New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline; Procaine Penicillin; and Sulfamethazine, 37622-37623 [2014-15274]
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Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules and Regulations
promotion indications in swine. Zoetis
requested voluntary withdrawal of
approval of these indications for use
because AUREOMIX Granular 500 Type
A medicated article is no longer
manufactured.
Therefore, under authority delegated
to the Commissioner of Food and Drugs
and redelegated to the Director of the
Center for Veterinary Medicine, and in
accordance with 21 CFR 514.116 Notice
of withdrawal of approval of
application, notice is given that
approval of those parts of NADA 035–
688 that pertain to use of procaine
penicillin for the production indications
of growth promotion and increased feed
efficiency in swine are hereby
withdrawn, effective July 2, 2014.
NADA 035–688 was identified as
being affected by guidance for industry
(GFI) #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.
Elsewhere in this issue of the Federal
Register, FDA is amending the animal
drug regulations to reflect the
withdrawal of approval of these parts of
NADA 035–688.
Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–15273 Filed 6–30–14; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA–2014–N–0002]
New Animal Drugs for Use in Animal
Feeds; Chlortetracycline and
Sulfamethazine; Chlortetracycline;
Procaine Penicillin; and
Sulfamethazine
AGENCY:
Food and Drug Administration,
HHS.
wreier-aviles on DSK5TPTVN1PROD with RULES
ACTION:
Final rule.
The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect the
withdrawal of approval of those parts of
a new animal drug application (NADA)
for a three-way, fixed-ratio, combination
drug Type A medicated article that
pertain to use of the procaine penicillin
SUMMARY:
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14:14 Jul 01, 2014
Jkt 232001
component for growth promotion
indications in swine and to reflect the
reformulation of the Type A medicated
article as a two-way, fixed-ratio,
combination drug product without
penicillin.
DATES:
This rule is effective July 2,
2014.
FOR FURTHER INFORMATION CONTACT:
Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV–130), Food
and Drug Administration, 7500 Standish
Pl., Rockville, MD 20855, 240–276–
8341, email: cindy.burnsteel@
fda.hhs.gov.
Zoetis Inc.
(Zoetis), 333 Portage St., Kalamazoo, MI
49007 has requested that FDA withdraw
approval of those parts of NADA 035–
688 for AUREOMIX Granular 500
(chlortetracycline, procaine penicillin,
and sulfamethazine) Type A medicated
article that pertain to use of the procaine
penicillin component for growth
promotion indications in swine. Zoetis
requested voluntary withdrawal of
approval of these indications for use
because AUREOMIX Granular 500 Type
A medicated article is no longer
manufactured.
With the withdrawal of approval of
the production indications for procaine
penicillin, the product approved under
NADA 035–688 was reformulated as
AUREOMIX S Granular
(chlortetracycline and sulfamethazine)
Type A Medicated Article, a two-way,
fixed-ratio, combination drug Type A
medicated article that does not contain
penicillin procaine and is not labeled
for production indications.
The Agency has determined under 21
CFR 25.33(a)(3) and (g) that these
actions are categorically excluded from
the requirement to submit an
environmental assessment or an
environmental impact statement
because they are of a type that do not
individually or cumulatively have a
significant effect on the human
environment.
Elsewhere in this issue of the Federal
Register, FDA gave notice that the
approval of those parts of NADA 035–
688 pertaining to the procaine penicillin
component indications for growth
promotion and increased feed efficiency
in swine is withdrawn, effective July 2,
2014. As provided for in the regulatory
text of this document, the animal drug
regulations are amended to reflect this
partial withdrawal of approval and
subsequent product reformulation.
NADA 035–688 was identified as
being affected by guidance for industry
(GFI) #213, ‘‘New Animal Drugs and
New Animal Drug Combination
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
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.
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 in 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 Director of the Center for Veterinary
Medicine, 21 CFR part 558 is amended
as follows:
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
■
Authority: 21 U.S.C. 360b, 371.
■
2. Revise § 558.140 to read as follows:
§ 558.140 Chlortetracycline and
sulfamethazine.
(a) Specifications. Type A medicated
articles containing:
(1) 35 grams (g) per pound (/lb) each,
chlortetracycline and sulfamethazine.
(2) 40 g/lb each, chlortetracycline and
sulfamethazine.
