Civil Money Penalties Hearings; Maximum Penalty Amounts; Technical Amendment, 15883-15884 [E8-6082]
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Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations
(Lat 35°30′26″ N, long 98°20′33″ W)
That airspace extending upward from 700
feet above the surface within a 6.45-mile
radius of Hinton Muni Airport.
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Issued in Fort Worth, TX, on March 13,
2008.
Gene L. Kasson,
Acting Manager, System Support Group, ATO
Central Service Center.
[FR Doc. E8–5931 Filed 3–25–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 1
Civil Money Penalties Hearings;
Maximum Penalty Amounts; Technical
Amendment
Authority: 15 U.S.C. 1453, 1454, 1455; 19
U.S.C. 1490, 1491; 21 U.S.C. 321, 331, 332,
333, 334, 335a, 343, 350c, 350d, 352, 355,
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C.
216, 241, 243, 262, 264.
2. Section 1.231 is amended by
revising paragraph (b)(2) to read as
follows:
I
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
sroberts on PROD1PC70 with RULES
BILLING CODE 4160–01–S
1. The authority citation for 21 CFR
part 1 continues to read as follows:
Registration of Food Facilities Under
the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002; Technical
Amendment
§ 1.231
How and where do you register?
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SUMMARY: The Food and Drug
Administration (FDA) is amending its
regulations to change the fax number to
which food facility registration forms
under the Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism
Act) can be sent. This action is editorial
in nature and is intended to improve the
accuracy of the agency’s regulations.
DATES: This rule is effective March 26,
2008.
FOR FURTHER INFORMATION CONTACT:
Catherine Copp, Center for Food Safety
and Applied Nutrition (HFS–4), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–2379.
SUPPLEMENTARY INFORMATION: FDA is
amending its regulations in part 1 (21
CFR part 1). Several sections in part 1
cite a fax number to which food facility
registration forms under the
Bioterrorism Act (Public Law 107–188)
can be sent. This rule replaces the
obsolete information with correct
information.
The final rule contains no collection
of information. Therefore, clearance by
the Office of Management and Budget
under the Paperwork Reduction Act of
1995 is not required.
Publication of this document
constitutes final action on these changes
18:14 Mar 25, 2008
Jkt 214001
Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6052 Filed 3–25–08; 8:45 am]
Cosmetics, Drugs, Exports, Food
labeling, Imports, Labeling, Reporting
and recordkeeping requirements.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 1 is
amended as follows:
I
[Docket No. FDA–2008–N–0160] (formerly
Docket No. 2002N–0276)
VerDate Aug<31>2005
List of Subjects in 21 CFR Part 1
paragraph (d)(1) of this section or fax it
to 301–436–2804 or 1–800–573–0846.
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PART 1—GENERAL ENFORCEMENT
REGULATIONS
BILLING CODE 4910–13–P
AGENCY:
under the Administrative Procedure Act
(5 U.S.C. 553). These amendments
remove obsolete information and are not
substantive. FDA therefore, for good
cause, finds under 5 U.S.C. 553(b)(3)(B)
and (d)(3) that notice and comment are
unnecessary.
15883
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(b) * * *
(2) When you receive the form, you
must fill it out completely and legibly
and either mail it to the address in
paragraph (b)(1) of this section or fax it
to 301–436–2804 or 1–800–573–0846.
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I 3. Section 1.234 is amended by
revising paragraph (d)(2) to read as
follows:
§ 1.234 How and when do you update your
facility’s registration information?
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(d) * * *
(2) When you receive the form, you
must legibly fill out the sections of the
form reflecting your updated
information and either mail it to the
address in paragraph (d)(1) of this
section or fax it to 301–436–2804 or
1–800–573–0846.
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I 4. Section 1.235 is amended by
revising paragraph (d)(2) to read as
follows:
§ 1.235 How and when do you cancel your
facility’s registration information?
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(d) * * *
(2) When you receive the form, you
must completely and legibly fill out the
form and either mail it to the address in
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 17
AGENCY:
Food and Drug Administration,
HHS.
Final rule; technical
amendment.
ACTION:
SUMMARY: The Food and Drug
Administration (FDA) is amending its
civil money penalties regulations to
correct an inadvertent typographical
error. This action is editorial in nature
and is intended to improve the accuracy
of the agency’s regulations.
DATES: This rule is effective March 26,
2008.
FOR FURTHER INFORMATION CONTACT:
Joyce Strong, Office of Policy, Planning,
and Preparedness (HF–27), Food and
Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–827–
7010.
FDA is
amending its regulations in 21 CFR part
17 to correct an inadvertent
typographical error.
Publication of this document
constitutes final action on this change
under the Administrative Procedure Act
(5 U.S.C. 553). Notice and public
procedures are unnecessary because
FDA is merely correcting a
nonsubstantive error.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 17
Administrative practice and
procedure, Penalties.
I Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR part 17 is
amended as follows:
PART 17—CIVIL MONEY PENALTIES
HEARINGS
1. The authority citation for 21 CFR
part 17 continues to read as follows:
I
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15884
Federal Register / Vol. 73, No. 59 / Wednesday, March 26, 2008 / Rules and Regulations
Authority: 21 U.S.C. 331, 333, 337, 351,
352, 355, 360, 360c, 360f, 360i, 360j, 371; 42
U.S.C. 262, 263b, 300aa–28; 5 U.S.C. 554,
555, 556, 557.
