viewing Documents Associated With
This Rule
To view the interim rule published on
May 9, 2016, or other documents in the
docket for the Cargo Securing Manuals
rulemaking, go to www.regulations.gov,
type the docket number, USCG–2000–
7080, in the ‘‘SEARCH’’ box and click
‘‘SEARCH.’’ Click on ‘‘Open Docket
Folder’’ in the first item listed. Use the
following link to go directly to the
docket: www.regulations.gov/
document?D=USCG-2000-7080-0040.
Background
In 2013 the Coast Guard proposed to
revise 33 CFR 160.215, ‘‘Notice of
hazardous conditions,’’ as part of its
supplemental notice of proposed
rulemaking regarding cargo securing
manuals (78 FR 68784, November 15,
2013). In 2015, a different rulemaking,
regarding notices of arrival,
redesignated § 160.215 as § 160.216, and
inserted a provision on force majeure in
§ 160.215 (80 FR 5281, January 30,
2015). In 2016, the Coast Guard
published an interim rule on cargo
securing manuals that implemented
changes it had proposed in 2013,
including the amendment of § 160.215
(81 FR 27992, May 9, 2016). Because the
2016 rule amended § 160.215 when it
should have amended the redesignated
section, § 160.216, the force majeure
provision was unintentionally removed
and part 160 contained two consecutive
sections on notice of hazardous
conditions. It was an error for the
interim rule to revise § 160.215 and
replace the force majeure provision.
This rule corrects that error and a crossreference in 33 CFR 97.115 to § 160.215.
Need for Correction
As discussed above, the interim rule
published May 9, 2016, incorrectly
PO 00000
Frm 00008
Fmt 4700
Sfmt 4700
replaced force majeure regulations in
§ 160.215, instead of amending notice of
hazardous conditions regulations in
§ 160.216.
List of Subjects
33 CFR Part 97
Cargo stowage and securing, Cargo
vessels, Hazardous materials,
Incorporation by reference, Reporting
and recordkeeping requirements.
33 CFR Part 160
Administrative practice and
procedure, Harbors, Hazardous
materials transportation, Marine safety,
Navigation (water), Personally
identifiable information, Reporting and
recordkeeping requirements, Seamen,
Vessels, Waterways.
For the reasons stated in the
preamble, 33 CFR parts 97 and 160 are
amended as follows:
PART 97—RULES FOR THE SAFE
OPERATION OF VESSELS, STOWAGE
AND SECURING OF CARGOES
1. The authority citation for part 97
continues to read as follows:
■
Authority: 46 U.S.C. 2103, 3306; E.O.
12234; Department of Homeland Security
Delegation No. 0170.1(92)(a) and (b).
§ 97.115
[Amended]
2. In § 97.115(a), remove ‘‘160.215’’,
and add, in its place, ‘‘160.216’’.
■
PART 160—PORTS AND WATERWAYS
SAFETY—GENERAL
3. The authority citation for part 160
continues to read as follows:
■
Authority: 33 U.S.C. 1223, 1231; 46 U.S.C.
Chapter 701; Department of Homeland
Security Delegation No. 0170.1. Subpart C is
also issued under the authority of 33 U.S.C.
1225 and 46 U.S.C. 3715.
§ 160.216
■
4. Remove § 160.216.
§ 160.215
■
[Removed]
[Redesignated as § 160.216]
5. Redesignate § 160.215 as § 160.216.
E:\FR\FM\29AUR1.SGM
29AUR1
]]>Agencies
[Federal Register Volume 81, Number 167 (Monday, August 29, 2016)]
[Rules and Regulations]
[Pages 59135-59136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19915]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2016-N-0002]
New Animal Drugs for Use in Animal Feed; Withdrawal of Approval
of a New Animal Drug Application
AGENCY: Food and Drug Administration, HHS.
ACTION: Notification of withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of eight new animal drug applications (NADAs) at the sponsor's request
because these products are no longer manufactured or marketed.
DATES: Withdrawal of approval is effective September 8, 2016.
FOR FURTHER INFORMATION CONTACT: Sujaya Dessai, Center for Veterinary
Medicine (HFV-212), Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855, 240-402-5761, sujaya.dessai@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Elanco Animal Health, A Division of Eli
Lilly & Co., Lilly Corporate Center, Indianapolis, IN 46285 has
requested that FDA withdraw approval of the NADAs listed in the
following table because the products are no longer manufactured or
marketed:
------------------------------------------------------------------------
21 CFR
File No. Product name section
------------------------------------------------------------------------
012-548 \1\............ TYLOSIN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B).
013-162 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
[[Page 59136]]
013-388 \1\............ TYLAN (tylosin phosphate)/ 558.274
HYGROMIX (hygromycin B) Premix.
015-166 \1\............ TYLAN TM (tylosin phosphate) 558.625
Type A medicated article.
127-507 \1\............ TYLAN 5 SULFA-G (tylosin 558.630
phosphate and sulfamethazine),
TYLAN 10 SULFA-G (tylosin
phosphate and sulfamethazine),
TYLAN 20 SULFA-G (tylosin
phosphate and sulfamethazine),
TYLAN 40 SULFA-G (tylosin
phosphate and sulfamethazine).
141-164 \1\............ TYLAN (tylosin phosphate)/COBAN 558.355
(monensin).
141-170 \1\............ TYLAN (tylosin phosphate)/ 558.363
MONTEBAN (narasin).
141-198 \1\............ TYLAN TM (tylosin phosphate)/ 558.550
BIO-COX (salinomycin).
------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for
industry #213, ``New Animal Drugs and New Animal Drug Combination
Products Administered in or on Medicated Feed or Drinking Water of
Food-Producing Animals: Recommendations for Drug Sponsors for
Voluntarily Aligning Product Use Conditions with GFI #209,'' December
2013.
Therefore, under authority delegated to the Commissioner of Food
and Drugs and redelegated to the Center for Veterinary Medicine, and in
accordance with Sec. 514.116 Notice of withdrawal of approval of
application (21 CFR 514.116), notice is given that approval of NADAs
012-548, 013-162, 013-388, 015-166, 127-507, 141-164, 141-170, and 141-
198, and all supplements and amendments thereto, is hereby withdrawn,
effective September 8, 2016.
Elsewhere in this issue of the Federal Register, FDA is amending
the animal drug regulations to reflect the voluntary withdrawal of
approval of these applications.
Dated: August 8, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-19915 Filed 8-26-16; 8:45 am]
BILLING CODE 4164-01-P