(b) Sponsors. See sponsors numbers
in § 510.600(c) of this chapter as follow:
(1) Nos. 054771 and 048164 for use of
product described in paragraph (a)(1) as
in paragraph (d)(1) of this section.
(2) No. 054771 for use of product
described in paragraph (a)(2) as in
paragraph (d)(2) of this section.
(c) Related tolerances. See §§ 556.150
and 556.670 of this chapter.
(d) Conditions of use—(1) Cattle. It is
used in feed for beef cattle as follows:
(i) Amount. 350 milligrams per head
per day each, chlortetracycline and
sulfamethazine.
(ii) Indications for use. Aid in the
maintenance of weight gains in the
presence of respiratory disease such as
shipping fever.
(iii) Limitations. Feed for 28 days;
withdraw 7 days prior to slaughter. A
withdrawal period has not been
established for this product in preruminating calves. Do not use in calves
to be processed for veal.
(2) Swine. It is used in swine feed as
follows:
(i) Amount. 100 g/ton each,
chlortetracycline and sulfamethazine.
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02JYR1
Federal Register / Vol. 79, No. 127 / Wednesday, July 2, 2014 / Rules and Regulations
(ii) Indications for use. For reduction
of the incidence of cervical abscesses;
treatment of bacterial swine enteritis
(salmonellosis or necrotic enteritis
caused by Salmonella choleraesuis and
vibrionic dysentery); prevention of these
diseases during times of stress; and
maintenance of weight gains in the
presence of atrophic rhinitis.
(iii) Limitations. Feed as the sole
ration. Withdraw 15 days prior to
slaughter.
§ 558.145
[Amended]
3. In § 558.145, in paragraph (a)(2),
remove ‘‘Nos. 048164 and 054771’’ and
in its place add ‘‘No. 048164’’.
■
Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014–15274 Filed 6–30–14; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA–351]
Schedules of Controlled Substances:
Placement of Tramadol Into Schedule
IV
Drug Enforcement
Administration, Department of Justice.
ACTION: Final rule.
AGENCY:
With the issuance of this final
rule, the Deputy Administrator of the
Drug Enforcement Administration
places the substance
2-[(dimethylamino)methyl]-1-(3methoxyphenyl)cyclohexanol
(tramadol), including its salts, isomers,
and salts of isomers, into schedule IV of
the Controlled Substances Act. This
scheduling action is pursuant to the
Controlled Substances Act which
requires that such actions be made on
the record after opportunity for a
hearing through formal rulemaking.
This action imposes the regulatory
controls and administrative, civil, and
criminal sanctions applicable to
schedule IV controlled substances on
persons who handle (manufacture,
distribute, dispense, import, export,
engage in research, conduct
instructional activities with, or possess)
or propose to handle tramadol.
DATES: Effective August 18, 2014.
FOR FURTHER INFORMATION CONTACT:
Erika Gehrmann, Office of Diversion
Control, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (202) 598–6812.
wreier-aviles on DSK5TPTVN1PROD with RULES
SUMMARY:
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16:56 Jul 01, 2014
Jkt 232001
SUPPLEMENTARY INFORMATION:
Legal Authority
The Drug Enforcement
Administration (DEA) implements and
enforces titles II and III of the
Comprehensive Drug Abuse Prevention
and Control Act of 1970, as amended.
Titles II and III are referred to as the
‘‘Controlled Substances Act’’ and the
‘‘Controlled Substances Import and
Export Act,’’ respectively, but they are
collectively referred to as the
‘‘Controlled Substances Act’’ or the
‘‘CSA’’ for the purposes of this action.
21 U.S.C. 801–971. The DEA publishes
the implementing regulations for these
statutes in title 21 of the Code of Federal
Regulations (CFR), parts 1300 to 1321.
The CSA and its implementing
regulations are designed to prevent,
detect, and eliminate the diversion of
controlled substances and listed
chemicals into the illicit market while
providing for the legitimate medical,
scientific, research, and industrial needs
of the United States. Controlled
substances have the potential for abuse
and dependence and are controlled to
protect the public health and safety.
Under the CSA, every controlled
substance is classified in one of five
schedules based upon its potential for
abuse, currently accepted medical use,
and the degree of dependence the drug
or other substance may cause. 21 U.S.C.
812. The initial schedules of controlled
substances established by Congress are
found at 21 U.S.C. 812(c) and the
current list of scheduled substances is
published at 21 CFR part 1308.