2. In § 17.2, revise the introductory
text to read as follows:
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§ 17.2
Maximum penalty amounts.
The following table shows maximum
civil monetary penalties associated with
the statutory provisions authorizing
civil monetary penalties under the act or
the Public Health Service Act:
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Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–6082 Filed 3–25–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 558
New Animal Drugs for Use in Animal
Feeds; Bacitracin Methylene
Disalicylate and Nicarbazin
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
SUMMARY: The Food and Drug
Administration (FDA) is amending the
animal drug regulations to reflect
approval of a new animal drug
application (NADA) filed by Alpharma,
Inc. The NADA provides for use of
approved, single-ingredient Type A
medicated articles containing bacitracin
methylene disalicylate and nicarbazin to
formulate two-way combination drug
Type C medicated feeds for broiler
chickens.
DATES: This rule is effective March 26,
2008.
FOR FURTHER INFORMATION CONTACT:
Timothy Schell, Center for Veterinary
Medicine (HFV–128), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–276–8116, email: timothy.schell@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Alpharma,
Inc., 440 Rt. 22, Bridgewater, NJ 08807,
filed NADA 141–279 that provides for
use of BMD (bacitracin methylene
disalicylate) and NICARB (nicarbazin)
Type A medicated articles to formulate
two-way combination drug Type C
medicated feeds for broiler chickens.
The NADA is approved as of February
21, 2008, and the regulations are
amended in 21 CFR 558.366 to reflect
the approval.
In accordance with the freedom of
information provisions of 21 CFR part
20 and 21 CFR 514.11(e)(2)(ii), a
summary of safety and effectiveness
data and information submitted to
support approval of this application
may be seen in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852, between 9
a.m. and 4 p.m., Monday through
Friday.
Combination in
grams per ton
Nicarbazin in grams per ton
113.5 (0.0125 pct)
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VerDate Aug<31>2005
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16:40 Mar 25, 2008
PART 558—NEW ANIMAL DRUGS FOR
USE IN ANIMAL FEEDS
1. The authority citation for 21 CFR
part 558 continues to read as follows:
I
Authority: 21 U.S.C. 360b, 371.
2. In the table in paragraph (d) of
§ 558.366, alphabetically add new
entries for ‘‘Bacitracin methylene
disalicylate 4 to 50’’ and ‘‘Bacitracin
methylene disalicylate 50’’ to read as
follows:
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§ 558.366
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Feed continuously as sole ration from
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a
treatment for outbreaks of coccidiosis;
do not use in flushing mashes; do not
feed to laying hens; withdraw 4 days
before slaughter.
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Feed continuously as sole ration from
time chicks are placed on litter until
past the time when coccidiosis is ordinarily a hazard; do not use as a
treatment for outbreaks of coccidiosis;
do not use in flushing mashes; do not
feed to laying hens; withdraw 4 days
before slaughter.
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Broiler chickens; aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; as an aid in the prevention of
necrotic enteritis caused or complicated by Clostridium spp. or other
organisms susceptible to bacitracin.
PO 00000
Nicarbazin.
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Jkt 214001
Animal drugs, Animal feeds.
I 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 part 558 is amended as follows:
Limitations
Broiler chickens; aid in preventing
outbreaks of cecal (Eimeria tenella)
and intestinal (E. acervulina, E. maxima, E. necatrix, and E. brunetti) coccidiosis; for increased rate of weight
gain and improved feed efficiency.
Bacitracin methylene disalicylate
50.
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List of Subjects in 21 CFR Part 558
Indications for use
Bacitracin methylene disalicylate 4
to 50.
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The agency has determined under 21
CFR 25.33(a)(2) that this action is of a
type that does not individually or
cumulatively have a significant effect on
the human environment. Therefore,
neither an environmental assessment
nor an environmental impact statement
is required.
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.
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]]>Agencies
[Federal Register Volume 73, Number 59 (Wednesday, March 26, 2008)]
[Rules and Regulations]
[Pages 15883-15884]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-6082]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 17
Civil Money Penalties Hearings; Maximum Penalty Amounts;
Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending its civil
money penalties regulations to correct an inadvertent typographical
error. This action is editorial in nature and is intended to improve
the accuracy of the agency's regulations.
DATES: This rule is effective March 26, 2008.
FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy,
Planning, and Preparedness (HF-27), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-7010.
SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR
part 17 to correct an inadvertent typographical error.
Publication of this document constitutes final action on this
change under the Administrative Procedure Act (5 U.S.C. 553). Notice
and public procedures are unnecessary because FDA is merely correcting
a nonsubstantive error.
List of Subjects in 21 CFR Part 17
Administrative practice and procedure, Penalties.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
17 is amended as follows:
PART 17--CIVIL MONEY PENALTIES HEARINGS
0
1. The authority citation for 21 CFR part 17 continues to read as
follows:
[[Page 15884]]
Authority: 21 U.S.C. 331, 333, 337, 351, 352, 355, 360, 360c,
360f, 360i, 360j, 371; 42 U.S.C. 262, 263b, 300aa-28; 5 U.S.C. 554,
555, 556, 557.
0
2. In Sec. 17.2, revise the introductory text to read as follows:
Sec. 17.2 Maximum penalty amounts.
The following table shows maximum civil monetary penalties
associated with the statutory provisions authorizing civil monetary
penalties under the act or the Public Health Service Act:
* * * * *
Dated: March 18, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6082 Filed 3-25-08; 8:45 am]
BILLING CODE 4160-01-S