Pursuant to 21 U.S.C. 811(a)(1), the
Attorney General may, by rule, ‘‘add to
such a schedule or transfer between
such schedules any drug or other
substance if he (A) finds that such drug
or other substance has a potential for
abuse, and (B) makes with respect to
such drug or other substance the
findings prescribed by [21 U.S.C. 812(b)]
for the schedule in which such drug is
to be placed * * *.’’ The Attorney
General has delegated scheduling
authority under 21 U.S.C. 811 to the
Administrator of the DEA, 28 CFR
0.100, who in turn has redelegated that
authority to the Deputy Administrator of
the DEA, 28 CFR part 0, appendix to
subpart R.
The CSA provides that scheduling of
any drug or other substance may be
initiated by the Attorney General (1) on
his own motion, (2) at the request of the
Secretary of the Department of Health
and Human Services (HHS),1 or (3) on
1 As discussed in a memorandum of
understanding entered into by the Food and Drug
Administration (FDA) and the National Institute on
Drug Abuse (NIDA), the FDA acts as the lead agency
PO 00000
Frm 00007
Fmt 4700
Sfmt 4700
37623
the petition of any interested party. 21
U.S.C. 811(a). This action was initiated
by four petitions to schedule tramadol
under the CSA, and is supported by,
inter alia, a recommendation from the
Assistant Secretary of the HHS and an
evaluation of all relevant data by the
DEA. This action imposes the regulatory
controls and administrative, civil, and
criminal sanctions applicable to
schedule IV controlled substances on
persons who handle or propose to
handle tramadol.2
Background
Tramadol is a centrally acting opioid
analgesic that produces its primary
opioid-like action through an active
metabolite, referred to as the ‘‘M1’’
metabolite (O-desmethyltramadol). It
was first approved for use in the United
States by the U.S. Food and Drug
Administration (FDA) in 1995 under the
trade name ULTRAM®. Subsequently,
the FDA approved for marketing
generic, combination, and extended
release tramadol products.
Because of its chemical structure,
2-[(dimethylamino)methyl]-1-(3methoxyphenyl) cyclohexanol can exist
as different isomeric forms. Thus,
various prefixes can be associated with
the name. Some examples of these
prefixes include dextro, levo, d, l, R, S,
cis, trans, erythro, threo, (+), (¥),
racemic, and may include combinations
of these prefixes sometimes with
numerical designations. Any such
isomer is, in fact,
2-[(dimethylamino)methyl]-1-(3methoxyphenyl)cyclohexanol. Tramadol
is typically formulated as a racemic
mixture identified as (±)-cis-2[(dimethylamino)methyl]-1-(3methoxyphenyl)cyclohexanol
hydrochloride.3
HHS and DEA Eight-Factor Analyses
On September 16, 2010, the Assistant
Secretary of the HHS provided to the
DEA a scientific and medical evaluation
and scheduling recommendation
entitled ‘‘Basis for the Recommendation
to Schedule Tramadol in Schedule IV of
the Controlled Substances Act.’’ After
considering the eight factors in 21
within the HHS in carrying out the Secretary’s
scheduling responsibilities under the CSA, with the
concurrence of NIDA. 50 FR 9518, Mar. 8, 1985.
The Secretary of the HHS has delegated to the
Assistant Secretary for Health of the HHS the
authority to make domestic drug scheduling
recommendations. 58 FR 35460, July 1, 1993.
2 See infra note 3.
3 For simplicity, from this point forward in the
document, ‘‘tramadol’’ is used to refer to
2-[(dimethylamino)methyl]-1-(3methoxyphenyl)cyclohexanol, its salts, isomers,
salts of isomers, and all isomeric configurations of
possible forms.
E:\FR\FM\02JYR1.SGM
02JYR1
]]>Agencies
[Federal Register Volume 79, Number 127 (Wednesday, July 2, 2014)]
[Rules and Regulations]
[Pages 37622-37623]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15274]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
[Docket No. FDA-2014-N-0002]
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and
Sulfamethazine; Chlortetracycline; Procaine Penicillin; and
Sulfamethazine
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 those parts
of a new animal drug application (NADA) for a three-way, fixed-ratio,
combination drug Type A medicated article that pertain to use of the
procaine penicillin component for growth promotion indications in swine
and to reflect the reformulation of the Type A medicated article as a
two-way, fixed-ratio, combination drug product without penicillin.
DATES: This rule is effective July 2, 2014.
FOR FURTHER INFORMATION CONTACT: Cindy L. Burnsteel, Center for
Veterinary Medicine (HFV-130), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-276-8341, email:
cindy.burnsteel@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Zoetis Inc. (Zoetis), 333 Portage St.,
Kalamazoo, MI 49007 has requested that FDA withdraw approval of those
parts of NADA 035-688 for AUREOMIX Granular 500 (chlortetracycline,
procaine penicillin, and sulfamethazine) Type A medicated article that
pertain to use of the procaine penicillin component for growth
promotion indications in swine. Zoetis requested voluntary withdrawal
of approval of these indications for use because AUREOMIX Granular 500
Type A medicated article is no longer manufactured.
With the withdrawal of approval of the production indications for
procaine penicillin, the product approved under NADA 035-688 was
reformulated as AUREOMIX S Granular (chlortetracycline and
sulfamethazine) Type A Medicated Article, a two-way, fixed-ratio,
combination drug Type A medicated article that does not contain
penicillin procaine and is not labeled for production indications.
The Agency has determined under 21 CFR 25.33(a)(3) and (g) that
these actions are categorically excluded from the requirement to submit
an environmental assessment or an environmental impact statement
because they are of a type that do not individually or cumulatively
have a significant effect on the human environment.
Elsewhere in this issue of the Federal Register, FDA gave notice
that the approval of those parts of NADA 035-688 pertaining to the
procaine penicillin component indications for growth promotion and
increased feed efficiency in swine is withdrawn, effective July 2,
2014. As provided for in the regulatory text of this document, the
animal drug regulations are amended to reflect this partial withdrawal
of approval and subsequent product reformulation.
NADA 035-688 was identified as being affected by guidance for
industry (GFI) 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.
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 in 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 Director of the Center for Veterinary Medicine, 21
CFR part 558 is amended as follows:
PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
0
1. The authority citation for 21 CFR part 558 continues to read as
follows:
Authority: 21 U.S.C. 360b, 371.
0
2. Revise Sec. 558.140 to read as follows:
Sec. 558.140 Chlortetracycline and sulfamethazine.
(a) Specifications. Type A medicated articles containing:
(1) 35 grams (g) per pound (/lb) each, chlortetracycline and
sulfamethazine.
(2) 40 g/lb each, chlortetracycline and sulfamethazine.
(b) Sponsors. See sponsors numbers in Sec. 510.600(c) of this
chapter as follow:
(1) Nos. 054771 and 048164 for use of product described in
paragraph (a)(1) as in paragraph (d)(1) of this section.
(2) No. 054771 for use of product described in paragraph (a)(2) as
in paragraph (d)(2) of this section.
(c) Related tolerances. See Sec. Sec. 556.150 and 556.670 of this
chapter.
(d) Conditions of use--(1) Cattle. It is used in feed for beef
cattle as follows:
(i) Amount. 350 milligrams per head per day each, chlortetracycline
and sulfamethazine.
(ii) Indications for use. Aid in the maintenance of weight gains in
the presence of respiratory disease such as shipping fever.
(iii) Limitations. Feed for 28 days; withdraw 7 days prior to
slaughter. A withdrawal period has not been established for this
product in pre-ruminating calves. Do not use in calves to be processed
for veal.
(2) Swine. It is used in swine feed as follows:
(i) Amount. 100 g/ton each, chlortetracycline and sulfamethazine.
[[Page 37623]]
(ii) Indications for use. For reduction of the incidence of
cervical abscesses; treatment of bacterial swine enteritis
(salmonellosis or necrotic enteritis caused by Salmonella choleraesuis
and vibrionic dysentery); prevention of these diseases during times of
stress; and maintenance of weight gains in the presence of atrophic
rhinitis.
(iii) Limitations. Feed as the sole ration. Withdraw 15 days prior
to slaughter.
Sec. 558.145 [Amended]
0
3. In Sec. 558.145, in paragraph (a)(2), remove ``Nos. 048164 and
054771'' and in its place add ``No. 048164''.
Dated: June 25, 2014.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. 2014-15274 Filed 6-30-14; 11:15 am]
BILLING CODE 4164-01-P
